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2019 at a glance: Hem-onc U.S. drug approvals
The rapid development and identification of novel drugs has translated into innovative therapies in hematology and oncology. The aim of this piece is to present newly approved drugs and expanded indications to serve as a reference guide for practicing clinicians.
This article reviews therapies that were newly approved so far in 2019, as well as those previously approved whose indications were expanded this past year. The list highlights the most clinically important approvals, as well as adverse events that are unique or especially severe.
New approvals
Fedratinib (Inrebic)
Class: JAK2 and FLT3 selective kinase inhibitor.
Disease: Intermediate or high-risk primary or secondary (postpolycythemia vera or postessential thrombocythemia) myelofibrosis.
Dose: 400 mg orally once daily, with or without food.
Adverse events (AEs): Black box warning: Fatal encephalopathy, including Wernicke’s (thiamine level monitoring suggested).
Trials: In JAKARTA (NCT01437787), 37% of patients achieved a 35% or greater reduction in spleen volume and 40% received a 50% or greater reduction in myelofibrosis-related symptoms. In Jakarta-2, there was a 55% spleen response in patients resistant or intolerant to ruxolitinib.
Entrectinib (Rozlytrek)
Class: Tropomyosin receptor tyrosine kinase inhibitor.
Disease: Solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion and for ROS-1 positive non–small cell lung cancer (NSCLC).
Dose: 600 mg orally once daily.
AEs: Heart failure, QT prolongation, skeletal fractures, hepatotoxicity, central nervous system effects, and hyperuricemia.
Trial: ALKA, STARTRK-1 (NCT02097810) and STARTRK-2 (NCT02568267): Overall response rate of 57% for NTRK positive patients; response rate of 77% in ROS-1 positive NSCLC.
Pexidartinib (Turalio)
Class: Small molecule tyrosine kinase inhibitor targeting CSF1R.
Disease: Symptomatic tenosynovial giant cell tumor.
Dose: 400 mg orally twice daily without food.
AEs: Black box warning on hepatotoxicity.
Trial: ENLIVEN (NCT02371369): Overall response rate of 38% at 25 weeks, with a 15% complete response rate and a 23% partial response rate.
Darolutamide (Nubeqa)
Class: Androgen receptor inhibitor.
Disease: Nonmetastatic castration-resistant prostate cancer.
Dose: 600 mg orally twice daily with food with concomitant androgen deprivation therapy.
AEs: Fatigue, extremity pain, and rash.
Trial: ARAMIS (NCT02200614): Median metastasis free survival was 40.4 months for patients with darolutamide, compared with 18.4 months for controls.
Selinexor (Xpovio)
Class: Reversible inhibitor of nuclear export of tumor suppressor proteins, growth regulators, and mRNAs of oncogenic proteins.
Disease: Relapsed or refractory multiple myeloma. Indicated for patients who have received at least four prior therapies, including at least two immunomodulatory agents and an anti-CD38 monoclonal antibody.
Dose: 80 mg orally in combination with oral dexamethasone on days 1 and 3 of each week.
AEs: Thrombocytopenia, fatigue, pancytopenia, and hyponatremia.
Trial: STORM (NCT02336815): Overall response rate 25.3% with a median time to first response of 4 weeks and 3.8-month median duration of response.
Polatuzumab vedotin-piiq (Polivy)
Class: CD79b-directed antibody-drug conjugate.
Disease: Relapsed or refractory diffuse large B-cell lymphoma. Indicated for patients who have had at least two prior therapies.
Dose: 1.8 mg/kg intravenous infusion every 21 days for six cycles in combination with bendamustine and a rituximab product.
AEs: Pancytopenia, peripheral neuropathy.
Trial: GO29365 (NCT02257567): Complete response rate was 40% for polatuzumab vedotin-piiq plus bendamustine/rituximab, compared with 18% with bendamustine/rituximab alone.*
Caplacizumab-yhdp (Cablivi)
Class: Monoclonal antibody fragment directed against von Willebrand factor.
Disease: Thrombotic thrombocytopenic purpura.
Dose: 11 mg IV initially, then daily subcutaneously; in combination with plasma exchange and immunosuppressive therapy.
AEs: Epistaxis, headache, and gingival bleeding.
Trial: Hercules trial (NCT02553317): More rapid normalization of platelets, lower incidence of composite TTP-related death, and lower rate of recurrence when added to plasma exchange and steroids.
Alpelisib (Piqray)
Class: Phosphatidylinositol-3-kinase (PI3K) inhibitor.
Disease: Hormone receptor positive HER2-negative PIK3CA-mutated, advanced or metastatic breast cancer.
Dose: 300 mg orally once daily with food with concomitant fulvestrant.
AEs: Hyperglycemia, pancytopenia.
Trial: SOLAR-1 (NCT02437318): 11-month progression-free survival among patients treated with alpelisib and fulvestrant, compared with 5.7 months in fulvestrant alone control arm; overall response rate of 36% versus 16%, respectively.
Erdafitinib (Balversa)
Class: Fibroblast growth factor receptor kinase inhibitor.
Disease: Locally advanced or metastatic urothelial carcinoma with FGFR3 or FGFR2 mutations.
Dose: 8 mg orally once daily, with or without food.
AEs: Ocular disorders including retinopathy or retinal detachment.
Trial: BLC2001 (NCT02365597): Objective response rate of 32.2%, with a complete response in 2.3% of patients and partial response in 29.9% of patients.
Biosimilar approvals
Trastuzumab and hyaluronidase-oysk (Herceptin Hylecta)
Biosimilar to: Trastuzumab.
Indication: HER2-overexpressing breast cancer.
Dr. Bryer is a resident in the department of internal medicine at the University of Pennsylvania, Philadelphia. Dr. Mintzer is chief of hematology-oncology at Pennsylvania Hospital and professor of medicine at the University of Pennsylvania. Dr. Henry is a hematologist-oncologist at Pennsylvania Hospital and professor of medicine at the University of Pennsylvania.
*Correction, 11/7/2019: An earlier version of this article misstated the drug combination in the GO29365 trial.
The rapid development and identification of novel drugs has translated into innovative therapies in hematology and oncology. The aim of this piece is to present newly approved drugs and expanded indications to serve as a reference guide for practicing clinicians.
This article reviews therapies that were newly approved so far in 2019, as well as those previously approved whose indications were expanded this past year. The list highlights the most clinically important approvals, as well as adverse events that are unique or especially severe.
New approvals
Fedratinib (Inrebic)
Class: JAK2 and FLT3 selective kinase inhibitor.
Disease: Intermediate or high-risk primary or secondary (postpolycythemia vera or postessential thrombocythemia) myelofibrosis.
Dose: 400 mg orally once daily, with or without food.
Adverse events (AEs): Black box warning: Fatal encephalopathy, including Wernicke’s (thiamine level monitoring suggested).
Trials: In JAKARTA (NCT01437787), 37% of patients achieved a 35% or greater reduction in spleen volume and 40% received a 50% or greater reduction in myelofibrosis-related symptoms. In Jakarta-2, there was a 55% spleen response in patients resistant or intolerant to ruxolitinib.
Entrectinib (Rozlytrek)
Class: Tropomyosin receptor tyrosine kinase inhibitor.
Disease: Solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion and for ROS-1 positive non–small cell lung cancer (NSCLC).
Dose: 600 mg orally once daily.
AEs: Heart failure, QT prolongation, skeletal fractures, hepatotoxicity, central nervous system effects, and hyperuricemia.
Trial: ALKA, STARTRK-1 (NCT02097810) and STARTRK-2 (NCT02568267): Overall response rate of 57% for NTRK positive patients; response rate of 77% in ROS-1 positive NSCLC.
Pexidartinib (Turalio)
Class: Small molecule tyrosine kinase inhibitor targeting CSF1R.
Disease: Symptomatic tenosynovial giant cell tumor.
Dose: 400 mg orally twice daily without food.
AEs: Black box warning on hepatotoxicity.
Trial: ENLIVEN (NCT02371369): Overall response rate of 38% at 25 weeks, with a 15% complete response rate and a 23% partial response rate.
Darolutamide (Nubeqa)
Class: Androgen receptor inhibitor.
Disease: Nonmetastatic castration-resistant prostate cancer.
Dose: 600 mg orally twice daily with food with concomitant androgen deprivation therapy.
AEs: Fatigue, extremity pain, and rash.
Trial: ARAMIS (NCT02200614): Median metastasis free survival was 40.4 months for patients with darolutamide, compared with 18.4 months for controls.
Selinexor (Xpovio)
Class: Reversible inhibitor of nuclear export of tumor suppressor proteins, growth regulators, and mRNAs of oncogenic proteins.
Disease: Relapsed or refractory multiple myeloma. Indicated for patients who have received at least four prior therapies, including at least two immunomodulatory agents and an anti-CD38 monoclonal antibody.
Dose: 80 mg orally in combination with oral dexamethasone on days 1 and 3 of each week.
AEs: Thrombocytopenia, fatigue, pancytopenia, and hyponatremia.
Trial: STORM (NCT02336815): Overall response rate 25.3% with a median time to first response of 4 weeks and 3.8-month median duration of response.
Polatuzumab vedotin-piiq (Polivy)
Class: CD79b-directed antibody-drug conjugate.
Disease: Relapsed or refractory diffuse large B-cell lymphoma. Indicated for patients who have had at least two prior therapies.
Dose: 1.8 mg/kg intravenous infusion every 21 days for six cycles in combination with bendamustine and a rituximab product.
AEs: Pancytopenia, peripheral neuropathy.
Trial: GO29365 (NCT02257567): Complete response rate was 40% for polatuzumab vedotin-piiq plus bendamustine/rituximab, compared with 18% with bendamustine/rituximab alone.*
Caplacizumab-yhdp (Cablivi)
Class: Monoclonal antibody fragment directed against von Willebrand factor.
Disease: Thrombotic thrombocytopenic purpura.
Dose: 11 mg IV initially, then daily subcutaneously; in combination with plasma exchange and immunosuppressive therapy.
AEs: Epistaxis, headache, and gingival bleeding.
Trial: Hercules trial (NCT02553317): More rapid normalization of platelets, lower incidence of composite TTP-related death, and lower rate of recurrence when added to plasma exchange and steroids.
Alpelisib (Piqray)
Class: Phosphatidylinositol-3-kinase (PI3K) inhibitor.
Disease: Hormone receptor positive HER2-negative PIK3CA-mutated, advanced or metastatic breast cancer.
Dose: 300 mg orally once daily with food with concomitant fulvestrant.
AEs: Hyperglycemia, pancytopenia.
Trial: SOLAR-1 (NCT02437318): 11-month progression-free survival among patients treated with alpelisib and fulvestrant, compared with 5.7 months in fulvestrant alone control arm; overall response rate of 36% versus 16%, respectively.
Erdafitinib (Balversa)
Class: Fibroblast growth factor receptor kinase inhibitor.
Disease: Locally advanced or metastatic urothelial carcinoma with FGFR3 or FGFR2 mutations.
Dose: 8 mg orally once daily, with or without food.
AEs: Ocular disorders including retinopathy or retinal detachment.
Trial: BLC2001 (NCT02365597): Objective response rate of 32.2%, with a complete response in 2.3% of patients and partial response in 29.9% of patients.
Biosimilar approvals
Trastuzumab and hyaluronidase-oysk (Herceptin Hylecta)
Biosimilar to: Trastuzumab.
Indication: HER2-overexpressing breast cancer.
Dr. Bryer is a resident in the department of internal medicine at the University of Pennsylvania, Philadelphia. Dr. Mintzer is chief of hematology-oncology at Pennsylvania Hospital and professor of medicine at the University of Pennsylvania. Dr. Henry is a hematologist-oncologist at Pennsylvania Hospital and professor of medicine at the University of Pennsylvania.
*Correction, 11/7/2019: An earlier version of this article misstated the drug combination in the GO29365 trial.
The rapid development and identification of novel drugs has translated into innovative therapies in hematology and oncology. The aim of this piece is to present newly approved drugs and expanded indications to serve as a reference guide for practicing clinicians.
This article reviews therapies that were newly approved so far in 2019, as well as those previously approved whose indications were expanded this past year. The list highlights the most clinically important approvals, as well as adverse events that are unique or especially severe.
New approvals
Fedratinib (Inrebic)
Class: JAK2 and FLT3 selective kinase inhibitor.
Disease: Intermediate or high-risk primary or secondary (postpolycythemia vera or postessential thrombocythemia) myelofibrosis.
Dose: 400 mg orally once daily, with or without food.
Adverse events (AEs): Black box warning: Fatal encephalopathy, including Wernicke’s (thiamine level monitoring suggested).
Trials: In JAKARTA (NCT01437787), 37% of patients achieved a 35% or greater reduction in spleen volume and 40% received a 50% or greater reduction in myelofibrosis-related symptoms. In Jakarta-2, there was a 55% spleen response in patients resistant or intolerant to ruxolitinib.
Entrectinib (Rozlytrek)
Class: Tropomyosin receptor tyrosine kinase inhibitor.
Disease: Solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion and for ROS-1 positive non–small cell lung cancer (NSCLC).
Dose: 600 mg orally once daily.
AEs: Heart failure, QT prolongation, skeletal fractures, hepatotoxicity, central nervous system effects, and hyperuricemia.
Trial: ALKA, STARTRK-1 (NCT02097810) and STARTRK-2 (NCT02568267): Overall response rate of 57% for NTRK positive patients; response rate of 77% in ROS-1 positive NSCLC.
Pexidartinib (Turalio)
Class: Small molecule tyrosine kinase inhibitor targeting CSF1R.
Disease: Symptomatic tenosynovial giant cell tumor.
Dose: 400 mg orally twice daily without food.
AEs: Black box warning on hepatotoxicity.
Trial: ENLIVEN (NCT02371369): Overall response rate of 38% at 25 weeks, with a 15% complete response rate and a 23% partial response rate.
Darolutamide (Nubeqa)
Class: Androgen receptor inhibitor.
Disease: Nonmetastatic castration-resistant prostate cancer.
Dose: 600 mg orally twice daily with food with concomitant androgen deprivation therapy.
AEs: Fatigue, extremity pain, and rash.
Trial: ARAMIS (NCT02200614): Median metastasis free survival was 40.4 months for patients with darolutamide, compared with 18.4 months for controls.
Selinexor (Xpovio)
Class: Reversible inhibitor of nuclear export of tumor suppressor proteins, growth regulators, and mRNAs of oncogenic proteins.
Disease: Relapsed or refractory multiple myeloma. Indicated for patients who have received at least four prior therapies, including at least two immunomodulatory agents and an anti-CD38 monoclonal antibody.
Dose: 80 mg orally in combination with oral dexamethasone on days 1 and 3 of each week.
AEs: Thrombocytopenia, fatigue, pancytopenia, and hyponatremia.
Trial: STORM (NCT02336815): Overall response rate 25.3% with a median time to first response of 4 weeks and 3.8-month median duration of response.
Polatuzumab vedotin-piiq (Polivy)
Class: CD79b-directed antibody-drug conjugate.
Disease: Relapsed or refractory diffuse large B-cell lymphoma. Indicated for patients who have had at least two prior therapies.
Dose: 1.8 mg/kg intravenous infusion every 21 days for six cycles in combination with bendamustine and a rituximab product.
AEs: Pancytopenia, peripheral neuropathy.
Trial: GO29365 (NCT02257567): Complete response rate was 40% for polatuzumab vedotin-piiq plus bendamustine/rituximab, compared with 18% with bendamustine/rituximab alone.*
Caplacizumab-yhdp (Cablivi)
Class: Monoclonal antibody fragment directed against von Willebrand factor.
Disease: Thrombotic thrombocytopenic purpura.
Dose: 11 mg IV initially, then daily subcutaneously; in combination with plasma exchange and immunosuppressive therapy.
AEs: Epistaxis, headache, and gingival bleeding.
Trial: Hercules trial (NCT02553317): More rapid normalization of platelets, lower incidence of composite TTP-related death, and lower rate of recurrence when added to plasma exchange and steroids.
Alpelisib (Piqray)
Class: Phosphatidylinositol-3-kinase (PI3K) inhibitor.
Disease: Hormone receptor positive HER2-negative PIK3CA-mutated, advanced or metastatic breast cancer.
Dose: 300 mg orally once daily with food with concomitant fulvestrant.
AEs: Hyperglycemia, pancytopenia.
Trial: SOLAR-1 (NCT02437318): 11-month progression-free survival among patients treated with alpelisib and fulvestrant, compared with 5.7 months in fulvestrant alone control arm; overall response rate of 36% versus 16%, respectively.
Erdafitinib (Balversa)
Class: Fibroblast growth factor receptor kinase inhibitor.
Disease: Locally advanced or metastatic urothelial carcinoma with FGFR3 or FGFR2 mutations.
Dose: 8 mg orally once daily, with or without food.
AEs: Ocular disorders including retinopathy or retinal detachment.
Trial: BLC2001 (NCT02365597): Objective response rate of 32.2%, with a complete response in 2.3% of patients and partial response in 29.9% of patients.
Biosimilar approvals
Trastuzumab and hyaluronidase-oysk (Herceptin Hylecta)
Biosimilar to: Trastuzumab.
Indication: HER2-overexpressing breast cancer.
Dr. Bryer is a resident in the department of internal medicine at the University of Pennsylvania, Philadelphia. Dr. Mintzer is chief of hematology-oncology at Pennsylvania Hospital and professor of medicine at the University of Pennsylvania. Dr. Henry is a hematologist-oncologist at Pennsylvania Hospital and professor of medicine at the University of Pennsylvania.
*Correction, 11/7/2019: An earlier version of this article misstated the drug combination in the GO29365 trial.
2018 at a glance: Recently approved therapies in oncology
Advances in genomics and technology perpetually change and improve therapies in oncology. Enhanced comprehension of cellular signaling, division, and replication has created a platform to selectively restrict neoplastic growth while preserving the integrity of benign cells.
This article reviews therapies that were newly approved in 2018, as well as those previously approved whose indications were expanded this past year. The list highlights the most clinically important approvals, as well as adverse events that are unique or especially severe.
Click on the PDF above to download the full article and charts in an easy-to-print format.
Apalutamide (Erleada)
Class: Androgen receptor inhibitor.
Disease: Nonmetastatic castration-resistant prostate cancer.
Dose: 240 mg orally, once daily.
Adverse Events (AEs): Hyperkalemia and increased risks of seizures, falls, and fractures.
Phase 3 SPARTAN trial (NCT01946204): 40.5-month metastasis-free survival rate, compared with 16.2 months in the placebo group.
Cemiplimab (Libtayo)
Class: Antibody against programmed cell death protein-1 (PD-1).
Disease: Metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC that is ineligible for curative surgery/radiation.
Dose: 350 mg intravenous infusion every 3 weeks.
AEs: Pneumonitis, autoimmune myocarditis, hepatitis, and aseptic meningitis.
1423 and 1540 trials (NCT02383212 and NCT02760498): 47.2% of patients who received cemiplimab had complete disappearance of the tumor or a decrease in tumor size.
Dacomitinib (Vizimpro)
Class: Second-generation tyrosine kinase inhibitor.
Disease: Metastatic non–small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutation.
Dose: 45 mg orally once daily.
AEs: Dermatotoxicity and diarrhea.
ARCHER1050 trial (NCT01774721): Patients who received dacomitinib demonstrated an improved overall survival, with a median of 34.1 months, compared with 26.8 months with gefitinib.
Duvelisib (Copiktra)
Class: Dual inhibitor of phosphatidylinositol 3-kinase delta and gamma.
Disease: Relapsed or refractory chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma, or relapsed or refractory follicular lymphoma after at least two prior systemic therapies.
Dose: 25 mg orally twice daily.
AEs: Infection, diarrhea or colitis, and pneumonia.
Phase 3 DUO trial (NCT02004522): Progression-free survival in the duvelisib arm was 7.3 months longer than that in the ofatumumab arm. The overall response rate for patients receiving duvelisib was 78%, compared with 39% for those receiving ofatumumab.
Gilteritinib (Xospata)
Class: Inhibits the FLT3 internal tandem duplication (ITD) and FLT3 tyrosine kinase domain (TKD).
Disease: Relapsed or refractory acute myeloid leukemia (AML) with an FLT3 mutation.
Dose: 120 mg orally daily.
ADMIRAL trial (NCT02421939): 21% of the patients who received gilteritinib exhibited complete remission or complete remission with partial hematologic recovery.
Glasdegib (Daurismo)
Class: Hedgehog pathway inhibitor.
Disease: Adults over age 75 years with newly diagnosed AML and other medical comorbidities that preclude them from intensive chemotherapy.
Dose: The recommended dose is 100 mg orally continuously in 28-day cycles.
AE: QT prolongation and embryo-fetal toxicity
Phase 2 BRIGHT 1003 trial (NCT01546038): 3.9-month overall survival advantage for glasdegib plus cytarabine, compared with cytarabine alone. Overall, 15% of the glasdegib plus low dose cytarabine arm achieved complete remission, compared with the 1% complete remission rate in patients who received cytarabine alone.
Iobenguane I 131 (Azedra)
Class: Radiopharmaceutical agent; induces cell death within the noradrenaline transporter.
Disease: Iobenguane scan–positive, unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma
Dose: Initial intravenous dosimetric dose, followed by two therapeutic doses.
AE: Pancytopenia and elevated international normalized ratio (INR).
IB12B trial (NCT00874614): One-quarter of patients receiving this therapy had at least a 50% reduction in the dose and number of antihypertensives for at least 6 months; almost all patients had a tumor response.
Ivosidenib (Tibsovo)
Class: Small-molecule inhibitor of mutant isocitrate dehydrogenase (IDH1).
Disease: Refractory AML and an IDH1 mutation
Dose: 500 mg orally daily.
AG120-C-001 trial (NCT02074839): Overall response rate of 41.6% in patients who received ivosidenib, with a 30.4% rate of complete remission or complete remission with partial hematologic recovery.
Larotrectinib (Vitrakvi)
Class: Oral tyrosine kinase inhibitor.
Disease: Advanced solid tumors harboring a neurotrophic tyrosine receptor kinase (NTRK) gene fusion.
Dose: 100 mg orally twice daily.
LOXO-TRK-14001, SCOUT, and NAVIGATE trials (NCT02122913, NCT02637687, and NCT02576431): Patients who received larotrectinib had durable responses regardless of patient age, tumor type, and fusion status.
Lutetium Lu 177 dotatate (Lutathera)
Class: Radiolabeled somatostatin analogue.
Disease: Somatostatin receptor–positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs).
Dose: Intravenous infusion 7.4 GBq (200 mCi) every 8 weeks for a total of four doses.
NETTER-1 trial (NCT01578239): 65% of adults who received lutetium Lu 177 showed improved progression-free survival at 20 months, compared with just 10.8% in the control group.
Mogamulizumab (Poteligeo)
Class: Monoclonal antibody that binds to a protein (CC chemokine receptor type 4).
Disease: Relapsed or refractory mycosis fungoides or Sézary syndrome.
Dose: Intravenous infusion 1 mg/kg.
AE: Dermatologic toxicity.
MAVORIC trial (NCT01728805): Patients who received mogamulizumab had improved progression-free survival (median 7.7 months), compared with those taking vorinostat (median 3.1 months).
Moxetumomab pasudotox-tdfk (Lumoxiti)
Class: CD22-directed cytotoxin fused with a fragment of Pseudomonas exotoxin A.
Disease: Relapsed or refractory hairy cell leukemia previously treated with at least two prior systemic therapies, including a purine nucleoside analogue.
Dose: Intravenously as 0.04 mg/kg.
AE: Hemolytic uremic syndrome.
1053 trial (NCT01829711): 30% of the patients who received moxetumomab pasudotox-tdfk had a durable complete response confirmed by maintenance hematologic remission.
Talazoparib (Talzenna)
Class: Poly (ADP-ribose) polymerase (PARP) inhibitor.
Disease: gBRCAm HER2-negative locally advanced or metastatic breast cancer.
Dose: 1 mg orally per day.
EMBRACA trial (NCT01945775): Patients who received talazoparib demonstrated significantly longer progression-free survival, with a median of 8.6 months versis 5.6 months in the control arm.
Dr. Bryer is a resident in the department of internal medicine at the University of Pennsylvania, Philadelphia. Dr. Mentzer is chief of hematology-oncology at Pennsylvania Hospital and professor of medicine at the University of Pennsylvania. Dr. Henry is a hematologist-oncologist at Pennsylvania Hospital and a professor of medicine at the University of Pennsylvania.
Advances in genomics and technology perpetually change and improve therapies in oncology. Enhanced comprehension of cellular signaling, division, and replication has created a platform to selectively restrict neoplastic growth while preserving the integrity of benign cells.
This article reviews therapies that were newly approved in 2018, as well as those previously approved whose indications were expanded this past year. The list highlights the most clinically important approvals, as well as adverse events that are unique or especially severe.
Click on the PDF above to download the full article and charts in an easy-to-print format.
Apalutamide (Erleada)
Class: Androgen receptor inhibitor.
Disease: Nonmetastatic castration-resistant prostate cancer.
Dose: 240 mg orally, once daily.
Adverse Events (AEs): Hyperkalemia and increased risks of seizures, falls, and fractures.
Phase 3 SPARTAN trial (NCT01946204): 40.5-month metastasis-free survival rate, compared with 16.2 months in the placebo group.
Cemiplimab (Libtayo)
Class: Antibody against programmed cell death protein-1 (PD-1).
Disease: Metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC that is ineligible for curative surgery/radiation.
Dose: 350 mg intravenous infusion every 3 weeks.
AEs: Pneumonitis, autoimmune myocarditis, hepatitis, and aseptic meningitis.
1423 and 1540 trials (NCT02383212 and NCT02760498): 47.2% of patients who received cemiplimab had complete disappearance of the tumor or a decrease in tumor size.
Dacomitinib (Vizimpro)
Class: Second-generation tyrosine kinase inhibitor.
Disease: Metastatic non–small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutation.
Dose: 45 mg orally once daily.
AEs: Dermatotoxicity and diarrhea.
ARCHER1050 trial (NCT01774721): Patients who received dacomitinib demonstrated an improved overall survival, with a median of 34.1 months, compared with 26.8 months with gefitinib.
Duvelisib (Copiktra)
Class: Dual inhibitor of phosphatidylinositol 3-kinase delta and gamma.
Disease: Relapsed or refractory chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma, or relapsed or refractory follicular lymphoma after at least two prior systemic therapies.
Dose: 25 mg orally twice daily.
AEs: Infection, diarrhea or colitis, and pneumonia.
Phase 3 DUO trial (NCT02004522): Progression-free survival in the duvelisib arm was 7.3 months longer than that in the ofatumumab arm. The overall response rate for patients receiving duvelisib was 78%, compared with 39% for those receiving ofatumumab.
Gilteritinib (Xospata)
Class: Inhibits the FLT3 internal tandem duplication (ITD) and FLT3 tyrosine kinase domain (TKD).
Disease: Relapsed or refractory acute myeloid leukemia (AML) with an FLT3 mutation.
Dose: 120 mg orally daily.
ADMIRAL trial (NCT02421939): 21% of the patients who received gilteritinib exhibited complete remission or complete remission with partial hematologic recovery.
Glasdegib (Daurismo)
Class: Hedgehog pathway inhibitor.
Disease: Adults over age 75 years with newly diagnosed AML and other medical comorbidities that preclude them from intensive chemotherapy.
Dose: The recommended dose is 100 mg orally continuously in 28-day cycles.
AE: QT prolongation and embryo-fetal toxicity
Phase 2 BRIGHT 1003 trial (NCT01546038): 3.9-month overall survival advantage for glasdegib plus cytarabine, compared with cytarabine alone. Overall, 15% of the glasdegib plus low dose cytarabine arm achieved complete remission, compared with the 1% complete remission rate in patients who received cytarabine alone.
Iobenguane I 131 (Azedra)
Class: Radiopharmaceutical agent; induces cell death within the noradrenaline transporter.
Disease: Iobenguane scan–positive, unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma
Dose: Initial intravenous dosimetric dose, followed by two therapeutic doses.
AE: Pancytopenia and elevated international normalized ratio (INR).
IB12B trial (NCT00874614): One-quarter of patients receiving this therapy had at least a 50% reduction in the dose and number of antihypertensives for at least 6 months; almost all patients had a tumor response.
Ivosidenib (Tibsovo)
Class: Small-molecule inhibitor of mutant isocitrate dehydrogenase (IDH1).
Disease: Refractory AML and an IDH1 mutation
Dose: 500 mg orally daily.
AG120-C-001 trial (NCT02074839): Overall response rate of 41.6% in patients who received ivosidenib, with a 30.4% rate of complete remission or complete remission with partial hematologic recovery.
Larotrectinib (Vitrakvi)
Class: Oral tyrosine kinase inhibitor.
Disease: Advanced solid tumors harboring a neurotrophic tyrosine receptor kinase (NTRK) gene fusion.
Dose: 100 mg orally twice daily.
LOXO-TRK-14001, SCOUT, and NAVIGATE trials (NCT02122913, NCT02637687, and NCT02576431): Patients who received larotrectinib had durable responses regardless of patient age, tumor type, and fusion status.
Lutetium Lu 177 dotatate (Lutathera)
Class: Radiolabeled somatostatin analogue.
Disease: Somatostatin receptor–positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs).
Dose: Intravenous infusion 7.4 GBq (200 mCi) every 8 weeks for a total of four doses.
NETTER-1 trial (NCT01578239): 65% of adults who received lutetium Lu 177 showed improved progression-free survival at 20 months, compared with just 10.8% in the control group.
Mogamulizumab (Poteligeo)
Class: Monoclonal antibody that binds to a protein (CC chemokine receptor type 4).
Disease: Relapsed or refractory mycosis fungoides or Sézary syndrome.
Dose: Intravenous infusion 1 mg/kg.
AE: Dermatologic toxicity.
MAVORIC trial (NCT01728805): Patients who received mogamulizumab had improved progression-free survival (median 7.7 months), compared with those taking vorinostat (median 3.1 months).
Moxetumomab pasudotox-tdfk (Lumoxiti)
Class: CD22-directed cytotoxin fused with a fragment of Pseudomonas exotoxin A.
Disease: Relapsed or refractory hairy cell leukemia previously treated with at least two prior systemic therapies, including a purine nucleoside analogue.
Dose: Intravenously as 0.04 mg/kg.
AE: Hemolytic uremic syndrome.
1053 trial (NCT01829711): 30% of the patients who received moxetumomab pasudotox-tdfk had a durable complete response confirmed by maintenance hematologic remission.
Talazoparib (Talzenna)
Class: Poly (ADP-ribose) polymerase (PARP) inhibitor.
Disease: gBRCAm HER2-negative locally advanced or metastatic breast cancer.
Dose: 1 mg orally per day.
EMBRACA trial (NCT01945775): Patients who received talazoparib demonstrated significantly longer progression-free survival, with a median of 8.6 months versis 5.6 months in the control arm.
Dr. Bryer is a resident in the department of internal medicine at the University of Pennsylvania, Philadelphia. Dr. Mentzer is chief of hematology-oncology at Pennsylvania Hospital and professor of medicine at the University of Pennsylvania. Dr. Henry is a hematologist-oncologist at Pennsylvania Hospital and a professor of medicine at the University of Pennsylvania.
Advances in genomics and technology perpetually change and improve therapies in oncology. Enhanced comprehension of cellular signaling, division, and replication has created a platform to selectively restrict neoplastic growth while preserving the integrity of benign cells.
This article reviews therapies that were newly approved in 2018, as well as those previously approved whose indications were expanded this past year. The list highlights the most clinically important approvals, as well as adverse events that are unique or especially severe.
Click on the PDF above to download the full article and charts in an easy-to-print format.
Apalutamide (Erleada)
Class: Androgen receptor inhibitor.
Disease: Nonmetastatic castration-resistant prostate cancer.
Dose: 240 mg orally, once daily.
Adverse Events (AEs): Hyperkalemia and increased risks of seizures, falls, and fractures.
Phase 3 SPARTAN trial (NCT01946204): 40.5-month metastasis-free survival rate, compared with 16.2 months in the placebo group.
Cemiplimab (Libtayo)
Class: Antibody against programmed cell death protein-1 (PD-1).
Disease: Metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC that is ineligible for curative surgery/radiation.
Dose: 350 mg intravenous infusion every 3 weeks.
AEs: Pneumonitis, autoimmune myocarditis, hepatitis, and aseptic meningitis.
1423 and 1540 trials (NCT02383212 and NCT02760498): 47.2% of patients who received cemiplimab had complete disappearance of the tumor or a decrease in tumor size.
Dacomitinib (Vizimpro)
Class: Second-generation tyrosine kinase inhibitor.
Disease: Metastatic non–small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutation.
Dose: 45 mg orally once daily.
AEs: Dermatotoxicity and diarrhea.
ARCHER1050 trial (NCT01774721): Patients who received dacomitinib demonstrated an improved overall survival, with a median of 34.1 months, compared with 26.8 months with gefitinib.
Duvelisib (Copiktra)
Class: Dual inhibitor of phosphatidylinositol 3-kinase delta and gamma.
Disease: Relapsed or refractory chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma, or relapsed or refractory follicular lymphoma after at least two prior systemic therapies.
Dose: 25 mg orally twice daily.
AEs: Infection, diarrhea or colitis, and pneumonia.
Phase 3 DUO trial (NCT02004522): Progression-free survival in the duvelisib arm was 7.3 months longer than that in the ofatumumab arm. The overall response rate for patients receiving duvelisib was 78%, compared with 39% for those receiving ofatumumab.
Gilteritinib (Xospata)
Class: Inhibits the FLT3 internal tandem duplication (ITD) and FLT3 tyrosine kinase domain (TKD).
Disease: Relapsed or refractory acute myeloid leukemia (AML) with an FLT3 mutation.
Dose: 120 mg orally daily.
ADMIRAL trial (NCT02421939): 21% of the patients who received gilteritinib exhibited complete remission or complete remission with partial hematologic recovery.
Glasdegib (Daurismo)
Class: Hedgehog pathway inhibitor.
Disease: Adults over age 75 years with newly diagnosed AML and other medical comorbidities that preclude them from intensive chemotherapy.
Dose: The recommended dose is 100 mg orally continuously in 28-day cycles.
AE: QT prolongation and embryo-fetal toxicity
Phase 2 BRIGHT 1003 trial (NCT01546038): 3.9-month overall survival advantage for glasdegib plus cytarabine, compared with cytarabine alone. Overall, 15% of the glasdegib plus low dose cytarabine arm achieved complete remission, compared with the 1% complete remission rate in patients who received cytarabine alone.
Iobenguane I 131 (Azedra)
Class: Radiopharmaceutical agent; induces cell death within the noradrenaline transporter.
Disease: Iobenguane scan–positive, unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma
Dose: Initial intravenous dosimetric dose, followed by two therapeutic doses.
AE: Pancytopenia and elevated international normalized ratio (INR).
IB12B trial (NCT00874614): One-quarter of patients receiving this therapy had at least a 50% reduction in the dose and number of antihypertensives for at least 6 months; almost all patients had a tumor response.
Ivosidenib (Tibsovo)
Class: Small-molecule inhibitor of mutant isocitrate dehydrogenase (IDH1).
Disease: Refractory AML and an IDH1 mutation
Dose: 500 mg orally daily.
AG120-C-001 trial (NCT02074839): Overall response rate of 41.6% in patients who received ivosidenib, with a 30.4% rate of complete remission or complete remission with partial hematologic recovery.
Larotrectinib (Vitrakvi)
Class: Oral tyrosine kinase inhibitor.
Disease: Advanced solid tumors harboring a neurotrophic tyrosine receptor kinase (NTRK) gene fusion.
Dose: 100 mg orally twice daily.
LOXO-TRK-14001, SCOUT, and NAVIGATE trials (NCT02122913, NCT02637687, and NCT02576431): Patients who received larotrectinib had durable responses regardless of patient age, tumor type, and fusion status.
Lutetium Lu 177 dotatate (Lutathera)
Class: Radiolabeled somatostatin analogue.
Disease: Somatostatin receptor–positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs).
Dose: Intravenous infusion 7.4 GBq (200 mCi) every 8 weeks for a total of four doses.
NETTER-1 trial (NCT01578239): 65% of adults who received lutetium Lu 177 showed improved progression-free survival at 20 months, compared with just 10.8% in the control group.
Mogamulizumab (Poteligeo)
Class: Monoclonal antibody that binds to a protein (CC chemokine receptor type 4).
Disease: Relapsed or refractory mycosis fungoides or Sézary syndrome.
Dose: Intravenous infusion 1 mg/kg.
AE: Dermatologic toxicity.
MAVORIC trial (NCT01728805): Patients who received mogamulizumab had improved progression-free survival (median 7.7 months), compared with those taking vorinostat (median 3.1 months).
Moxetumomab pasudotox-tdfk (Lumoxiti)
Class: CD22-directed cytotoxin fused with a fragment of Pseudomonas exotoxin A.
Disease: Relapsed or refractory hairy cell leukemia previously treated with at least two prior systemic therapies, including a purine nucleoside analogue.
Dose: Intravenously as 0.04 mg/kg.
AE: Hemolytic uremic syndrome.
1053 trial (NCT01829711): 30% of the patients who received moxetumomab pasudotox-tdfk had a durable complete response confirmed by maintenance hematologic remission.
Talazoparib (Talzenna)
Class: Poly (ADP-ribose) polymerase (PARP) inhibitor.
Disease: gBRCAm HER2-negative locally advanced or metastatic breast cancer.
Dose: 1 mg orally per day.
EMBRACA trial (NCT01945775): Patients who received talazoparib demonstrated significantly longer progression-free survival, with a median of 8.6 months versis 5.6 months in the control arm.
Dr. Bryer is a resident in the department of internal medicine at the University of Pennsylvania, Philadelphia. Dr. Mentzer is chief of hematology-oncology at Pennsylvania Hospital and professor of medicine at the University of Pennsylvania. Dr. Henry is a hematologist-oncologist at Pennsylvania Hospital and a professor of medicine at the University of Pennsylvania.
Gender Disparities for Academic Hospitalists
Gender disparities still exist for women in academic medicine.[1, 2, 3, 4, 5, 6, 7, 8, 9] The most recent data from the Association of American Medical Colleges (AAMC) show that although gender disparities are decreasing, women are still under‐represented in the assistant, associate, and full‐professor ranks as well as in leadership positions.[1]
Some studies indicate that gender differences are less evident when examining younger cohorts.[1, 10, 11, 12, 13] Hospital medicine emerged around 1996, when the term hospitalist was first coined.[14] The gender distribution of academic hospitalists is likely nearly equal,[15, 16] and they are generally younger physicians.[15, 17, 18, 19, 20] Accordingly, we questioned whether gender disparities existed in academic hospital medicine (HM) and, if so, whether these disparities were greater than those that might exist in academic general internal medicine (GIM).
METHODS
This study consisted of both prospective and retrospective observation of data collected for academic adult hospitalists and general internists who practice in the United States. It was approved by the Colorado Multiple Institutional Review Board.
Gender distribution was assessed with respect to: (1) academic HM and GIM faculty, (2) leadership (ie, division or section heads), and (3) scholarly work (ie, speaking opportunities and publications). Data were collected between October 1, 2012 and August 31, 2014.
Gender Distribution of Faculty and Division/Section Heads
All US internal medicine residency programs were identified from the list of members or affiliates of the AAMC that were fully accredited by the Liaison Committee on Medical Education[21] using the Graduate Medical Education Directory.[22] We then determined the primary training hospital(s) affiliated with each program and selected those that were considered to be university hospitals and eliminated those that did not have divisions or sections of HM or GIM. We determined the gender of the respective division/section heads on the basis of the faculty member's first name (and often from accompanying photos) as well as from information obtained via Internet searches and, if necessary, contacted the individual institutions via email or phone call(s). We also determined the number and gender of all of the HM and GIM faculty members in a random sample of 25% of these hospitals from information on their respective websites.
Gender Distribution for Scholarly Productivity
We determined the gender and specialty of all speakers at the Society of Hospital Medicine and the Society of General Internal Medicine national conferences from 2006 to 2012. A list of speakers at each conference was obtained from conference pamphlets or agendas that were available via Internet searches or obtained directly from the organization. We also determined whether each presenter was a featured speaker (defined as one whose talk was unopposed by other sessions), plenary speaker (defined as such in the conference pamphlets), or if they spoke in a group format (also as indicated in the conference pamphlets). Because of the low number of featured and plenary speakers, these data were combined. Faculty labeled as additional faculty when presenting in a group format were excluded as were speakers at precourses, those presenting abstracts, and those participating in interest group sessions.
For authorship, a PubMed search was used to identify all articles published in the Journal of Hospital Medicine (JHM) and the Journal of General Internal Medicine (JGIM) from January 1, 2006 through December 31, 2012, and the gender and specialty of all the first and last authors were determined as described above. Specialty was determined from the division, section or department affiliation indicated for each author and by Internet searches. In some instances, it was necessary to contact the authors or their departments directly to verify their specialty. When articles had only 1 author, the author was considered a first author.
Duplicate records (eg, same author, same journal) and articles without an author were excluded, as were authors who did not have an MD, DO, or MBBS degree and those who were not affiliated with an institution in the United States. All manuscripts, with the exception of errata, were analyzed together as well as in 3 subgroups: original research, editorials, and others.
A second investigator corroborated data regarding gender and specialty for all speakers and authors to strengthen data integrity. On the rare occasion when discrepancies were found, a third investigator adjudicated the results.
Definitions
Physicians were defined as being hospitalists if they were listed as a member of a division or section of HM on their publications or if Internet searches indicated that they were a hospitalist or primarily worked on inpatient medical services. Physicians were considered to be general internists if they were listed as such on their publications and their specialty could be verified in Web‐based searches. If physicians appeared to have changing roles over time, we attempted to assign their specialty based upon their role at the time the article was published or the presentation was delivered. If necessary, phone calls and/or emails were also done to determine the physician's specialty.
Analysis
REDCap, a secure, Web‐based application for building and managing online surveys and databases, was used to collect and manage all study data.[23] All analyses were performed using SAS Enterprise Guide 4.3 (SAS Institute, Inc., Cary, NC). A [2] test was used to compare proportions of male versus female physicians, and data from hospitalists versus general internists. Because we performed multiple comparisons when analyzing presentations and publications, a Bonferroni adjustment was made such that a P<0.0125 for presentations and P<0.006 (within specialty) or P<0.0125 (between specialty) for the publication analyses were considered significant. P<0.05 was considered significant for all other comparisons.
RESULTS
Gender Distribution of Faculty
Eighteen HM and 20 GIM programs from university hospitals were randomly selected for review (see Supporting Figure 1 in the online version of this article). Seven of the HM programs and 1 of the GIM programs did not have a website, did not differentiate hospitalists from other faculty, or did not list their faculty on the website and were excluded from the analysis. In the remaining 11 HM programs and 19 GIM programs, women made up 277/568 (49%) and 555/1099 (51%) of the faculty, respectively (P=0.50).
Gender Distribution of Division/Section Heads
Eighty‐six of the programs were classified as university hospitals (see Supporting Figure 1 in the online version of this article), and in these, women led 11/69 (16%) of the HM divisions or sections and 28/80 (35%) of the GIM divisions (P=0.008).
Gender Distribution for Scholarly Productivity
Speaking Opportunities
A total of 1227 presentations were given at the 2 conferences from 2006 to 2012, with 1343 of the speakers meeting inclusion criteria (see Supporting Figure 2 in the online version of this article). Hospitalists accounted for 557 of the speakers, of which 146 (26%) were women. General internists accounted for 580 of the speakers, of which 291 (50%) were women (P<0.0001) (Table 1).
Male, N (%) | Female, N (%) | |
---|---|---|
| ||
Hospitalists | ||
All presentations | 411 (74) | 146 (26)* |
Featured or plenary presentations | 49 (91) | 5 (9)* |
General internists | ||
All presentations | 289 (50) | 291 (50) |
Featured or plenary presentations | 27 (55) | 22 (45) |
Of the 117 featured or plenary speakers, 54 were hospitalists and 5 (9%) of these were women. Of the 49 who were general internists, 22 (45%) were women (P<0.0001).
Authorship
The PubMed search identified a total of 3285 articles published in the JHM and the JGIM from 2006 to 2012, and 2172 first authors and 1869 last authors met inclusion criteria (see Supporting Figure 3 in the online version of this article). Hospitalists were listed as first or last authors on 464 and 305 articles, respectively, and of these, women were first authors on 153 (33%) and last authors on 63 (21%). General internists were listed as first or last authors on 895 and 769 articles, respectively, with women as first authors on 423 (47%) and last authors on 265 (34%). Compared with general internists, fewer women hospitalists were listed as either first or last authors (both P<0.0001) (Table 2).
First Author | Last Author | |||
---|---|---|---|---|
Male, N (%) | Female, N (%) | Male, N (%) | Female, N (%) | |
| ||||
Hospitalists | ||||
All publications | 311 (67) | 153 (33)* | 242 (79) | 63 (21)* |
Original investigations/brief reports | 124 (61) | 79 (39)* | 96 (76) | 30 (24)* |
Editorials | 34 (77) | 10 (23)* | 18 (86) | 3 (14)* |
Other | 153 (71) | 64 (29)* | 128 (81) | 30 (19)* |
General internists | ||||
All publications | 472 (53) | 423 (47) | 504 (66) | 265 (34)* |
Original investigations/brief reports | 218 (46) | 261 (54) | 310 (65) | 170 (35)* |
Editorial | 98 (68) | 46 (32)* | 43 (73) | 16 (27)* |
Other | 156 (57) | 116 (43) | 151 (66) | 79 (34)* |
Fewer women hospitalists were listed as first or last authors on all article types. For original research articles written by general internists, there was a trend for more women to be listed as first authors than men (261/479, 54%), but this difference was not statistically significant.
DISCUSSION
The important findings of this study are that, despite an equal gender distribution of academic HM and GIM faculty, fewer women were HM division/section chiefs, fewer women were speakers at the 2 selected national meetings, and fewer women were first or last authors of publications in 2 selected journals in comparison with general internists.
Previous studies have found that women lag behind their male counterparts with respect to academic productivity, leadership, and promotion.[1, 5, 7] Some studies suggest, however, that gender differences are reduced when younger cohorts are examined.[1, 10, 11, 12, 13] Surveys indicate that that the mean age of hospitalists is younger than most other specialties.[15, 19, 20, 24] The mean age of academic GIM physicians is unknown, but surveys of GIM (not differentiating academic from nonacademic) suggest that it is an older cohort than that of HM.[24] Despite hospitalists being a younger cohort, we found gender disparities in all areas investigated.
Our findings with respect to gender disparities in HM division or section leadership are consistent with the annual AAMC Women in US Academic Medicine and Science Benchmarking Report that found only 22% of all permanent division or section heads were women.[1]
Gender disparities with respect to authorship of medical publications have been previously noted,[3, 6, 15, 25] but to our knowledge, this is the first study to investigate the gender of authors who were hospitalists. Although we found a higher proportion of women hospitalists who were first or last authors than was observed by Jagsi and colleagues,[3] women hospitalists were still under‐represented with respect to this measure of academic productivity. Erren et al. reviewed 6 major journals from 2010 and 2011, and found that first authorship of original research by women ranged from 23.7% to 46.7%, and for last authorship from 18.3% to 28.8%.[25] Interestingly, we found no significant gender difference for first authors who were general internists, and there was a trend toward more women general internists being first authors than men for original research, reviews, and brief reports (data not shown).
Our study did not attempt to answer the question of why gender disparities persist, but many previous studies have explored this issue.[4, 8, 12, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42] Issues raised by others include the quantity of academic work (ie, publications and grants obtained), differences in hours worked and allocation of time, lack of mentorship, family responsibilities, discrimination, differences in career motivation, and levels of institutional support, to name a few.
The under‐representation of women hospitalists in leadership, authorship, and speaking opportunities may be consistent with gender‐related differences in research productivity. Fewer publications could lead to fewer national presentations, which could lead to fewer leadership opportunities. Our findings with respect to general internists are not consistent with this idea, however, as whereas women were under‐represented in GIM leadership positions, we found no disparities with respect to the gender of first authors or speakers at national meetings for general internists. The finding that hospitalists had gender disparities with respect to first authors and national speakers but general internists did not, argues against several hypotheses (ie, that women lack mentorship, have less career motivation, fewer career building opportunities).
One notable hypothesis, and perhaps one that is often discussed in the literature, is that women shoulder the majority of family responsibilities, and this may result in women having less time for their careers. Jolly and colleagues studied physician‐researchers and noted that women were more likely than men to have spouses or domestic partners who were fully employed, spent 8.5 more hours per week on domestic activities, and were more likely to take time off during disruptions of usual child care.[33] Carr and colleagues found that women with children (compared to men with children) had fewer publications, slower self‐perceived career progress, and lower career satisfaction, but having children had little effect on faculty aspirations and goals.[2] Kaplan et al., however, found that family responsibilities do not appear to account for sex differences in academic advancement.[4] Interestingly, in a study comparing physicians from Generation X to those of the Baby Boomer age, Generation X women reported working more than their male Generation X counterparts, and both had more of a focus on worklife balance than the older generation.[12]
The nature the of 2 specialties' work environment and job requirements could have also resulted in some of the differences seen. Primary care clinical work is typically conducted Monday through Friday, and hospitalist work frequently includes some weekend, evening, night, and holiday coverage. Although these are known differences, both specialties have also been noted to offer many advantages to women and men alike, including collaborative working environments and flexible work hours.[16]
Finally, finding disparity in leadership positions in both specialties supports the possibility that those responsible for hiring could have implicit gender biases. Under‐representation in entry‐level positions is also not a likely explanation for the differences we observed, because nearly an equal number of men and women graduate from medical school, pursue residency training in internal medicine, and become either academic hospitalists or general internists at university settings.[1, 15, 24] This hypothesis could, however, explain why disparities exist with respect to senior authorship and leadership positions, as typically, these individuals have been in practice longer and the current trends of improved gender equality have not always been the case.
Our study has a number of limitations. First, we only examined publications in 2 journals and presentations at 2 national conferences, although the journals and conferences selected are considered to be the major ones in the 2 specialties. Second, using Internet searches may have resulted in inaccurate gender and specialty assignment, but previous studies have used similar methodology.[3, 43] Additionally, we also attempted to contact individuals for direct confirmation when the information we obtained was not clear and had a second investigator independently verify the gender and specialty data. Third, we utilized division/department websites when available to determine the gender of HM divisions/sections. If not recently updated, these websites may not have reflected the most current leader of the unit, but this concern would seemingly pertain to both hospitalists and general internists. Fourth, we opted to only study faculty and division/section heads at university hospitals, as typically these institutions had GIM and hospitalist groups and also typically had websites. Because we only studied faculty and leadership at university hospitals, our data are not generalizable to all hospitalist and GIM groups. Finally, we excluded pediatric hospitalists, and thus, this study is representative of adult hospitalists only. Including pediatric hospitalists was out of the scope of this project.
Our study also had a number of strengths. To our knowledge, this is the first study to provide an estimate of the gender distribution in academic HM, of hospitalists as speakers at national meetings, as first and last authors, and of HM division or section heads, and is the first to compare these results with those observed for general internists. In addition, we examined 7 years of data from 2 of the major journals and national conferences for these specialties.
In summary, despite HM being a newer field with a younger cohort of physicians, we found that gender disparities exist for women with respect to authorship, national speaking opportunities, and division or section leadership. Identifying why these gender differences exist presents an important next step.
Disclosures: Nothing to report. Marisha Burden, MD and Maria G. Frank, MD are coprincipal authors.
- Association of American Medical Colleges. Women in U.S. academic medicine and science: Statistics and benchmarking report. 2012. Available at: https://members.aamc.org/eweb/upload/Women%20in%20U%20S%20%20Academic%20Medicine%20Statistics%20and%20Benchmarking%20Report%202011-20123.pdf. Accessed September 1, 2014.
- Relation of family responsibilities and gender to the productivity and career satisfaction of medical faculty. Ann Intern Med. 1998;129:532–538. , , , et al.
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- Pew Research Center. On pay gap, millenial women near parity—for now. December 2013. Available at: http://www.pewsocialtrends.org/files/2013/12/gender-and-work_final.pdf. Published December 11, 2013. Accessed February 5, 2015.
- The emerging role of "hospitalists" in the American health care system. N Engl J Med. 1996;335:514–517. , .
- Mentorship, productivity, and promotion among academic hospitalists. J Gen Intern Med. 2012;27:23–27. , , , , , .
- The gender factor. The Hospitalist. Available at: http://www.the‐hospitalist.org/article/the‐gender‐factor. Published March 1, 2006. Accessed September 1, 2014. .
- Association of American Medical Colleges. Analysis in brief: Supplemental information for estimating the number and characteristics of hospitalist physicians in the United States and their possible workforce implications. Available at: https://www.aamc.org/download/300686/data/aibvol12_no3-supplemental.pdf. Published August 2012. Accessed September 1, 2014.
- Survey of US academic hospitalist leaders about mentorship and academic activities in hospitalist groups. J Hosp Med. 2011;6:5–9. , , , .
- State of Hospital Medicine: 2011 Report Based on 2010 Data. Medical Group Management Association and Society of Hospital Medicine. www.mgma.com, www.hospitalmedicine.org.
- Today's Hospitalist Survey. Compensation and Career Survey Results. 2013. Available at: http://www.todayshospitalist.com/index.php?b=salary_survey_results. Accessed January 11, 2015.
- Association of American Medical Colleges. Women in U.S. Academic Medicine: Statistics and Benchmarking Report. 2009–2010. Available at: https://www.aamc.org/download/182674/data/gwims_stats_2009‐2010.pdf. Accessed September 1, 2014.
- American Medical Association. Graduate Medical Education Directory 2012–2013. Chicago, IL: American Medical Association; 2012:182–203.
- Research electronic data capture (REDCap)—a metadata‐driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009;42:377–381. , , , , , .
- Association of American Medical Colleges. 2012 Physician Specialty Data Book. Center for Workforce Studies. Available at: https://www.aamc.org/download/313228/data/2012physicianspecialtydatabook.pdf. Published November 2012. Accessed September 1, 2014.
- Representation of women as authors, reviewers, editors in chief, and editorial board members at 6 general medical journals in 2010 and 2011. JAMA Intern Med. 2014;174:633–635. , , , .
- Relationships of gender and career motivation to medical faculty members' production of academic publications. Acad Med. 1998;73:180–186. , , , et al.
- Faculty perceptions of gender discrimination and sexual harassment in academic medicine. Ann Intern Med. 2000;132:889–896. , , , et al.
- Attitudes of clinical faculty about career progress, career success and recognition, and commitment to academic medicine. Results of a survey. Arch Intern Med. 2000;160:2625–2629. , , , .
- A "ton of feathers": gender discrimination in academic medical careers and how to manage it. J Womens Health (Larchmt). 2003;12:1009–1018. , , , , .
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- Career satisfaction of US women physicians: results from the Women Physicians' Health Study. Society of General Internal Medicine Career Satisfaction Study Group. Arch Intern Med. 1999;159:1417–1426. , , , .
- Doing the same and earning less: male and female physicians in a new medical specialty. Inquiry. 2004;41:301–315. .
- Gender differences in time spent on parenting and domestic responsibilities by high‐achieving young physician‐researchers. Ann Intern Med. 2014;160:344–353. , , , , , .
- Stories from early‐career women physicians who have left academic medicine: a qualitative study at a single institution. Acad Med. 2011;86:752–758. , , , , .
- The $16,819 pay gap for newly trained physicians: the unexplained trend of men earning more than women. Health Aff (Millwood). 2011;30:193–201. , , , .
- Experiencing the culture of academic medicine: gender matters, a national study. J Gen Intern Med. 2013;28:201–207. , , , , .
- Gender pay gaps in hospital medicine. The Hospitalist. Available at: http://www.the‐hospitalist.org/article/gender‐pay‐gaps‐in‐hospital‐medicine. Published February 29, 2012. Accessed September 1, 2014. .
- Mentoring in academic medicine: a systematic review. JAMA. 2006;296:1103–1115. , , .
- Inequality quantified: mind the gender gap. Nature. 2013;495:22–24. .
- Gender differences in academic advancement: patterns, causes, and potential solutions in one US College of Medicine. Acad Med. 2003;78:500–508. , , , et al.
- Why aren't there more women leaders in academic medicine? The views of clinical department chairs. Acad Med. 2001;76:453–465. , .
- Gender factors in reviewer recommendations for manuscript publication. J Appl Behav Anal. 1990;23:539–543. .
- Scientific impact of women in academic surgery. J Surg Res. 2008;148:13–16. , , , .
Gender disparities still exist for women in academic medicine.[1, 2, 3, 4, 5, 6, 7, 8, 9] The most recent data from the Association of American Medical Colleges (AAMC) show that although gender disparities are decreasing, women are still under‐represented in the assistant, associate, and full‐professor ranks as well as in leadership positions.[1]
Some studies indicate that gender differences are less evident when examining younger cohorts.[1, 10, 11, 12, 13] Hospital medicine emerged around 1996, when the term hospitalist was first coined.[14] The gender distribution of academic hospitalists is likely nearly equal,[15, 16] and they are generally younger physicians.[15, 17, 18, 19, 20] Accordingly, we questioned whether gender disparities existed in academic hospital medicine (HM) and, if so, whether these disparities were greater than those that might exist in academic general internal medicine (GIM).
METHODS
This study consisted of both prospective and retrospective observation of data collected for academic adult hospitalists and general internists who practice in the United States. It was approved by the Colorado Multiple Institutional Review Board.
Gender distribution was assessed with respect to: (1) academic HM and GIM faculty, (2) leadership (ie, division or section heads), and (3) scholarly work (ie, speaking opportunities and publications). Data were collected between October 1, 2012 and August 31, 2014.
Gender Distribution of Faculty and Division/Section Heads
All US internal medicine residency programs were identified from the list of members or affiliates of the AAMC that were fully accredited by the Liaison Committee on Medical Education[21] using the Graduate Medical Education Directory.[22] We then determined the primary training hospital(s) affiliated with each program and selected those that were considered to be university hospitals and eliminated those that did not have divisions or sections of HM or GIM. We determined the gender of the respective division/section heads on the basis of the faculty member's first name (and often from accompanying photos) as well as from information obtained via Internet searches and, if necessary, contacted the individual institutions via email or phone call(s). We also determined the number and gender of all of the HM and GIM faculty members in a random sample of 25% of these hospitals from information on their respective websites.
Gender Distribution for Scholarly Productivity
We determined the gender and specialty of all speakers at the Society of Hospital Medicine and the Society of General Internal Medicine national conferences from 2006 to 2012. A list of speakers at each conference was obtained from conference pamphlets or agendas that were available via Internet searches or obtained directly from the organization. We also determined whether each presenter was a featured speaker (defined as one whose talk was unopposed by other sessions), plenary speaker (defined as such in the conference pamphlets), or if they spoke in a group format (also as indicated in the conference pamphlets). Because of the low number of featured and plenary speakers, these data were combined. Faculty labeled as additional faculty when presenting in a group format were excluded as were speakers at precourses, those presenting abstracts, and those participating in interest group sessions.
For authorship, a PubMed search was used to identify all articles published in the Journal of Hospital Medicine (JHM) and the Journal of General Internal Medicine (JGIM) from January 1, 2006 through December 31, 2012, and the gender and specialty of all the first and last authors were determined as described above. Specialty was determined from the division, section or department affiliation indicated for each author and by Internet searches. In some instances, it was necessary to contact the authors or their departments directly to verify their specialty. When articles had only 1 author, the author was considered a first author.
Duplicate records (eg, same author, same journal) and articles without an author were excluded, as were authors who did not have an MD, DO, or MBBS degree and those who were not affiliated with an institution in the United States. All manuscripts, with the exception of errata, were analyzed together as well as in 3 subgroups: original research, editorials, and others.
A second investigator corroborated data regarding gender and specialty for all speakers and authors to strengthen data integrity. On the rare occasion when discrepancies were found, a third investigator adjudicated the results.
Definitions
Physicians were defined as being hospitalists if they were listed as a member of a division or section of HM on their publications or if Internet searches indicated that they were a hospitalist or primarily worked on inpatient medical services. Physicians were considered to be general internists if they were listed as such on their publications and their specialty could be verified in Web‐based searches. If physicians appeared to have changing roles over time, we attempted to assign their specialty based upon their role at the time the article was published or the presentation was delivered. If necessary, phone calls and/or emails were also done to determine the physician's specialty.
Analysis
REDCap, a secure, Web‐based application for building and managing online surveys and databases, was used to collect and manage all study data.[23] All analyses were performed using SAS Enterprise Guide 4.3 (SAS Institute, Inc., Cary, NC). A [2] test was used to compare proportions of male versus female physicians, and data from hospitalists versus general internists. Because we performed multiple comparisons when analyzing presentations and publications, a Bonferroni adjustment was made such that a P<0.0125 for presentations and P<0.006 (within specialty) or P<0.0125 (between specialty) for the publication analyses were considered significant. P<0.05 was considered significant for all other comparisons.
RESULTS
Gender Distribution of Faculty
Eighteen HM and 20 GIM programs from university hospitals were randomly selected for review (see Supporting Figure 1 in the online version of this article). Seven of the HM programs and 1 of the GIM programs did not have a website, did not differentiate hospitalists from other faculty, or did not list their faculty on the website and were excluded from the analysis. In the remaining 11 HM programs and 19 GIM programs, women made up 277/568 (49%) and 555/1099 (51%) of the faculty, respectively (P=0.50).
Gender Distribution of Division/Section Heads
Eighty‐six of the programs were classified as university hospitals (see Supporting Figure 1 in the online version of this article), and in these, women led 11/69 (16%) of the HM divisions or sections and 28/80 (35%) of the GIM divisions (P=0.008).
Gender Distribution for Scholarly Productivity
Speaking Opportunities
A total of 1227 presentations were given at the 2 conferences from 2006 to 2012, with 1343 of the speakers meeting inclusion criteria (see Supporting Figure 2 in the online version of this article). Hospitalists accounted for 557 of the speakers, of which 146 (26%) were women. General internists accounted for 580 of the speakers, of which 291 (50%) were women (P<0.0001) (Table 1).
Male, N (%) | Female, N (%) | |
---|---|---|
| ||
Hospitalists | ||
All presentations | 411 (74) | 146 (26)* |
Featured or plenary presentations | 49 (91) | 5 (9)* |
General internists | ||
All presentations | 289 (50) | 291 (50) |
Featured or plenary presentations | 27 (55) | 22 (45) |
Of the 117 featured or plenary speakers, 54 were hospitalists and 5 (9%) of these were women. Of the 49 who were general internists, 22 (45%) were women (P<0.0001).
Authorship
The PubMed search identified a total of 3285 articles published in the JHM and the JGIM from 2006 to 2012, and 2172 first authors and 1869 last authors met inclusion criteria (see Supporting Figure 3 in the online version of this article). Hospitalists were listed as first or last authors on 464 and 305 articles, respectively, and of these, women were first authors on 153 (33%) and last authors on 63 (21%). General internists were listed as first or last authors on 895 and 769 articles, respectively, with women as first authors on 423 (47%) and last authors on 265 (34%). Compared with general internists, fewer women hospitalists were listed as either first or last authors (both P<0.0001) (Table 2).
First Author | Last Author | |||
---|---|---|---|---|
Male, N (%) | Female, N (%) | Male, N (%) | Female, N (%) | |
| ||||
Hospitalists | ||||
All publications | 311 (67) | 153 (33)* | 242 (79) | 63 (21)* |
Original investigations/brief reports | 124 (61) | 79 (39)* | 96 (76) | 30 (24)* |
Editorials | 34 (77) | 10 (23)* | 18 (86) | 3 (14)* |
Other | 153 (71) | 64 (29)* | 128 (81) | 30 (19)* |
General internists | ||||
All publications | 472 (53) | 423 (47) | 504 (66) | 265 (34)* |
Original investigations/brief reports | 218 (46) | 261 (54) | 310 (65) | 170 (35)* |
Editorial | 98 (68) | 46 (32)* | 43 (73) | 16 (27)* |
Other | 156 (57) | 116 (43) | 151 (66) | 79 (34)* |
Fewer women hospitalists were listed as first or last authors on all article types. For original research articles written by general internists, there was a trend for more women to be listed as first authors than men (261/479, 54%), but this difference was not statistically significant.
DISCUSSION
The important findings of this study are that, despite an equal gender distribution of academic HM and GIM faculty, fewer women were HM division/section chiefs, fewer women were speakers at the 2 selected national meetings, and fewer women were first or last authors of publications in 2 selected journals in comparison with general internists.
Previous studies have found that women lag behind their male counterparts with respect to academic productivity, leadership, and promotion.[1, 5, 7] Some studies suggest, however, that gender differences are reduced when younger cohorts are examined.[1, 10, 11, 12, 13] Surveys indicate that that the mean age of hospitalists is younger than most other specialties.[15, 19, 20, 24] The mean age of academic GIM physicians is unknown, but surveys of GIM (not differentiating academic from nonacademic) suggest that it is an older cohort than that of HM.[24] Despite hospitalists being a younger cohort, we found gender disparities in all areas investigated.
Our findings with respect to gender disparities in HM division or section leadership are consistent with the annual AAMC Women in US Academic Medicine and Science Benchmarking Report that found only 22% of all permanent division or section heads were women.[1]
Gender disparities with respect to authorship of medical publications have been previously noted,[3, 6, 15, 25] but to our knowledge, this is the first study to investigate the gender of authors who were hospitalists. Although we found a higher proportion of women hospitalists who were first or last authors than was observed by Jagsi and colleagues,[3] women hospitalists were still under‐represented with respect to this measure of academic productivity. Erren et al. reviewed 6 major journals from 2010 and 2011, and found that first authorship of original research by women ranged from 23.7% to 46.7%, and for last authorship from 18.3% to 28.8%.[25] Interestingly, we found no significant gender difference for first authors who were general internists, and there was a trend toward more women general internists being first authors than men for original research, reviews, and brief reports (data not shown).
Our study did not attempt to answer the question of why gender disparities persist, but many previous studies have explored this issue.[4, 8, 12, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42] Issues raised by others include the quantity of academic work (ie, publications and grants obtained), differences in hours worked and allocation of time, lack of mentorship, family responsibilities, discrimination, differences in career motivation, and levels of institutional support, to name a few.
The under‐representation of women hospitalists in leadership, authorship, and speaking opportunities may be consistent with gender‐related differences in research productivity. Fewer publications could lead to fewer national presentations, which could lead to fewer leadership opportunities. Our findings with respect to general internists are not consistent with this idea, however, as whereas women were under‐represented in GIM leadership positions, we found no disparities with respect to the gender of first authors or speakers at national meetings for general internists. The finding that hospitalists had gender disparities with respect to first authors and national speakers but general internists did not, argues against several hypotheses (ie, that women lack mentorship, have less career motivation, fewer career building opportunities).
One notable hypothesis, and perhaps one that is often discussed in the literature, is that women shoulder the majority of family responsibilities, and this may result in women having less time for their careers. Jolly and colleagues studied physician‐researchers and noted that women were more likely than men to have spouses or domestic partners who were fully employed, spent 8.5 more hours per week on domestic activities, and were more likely to take time off during disruptions of usual child care.[33] Carr and colleagues found that women with children (compared to men with children) had fewer publications, slower self‐perceived career progress, and lower career satisfaction, but having children had little effect on faculty aspirations and goals.[2] Kaplan et al., however, found that family responsibilities do not appear to account for sex differences in academic advancement.[4] Interestingly, in a study comparing physicians from Generation X to those of the Baby Boomer age, Generation X women reported working more than their male Generation X counterparts, and both had more of a focus on worklife balance than the older generation.[12]
The nature the of 2 specialties' work environment and job requirements could have also resulted in some of the differences seen. Primary care clinical work is typically conducted Monday through Friday, and hospitalist work frequently includes some weekend, evening, night, and holiday coverage. Although these are known differences, both specialties have also been noted to offer many advantages to women and men alike, including collaborative working environments and flexible work hours.[16]
Finally, finding disparity in leadership positions in both specialties supports the possibility that those responsible for hiring could have implicit gender biases. Under‐representation in entry‐level positions is also not a likely explanation for the differences we observed, because nearly an equal number of men and women graduate from medical school, pursue residency training in internal medicine, and become either academic hospitalists or general internists at university settings.[1, 15, 24] This hypothesis could, however, explain why disparities exist with respect to senior authorship and leadership positions, as typically, these individuals have been in practice longer and the current trends of improved gender equality have not always been the case.
Our study has a number of limitations. First, we only examined publications in 2 journals and presentations at 2 national conferences, although the journals and conferences selected are considered to be the major ones in the 2 specialties. Second, using Internet searches may have resulted in inaccurate gender and specialty assignment, but previous studies have used similar methodology.[3, 43] Additionally, we also attempted to contact individuals for direct confirmation when the information we obtained was not clear and had a second investigator independently verify the gender and specialty data. Third, we utilized division/department websites when available to determine the gender of HM divisions/sections. If not recently updated, these websites may not have reflected the most current leader of the unit, but this concern would seemingly pertain to both hospitalists and general internists. Fourth, we opted to only study faculty and division/section heads at university hospitals, as typically these institutions had GIM and hospitalist groups and also typically had websites. Because we only studied faculty and leadership at university hospitals, our data are not generalizable to all hospitalist and GIM groups. Finally, we excluded pediatric hospitalists, and thus, this study is representative of adult hospitalists only. Including pediatric hospitalists was out of the scope of this project.
Our study also had a number of strengths. To our knowledge, this is the first study to provide an estimate of the gender distribution in academic HM, of hospitalists as speakers at national meetings, as first and last authors, and of HM division or section heads, and is the first to compare these results with those observed for general internists. In addition, we examined 7 years of data from 2 of the major journals and national conferences for these specialties.
In summary, despite HM being a newer field with a younger cohort of physicians, we found that gender disparities exist for women with respect to authorship, national speaking opportunities, and division or section leadership. Identifying why these gender differences exist presents an important next step.
Disclosures: Nothing to report. Marisha Burden, MD and Maria G. Frank, MD are coprincipal authors.
Gender disparities still exist for women in academic medicine.[1, 2, 3, 4, 5, 6, 7, 8, 9] The most recent data from the Association of American Medical Colleges (AAMC) show that although gender disparities are decreasing, women are still under‐represented in the assistant, associate, and full‐professor ranks as well as in leadership positions.[1]
Some studies indicate that gender differences are less evident when examining younger cohorts.[1, 10, 11, 12, 13] Hospital medicine emerged around 1996, when the term hospitalist was first coined.[14] The gender distribution of academic hospitalists is likely nearly equal,[15, 16] and they are generally younger physicians.[15, 17, 18, 19, 20] Accordingly, we questioned whether gender disparities existed in academic hospital medicine (HM) and, if so, whether these disparities were greater than those that might exist in academic general internal medicine (GIM).
METHODS
This study consisted of both prospective and retrospective observation of data collected for academic adult hospitalists and general internists who practice in the United States. It was approved by the Colorado Multiple Institutional Review Board.
Gender distribution was assessed with respect to: (1) academic HM and GIM faculty, (2) leadership (ie, division or section heads), and (3) scholarly work (ie, speaking opportunities and publications). Data were collected between October 1, 2012 and August 31, 2014.
Gender Distribution of Faculty and Division/Section Heads
All US internal medicine residency programs were identified from the list of members or affiliates of the AAMC that were fully accredited by the Liaison Committee on Medical Education[21] using the Graduate Medical Education Directory.[22] We then determined the primary training hospital(s) affiliated with each program and selected those that were considered to be university hospitals and eliminated those that did not have divisions or sections of HM or GIM. We determined the gender of the respective division/section heads on the basis of the faculty member's first name (and often from accompanying photos) as well as from information obtained via Internet searches and, if necessary, contacted the individual institutions via email or phone call(s). We also determined the number and gender of all of the HM and GIM faculty members in a random sample of 25% of these hospitals from information on their respective websites.
Gender Distribution for Scholarly Productivity
We determined the gender and specialty of all speakers at the Society of Hospital Medicine and the Society of General Internal Medicine national conferences from 2006 to 2012. A list of speakers at each conference was obtained from conference pamphlets or agendas that were available via Internet searches or obtained directly from the organization. We also determined whether each presenter was a featured speaker (defined as one whose talk was unopposed by other sessions), plenary speaker (defined as such in the conference pamphlets), or if they spoke in a group format (also as indicated in the conference pamphlets). Because of the low number of featured and plenary speakers, these data were combined. Faculty labeled as additional faculty when presenting in a group format were excluded as were speakers at precourses, those presenting abstracts, and those participating in interest group sessions.
For authorship, a PubMed search was used to identify all articles published in the Journal of Hospital Medicine (JHM) and the Journal of General Internal Medicine (JGIM) from January 1, 2006 through December 31, 2012, and the gender and specialty of all the first and last authors were determined as described above. Specialty was determined from the division, section or department affiliation indicated for each author and by Internet searches. In some instances, it was necessary to contact the authors or their departments directly to verify their specialty. When articles had only 1 author, the author was considered a first author.
Duplicate records (eg, same author, same journal) and articles without an author were excluded, as were authors who did not have an MD, DO, or MBBS degree and those who were not affiliated with an institution in the United States. All manuscripts, with the exception of errata, were analyzed together as well as in 3 subgroups: original research, editorials, and others.
A second investigator corroborated data regarding gender and specialty for all speakers and authors to strengthen data integrity. On the rare occasion when discrepancies were found, a third investigator adjudicated the results.
Definitions
Physicians were defined as being hospitalists if they were listed as a member of a division or section of HM on their publications or if Internet searches indicated that they were a hospitalist or primarily worked on inpatient medical services. Physicians were considered to be general internists if they were listed as such on their publications and their specialty could be verified in Web‐based searches. If physicians appeared to have changing roles over time, we attempted to assign their specialty based upon their role at the time the article was published or the presentation was delivered. If necessary, phone calls and/or emails were also done to determine the physician's specialty.
Analysis
REDCap, a secure, Web‐based application for building and managing online surveys and databases, was used to collect and manage all study data.[23] All analyses were performed using SAS Enterprise Guide 4.3 (SAS Institute, Inc., Cary, NC). A [2] test was used to compare proportions of male versus female physicians, and data from hospitalists versus general internists. Because we performed multiple comparisons when analyzing presentations and publications, a Bonferroni adjustment was made such that a P<0.0125 for presentations and P<0.006 (within specialty) or P<0.0125 (between specialty) for the publication analyses were considered significant. P<0.05 was considered significant for all other comparisons.
RESULTS
Gender Distribution of Faculty
Eighteen HM and 20 GIM programs from university hospitals were randomly selected for review (see Supporting Figure 1 in the online version of this article). Seven of the HM programs and 1 of the GIM programs did not have a website, did not differentiate hospitalists from other faculty, or did not list their faculty on the website and were excluded from the analysis. In the remaining 11 HM programs and 19 GIM programs, women made up 277/568 (49%) and 555/1099 (51%) of the faculty, respectively (P=0.50).
Gender Distribution of Division/Section Heads
Eighty‐six of the programs were classified as university hospitals (see Supporting Figure 1 in the online version of this article), and in these, women led 11/69 (16%) of the HM divisions or sections and 28/80 (35%) of the GIM divisions (P=0.008).
Gender Distribution for Scholarly Productivity
Speaking Opportunities
A total of 1227 presentations were given at the 2 conferences from 2006 to 2012, with 1343 of the speakers meeting inclusion criteria (see Supporting Figure 2 in the online version of this article). Hospitalists accounted for 557 of the speakers, of which 146 (26%) were women. General internists accounted for 580 of the speakers, of which 291 (50%) were women (P<0.0001) (Table 1).
Male, N (%) | Female, N (%) | |
---|---|---|
| ||
Hospitalists | ||
All presentations | 411 (74) | 146 (26)* |
Featured or plenary presentations | 49 (91) | 5 (9)* |
General internists | ||
All presentations | 289 (50) | 291 (50) |
Featured or plenary presentations | 27 (55) | 22 (45) |
Of the 117 featured or plenary speakers, 54 were hospitalists and 5 (9%) of these were women. Of the 49 who were general internists, 22 (45%) were women (P<0.0001).
Authorship
The PubMed search identified a total of 3285 articles published in the JHM and the JGIM from 2006 to 2012, and 2172 first authors and 1869 last authors met inclusion criteria (see Supporting Figure 3 in the online version of this article). Hospitalists were listed as first or last authors on 464 and 305 articles, respectively, and of these, women were first authors on 153 (33%) and last authors on 63 (21%). General internists were listed as first or last authors on 895 and 769 articles, respectively, with women as first authors on 423 (47%) and last authors on 265 (34%). Compared with general internists, fewer women hospitalists were listed as either first or last authors (both P<0.0001) (Table 2).
First Author | Last Author | |||
---|---|---|---|---|
Male, N (%) | Female, N (%) | Male, N (%) | Female, N (%) | |
| ||||
Hospitalists | ||||
All publications | 311 (67) | 153 (33)* | 242 (79) | 63 (21)* |
Original investigations/brief reports | 124 (61) | 79 (39)* | 96 (76) | 30 (24)* |
Editorials | 34 (77) | 10 (23)* | 18 (86) | 3 (14)* |
Other | 153 (71) | 64 (29)* | 128 (81) | 30 (19)* |
General internists | ||||
All publications | 472 (53) | 423 (47) | 504 (66) | 265 (34)* |
Original investigations/brief reports | 218 (46) | 261 (54) | 310 (65) | 170 (35)* |
Editorial | 98 (68) | 46 (32)* | 43 (73) | 16 (27)* |
Other | 156 (57) | 116 (43) | 151 (66) | 79 (34)* |
Fewer women hospitalists were listed as first or last authors on all article types. For original research articles written by general internists, there was a trend for more women to be listed as first authors than men (261/479, 54%), but this difference was not statistically significant.
DISCUSSION
The important findings of this study are that, despite an equal gender distribution of academic HM and GIM faculty, fewer women were HM division/section chiefs, fewer women were speakers at the 2 selected national meetings, and fewer women were first or last authors of publications in 2 selected journals in comparison with general internists.
Previous studies have found that women lag behind their male counterparts with respect to academic productivity, leadership, and promotion.[1, 5, 7] Some studies suggest, however, that gender differences are reduced when younger cohorts are examined.[1, 10, 11, 12, 13] Surveys indicate that that the mean age of hospitalists is younger than most other specialties.[15, 19, 20, 24] The mean age of academic GIM physicians is unknown, but surveys of GIM (not differentiating academic from nonacademic) suggest that it is an older cohort than that of HM.[24] Despite hospitalists being a younger cohort, we found gender disparities in all areas investigated.
Our findings with respect to gender disparities in HM division or section leadership are consistent with the annual AAMC Women in US Academic Medicine and Science Benchmarking Report that found only 22% of all permanent division or section heads were women.[1]
Gender disparities with respect to authorship of medical publications have been previously noted,[3, 6, 15, 25] but to our knowledge, this is the first study to investigate the gender of authors who were hospitalists. Although we found a higher proportion of women hospitalists who were first or last authors than was observed by Jagsi and colleagues,[3] women hospitalists were still under‐represented with respect to this measure of academic productivity. Erren et al. reviewed 6 major journals from 2010 and 2011, and found that first authorship of original research by women ranged from 23.7% to 46.7%, and for last authorship from 18.3% to 28.8%.[25] Interestingly, we found no significant gender difference for first authors who were general internists, and there was a trend toward more women general internists being first authors than men for original research, reviews, and brief reports (data not shown).
Our study did not attempt to answer the question of why gender disparities persist, but many previous studies have explored this issue.[4, 8, 12, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42] Issues raised by others include the quantity of academic work (ie, publications and grants obtained), differences in hours worked and allocation of time, lack of mentorship, family responsibilities, discrimination, differences in career motivation, and levels of institutional support, to name a few.
The under‐representation of women hospitalists in leadership, authorship, and speaking opportunities may be consistent with gender‐related differences in research productivity. Fewer publications could lead to fewer national presentations, which could lead to fewer leadership opportunities. Our findings with respect to general internists are not consistent with this idea, however, as whereas women were under‐represented in GIM leadership positions, we found no disparities with respect to the gender of first authors or speakers at national meetings for general internists. The finding that hospitalists had gender disparities with respect to first authors and national speakers but general internists did not, argues against several hypotheses (ie, that women lack mentorship, have less career motivation, fewer career building opportunities).
One notable hypothesis, and perhaps one that is often discussed in the literature, is that women shoulder the majority of family responsibilities, and this may result in women having less time for their careers. Jolly and colleagues studied physician‐researchers and noted that women were more likely than men to have spouses or domestic partners who were fully employed, spent 8.5 more hours per week on domestic activities, and were more likely to take time off during disruptions of usual child care.[33] Carr and colleagues found that women with children (compared to men with children) had fewer publications, slower self‐perceived career progress, and lower career satisfaction, but having children had little effect on faculty aspirations and goals.[2] Kaplan et al., however, found that family responsibilities do not appear to account for sex differences in academic advancement.[4] Interestingly, in a study comparing physicians from Generation X to those of the Baby Boomer age, Generation X women reported working more than their male Generation X counterparts, and both had more of a focus on worklife balance than the older generation.[12]
The nature the of 2 specialties' work environment and job requirements could have also resulted in some of the differences seen. Primary care clinical work is typically conducted Monday through Friday, and hospitalist work frequently includes some weekend, evening, night, and holiday coverage. Although these are known differences, both specialties have also been noted to offer many advantages to women and men alike, including collaborative working environments and flexible work hours.[16]
Finally, finding disparity in leadership positions in both specialties supports the possibility that those responsible for hiring could have implicit gender biases. Under‐representation in entry‐level positions is also not a likely explanation for the differences we observed, because nearly an equal number of men and women graduate from medical school, pursue residency training in internal medicine, and become either academic hospitalists or general internists at university settings.[1, 15, 24] This hypothesis could, however, explain why disparities exist with respect to senior authorship and leadership positions, as typically, these individuals have been in practice longer and the current trends of improved gender equality have not always been the case.
Our study has a number of limitations. First, we only examined publications in 2 journals and presentations at 2 national conferences, although the journals and conferences selected are considered to be the major ones in the 2 specialties. Second, using Internet searches may have resulted in inaccurate gender and specialty assignment, but previous studies have used similar methodology.[3, 43] Additionally, we also attempted to contact individuals for direct confirmation when the information we obtained was not clear and had a second investigator independently verify the gender and specialty data. Third, we utilized division/department websites when available to determine the gender of HM divisions/sections. If not recently updated, these websites may not have reflected the most current leader of the unit, but this concern would seemingly pertain to both hospitalists and general internists. Fourth, we opted to only study faculty and division/section heads at university hospitals, as typically these institutions had GIM and hospitalist groups and also typically had websites. Because we only studied faculty and leadership at university hospitals, our data are not generalizable to all hospitalist and GIM groups. Finally, we excluded pediatric hospitalists, and thus, this study is representative of adult hospitalists only. Including pediatric hospitalists was out of the scope of this project.
Our study also had a number of strengths. To our knowledge, this is the first study to provide an estimate of the gender distribution in academic HM, of hospitalists as speakers at national meetings, as first and last authors, and of HM division or section heads, and is the first to compare these results with those observed for general internists. In addition, we examined 7 years of data from 2 of the major journals and national conferences for these specialties.
In summary, despite HM being a newer field with a younger cohort of physicians, we found that gender disparities exist for women with respect to authorship, national speaking opportunities, and division or section leadership. Identifying why these gender differences exist presents an important next step.
Disclosures: Nothing to report. Marisha Burden, MD and Maria G. Frank, MD are coprincipal authors.
- Association of American Medical Colleges. Women in U.S. academic medicine and science: Statistics and benchmarking report. 2012. Available at: https://members.aamc.org/eweb/upload/Women%20in%20U%20S%20%20Academic%20Medicine%20Statistics%20and%20Benchmarking%20Report%202011-20123.pdf. Accessed September 1, 2014.
- Relation of family responsibilities and gender to the productivity and career satisfaction of medical faculty. Ann Intern Med. 1998;129:532–538. , , , et al.
- The “gender gap” in authorship of academic medical literature—a 35‐year perspective. N Engl J Med. 2006;355:281–287. , , , et al.
- Sex differences in academic advancement. Results of a national study of pediatricians. N Engl J Med. 1996;335:1282–1289. , , , , , .
- Women physicians in academic medicine: new insights from cohort studies. N Engl J Med. 2000;342:399–405. .
- Gender differences in academic productivity and leadership appointments of physicians throughout academic careers. Acad Med. 2011;86:43–47. , , , , .
- Promotion of women physicians in academic medicine. Glass ceiling or sticky floor? JAMA. 1995;273:1022–1025. , , , .
- Compensation and advancement of women in academic medicine: is there equity? Ann Intern Med. 2004;141:205–212. , , , .
- Women physicians: choosing a career in academic medicine. Acad Med. 2012;87:105–114. , , .
- The status of women at one academic medical center. Breaking through the glass ceiling. JAMA. 1990;264:1813–1817. , , , .
- Status of women in academic anesthesiology. Anesthesiology. 1986;64:496–500. , .
- The generation and gender shifts in medicine: an exploratory survey of internal medicine physicians. BMC Health Serv Res. 2006;6:55. , , .
- Pew Research Center. On pay gap, millenial women near parity—for now. December 2013. Available at: http://www.pewsocialtrends.org/files/2013/12/gender-and-work_final.pdf. Published December 11, 2013. Accessed February 5, 2015.
- The emerging role of "hospitalists" in the American health care system. N Engl J Med. 1996;335:514–517. , .
- Mentorship, productivity, and promotion among academic hospitalists. J Gen Intern Med. 2012;27:23–27. , , , , , .
- The gender factor. The Hospitalist. Available at: http://www.the‐hospitalist.org/article/the‐gender‐factor. Published March 1, 2006. Accessed September 1, 2014. .
- Association of American Medical Colleges. Analysis in brief: Supplemental information for estimating the number and characteristics of hospitalist physicians in the United States and their possible workforce implications. Available at: https://www.aamc.org/download/300686/data/aibvol12_no3-supplemental.pdf. Published August 2012. Accessed September 1, 2014.
- Survey of US academic hospitalist leaders about mentorship and academic activities in hospitalist groups. J Hosp Med. 2011;6:5–9. , , , .
- State of Hospital Medicine: 2011 Report Based on 2010 Data. Medical Group Management Association and Society of Hospital Medicine. www.mgma.com, www.hospitalmedicine.org.
- Today's Hospitalist Survey. Compensation and Career Survey Results. 2013. Available at: http://www.todayshospitalist.com/index.php?b=salary_survey_results. Accessed January 11, 2015.
- Association of American Medical Colleges. Women in U.S. Academic Medicine: Statistics and Benchmarking Report. 2009–2010. Available at: https://www.aamc.org/download/182674/data/gwims_stats_2009‐2010.pdf. Accessed September 1, 2014.
- American Medical Association. Graduate Medical Education Directory 2012–2013. Chicago, IL: American Medical Association; 2012:182–203.
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- Association of American Medical Colleges. 2012 Physician Specialty Data Book. Center for Workforce Studies. Available at: https://www.aamc.org/download/313228/data/2012physicianspecialtydatabook.pdf. Published November 2012. Accessed September 1, 2014.
- Representation of women as authors, reviewers, editors in chief, and editorial board members at 6 general medical journals in 2010 and 2011. JAMA Intern Med. 2014;174:633–635. , , , .
- Relationships of gender and career motivation to medical faculty members' production of academic publications. Acad Med. 1998;73:180–186. , , , et al.
- Faculty perceptions of gender discrimination and sexual harassment in academic medicine. Ann Intern Med. 2000;132:889–896. , , , et al.
- Attitudes of clinical faculty about career progress, career success and recognition, and commitment to academic medicine. Results of a survey. Arch Intern Med. 2000;160:2625–2629. , , , .
- A "ton of feathers": gender discrimination in academic medical careers and how to manage it. J Womens Health (Larchmt). 2003;12:1009–1018. , , , , .
- Perceived obstacles to career success for women in academic surgery. Arch Surg. 2000;135:972–977. , , .
- Career satisfaction of US women physicians: results from the Women Physicians' Health Study. Society of General Internal Medicine Career Satisfaction Study Group. Arch Intern Med. 1999;159:1417–1426. , , , .
- Doing the same and earning less: male and female physicians in a new medical specialty. Inquiry. 2004;41:301–315. .
- Gender differences in time spent on parenting and domestic responsibilities by high‐achieving young physician‐researchers. Ann Intern Med. 2014;160:344–353. , , , , , .
- Stories from early‐career women physicians who have left academic medicine: a qualitative study at a single institution. Acad Med. 2011;86:752–758. , , , , .
- The $16,819 pay gap for newly trained physicians: the unexplained trend of men earning more than women. Health Aff (Millwood). 2011;30:193–201. , , , .
- Experiencing the culture of academic medicine: gender matters, a national study. J Gen Intern Med. 2013;28:201–207. , , , , .
- Gender pay gaps in hospital medicine. The Hospitalist. Available at: http://www.the‐hospitalist.org/article/gender‐pay‐gaps‐in‐hospital‐medicine. Published February 29, 2012. Accessed September 1, 2014. .
- Mentoring in academic medicine: a systematic review. JAMA. 2006;296:1103–1115. , , .
- Inequality quantified: mind the gender gap. Nature. 2013;495:22–24. .
- Gender differences in academic advancement: patterns, causes, and potential solutions in one US College of Medicine. Acad Med. 2003;78:500–508. , , , et al.
- Why aren't there more women leaders in academic medicine? The views of clinical department chairs. Acad Med. 2001;76:453–465. , .
- Gender factors in reviewer recommendations for manuscript publication. J Appl Behav Anal. 1990;23:539–543. .
- Scientific impact of women in academic surgery. J Surg Res. 2008;148:13–16. , , , .
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