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Nutrition status predicts outcomes in liver transplant
WASHINGTON – Efforts to improve nutritional status prior to transplant may lead to improved patient outcomes and economic benefits after orthotopic liver transplant.
Clinicians at Austin Health, a tertiary health center in Melbourne, reviewed prospectively acquired data on 390 adult patients who underwent orthotopic liver transplant at their institution between January 2009 and June 2016, according to Brooke Chapman, a dietitian on the center’s transplant team.
“Hand-grip strength test is a functional measure of upper-body strength,” Ms. Chapman said at the annual meeting of the American Association for the Study of Liver Diseases. “It’s quick and cheap and reliable but importantly, it does respond quite readily to changes in nutritional intake and nutrition status.”
Assessments were made as patients were wait listed for liver transplant. Hand-grip strength and subjective global assessment were repeated at the time of transplant.
Patients with fulminant liver failure and those requiring retransplantation were excluded from the final analysis, leaving 321 patients in the cohort. More than two-thirds (69%) were men and the median age was 52 years old. About half of patients had a diagnosis of hepatocellular carcinoma or hepatitis C infection. The median MELD (Model for Endstage Liver Disease) score was 18, with a range of 6-40, and the median time on the wait list was 140 days.
We saw a “high prevalence of malnutrition in patients undergoing liver transplant and the deterioration in nutritional status despite our best efforts while they are on the waiting list,” Ms. Chapman said.
At baseline, two-thirds of patients were malnourished – either mildly to moderately or severely; by transplantation, 77% were malnourished.
“At assessment, we are prescribing and educating patients on a high-calorie, high-protein diet initially, and we give oral nutrition support therapies,” she said. “We really try to get them to improve oral intake, but for patients who do require more aggressive intervention, we will feed them via nasogastric tube.”
Just over half (55%) of patients fell below the cutoff for sarcopenia on the hand-grip test at baseline and at transplant. More than a quarter of patients (27%) were not able to complete the 6-minute walk test.
“On univariate analysis, we saw malnutrition to be strongly associated with increased ICU and hospital length of stay,” Ms. Chapman noted. Severely malnourished patients spent significantly more time in the ICU than did well-nourished patients – a mean 147 hours vs. 89 hours (P = .001). Mean length of stay also was significantly longer at 40 days vs. 16 days (P = .003).
There was also an increased incidence of infection in severely malnourished patients as compared with well-nourished patients – 55.2% vs. 33.8%, she said.
“Aggressive strategies to combat malnutrition and deconditioning in the pretransplant period may lead to improved outcomes after transplant,” Ms. Chapman concluded.
The study was funded by Austin Health. Ms. Chapman declared no relevant conflicts of interest.
dfulton@frontlinemedcom.com
On Twitter @denisefulton
WASHINGTON – Efforts to improve nutritional status prior to transplant may lead to improved patient outcomes and economic benefits after orthotopic liver transplant.
Clinicians at Austin Health, a tertiary health center in Melbourne, reviewed prospectively acquired data on 390 adult patients who underwent orthotopic liver transplant at their institution between January 2009 and June 2016, according to Brooke Chapman, a dietitian on the center’s transplant team.
“Hand-grip strength test is a functional measure of upper-body strength,” Ms. Chapman said at the annual meeting of the American Association for the Study of Liver Diseases. “It’s quick and cheap and reliable but importantly, it does respond quite readily to changes in nutritional intake and nutrition status.”
Assessments were made as patients were wait listed for liver transplant. Hand-grip strength and subjective global assessment were repeated at the time of transplant.
Patients with fulminant liver failure and those requiring retransplantation were excluded from the final analysis, leaving 321 patients in the cohort. More than two-thirds (69%) were men and the median age was 52 years old. About half of patients had a diagnosis of hepatocellular carcinoma or hepatitis C infection. The median MELD (Model for Endstage Liver Disease) score was 18, with a range of 6-40, and the median time on the wait list was 140 days.
We saw a “high prevalence of malnutrition in patients undergoing liver transplant and the deterioration in nutritional status despite our best efforts while they are on the waiting list,” Ms. Chapman said.
At baseline, two-thirds of patients were malnourished – either mildly to moderately or severely; by transplantation, 77% were malnourished.
“At assessment, we are prescribing and educating patients on a high-calorie, high-protein diet initially, and we give oral nutrition support therapies,” she said. “We really try to get them to improve oral intake, but for patients who do require more aggressive intervention, we will feed them via nasogastric tube.”
Just over half (55%) of patients fell below the cutoff for sarcopenia on the hand-grip test at baseline and at transplant. More than a quarter of patients (27%) were not able to complete the 6-minute walk test.
“On univariate analysis, we saw malnutrition to be strongly associated with increased ICU and hospital length of stay,” Ms. Chapman noted. Severely malnourished patients spent significantly more time in the ICU than did well-nourished patients – a mean 147 hours vs. 89 hours (P = .001). Mean length of stay also was significantly longer at 40 days vs. 16 days (P = .003).
There was also an increased incidence of infection in severely malnourished patients as compared with well-nourished patients – 55.2% vs. 33.8%, she said.
“Aggressive strategies to combat malnutrition and deconditioning in the pretransplant period may lead to improved outcomes after transplant,” Ms. Chapman concluded.
The study was funded by Austin Health. Ms. Chapman declared no relevant conflicts of interest.
dfulton@frontlinemedcom.com
On Twitter @denisefulton
WASHINGTON – Efforts to improve nutritional status prior to transplant may lead to improved patient outcomes and economic benefits after orthotopic liver transplant.
Clinicians at Austin Health, a tertiary health center in Melbourne, reviewed prospectively acquired data on 390 adult patients who underwent orthotopic liver transplant at their institution between January 2009 and June 2016, according to Brooke Chapman, a dietitian on the center’s transplant team.
“Hand-grip strength test is a functional measure of upper-body strength,” Ms. Chapman said at the annual meeting of the American Association for the Study of Liver Diseases. “It’s quick and cheap and reliable but importantly, it does respond quite readily to changes in nutritional intake and nutrition status.”
Assessments were made as patients were wait listed for liver transplant. Hand-grip strength and subjective global assessment were repeated at the time of transplant.
Patients with fulminant liver failure and those requiring retransplantation were excluded from the final analysis, leaving 321 patients in the cohort. More than two-thirds (69%) were men and the median age was 52 years old. About half of patients had a diagnosis of hepatocellular carcinoma or hepatitis C infection. The median MELD (Model for Endstage Liver Disease) score was 18, with a range of 6-40, and the median time on the wait list was 140 days.
We saw a “high prevalence of malnutrition in patients undergoing liver transplant and the deterioration in nutritional status despite our best efforts while they are on the waiting list,” Ms. Chapman said.
At baseline, two-thirds of patients were malnourished – either mildly to moderately or severely; by transplantation, 77% were malnourished.
“At assessment, we are prescribing and educating patients on a high-calorie, high-protein diet initially, and we give oral nutrition support therapies,” she said. “We really try to get them to improve oral intake, but for patients who do require more aggressive intervention, we will feed them via nasogastric tube.”
Just over half (55%) of patients fell below the cutoff for sarcopenia on the hand-grip test at baseline and at transplant. More than a quarter of patients (27%) were not able to complete the 6-minute walk test.
“On univariate analysis, we saw malnutrition to be strongly associated with increased ICU and hospital length of stay,” Ms. Chapman noted. Severely malnourished patients spent significantly more time in the ICU than did well-nourished patients – a mean 147 hours vs. 89 hours (P = .001). Mean length of stay also was significantly longer at 40 days vs. 16 days (P = .003).
There was also an increased incidence of infection in severely malnourished patients as compared with well-nourished patients – 55.2% vs. 33.8%, she said.
“Aggressive strategies to combat malnutrition and deconditioning in the pretransplant period may lead to improved outcomes after transplant,” Ms. Chapman concluded.
The study was funded by Austin Health. Ms. Chapman declared no relevant conflicts of interest.
dfulton@frontlinemedcom.com
On Twitter @denisefulton
AT THE LIVER MEETING 2017
Key clinical point:
Major finding: Severely malnourished patients spent a mean of 147 hours in the ICU vs. 89 hours for well-nourished patients. Mean length of stay also was significantly longer at 40 days vs. 16 days (P = .003).
Data source: Retrospective review of data on 390 adults awaiting liver transplantation between Jan. 2009 and June 2016.
Disclosures: The study was funded by the institutions. The authors reported no relevant conflicts of interest.
FDA approves second CAR-T therapy
A second chimeric antigen receptor (CAR) T-cell therapy has gained FDA approval, this time for the treatment of large B-cell lymphoma in adults.
“Today marks another milestone in the development of a whole new scientific paradigm for the treatment of serious diseases,” FDA Commissioner Scott Gottlieb, MD, said in a statement. “This approval demonstrates the continued momentum of this promising new area of medicine, and we’re committed to supporting and helping expedite the development of these products.”
Approval was based on ZUMA-1, a multicenter clinical trial of 101 adults with refractory or relapsed large B-cell lymphoma. Almost three-quarters (72%) of patients responded, including 51% who achieved complete remission.
CAR-T therapy can cause severe, life-threatening side effects, most notably cytokine release syndrome (CRS) and neurologic toxicities, for which axicabtagene ciloleucel will carry a boxed warning and will come with a risk evaluation and mitigation strategy (REMS), according to the FDA.
The list price for a single treatment of axicabtagene ciloleucel is $373,000, according to the manufacturer.
“We will soon release a comprehensive policy to address how we plan to support the development of cell-based regenerative medicine,” Dr. Gottlieb said in a statement. “That policy will also clarify how we will apply our expedited programs to breakthrough products that use CAR-T cells and other gene therapies. We remain committed to supporting the efficient development of safe and effective treatments that leverage these new scientific platforms.”
Axicabtagene ciloleucel was developed by Kite Pharma, which was acquired recently by Gilead Sciences.
dfulton@frontlinemedcom.com
On Twitter @denisefulton
A second chimeric antigen receptor (CAR) T-cell therapy has gained FDA approval, this time for the treatment of large B-cell lymphoma in adults.
“Today marks another milestone in the development of a whole new scientific paradigm for the treatment of serious diseases,” FDA Commissioner Scott Gottlieb, MD, said in a statement. “This approval demonstrates the continued momentum of this promising new area of medicine, and we’re committed to supporting and helping expedite the development of these products.”
Approval was based on ZUMA-1, a multicenter clinical trial of 101 adults with refractory or relapsed large B-cell lymphoma. Almost three-quarters (72%) of patients responded, including 51% who achieved complete remission.
CAR-T therapy can cause severe, life-threatening side effects, most notably cytokine release syndrome (CRS) and neurologic toxicities, for which axicabtagene ciloleucel will carry a boxed warning and will come with a risk evaluation and mitigation strategy (REMS), according to the FDA.
The list price for a single treatment of axicabtagene ciloleucel is $373,000, according to the manufacturer.
“We will soon release a comprehensive policy to address how we plan to support the development of cell-based regenerative medicine,” Dr. Gottlieb said in a statement. “That policy will also clarify how we will apply our expedited programs to breakthrough products that use CAR-T cells and other gene therapies. We remain committed to supporting the efficient development of safe and effective treatments that leverage these new scientific platforms.”
Axicabtagene ciloleucel was developed by Kite Pharma, which was acquired recently by Gilead Sciences.
dfulton@frontlinemedcom.com
On Twitter @denisefulton
A second chimeric antigen receptor (CAR) T-cell therapy has gained FDA approval, this time for the treatment of large B-cell lymphoma in adults.
“Today marks another milestone in the development of a whole new scientific paradigm for the treatment of serious diseases,” FDA Commissioner Scott Gottlieb, MD, said in a statement. “This approval demonstrates the continued momentum of this promising new area of medicine, and we’re committed to supporting and helping expedite the development of these products.”
Approval was based on ZUMA-1, a multicenter clinical trial of 101 adults with refractory or relapsed large B-cell lymphoma. Almost three-quarters (72%) of patients responded, including 51% who achieved complete remission.
CAR-T therapy can cause severe, life-threatening side effects, most notably cytokine release syndrome (CRS) and neurologic toxicities, for which axicabtagene ciloleucel will carry a boxed warning and will come with a risk evaluation and mitigation strategy (REMS), according to the FDA.
The list price for a single treatment of axicabtagene ciloleucel is $373,000, according to the manufacturer.
“We will soon release a comprehensive policy to address how we plan to support the development of cell-based regenerative medicine,” Dr. Gottlieb said in a statement. “That policy will also clarify how we will apply our expedited programs to breakthrough products that use CAR-T cells and other gene therapies. We remain committed to supporting the efficient development of safe and effective treatments that leverage these new scientific platforms.”
Axicabtagene ciloleucel was developed by Kite Pharma, which was acquired recently by Gilead Sciences.
dfulton@frontlinemedcom.com
On Twitter @denisefulton
Inotuzumab ozogamicin approved for relapsed/refractory ALL
The Food and Drug Administration has approved the antibody drug conjugate inotuzumab ozogamicin for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
The treatment, to be marketed by Pfizer as Besponsa, won approval based on the results of the INO-VATE ALL trial, which randomized 326 patients to receive either inotuzumab ozogamicin (164 patients) or a chemotherapy regimen of the investigator’s choice (162 patients). To be considered for inclusion in the trial, patients with Philadelphia chromosome–negative or –positive relapsed or refractory B-cell precursor ALL were required to have at least 5% bone marrow blasts and have received one or two induction chemotherapy regimens.
Adverse events that occurred in more than 20% of patients included thrombocytopenia, neutropenia, anemia, leukopenia, fatigue, hemorrhage, pyrexia, nausea, headache, febrile neutropenia, abdominal pain, and hyperbilirubinemia, as well as increases in gamma-glutamyltransferase and transaminases. Adverse events that led to discontinuation of treatment were infection, thrombocytopenia, hyperbilirubinemia, hemorrhage, and increases in transaminases.
Preliminary results were published in August 2016 (N Engl J Med. 2016;375:740-53).
Inotuzumab ozogamicin was granted orphan drug and breakthrough status, as well as priority review, by the FDA in February 2017.
dfulton@frontlinemedcom.com
On Twitter @denisefulton
The Food and Drug Administration has approved the antibody drug conjugate inotuzumab ozogamicin for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
The treatment, to be marketed by Pfizer as Besponsa, won approval based on the results of the INO-VATE ALL trial, which randomized 326 patients to receive either inotuzumab ozogamicin (164 patients) or a chemotherapy regimen of the investigator’s choice (162 patients). To be considered for inclusion in the trial, patients with Philadelphia chromosome–negative or –positive relapsed or refractory B-cell precursor ALL were required to have at least 5% bone marrow blasts and have received one or two induction chemotherapy regimens.
Adverse events that occurred in more than 20% of patients included thrombocytopenia, neutropenia, anemia, leukopenia, fatigue, hemorrhage, pyrexia, nausea, headache, febrile neutropenia, abdominal pain, and hyperbilirubinemia, as well as increases in gamma-glutamyltransferase and transaminases. Adverse events that led to discontinuation of treatment were infection, thrombocytopenia, hyperbilirubinemia, hemorrhage, and increases in transaminases.
Preliminary results were published in August 2016 (N Engl J Med. 2016;375:740-53).
Inotuzumab ozogamicin was granted orphan drug and breakthrough status, as well as priority review, by the FDA in February 2017.
dfulton@frontlinemedcom.com
On Twitter @denisefulton
The Food and Drug Administration has approved the antibody drug conjugate inotuzumab ozogamicin for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
The treatment, to be marketed by Pfizer as Besponsa, won approval based on the results of the INO-VATE ALL trial, which randomized 326 patients to receive either inotuzumab ozogamicin (164 patients) or a chemotherapy regimen of the investigator’s choice (162 patients). To be considered for inclusion in the trial, patients with Philadelphia chromosome–negative or –positive relapsed or refractory B-cell precursor ALL were required to have at least 5% bone marrow blasts and have received one or two induction chemotherapy regimens.
Adverse events that occurred in more than 20% of patients included thrombocytopenia, neutropenia, anemia, leukopenia, fatigue, hemorrhage, pyrexia, nausea, headache, febrile neutropenia, abdominal pain, and hyperbilirubinemia, as well as increases in gamma-glutamyltransferase and transaminases. Adverse events that led to discontinuation of treatment were infection, thrombocytopenia, hyperbilirubinemia, hemorrhage, and increases in transaminases.
Preliminary results were published in August 2016 (N Engl J Med. 2016;375:740-53).
Inotuzumab ozogamicin was granted orphan drug and breakthrough status, as well as priority review, by the FDA in February 2017.
dfulton@frontlinemedcom.com
On Twitter @denisefulton
FDA approves new fluoroquinolone for skin, skin structure infections
The Food and Drug Administration has approved delafloxacin, a fluoroquinolone, for the treatment of acute bacterial skin and skin structure infections, according to an agency announcement June 19.
Delafloxacin, which will be marketed by Melinta Therapeutics as Baxdela, was designated a qualified infectious disease product (QIDP) and granted fast-track and priority review. These classifications are designed to speed approval of antibacterial products to treat serious or life-threatening infections, according to an FDA statement.
Common adverse events seen with use of delafloxacin included nausea, diarrhea, headache, elevated liver enzymes, and vomiting.
The approval requires Melinta Therapeutics to conduct a 5-year postmarketing surveillance study to look for resistance to delafloxacin; the final report on that study must be submitted by the end of 2022.
The drug was not subject to FDA advisory committee review because its new drug application “did not raise significant safety or efficacy issues that were unexpected” for a drug in its class, according to FDA officials.
For more information see the Drugs@FDA listing for Baxdela.
dfulton@frontlinemedcom.com
On Twitter @denisefulton
The Food and Drug Administration has approved delafloxacin, a fluoroquinolone, for the treatment of acute bacterial skin and skin structure infections, according to an agency announcement June 19.
Delafloxacin, which will be marketed by Melinta Therapeutics as Baxdela, was designated a qualified infectious disease product (QIDP) and granted fast-track and priority review. These classifications are designed to speed approval of antibacterial products to treat serious or life-threatening infections, according to an FDA statement.
Common adverse events seen with use of delafloxacin included nausea, diarrhea, headache, elevated liver enzymes, and vomiting.
The approval requires Melinta Therapeutics to conduct a 5-year postmarketing surveillance study to look for resistance to delafloxacin; the final report on that study must be submitted by the end of 2022.
The drug was not subject to FDA advisory committee review because its new drug application “did not raise significant safety or efficacy issues that were unexpected” for a drug in its class, according to FDA officials.
For more information see the Drugs@FDA listing for Baxdela.
dfulton@frontlinemedcom.com
On Twitter @denisefulton
The Food and Drug Administration has approved delafloxacin, a fluoroquinolone, for the treatment of acute bacterial skin and skin structure infections, according to an agency announcement June 19.
Delafloxacin, which will be marketed by Melinta Therapeutics as Baxdela, was designated a qualified infectious disease product (QIDP) and granted fast-track and priority review. These classifications are designed to speed approval of antibacterial products to treat serious or life-threatening infections, according to an FDA statement.
Common adverse events seen with use of delafloxacin included nausea, diarrhea, headache, elevated liver enzymes, and vomiting.
The approval requires Melinta Therapeutics to conduct a 5-year postmarketing surveillance study to look for resistance to delafloxacin; the final report on that study must be submitted by the end of 2022.
The drug was not subject to FDA advisory committee review because its new drug application “did not raise significant safety or efficacy issues that were unexpected” for a drug in its class, according to FDA officials.
For more information see the Drugs@FDA listing for Baxdela.
dfulton@frontlinemedcom.com
On Twitter @denisefulton
Docs to Senate: Abandon your secret efforts on ACA repeal/replace
Six major organizations representing physicians have written to Senate leaders asking them to step back and take a different tack on health reform.
Senators have been meeting behind closed doors to craft health reform legislation as an alternative to the House-passed American Health Care Act (AHCA). To date, no draft legislation has surfaced publicly and no hearings have been held to discuss health reform provisions under consideration.
The letter was signed by the American Academy of Family Physicians, the American Academy of Pediatrics, the American College of Physicians, the American Congress of Obstetricians and Gynecologists, the American Osteopathic Association, and the American Psychiatric Association.
The groups raised their specific objections to two provisions of the AHCA that senators are said to be considering: caps on Medicaid funding and repeal of the Affordable Care Act’s essential benefits package.
Throughout the current health reform efforts “our organizations continually offered constructive ideas on achieving agreement on legislation consistent with our shared principles,” according to the letter. “Regrettably, both the House and Senate seem to be heading to a vote on legislation that would violate those principles by rolling back coverage and patient protections for tens of millions of patients.”
dfulton@frontlinemedcom.com
On Twitter @denisefulton
Six major organizations representing physicians have written to Senate leaders asking them to step back and take a different tack on health reform.
Senators have been meeting behind closed doors to craft health reform legislation as an alternative to the House-passed American Health Care Act (AHCA). To date, no draft legislation has surfaced publicly and no hearings have been held to discuss health reform provisions under consideration.
The letter was signed by the American Academy of Family Physicians, the American Academy of Pediatrics, the American College of Physicians, the American Congress of Obstetricians and Gynecologists, the American Osteopathic Association, and the American Psychiatric Association.
The groups raised their specific objections to two provisions of the AHCA that senators are said to be considering: caps on Medicaid funding and repeal of the Affordable Care Act’s essential benefits package.
Throughout the current health reform efforts “our organizations continually offered constructive ideas on achieving agreement on legislation consistent with our shared principles,” according to the letter. “Regrettably, both the House and Senate seem to be heading to a vote on legislation that would violate those principles by rolling back coverage and patient protections for tens of millions of patients.”
dfulton@frontlinemedcom.com
On Twitter @denisefulton
Six major organizations representing physicians have written to Senate leaders asking them to step back and take a different tack on health reform.
Senators have been meeting behind closed doors to craft health reform legislation as an alternative to the House-passed American Health Care Act (AHCA). To date, no draft legislation has surfaced publicly and no hearings have been held to discuss health reform provisions under consideration.
The letter was signed by the American Academy of Family Physicians, the American Academy of Pediatrics, the American College of Physicians, the American Congress of Obstetricians and Gynecologists, the American Osteopathic Association, and the American Psychiatric Association.
The groups raised their specific objections to two provisions of the AHCA that senators are said to be considering: caps on Medicaid funding and repeal of the Affordable Care Act’s essential benefits package.
Throughout the current health reform efforts “our organizations continually offered constructive ideas on achieving agreement on legislation consistent with our shared principles,” according to the letter. “Regrettably, both the House and Senate seem to be heading to a vote on legislation that would violate those principles by rolling back coverage and patient protections for tens of millions of patients.”
dfulton@frontlinemedcom.com
On Twitter @denisefulton
Study underscores aggressive approach to inflammatory breast cancer
Aggressive resection to negative margins, combined with neoadjuvant chemotherapy and postsurgical radiation, resulted in a 96% 5-year locoregional recurrence-free survival in nonmetastatic inflammatory breast cancer, Kelly Rosso, MD, reported.
Dr. Rosso of MD Anderson Cancer Center, Houston, and her colleagues identified 277 women diagnosed with inflammatory breast cancer between 2007 and 2015 from a prospective database; 114 of those had nonmetastatic disease and received aggressive trimodality therapy with curative intent.
Median age at diagnosis was 52 years and all patients were diagnosed at Stage III; 55% presented with N2 disease while 45% presented with N3. Patients were followed for a median 3.6 years.
“Historically, prognosis for patients with inflammatory breast cancer has been very poor,” Dr. Rosso said at a press conference in advance of the annual meeting of the American Society of Breast Surgeons. “Data from our institution has failed to identify any significant improvement in survival from the 1970s to the 2000s.”
In this study, 29 patients died and 4 experienced a locoregional recurrence (3.5%) during follow-up. The 2-year probability of locoregional recurrence was low, at 3.19%, while the 2-year probability of recurrence or distant metastasis was 23.1%. The 5-year disease-free survival was 72.5%, significantly lower than local/regional recurrence-free survival because some patients developed metastatic cancer in other organs, Dr. Rosso reported.
Diminished overall survival and increased risk for recurrence or metastasis were more likely in women over the age of 65 years and those with HER2-negative status, limited clinical response to chemotherapy, and absence of a pathologically complete response. Recurrence or metastasis also were more likely in women with Stage IIIC disease and more lymphovascular involvement.
“It is encouraging to see the high 5-year breast cancer specific survival rates reported in this cohort,” Judy C. Boughey, MD, professor of surgery and vice chair of research at the Mayo Clinic, Rochester, Minn., said in a statement. “This study supports that the current management of these patients with neoadjuvant chemotherapy, mastectomy and post-mastectomy radiation is the optimal multimodal approach for inflammatory breast cancer. The improvements in systemic therapy, with increased use of directed therapy, being used in breast cancer, together with appropriate local-regional therapies, is likely responsible for the improvement in survival over historical cohorts.”
dfulton@frontlinemedcom.com
On Twitter @denisefulton
Aggressive resection to negative margins, combined with neoadjuvant chemotherapy and postsurgical radiation, resulted in a 96% 5-year locoregional recurrence-free survival in nonmetastatic inflammatory breast cancer, Kelly Rosso, MD, reported.
Dr. Rosso of MD Anderson Cancer Center, Houston, and her colleagues identified 277 women diagnosed with inflammatory breast cancer between 2007 and 2015 from a prospective database; 114 of those had nonmetastatic disease and received aggressive trimodality therapy with curative intent.
Median age at diagnosis was 52 years and all patients were diagnosed at Stage III; 55% presented with N2 disease while 45% presented with N3. Patients were followed for a median 3.6 years.
“Historically, prognosis for patients with inflammatory breast cancer has been very poor,” Dr. Rosso said at a press conference in advance of the annual meeting of the American Society of Breast Surgeons. “Data from our institution has failed to identify any significant improvement in survival from the 1970s to the 2000s.”
In this study, 29 patients died and 4 experienced a locoregional recurrence (3.5%) during follow-up. The 2-year probability of locoregional recurrence was low, at 3.19%, while the 2-year probability of recurrence or distant metastasis was 23.1%. The 5-year disease-free survival was 72.5%, significantly lower than local/regional recurrence-free survival because some patients developed metastatic cancer in other organs, Dr. Rosso reported.
Diminished overall survival and increased risk for recurrence or metastasis were more likely in women over the age of 65 years and those with HER2-negative status, limited clinical response to chemotherapy, and absence of a pathologically complete response. Recurrence or metastasis also were more likely in women with Stage IIIC disease and more lymphovascular involvement.
“It is encouraging to see the high 5-year breast cancer specific survival rates reported in this cohort,” Judy C. Boughey, MD, professor of surgery and vice chair of research at the Mayo Clinic, Rochester, Minn., said in a statement. “This study supports that the current management of these patients with neoadjuvant chemotherapy, mastectomy and post-mastectomy radiation is the optimal multimodal approach for inflammatory breast cancer. The improvements in systemic therapy, with increased use of directed therapy, being used in breast cancer, together with appropriate local-regional therapies, is likely responsible for the improvement in survival over historical cohorts.”
dfulton@frontlinemedcom.com
On Twitter @denisefulton
Aggressive resection to negative margins, combined with neoadjuvant chemotherapy and postsurgical radiation, resulted in a 96% 5-year locoregional recurrence-free survival in nonmetastatic inflammatory breast cancer, Kelly Rosso, MD, reported.
Dr. Rosso of MD Anderson Cancer Center, Houston, and her colleagues identified 277 women diagnosed with inflammatory breast cancer between 2007 and 2015 from a prospective database; 114 of those had nonmetastatic disease and received aggressive trimodality therapy with curative intent.
Median age at diagnosis was 52 years and all patients were diagnosed at Stage III; 55% presented with N2 disease while 45% presented with N3. Patients were followed for a median 3.6 years.
“Historically, prognosis for patients with inflammatory breast cancer has been very poor,” Dr. Rosso said at a press conference in advance of the annual meeting of the American Society of Breast Surgeons. “Data from our institution has failed to identify any significant improvement in survival from the 1970s to the 2000s.”
In this study, 29 patients died and 4 experienced a locoregional recurrence (3.5%) during follow-up. The 2-year probability of locoregional recurrence was low, at 3.19%, while the 2-year probability of recurrence or distant metastasis was 23.1%. The 5-year disease-free survival was 72.5%, significantly lower than local/regional recurrence-free survival because some patients developed metastatic cancer in other organs, Dr. Rosso reported.
Diminished overall survival and increased risk for recurrence or metastasis were more likely in women over the age of 65 years and those with HER2-negative status, limited clinical response to chemotherapy, and absence of a pathologically complete response. Recurrence or metastasis also were more likely in women with Stage IIIC disease and more lymphovascular involvement.
“It is encouraging to see the high 5-year breast cancer specific survival rates reported in this cohort,” Judy C. Boughey, MD, professor of surgery and vice chair of research at the Mayo Clinic, Rochester, Minn., said in a statement. “This study supports that the current management of these patients with neoadjuvant chemotherapy, mastectomy and post-mastectomy radiation is the optimal multimodal approach for inflammatory breast cancer. The improvements in systemic therapy, with increased use of directed therapy, being used in breast cancer, together with appropriate local-regional therapies, is likely responsible for the improvement in survival over historical cohorts.”
dfulton@frontlinemedcom.com
On Twitter @denisefulton
FROM ASBS 2017
Key clinical point:
Major finding: Locoregional recurrence occurred in 4 out of 114 women with inflammatory breast cancer treated with trimodality therapy.
Data source: A prospective database of 277 women diagnosed with inflammatory breast cancer between 2007 and 2015.
Disclosures: The study was unsponsored. Dr. Rosso disclosed no relevant conflicts of interest.
Multimodal breast cancer treatment linked with greater risk of lymphedema
Chemotherapy, radiation, and higher body mass index are strongly associated with increased risk of lymphedema in breast cancer patients who have undergone sentinel node biopsy or axillary lymph node dissection, according to analysis of data from the Rochester Epidemiology Project.
Judy C. Boughey, MD, professor of surgery and vice chair of research at the Mayo Clinic, Rochester, Minn., and her associates performed a chart review of 1,794 patients diagnosed with a first breast cancer in Olmsted County, Minn., between 1990 and 2010. Patients’ median age at diagnosis was 60 years. About half (48%) were diagnosed at stage I, while 17% were diagnosed at Stage 0, 29% at Stage II, and 6% at Stage III.
At a median of 10 years of follow-up, 209 patients had been diagnosed with breast cancer–related lymphedema, with most diagnoses occurring within 5 years of surgery. No cases of lymphedema were found in patients who did not have axillary surgery.
There was no significant difference in the rate of lymphedema based on type of breast cancer surgery (mastectomy vs. lumpectomy with breast-conserving surgery); however, lymphedema occurred significantly more frequently in patients who received ALND as compared to those who received SLN (15.9% vs. 5.3%). Lymphedema rates did not differ based on type of axillary surgery (3.5% for ALND and 4.1% for SLN) in a subset of 453 patients who did not receive radiation or chemotherapy.
Almost a third (31.3%) of patients who had nodal radiation, with or without breast or chest wall radiation, developed lymphedema by 5 years, as compared with 5.9% of patients who did not receive radiation (P less than .001). Similarly, patients who received chemotherapy were significantly more likely to develop lymphedema. At 5 years, lymphedema was present in 27.2% of patients who received anthracylcline/cyclophosphamide (AC) with a taxane agent, 29.7% of those who received a taxane agent without AC , and 6.0% of those who did not get chemotherapy (P less than .001).
Five-year incidence of lymphedema also increased significantly with body mass index, occurring in 17.1% of patients with a BMI greater than 35 kg/m2, 13% of those with a BMI between 30-34.99, and 14.4% of those with a BMI between 25-29.99, as compared with 8% of those with a BMI below 25.
On univariate analysis, increased stage was associated with risk of lymphedema, Dr. Boughey said. However, on multivariate analysis, stage was no longer associated with risk of lymphedema and “the dominate factors were BMI, type of axillary surgery, use of radiation therapy and particularly nodal radiation, and the use of chemotherapy.”
The highest rate of lymphedema was seen in a patients with the most advanced disease who had ALND with nodal radiation and AC with a taxane agent, she said.
“We think this is primarily due to the modalities of treatment rather that the pure phenomenon of stage,” Dr. Boughey added. “This study can help identify patients at a higher risk of lymphedema so that we can individualize the surveillance of these patients to allow them to have earlier identification and earlier treatment of lymphedema.”
dfulton@frontlinemedcom.com
On Twitter @denisefulton
Chemotherapy, radiation, and higher body mass index are strongly associated with increased risk of lymphedema in breast cancer patients who have undergone sentinel node biopsy or axillary lymph node dissection, according to analysis of data from the Rochester Epidemiology Project.
Judy C. Boughey, MD, professor of surgery and vice chair of research at the Mayo Clinic, Rochester, Minn., and her associates performed a chart review of 1,794 patients diagnosed with a first breast cancer in Olmsted County, Minn., between 1990 and 2010. Patients’ median age at diagnosis was 60 years. About half (48%) were diagnosed at stage I, while 17% were diagnosed at Stage 0, 29% at Stage II, and 6% at Stage III.
At a median of 10 years of follow-up, 209 patients had been diagnosed with breast cancer–related lymphedema, with most diagnoses occurring within 5 years of surgery. No cases of lymphedema were found in patients who did not have axillary surgery.
There was no significant difference in the rate of lymphedema based on type of breast cancer surgery (mastectomy vs. lumpectomy with breast-conserving surgery); however, lymphedema occurred significantly more frequently in patients who received ALND as compared to those who received SLN (15.9% vs. 5.3%). Lymphedema rates did not differ based on type of axillary surgery (3.5% for ALND and 4.1% for SLN) in a subset of 453 patients who did not receive radiation or chemotherapy.
Almost a third (31.3%) of patients who had nodal radiation, with or without breast or chest wall radiation, developed lymphedema by 5 years, as compared with 5.9% of patients who did not receive radiation (P less than .001). Similarly, patients who received chemotherapy were significantly more likely to develop lymphedema. At 5 years, lymphedema was present in 27.2% of patients who received anthracylcline/cyclophosphamide (AC) with a taxane agent, 29.7% of those who received a taxane agent without AC , and 6.0% of those who did not get chemotherapy (P less than .001).
Five-year incidence of lymphedema also increased significantly with body mass index, occurring in 17.1% of patients with a BMI greater than 35 kg/m2, 13% of those with a BMI between 30-34.99, and 14.4% of those with a BMI between 25-29.99, as compared with 8% of those with a BMI below 25.
On univariate analysis, increased stage was associated with risk of lymphedema, Dr. Boughey said. However, on multivariate analysis, stage was no longer associated with risk of lymphedema and “the dominate factors were BMI, type of axillary surgery, use of radiation therapy and particularly nodal radiation, and the use of chemotherapy.”
The highest rate of lymphedema was seen in a patients with the most advanced disease who had ALND with nodal radiation and AC with a taxane agent, she said.
“We think this is primarily due to the modalities of treatment rather that the pure phenomenon of stage,” Dr. Boughey added. “This study can help identify patients at a higher risk of lymphedema so that we can individualize the surveillance of these patients to allow them to have earlier identification and earlier treatment of lymphedema.”
dfulton@frontlinemedcom.com
On Twitter @denisefulton
Chemotherapy, radiation, and higher body mass index are strongly associated with increased risk of lymphedema in breast cancer patients who have undergone sentinel node biopsy or axillary lymph node dissection, according to analysis of data from the Rochester Epidemiology Project.
Judy C. Boughey, MD, professor of surgery and vice chair of research at the Mayo Clinic, Rochester, Minn., and her associates performed a chart review of 1,794 patients diagnosed with a first breast cancer in Olmsted County, Minn., between 1990 and 2010. Patients’ median age at diagnosis was 60 years. About half (48%) were diagnosed at stage I, while 17% were diagnosed at Stage 0, 29% at Stage II, and 6% at Stage III.
At a median of 10 years of follow-up, 209 patients had been diagnosed with breast cancer–related lymphedema, with most diagnoses occurring within 5 years of surgery. No cases of lymphedema were found in patients who did not have axillary surgery.
There was no significant difference in the rate of lymphedema based on type of breast cancer surgery (mastectomy vs. lumpectomy with breast-conserving surgery); however, lymphedema occurred significantly more frequently in patients who received ALND as compared to those who received SLN (15.9% vs. 5.3%). Lymphedema rates did not differ based on type of axillary surgery (3.5% for ALND and 4.1% for SLN) in a subset of 453 patients who did not receive radiation or chemotherapy.
Almost a third (31.3%) of patients who had nodal radiation, with or without breast or chest wall radiation, developed lymphedema by 5 years, as compared with 5.9% of patients who did not receive radiation (P less than .001). Similarly, patients who received chemotherapy were significantly more likely to develop lymphedema. At 5 years, lymphedema was present in 27.2% of patients who received anthracylcline/cyclophosphamide (AC) with a taxane agent, 29.7% of those who received a taxane agent without AC , and 6.0% of those who did not get chemotherapy (P less than .001).
Five-year incidence of lymphedema also increased significantly with body mass index, occurring in 17.1% of patients with a BMI greater than 35 kg/m2, 13% of those with a BMI between 30-34.99, and 14.4% of those with a BMI between 25-29.99, as compared with 8% of those with a BMI below 25.
On univariate analysis, increased stage was associated with risk of lymphedema, Dr. Boughey said. However, on multivariate analysis, stage was no longer associated with risk of lymphedema and “the dominate factors were BMI, type of axillary surgery, use of radiation therapy and particularly nodal radiation, and the use of chemotherapy.”
The highest rate of lymphedema was seen in a patients with the most advanced disease who had ALND with nodal radiation and AC with a taxane agent, she said.
“We think this is primarily due to the modalities of treatment rather that the pure phenomenon of stage,” Dr. Boughey added. “This study can help identify patients at a higher risk of lymphedema so that we can individualize the surveillance of these patients to allow them to have earlier identification and earlier treatment of lymphedema.”
dfulton@frontlinemedcom.com
On Twitter @denisefulton
FROM ASBS 2017
Key clinical point:
Major finding: More than 30% of patients receiving nodal radiation developed lymphedema vs. 5.9% of those who did not. Similarly, lymphedema developed in just under 30% of patients who received a taxane vs. 6.9% of those who did not.
Data source: Analysis of all 1,794 cases of first breast cancers diagnosed in Olmsted County, Minn., 1990-2010.
Disclosures: The Rochester Epidemiology Project receives federal funding from agencies of the Health & Human Services Department. Dr. Boughey reported no relevant financial conflicts of interest.
VIDEO: Geeks brave rain to March for Science
WASHINGTON – Peaceful protesters in hundreds of cities around the globe gathered on Earth Day, April 22, to voice their support for evidence-based policies and funding for scientific research at the March for Science.
In Washington, thousands of participants gathered on the rainy National Mall for teach-ins and speeches, then marched from the Washington Monument to Capitol Hill. A key concern for marchers here was cuts in science agency funding in the Trump administration’s budget proposal for fiscal year 2018.
Organizers now are calling on supporters to participate in a week of action to continue to demonstrate widespread support for their positions.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
dfulton@frontlinemedcom.com
On Twitter @denisefulton
WASHINGTON – Peaceful protesters in hundreds of cities around the globe gathered on Earth Day, April 22, to voice their support for evidence-based policies and funding for scientific research at the March for Science.
In Washington, thousands of participants gathered on the rainy National Mall for teach-ins and speeches, then marched from the Washington Monument to Capitol Hill. A key concern for marchers here was cuts in science agency funding in the Trump administration’s budget proposal for fiscal year 2018.
Organizers now are calling on supporters to participate in a week of action to continue to demonstrate widespread support for their positions.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
dfulton@frontlinemedcom.com
On Twitter @denisefulton
WASHINGTON – Peaceful protesters in hundreds of cities around the globe gathered on Earth Day, April 22, to voice their support for evidence-based policies and funding for scientific research at the March for Science.
In Washington, thousands of participants gathered on the rainy National Mall for teach-ins and speeches, then marched from the Washington Monument to Capitol Hill. A key concern for marchers here was cuts in science agency funding in the Trump administration’s budget proposal for fiscal year 2018.
Organizers now are calling on supporters to participate in a week of action to continue to demonstrate widespread support for their positions.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
dfulton@frontlinemedcom.com
On Twitter @denisefulton
Renflexis approved as second infliximab biosimilar
Infliximab-abda is the second infliximab biosimilar approved by the Food and Drug Administration, the agency announced April 21.
Infliximab-abda, to be marketed as Renflexis, is approved for all indications as the reference product, including Crohn’s diseases in adults and children, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis, according to the product label.
Like Remicade, Renflexis will come with a boxed warning and a Medication Guide that describes important information about its uses and risks, which include serious infections, lymphoma and other malignancies, liver injury, blood problems, lupuslike syndrome, psoriasis, and in rare cases, nervous system disorders.
Renflexis will be marketed by Merck Sharp & Dohme and is manufactured by Samsung Bioepis.
dfulton@frontlinemedcom.com
On Twitter @denisefulton
Infliximab-abda is the second infliximab biosimilar approved by the Food and Drug Administration, the agency announced April 21.
Infliximab-abda, to be marketed as Renflexis, is approved for all indications as the reference product, including Crohn’s diseases in adults and children, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis, according to the product label.
Like Remicade, Renflexis will come with a boxed warning and a Medication Guide that describes important information about its uses and risks, which include serious infections, lymphoma and other malignancies, liver injury, blood problems, lupuslike syndrome, psoriasis, and in rare cases, nervous system disorders.
Renflexis will be marketed by Merck Sharp & Dohme and is manufactured by Samsung Bioepis.
dfulton@frontlinemedcom.com
On Twitter @denisefulton
Infliximab-abda is the second infliximab biosimilar approved by the Food and Drug Administration, the agency announced April 21.
Infliximab-abda, to be marketed as Renflexis, is approved for all indications as the reference product, including Crohn’s diseases in adults and children, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis, according to the product label.
Like Remicade, Renflexis will come with a boxed warning and a Medication Guide that describes important information about its uses and risks, which include serious infections, lymphoma and other malignancies, liver injury, blood problems, lupuslike syndrome, psoriasis, and in rare cases, nervous system disorders.
Renflexis will be marketed by Merck Sharp & Dohme and is manufactured by Samsung Bioepis.
dfulton@frontlinemedcom.com
On Twitter @denisefulton
FDA sends baricitinib application back for revision
, according to a statement from manufacturer Eli Lilly.
The FDA complete response letter cited the need for additional data to determine the most appropriate doses for the once-daily oral medication and to suss out safety concerns across treatment arms.
In the recently published RA-BEAM trial, a manufacturer-sponsored, international, randomized, double-blind, phase III clinical trial involving 1,305 adults with moderate to severe active RA, 70% of patients taking baricitinib plus background therapy with methotrexate met the primary efficacy end point – the proportion of patients at week 12 who showed an ACR 20 response – compared with 40% for placebo (N Engl J Med. 2017;376:652-62).
dfulton@frontlinemedcom.com
On Twitter @denisefulton
, according to a statement from manufacturer Eli Lilly.
The FDA complete response letter cited the need for additional data to determine the most appropriate doses for the once-daily oral medication and to suss out safety concerns across treatment arms.
In the recently published RA-BEAM trial, a manufacturer-sponsored, international, randomized, double-blind, phase III clinical trial involving 1,305 adults with moderate to severe active RA, 70% of patients taking baricitinib plus background therapy with methotrexate met the primary efficacy end point – the proportion of patients at week 12 who showed an ACR 20 response – compared with 40% for placebo (N Engl J Med. 2017;376:652-62).
dfulton@frontlinemedcom.com
On Twitter @denisefulton
, according to a statement from manufacturer Eli Lilly.
The FDA complete response letter cited the need for additional data to determine the most appropriate doses for the once-daily oral medication and to suss out safety concerns across treatment arms.
In the recently published RA-BEAM trial, a manufacturer-sponsored, international, randomized, double-blind, phase III clinical trial involving 1,305 adults with moderate to severe active RA, 70% of patients taking baricitinib plus background therapy with methotrexate met the primary efficacy end point – the proportion of patients at week 12 who showed an ACR 20 response – compared with 40% for placebo (N Engl J Med. 2017;376:652-62).
dfulton@frontlinemedcom.com
On Twitter @denisefulton