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Junior resident participation in general surgery procedures declines
Junior-level residents are getting less operative experience in some common general surgery procedures, a large case review study has found.
The rise in laparoscopic surgery and the decline of open procedures have been accompanied by a reduction in junior resident participation in what previously would have been considered junior-level cases, reported Matthew Mullen, MD, and his associates at the department of surgery, University of Virginia, Charlottesville (J Surg Educ. 2016 August. doi: 10.1016/j.jsurg.2016.02.010).
“The general response from the surgical community has been that this issue would correct over time, and the distribution of cases to junior residents would normalize,” the investigators explained. In the present study, the investigators “sought to evaluate continuing trends in case distribution among junior and senior residents.”
A total of 185,335 surgical cases performed between 2005 and 2012, identified through a query of the Participant Use Data File, were analyzed. Junior residents were defined as PGY1-3. Of the surgical cases reviewed, 30.2% were appendectomies, 21.9% were inguinal herniorrhaphies, 14.2% were colectomies, and 33.8% were cholecystectomy.
Over the 8-year period, 66% of those procedures were laparoscopic, and each year the likelihood of surgery being performed laparoscopically increased steadily for appendectomy, inguinal herniorrhaphy, and colectomy but remained the same for cholecystectomies.
In the same 8-year period, the likelihood of junior resident participation across all of these procedures decreased by an average of 5.3% per year. This decrease was most drastic for laparoscopic cholecystectomy at 6.2% per year while participation did not change for laparoscopic inguinal herniorrhaphy and increased by 3.9% for partial colectomy.
Junior level participation in open surgeries over the 8 years also decreased by 9.4% for appendectomy, 10% for inguinal herniorrhaphy, 2.9% for partial colectomy, and 4.1% for cholecystectomy.
Among the limitations of the study, the data did not show whether the lack of operative experience among junior residents was compensated for in their senior year or if these patterns differed between academic and community training environments.
“The reason for diminishing junior resident case volume for the basic general surgery procedures we examined is not truly known. It is possible that these common and technically straightforward cases, traditionally the training ground for junior residents, now require advanced laparoscopic skills and therefore are no longer appropriate for junior-level residents,” Dr. Mullen and his associates wrote.
Nonetheless, the decline of junior resident participation in these procedures will have significant implications for general surgery resident education, the investigators concluded.
This study was funded by the National Institutes of Health. Author disclosures were not reported.
Junior-level residents are getting less operative experience in some common general surgery procedures, a large case review study has found.
The rise in laparoscopic surgery and the decline of open procedures have been accompanied by a reduction in junior resident participation in what previously would have been considered junior-level cases, reported Matthew Mullen, MD, and his associates at the department of surgery, University of Virginia, Charlottesville (J Surg Educ. 2016 August. doi: 10.1016/j.jsurg.2016.02.010).
“The general response from the surgical community has been that this issue would correct over time, and the distribution of cases to junior residents would normalize,” the investigators explained. In the present study, the investigators “sought to evaluate continuing trends in case distribution among junior and senior residents.”
A total of 185,335 surgical cases performed between 2005 and 2012, identified through a query of the Participant Use Data File, were analyzed. Junior residents were defined as PGY1-3. Of the surgical cases reviewed, 30.2% were appendectomies, 21.9% were inguinal herniorrhaphies, 14.2% were colectomies, and 33.8% were cholecystectomy.
Over the 8-year period, 66% of those procedures were laparoscopic, and each year the likelihood of surgery being performed laparoscopically increased steadily for appendectomy, inguinal herniorrhaphy, and colectomy but remained the same for cholecystectomies.
In the same 8-year period, the likelihood of junior resident participation across all of these procedures decreased by an average of 5.3% per year. This decrease was most drastic for laparoscopic cholecystectomy at 6.2% per year while participation did not change for laparoscopic inguinal herniorrhaphy and increased by 3.9% for partial colectomy.
Junior level participation in open surgeries over the 8 years also decreased by 9.4% for appendectomy, 10% for inguinal herniorrhaphy, 2.9% for partial colectomy, and 4.1% for cholecystectomy.
Among the limitations of the study, the data did not show whether the lack of operative experience among junior residents was compensated for in their senior year or if these patterns differed between academic and community training environments.
“The reason for diminishing junior resident case volume for the basic general surgery procedures we examined is not truly known. It is possible that these common and technically straightforward cases, traditionally the training ground for junior residents, now require advanced laparoscopic skills and therefore are no longer appropriate for junior-level residents,” Dr. Mullen and his associates wrote.
Nonetheless, the decline of junior resident participation in these procedures will have significant implications for general surgery resident education, the investigators concluded.
This study was funded by the National Institutes of Health. Author disclosures were not reported.
Junior-level residents are getting less operative experience in some common general surgery procedures, a large case review study has found.
The rise in laparoscopic surgery and the decline of open procedures have been accompanied by a reduction in junior resident participation in what previously would have been considered junior-level cases, reported Matthew Mullen, MD, and his associates at the department of surgery, University of Virginia, Charlottesville (J Surg Educ. 2016 August. doi: 10.1016/j.jsurg.2016.02.010).
“The general response from the surgical community has been that this issue would correct over time, and the distribution of cases to junior residents would normalize,” the investigators explained. In the present study, the investigators “sought to evaluate continuing trends in case distribution among junior and senior residents.”
A total of 185,335 surgical cases performed between 2005 and 2012, identified through a query of the Participant Use Data File, were analyzed. Junior residents were defined as PGY1-3. Of the surgical cases reviewed, 30.2% were appendectomies, 21.9% were inguinal herniorrhaphies, 14.2% were colectomies, and 33.8% were cholecystectomy.
Over the 8-year period, 66% of those procedures were laparoscopic, and each year the likelihood of surgery being performed laparoscopically increased steadily for appendectomy, inguinal herniorrhaphy, and colectomy but remained the same for cholecystectomies.
In the same 8-year period, the likelihood of junior resident participation across all of these procedures decreased by an average of 5.3% per year. This decrease was most drastic for laparoscopic cholecystectomy at 6.2% per year while participation did not change for laparoscopic inguinal herniorrhaphy and increased by 3.9% for partial colectomy.
Junior level participation in open surgeries over the 8 years also decreased by 9.4% for appendectomy, 10% for inguinal herniorrhaphy, 2.9% for partial colectomy, and 4.1% for cholecystectomy.
Among the limitations of the study, the data did not show whether the lack of operative experience among junior residents was compensated for in their senior year or if these patterns differed between academic and community training environments.
“The reason for diminishing junior resident case volume for the basic general surgery procedures we examined is not truly known. It is possible that these common and technically straightforward cases, traditionally the training ground for junior residents, now require advanced laparoscopic skills and therefore are no longer appropriate for junior-level residents,” Dr. Mullen and his associates wrote.
Nonetheless, the decline of junior resident participation in these procedures will have significant implications for general surgery resident education, the investigators concluded.
This study was funded by the National Institutes of Health. Author disclosures were not reported.
FROM THE JOURNAL OF SURGICAL EDUCATION
Key clinical point: Junior resident participation in certain general open and laparoscopic surgeries decreased from 2005 to 2012.
Major finding: Likelihood of junior resident participation in all procedures decreased by 5.3% per year over the 8-year period.
Data source: Meta-analysis of 185,335 surgical cases.
Disclosures: This study was funded by the National Institutes of Health. Author disclosures were not reported.
Guideline recommends 2-mm negative margins for DCIS
Surgical excision with 2-mm clear margins combined with whole-breast irradiation may be the optimal standard to reduce recurrence in patients with ductal carcinoma in situ (DCIS), according to a multidisciplinary consensus panel.
Despite the widespread use of surgical excision in breast-conserving therapy among patients with DCIS, there is no consensus on the optimal negative margin to prevent recurrence and re-excision. Therefore, the Society of Surgical Oncology, the American Society for Radiation Oncology, and the American Society of Clinical Oncology convened a panel to answer the following question: What margin width minimizes the risk of ipsilateral breast tumor recurrence in patients with DCIS receiving breast-conserving surgery?
The guideline panel reviewed 20 studies including 7,883 DCIS patients. A median of 100% of patients received whole-breast radiation therapy and a median of 21% received endocrine therapy. Patients were followed for a median of 6.5 years and the median incidence of recurrence was 8.3%.
“There is no debate that a positive margin ... implies a potentially incomplete resection and is associated with a higher rate of [recurrence],” according to Monica Morrow, MD, of Memorial Sloan-Kettering Cancer Center, and her fellow panelists. Further, the addition of whole-breast irradiation did not negate this increased risk, the panelists noted (J Clin Oncol. 2016 Aug. doi: 10.1200/JCO.2016.68.3573).
According to the meta-analysis, patients with 2-mm negative margins plus whole-breast irradiation were significantly less likely to experience ipsilateral breast tumor recurrence compared with patients who had excisions with positive margins.
“Margins of at least 2 mm are associated with a reduced risk of [recurrence] relative to narrower negative margin widths in patients receiving [whole-breast radiotherapy]. The routine practice of obtaining negative margin widths wider than 2 mm is not supported by the evidence,” they wrote.
The panel also noted that treatment with excision alone is associated with higher rates of recurrence compared with treatment involving with both excision and whole-breast radiation therapy. However, if patients are treated with excision alone, the optimal margin, which is unknown for this subset of patients, should be at least 2 millimeters, according to the guideline.
Due to variability in specimen sampling and in margin evaluation and assessment, “clinical judgment must be used in determining whether patients with smaller negative margin widths (0 or 1 mm) require re-excision,” the panelists noted. “The findings should not be extrapolated to DCIS patients treated with [accelerated partial breast irradiation] or those with invasive carcinoma for whom a separate guideline has been developed,” Dr. Morrow and her associates wrote.
The guideline development process was funded by the Susan G. Komen Foundation. The authors had no relevant disclosures to report.
On Twitter @jessnicolecraig
Surgical excision with 2-mm clear margins combined with whole-breast irradiation may be the optimal standard to reduce recurrence in patients with ductal carcinoma in situ (DCIS), according to a multidisciplinary consensus panel.
Despite the widespread use of surgical excision in breast-conserving therapy among patients with DCIS, there is no consensus on the optimal negative margin to prevent recurrence and re-excision. Therefore, the Society of Surgical Oncology, the American Society for Radiation Oncology, and the American Society of Clinical Oncology convened a panel to answer the following question: What margin width minimizes the risk of ipsilateral breast tumor recurrence in patients with DCIS receiving breast-conserving surgery?
The guideline panel reviewed 20 studies including 7,883 DCIS patients. A median of 100% of patients received whole-breast radiation therapy and a median of 21% received endocrine therapy. Patients were followed for a median of 6.5 years and the median incidence of recurrence was 8.3%.
“There is no debate that a positive margin ... implies a potentially incomplete resection and is associated with a higher rate of [recurrence],” according to Monica Morrow, MD, of Memorial Sloan-Kettering Cancer Center, and her fellow panelists. Further, the addition of whole-breast irradiation did not negate this increased risk, the panelists noted (J Clin Oncol. 2016 Aug. doi: 10.1200/JCO.2016.68.3573).
According to the meta-analysis, patients with 2-mm negative margins plus whole-breast irradiation were significantly less likely to experience ipsilateral breast tumor recurrence compared with patients who had excisions with positive margins.
“Margins of at least 2 mm are associated with a reduced risk of [recurrence] relative to narrower negative margin widths in patients receiving [whole-breast radiotherapy]. The routine practice of obtaining negative margin widths wider than 2 mm is not supported by the evidence,” they wrote.
The panel also noted that treatment with excision alone is associated with higher rates of recurrence compared with treatment involving with both excision and whole-breast radiation therapy. However, if patients are treated with excision alone, the optimal margin, which is unknown for this subset of patients, should be at least 2 millimeters, according to the guideline.
Due to variability in specimen sampling and in margin evaluation and assessment, “clinical judgment must be used in determining whether patients with smaller negative margin widths (0 or 1 mm) require re-excision,” the panelists noted. “The findings should not be extrapolated to DCIS patients treated with [accelerated partial breast irradiation] or those with invasive carcinoma for whom a separate guideline has been developed,” Dr. Morrow and her associates wrote.
The guideline development process was funded by the Susan G. Komen Foundation. The authors had no relevant disclosures to report.
On Twitter @jessnicolecraig
Surgical excision with 2-mm clear margins combined with whole-breast irradiation may be the optimal standard to reduce recurrence in patients with ductal carcinoma in situ (DCIS), according to a multidisciplinary consensus panel.
Despite the widespread use of surgical excision in breast-conserving therapy among patients with DCIS, there is no consensus on the optimal negative margin to prevent recurrence and re-excision. Therefore, the Society of Surgical Oncology, the American Society for Radiation Oncology, and the American Society of Clinical Oncology convened a panel to answer the following question: What margin width minimizes the risk of ipsilateral breast tumor recurrence in patients with DCIS receiving breast-conserving surgery?
The guideline panel reviewed 20 studies including 7,883 DCIS patients. A median of 100% of patients received whole-breast radiation therapy and a median of 21% received endocrine therapy. Patients were followed for a median of 6.5 years and the median incidence of recurrence was 8.3%.
“There is no debate that a positive margin ... implies a potentially incomplete resection and is associated with a higher rate of [recurrence],” according to Monica Morrow, MD, of Memorial Sloan-Kettering Cancer Center, and her fellow panelists. Further, the addition of whole-breast irradiation did not negate this increased risk, the panelists noted (J Clin Oncol. 2016 Aug. doi: 10.1200/JCO.2016.68.3573).
According to the meta-analysis, patients with 2-mm negative margins plus whole-breast irradiation were significantly less likely to experience ipsilateral breast tumor recurrence compared with patients who had excisions with positive margins.
“Margins of at least 2 mm are associated with a reduced risk of [recurrence] relative to narrower negative margin widths in patients receiving [whole-breast radiotherapy]. The routine practice of obtaining negative margin widths wider than 2 mm is not supported by the evidence,” they wrote.
The panel also noted that treatment with excision alone is associated with higher rates of recurrence compared with treatment involving with both excision and whole-breast radiation therapy. However, if patients are treated with excision alone, the optimal margin, which is unknown for this subset of patients, should be at least 2 millimeters, according to the guideline.
Due to variability in specimen sampling and in margin evaluation and assessment, “clinical judgment must be used in determining whether patients with smaller negative margin widths (0 or 1 mm) require re-excision,” the panelists noted. “The findings should not be extrapolated to DCIS patients treated with [accelerated partial breast irradiation] or those with invasive carcinoma for whom a separate guideline has been developed,” Dr. Morrow and her associates wrote.
The guideline development process was funded by the Susan G. Komen Foundation. The authors had no relevant disclosures to report.
On Twitter @jessnicolecraig
FROM THE JOURNAL OF CLINICAL ONCOLOGY
Key clinical point: Surgical excision with 2-mm clear margins combined with whole-breast irradiation may be the optimal standard to reduce recurrence in patients with ductal carcinoma in situ.
Major finding: Patients with 2-mm clear margins were significantly less likely to experience ipsilateral breast tumor recurrence compared with patients who had excisions with positive margins.
Data source: Meta-analysis of 20 studies and other published literature.
Disclosures: The Susan G. Komen Foundation funded the guideline development process. The panel members had no relevant disclosures.
Mortality rates higher among influenza B patients than influenza A patients
Influenza-attributable mortality was significantly greater in children with influenza B, compared with influenza A, investigators found.
Among those with influenza B, patients aged 10-16 years were most likely to require ICU admission, suggesting this subpopulation may be a target for immunization programs.
The percentage of clinical cases attributed to influenza B range from less than 1% to 44%, according to data published by the Centers for Disease Control and Prevention. However, influenza B is considered less virulent and less capable of causing pandemics and has therefore been less studied and outcomes of its disease less characterized, Dat Tran, MD, MSc, of the Hospital for Sick Children in Canada and his associates reported (Pediatrics. 2016 August. doi: 10.1542/peds.2015-4643).
The purpose of this study was to further understand the prevalence and severity of influenza B cases in comparison with influenza A and to identify pediatric subpopulations most at risk for contracting influenza B.
Children aged 16 years or younger hospitalized from laboratory-confirmed influenza A or B from September 2004 to June 2013 (excluding the pandemic year 2009-2010) were identified through active surveillance of admissions at the 12 pediatric referral centers of the Canadian Immunization Monitoring Program Active (IMPACT), a national surveillance initiative. Information regarding demographics, health status, vaccination status, presenting signs and symptoms, illness severity and mortality, treatment regimens, and ICU admission were collected and analyzed.
Of 4,155 influenza-related admissions during this time period, influenza B accounted for 1,510 (36.3%) cases and influenza A accounted for 2,645 (63.7%) cases.
Children admitted with influenza B tended to be older with a median age 3.9 years (interquartile range, 1.4-7.2), compared with a median of 2 years (IQR, 0.6-4.8 years) for children admitted with influenza A.
Children admitted with influenza B, compared with influenza A, had higher odds of having a vaccine-indicated condition (odds ratio, 1.30; 95% confidence interval, 1.14-1.47) and lower odds of having no underlying medical condition (OR, 0.80; 95% CI, 0.71-0.91), Dr. Tran and his associates reported.
“Compared with influenza A cases, children admitted with influenza B had greater adjusted odds of presenting with headache, abdominal pain, and myalgia, ranging from 1.38 for abdominal pain to 3.19 for myalgia,” they added. “There were no significant differences in antiviral or antibiotic prescription or use between influenza A and B cases.”
There was no significant difference in the proportion of influenza A or B patients admitted to the ICU (12.7% vs. 12.6%). Rather, multivariate modeling identified age and presence of an underlying condition as independent predictors of ICU admission.
Finally, influenza-attributable mortality was significantly greater in children with influenza B (adjusted OR, 2.65; 95% CI, 1.18-5.94). Influenza-attributable mortality occurred in 16 (1.1%) children with influenza B and only 10 (0.4%) children with influenza A. All-cause mortality followed a similar trend.
“Among hospitalized children, influenza A and B infections resulted in similar morbidity while mortality was greater for influenza B disease. Among healthy children hospitalized with influenza B, those aged 10-16 years were most likely to require ICU admission,” the investigators summarized.
“These children should be considered at high risk for complicated influenza B infection and be specifically targeted by immunization programs to receive influenza vaccination, and in particular, a [quadrivalent influenza vaccine],” they recommended.
This study was funded by GlaxoSmithKline Biologicals SA. The Canadian Immunization Monitoring Program Active is funded by the Public Health Agency of Canada. The investigators reported having no relevant disclosures.
Influenza-attributable mortality was significantly greater in children with influenza B, compared with influenza A, investigators found.
Among those with influenza B, patients aged 10-16 years were most likely to require ICU admission, suggesting this subpopulation may be a target for immunization programs.
The percentage of clinical cases attributed to influenza B range from less than 1% to 44%, according to data published by the Centers for Disease Control and Prevention. However, influenza B is considered less virulent and less capable of causing pandemics and has therefore been less studied and outcomes of its disease less characterized, Dat Tran, MD, MSc, of the Hospital for Sick Children in Canada and his associates reported (Pediatrics. 2016 August. doi: 10.1542/peds.2015-4643).
The purpose of this study was to further understand the prevalence and severity of influenza B cases in comparison with influenza A and to identify pediatric subpopulations most at risk for contracting influenza B.
Children aged 16 years or younger hospitalized from laboratory-confirmed influenza A or B from September 2004 to June 2013 (excluding the pandemic year 2009-2010) were identified through active surveillance of admissions at the 12 pediatric referral centers of the Canadian Immunization Monitoring Program Active (IMPACT), a national surveillance initiative. Information regarding demographics, health status, vaccination status, presenting signs and symptoms, illness severity and mortality, treatment regimens, and ICU admission were collected and analyzed.
Of 4,155 influenza-related admissions during this time period, influenza B accounted for 1,510 (36.3%) cases and influenza A accounted for 2,645 (63.7%) cases.
Children admitted with influenza B tended to be older with a median age 3.9 years (interquartile range, 1.4-7.2), compared with a median of 2 years (IQR, 0.6-4.8 years) for children admitted with influenza A.
Children admitted with influenza B, compared with influenza A, had higher odds of having a vaccine-indicated condition (odds ratio, 1.30; 95% confidence interval, 1.14-1.47) and lower odds of having no underlying medical condition (OR, 0.80; 95% CI, 0.71-0.91), Dr. Tran and his associates reported.
“Compared with influenza A cases, children admitted with influenza B had greater adjusted odds of presenting with headache, abdominal pain, and myalgia, ranging from 1.38 for abdominal pain to 3.19 for myalgia,” they added. “There were no significant differences in antiviral or antibiotic prescription or use between influenza A and B cases.”
There was no significant difference in the proportion of influenza A or B patients admitted to the ICU (12.7% vs. 12.6%). Rather, multivariate modeling identified age and presence of an underlying condition as independent predictors of ICU admission.
Finally, influenza-attributable mortality was significantly greater in children with influenza B (adjusted OR, 2.65; 95% CI, 1.18-5.94). Influenza-attributable mortality occurred in 16 (1.1%) children with influenza B and only 10 (0.4%) children with influenza A. All-cause mortality followed a similar trend.
“Among hospitalized children, influenza A and B infections resulted in similar morbidity while mortality was greater for influenza B disease. Among healthy children hospitalized with influenza B, those aged 10-16 years were most likely to require ICU admission,” the investigators summarized.
“These children should be considered at high risk for complicated influenza B infection and be specifically targeted by immunization programs to receive influenza vaccination, and in particular, a [quadrivalent influenza vaccine],” they recommended.
This study was funded by GlaxoSmithKline Biologicals SA. The Canadian Immunization Monitoring Program Active is funded by the Public Health Agency of Canada. The investigators reported having no relevant disclosures.
Influenza-attributable mortality was significantly greater in children with influenza B, compared with influenza A, investigators found.
Among those with influenza B, patients aged 10-16 years were most likely to require ICU admission, suggesting this subpopulation may be a target for immunization programs.
The percentage of clinical cases attributed to influenza B range from less than 1% to 44%, according to data published by the Centers for Disease Control and Prevention. However, influenza B is considered less virulent and less capable of causing pandemics and has therefore been less studied and outcomes of its disease less characterized, Dat Tran, MD, MSc, of the Hospital for Sick Children in Canada and his associates reported (Pediatrics. 2016 August. doi: 10.1542/peds.2015-4643).
The purpose of this study was to further understand the prevalence and severity of influenza B cases in comparison with influenza A and to identify pediatric subpopulations most at risk for contracting influenza B.
Children aged 16 years or younger hospitalized from laboratory-confirmed influenza A or B from September 2004 to June 2013 (excluding the pandemic year 2009-2010) were identified through active surveillance of admissions at the 12 pediatric referral centers of the Canadian Immunization Monitoring Program Active (IMPACT), a national surveillance initiative. Information regarding demographics, health status, vaccination status, presenting signs and symptoms, illness severity and mortality, treatment regimens, and ICU admission were collected and analyzed.
Of 4,155 influenza-related admissions during this time period, influenza B accounted for 1,510 (36.3%) cases and influenza A accounted for 2,645 (63.7%) cases.
Children admitted with influenza B tended to be older with a median age 3.9 years (interquartile range, 1.4-7.2), compared with a median of 2 years (IQR, 0.6-4.8 years) for children admitted with influenza A.
Children admitted with influenza B, compared with influenza A, had higher odds of having a vaccine-indicated condition (odds ratio, 1.30; 95% confidence interval, 1.14-1.47) and lower odds of having no underlying medical condition (OR, 0.80; 95% CI, 0.71-0.91), Dr. Tran and his associates reported.
“Compared with influenza A cases, children admitted with influenza B had greater adjusted odds of presenting with headache, abdominal pain, and myalgia, ranging from 1.38 for abdominal pain to 3.19 for myalgia,” they added. “There were no significant differences in antiviral or antibiotic prescription or use between influenza A and B cases.”
There was no significant difference in the proportion of influenza A or B patients admitted to the ICU (12.7% vs. 12.6%). Rather, multivariate modeling identified age and presence of an underlying condition as independent predictors of ICU admission.
Finally, influenza-attributable mortality was significantly greater in children with influenza B (adjusted OR, 2.65; 95% CI, 1.18-5.94). Influenza-attributable mortality occurred in 16 (1.1%) children with influenza B and only 10 (0.4%) children with influenza A. All-cause mortality followed a similar trend.
“Among hospitalized children, influenza A and B infections resulted in similar morbidity while mortality was greater for influenza B disease. Among healthy children hospitalized with influenza B, those aged 10-16 years were most likely to require ICU admission,” the investigators summarized.
“These children should be considered at high risk for complicated influenza B infection and be specifically targeted by immunization programs to receive influenza vaccination, and in particular, a [quadrivalent influenza vaccine],” they recommended.
This study was funded by GlaxoSmithKline Biologicals SA. The Canadian Immunization Monitoring Program Active is funded by the Public Health Agency of Canada. The investigators reported having no relevant disclosures.
FROM PEDIATRICS
Key clinical point: Influenza-attributable mortality was significantly greater in children with influenza B, compared with influenza A.
Major finding: Influenza-attributable mortality occurred in 16 (1.1%) children with influenza B and only 10 (0.4%) children with influenza A. Influenza-attributable mortality was significantly greater in children with influenza B (adjusted odds ratio, 2.65, 95% confidence interval, 1.18-5.94).
Data source: An observational study of 4,155 children admitted to the hospital with influenza A or B during nonpandemic years between September 2004 and June 2013.
Disclosures: This study was funded by GlaxoSmithKline Biologicals SA. The Canadian Immunization Monitoring Program Active is funded by the Public Health Agency of Canada. The investigators reported having no relevant disclosures.
Active surveillance may be feasible for some advanced RCC patients
For metastatic renal cell carcinoma patients with fewer adverse risk factors and fewer metastatic disease sites, initial active surveillance may be a safe and feasible approach to delay the toxicities of systemic therapy, investigators report.
Fifty-two patients with treatment-naive, asymptomatic, metastatic renal-cell carcinoma were enrolled in a prospective phase II trial and radiographically assessed at baseline, every 3 months for year 1, every 4 months for year 2, then every 6 months thereafter. Patients continued on observation until the treating physician and patient made the decision to initiate systemic therapy.
Median follow-up time was 38.1 months and median time on surveillance before treatment initiation – the primary endpoint of the study – was 14.9 months (95% confidence interval, 10.6-25.0), reported Brian Rini, MD, of the Cleveland Clinic Taussig Cancer Institute and his associates (Lancet Oncol. 2016. doi: 10.1016/S1470-2045(16)30196-6).
Forty-three (90%) of the 48 evaluable patients experienced disease progression during the study, median time to progression was 9.4 months, and 22 patients died from renal cell carcinoma. One patient developed brain metastases and died without receiving systemic therapy. In multivariable analysis, only the number of involved organs (P = .0414) and number of International Metastatic Database Consortium risk factors (P = .0403) were independently prognostic.
Using this analysis, Dr. Rini and associates identified two prognostic groups – a favorable group consisting of patients with no or one International Metastatic Database Consortium (IMDC) risk factors and two or fewer organs with metastatic disease, and an unfavorable group consisting of all other patients. The favorable group (n = 22) patients had an estimated median surveillance time of 22.2 months (95% CI, 13.8-33.3), whereas the unfavorable group (n = 19) had an estimated median surveillance time of 8.4 months (3.2-14.1; P = .0056).
Anxiety, depression, and quality of life did not change significantly over the period of surveillance, suggesting that living with untreated cancer did not cause psychological harm to patients in this study.
“Findings from our prospective trial show active surveillance to be a viable initial strategy in some patients with metastatic renal-cell carcinoma. The median surveillance period before start of systematic therapy was greater than 1 year, with no observed adverse effects on quality of life, anxiety and depression,” Dr. Rini and his associates said.
“Appropriate selection of patients and adequate monitoring, which should include CNS surveillance, is crucial in application of this approach,” they added.
This study was unfunded. One investigator reported receiving financial compensation from Pfizer and GlaxoSmithKline. All other investigators reported having no relevant disclosures.
On Twitter @jessnicolecraig
For metastatic renal cell carcinoma patients with fewer adverse risk factors and fewer metastatic disease sites, initial active surveillance may be a safe and feasible approach to delay the toxicities of systemic therapy, investigators report.
Fifty-two patients with treatment-naive, asymptomatic, metastatic renal-cell carcinoma were enrolled in a prospective phase II trial and radiographically assessed at baseline, every 3 months for year 1, every 4 months for year 2, then every 6 months thereafter. Patients continued on observation until the treating physician and patient made the decision to initiate systemic therapy.
Median follow-up time was 38.1 months and median time on surveillance before treatment initiation – the primary endpoint of the study – was 14.9 months (95% confidence interval, 10.6-25.0), reported Brian Rini, MD, of the Cleveland Clinic Taussig Cancer Institute and his associates (Lancet Oncol. 2016. doi: 10.1016/S1470-2045(16)30196-6).
Forty-three (90%) of the 48 evaluable patients experienced disease progression during the study, median time to progression was 9.4 months, and 22 patients died from renal cell carcinoma. One patient developed brain metastases and died without receiving systemic therapy. In multivariable analysis, only the number of involved organs (P = .0414) and number of International Metastatic Database Consortium risk factors (P = .0403) were independently prognostic.
Using this analysis, Dr. Rini and associates identified two prognostic groups – a favorable group consisting of patients with no or one International Metastatic Database Consortium (IMDC) risk factors and two or fewer organs with metastatic disease, and an unfavorable group consisting of all other patients. The favorable group (n = 22) patients had an estimated median surveillance time of 22.2 months (95% CI, 13.8-33.3), whereas the unfavorable group (n = 19) had an estimated median surveillance time of 8.4 months (3.2-14.1; P = .0056).
Anxiety, depression, and quality of life did not change significantly over the period of surveillance, suggesting that living with untreated cancer did not cause psychological harm to patients in this study.
“Findings from our prospective trial show active surveillance to be a viable initial strategy in some patients with metastatic renal-cell carcinoma. The median surveillance period before start of systematic therapy was greater than 1 year, with no observed adverse effects on quality of life, anxiety and depression,” Dr. Rini and his associates said.
“Appropriate selection of patients and adequate monitoring, which should include CNS surveillance, is crucial in application of this approach,” they added.
This study was unfunded. One investigator reported receiving financial compensation from Pfizer and GlaxoSmithKline. All other investigators reported having no relevant disclosures.
On Twitter @jessnicolecraig
For metastatic renal cell carcinoma patients with fewer adverse risk factors and fewer metastatic disease sites, initial active surveillance may be a safe and feasible approach to delay the toxicities of systemic therapy, investigators report.
Fifty-two patients with treatment-naive, asymptomatic, metastatic renal-cell carcinoma were enrolled in a prospective phase II trial and radiographically assessed at baseline, every 3 months for year 1, every 4 months for year 2, then every 6 months thereafter. Patients continued on observation until the treating physician and patient made the decision to initiate systemic therapy.
Median follow-up time was 38.1 months and median time on surveillance before treatment initiation – the primary endpoint of the study – was 14.9 months (95% confidence interval, 10.6-25.0), reported Brian Rini, MD, of the Cleveland Clinic Taussig Cancer Institute and his associates (Lancet Oncol. 2016. doi: 10.1016/S1470-2045(16)30196-6).
Forty-three (90%) of the 48 evaluable patients experienced disease progression during the study, median time to progression was 9.4 months, and 22 patients died from renal cell carcinoma. One patient developed brain metastases and died without receiving systemic therapy. In multivariable analysis, only the number of involved organs (P = .0414) and number of International Metastatic Database Consortium risk factors (P = .0403) were independently prognostic.
Using this analysis, Dr. Rini and associates identified two prognostic groups – a favorable group consisting of patients with no or one International Metastatic Database Consortium (IMDC) risk factors and two or fewer organs with metastatic disease, and an unfavorable group consisting of all other patients. The favorable group (n = 22) patients had an estimated median surveillance time of 22.2 months (95% CI, 13.8-33.3), whereas the unfavorable group (n = 19) had an estimated median surveillance time of 8.4 months (3.2-14.1; P = .0056).
Anxiety, depression, and quality of life did not change significantly over the period of surveillance, suggesting that living with untreated cancer did not cause psychological harm to patients in this study.
“Findings from our prospective trial show active surveillance to be a viable initial strategy in some patients with metastatic renal-cell carcinoma. The median surveillance period before start of systematic therapy was greater than 1 year, with no observed adverse effects on quality of life, anxiety and depression,” Dr. Rini and his associates said.
“Appropriate selection of patients and adequate monitoring, which should include CNS surveillance, is crucial in application of this approach,” they added.
This study was unfunded. One investigator reported receiving financial compensation from Pfizer and GlaxoSmithKline. All other investigators reported having no relevant disclosures.
On Twitter @jessnicolecraig
FROM LANCET ONCOLOGY
Key clinical point: For a subset of patients with metastatic renal cell carcinoma, initial active surveillance of metastasis may be a safe and feasible option.
Major finding: The favorable group (n = 22) patients and had an estimated median surveillance time of 22.2 months (95% CI, 13.8-33.3), whereas the unfavorable group (n = 19) had an estimated median surveillance time of 8.4 months (3.2-14.1; P = .0056)
Data source: A prospective phase II trial involving 52 patients with treatment-naive, metastatic renal cell carcinoma.
Disclosures: This study was unfunded. One investigator reported receiving financial compensation from Pfizer and GlaxoSmithKline. All other investigators reported having no relevant disclosures.
Estrogen receptor mutations linked with worse outcomes in MBC
Estrogen receptor mutations in estrogen receptor–positive metastatic breast cancer are more prevalent than previous studies and methodologies suggest, investigators found during a secondary analysis of patients enrolled in the BOLERO-2 trial.
Furthermore, two specific estrogen receptor 1 (ESR1) mutations, D538G and Y537S, were associated with reduced overall survival.
Of the 724 patients enrolled in the BOLERO-2, a phase III trial of women with postmenopausal ER-positive, HER2-nonamplified advanced breast cancer refractory to nonsteroidal aromatase inhibitors, 541 had evaluable cell-free DNA from baseline plasma samples and consented to genomic testing. Cell-free DNA (cfDNA) was extracted from patient’s plasma samples and assayed (via BioRad’s QX200 Droplet Digital PCR [polymerase chain reaction] System) for two specific ESR1 mutations, D538G and Y537S.
ESR1 mutations were detected in 156 of the 541 patients (28.8%), with D538G mutations occurring in 114 patients (21.1%), Y537S mutations occurring in 72 patients (13.3%), and both mutations occurring in 30 patients (5.55%), according to Sarat Chandarlapaty, MD, PhD, of Memorial Sloan Kettering Cancer Center, New York, and his associates.
Frequency of ESR1 mutation did not differ by age, race, or site of metastatic disease. However, mutation prevalence was significantly associated with ECOG status (P = .04). Also, “there was a threefold increase in mutation prevalence in patients who had failed first-line therapy for metastatic disease (33% were mutant) compared with those who were initiating first-line treatment for MBC (11% were mutant), in whom exposure to AI therapy occurred only in the adjuvant setting,” the researchers wrote (JAMA Oncol. 2016 Aug 11. doi: 10.1001/jamaoncol.2016.1279).
Overall, patients with ESR1 mutations had shorter median overall survival times. Among patients with only D538G mutations, median overall survival was 25.99 months (95% CI, 19.19-32.36 months). Patients with only Y537S mutations had a median overall survival of 19.98 months (95% CI,13.01-29.31 months) whereas patients with neither mutation had an overall survival of 32.1 months (95% CI, 28.09-36.4 months). Patients carrying both mutations had an even further reduced median overall survival of 15.15 months (95% CI, 10.87-27.43).
Patients in BOLERO-2 had been randomized in a 2:1 ratio to receive either exemestane plus everolimus or exemestane plus placebo. For this secondary analysis, researchers found that patients who had received exemestane therapy and had the D538G mutation experienced a shorter median progression-free survival time (2.69 months; hazard ratio, 1.71; 95% CI, 1.09-2.68) compared with patients with no mutations who received exemestane therapy (3.94 months). Patients with no mutations who received everolimus had a median progression-free survival of 8.48 months, and patients with D538G mutations who received everolimus had a median progression-free survival of 5.78 months.
“One of the key findings of this work is the high prevalence of ER mutations in this patient population,” the investigators said.
The investigators also noted the ease, feasibility, and affordability with which cfDNA can be analyzed for these genetic mutations, and they believe the digital drop polymerase chain reaction assay used in this study could easily be implemented into regular clinical practice.
This study was funded by Novartis and supported by the Integrated Genomics Operation Core. Four of the investigators reported being employed by Novartis, and Dr. Chandarlapaty reported receiving financial compensation from AstraZeneca.
On Twitter @jessnicolecraig
 |
Dr. Suzanne Fuqua |
The use of sensitive yet simple mutation monitoring of plasma as described in this study could provide indispensable predictive information for correcting the course of therapy in advanced or perhaps even early breast cancer. We eagerly await an illumination of what is not just evident on the surface, the “tip” of circulating cfDNA, but also what resistance networks lie beneath and drive the bulk of the metastatic ESR1 mutant-positive tumors in unique distant microenvironments.
Suzanne A.W. Fuqua, PhD, is a professor and researcher at the Lester and Sue Smith Breast Center at Baylor College of Medicine in Houston. Yassine Rechoum, PhD, is a postdoctoral fellow and Guowei Gu, PhD, is a postdoctoral associate at Baylor. These comments were excerpted from an invited commentary accompanying the study by Chandarlapaty et al. (JAMA Onc. 2016 Aug 11. doi:10.1001/jamaoncol.2016.1268).
|
Dr. Suzanne Fuqua |
The use of sensitive yet simple mutation monitoring of plasma as described in this study could provide indispensable predictive information for correcting the course of therapy in advanced or perhaps even early breast cancer. We eagerly await an illumination of what is not just evident on the surface, the “tip” of circulating cfDNA, but also what resistance networks lie beneath and drive the bulk of the metastatic ESR1 mutant-positive tumors in unique distant microenvironments.
Suzanne A.W. Fuqua, PhD, is a professor and researcher at the Lester and Sue Smith Breast Center at Baylor College of Medicine in Houston. Yassine Rechoum, PhD, is a postdoctoral fellow and Guowei Gu, PhD, is a postdoctoral associate at Baylor. These comments were excerpted from an invited commentary accompanying the study by Chandarlapaty et al. (JAMA Onc. 2016 Aug 11. doi:10.1001/jamaoncol.2016.1268).
|
Dr. Suzanne Fuqua |
The use of sensitive yet simple mutation monitoring of plasma as described in this study could provide indispensable predictive information for correcting the course of therapy in advanced or perhaps even early breast cancer. We eagerly await an illumination of what is not just evident on the surface, the “tip” of circulating cfDNA, but also what resistance networks lie beneath and drive the bulk of the metastatic ESR1 mutant-positive tumors in unique distant microenvironments.
Suzanne A.W. Fuqua, PhD, is a professor and researcher at the Lester and Sue Smith Breast Center at Baylor College of Medicine in Houston. Yassine Rechoum, PhD, is a postdoctoral fellow and Guowei Gu, PhD, is a postdoctoral associate at Baylor. These comments were excerpted from an invited commentary accompanying the study by Chandarlapaty et al. (JAMA Onc. 2016 Aug 11. doi:10.1001/jamaoncol.2016.1268).
Estrogen receptor mutations in estrogen receptor–positive metastatic breast cancer are more prevalent than previous studies and methodologies suggest, investigators found during a secondary analysis of patients enrolled in the BOLERO-2 trial.
Furthermore, two specific estrogen receptor 1 (ESR1) mutations, D538G and Y537S, were associated with reduced overall survival.
Of the 724 patients enrolled in the BOLERO-2, a phase III trial of women with postmenopausal ER-positive, HER2-nonamplified advanced breast cancer refractory to nonsteroidal aromatase inhibitors, 541 had evaluable cell-free DNA from baseline plasma samples and consented to genomic testing. Cell-free DNA (cfDNA) was extracted from patient’s plasma samples and assayed (via BioRad’s QX200 Droplet Digital PCR [polymerase chain reaction] System) for two specific ESR1 mutations, D538G and Y537S.
ESR1 mutations were detected in 156 of the 541 patients (28.8%), with D538G mutations occurring in 114 patients (21.1%), Y537S mutations occurring in 72 patients (13.3%), and both mutations occurring in 30 patients (5.55%), according to Sarat Chandarlapaty, MD, PhD, of Memorial Sloan Kettering Cancer Center, New York, and his associates.
Frequency of ESR1 mutation did not differ by age, race, or site of metastatic disease. However, mutation prevalence was significantly associated with ECOG status (P = .04). Also, “there was a threefold increase in mutation prevalence in patients who had failed first-line therapy for metastatic disease (33% were mutant) compared with those who were initiating first-line treatment for MBC (11% were mutant), in whom exposure to AI therapy occurred only in the adjuvant setting,” the researchers wrote (JAMA Oncol. 2016 Aug 11. doi: 10.1001/jamaoncol.2016.1279).
Overall, patients with ESR1 mutations had shorter median overall survival times. Among patients with only D538G mutations, median overall survival was 25.99 months (95% CI, 19.19-32.36 months). Patients with only Y537S mutations had a median overall survival of 19.98 months (95% CI,13.01-29.31 months) whereas patients with neither mutation had an overall survival of 32.1 months (95% CI, 28.09-36.4 months). Patients carrying both mutations had an even further reduced median overall survival of 15.15 months (95% CI, 10.87-27.43).
Patients in BOLERO-2 had been randomized in a 2:1 ratio to receive either exemestane plus everolimus or exemestane plus placebo. For this secondary analysis, researchers found that patients who had received exemestane therapy and had the D538G mutation experienced a shorter median progression-free survival time (2.69 months; hazard ratio, 1.71; 95% CI, 1.09-2.68) compared with patients with no mutations who received exemestane therapy (3.94 months). Patients with no mutations who received everolimus had a median progression-free survival of 8.48 months, and patients with D538G mutations who received everolimus had a median progression-free survival of 5.78 months.
“One of the key findings of this work is the high prevalence of ER mutations in this patient population,” the investigators said.
The investigators also noted the ease, feasibility, and affordability with which cfDNA can be analyzed for these genetic mutations, and they believe the digital drop polymerase chain reaction assay used in this study could easily be implemented into regular clinical practice.
This study was funded by Novartis and supported by the Integrated Genomics Operation Core. Four of the investigators reported being employed by Novartis, and Dr. Chandarlapaty reported receiving financial compensation from AstraZeneca.
On Twitter @jessnicolecraig
Estrogen receptor mutations in estrogen receptor–positive metastatic breast cancer are more prevalent than previous studies and methodologies suggest, investigators found during a secondary analysis of patients enrolled in the BOLERO-2 trial.
Furthermore, two specific estrogen receptor 1 (ESR1) mutations, D538G and Y537S, were associated with reduced overall survival.
Of the 724 patients enrolled in the BOLERO-2, a phase III trial of women with postmenopausal ER-positive, HER2-nonamplified advanced breast cancer refractory to nonsteroidal aromatase inhibitors, 541 had evaluable cell-free DNA from baseline plasma samples and consented to genomic testing. Cell-free DNA (cfDNA) was extracted from patient’s plasma samples and assayed (via BioRad’s QX200 Droplet Digital PCR [polymerase chain reaction] System) for two specific ESR1 mutations, D538G and Y537S.
ESR1 mutations were detected in 156 of the 541 patients (28.8%), with D538G mutations occurring in 114 patients (21.1%), Y537S mutations occurring in 72 patients (13.3%), and both mutations occurring in 30 patients (5.55%), according to Sarat Chandarlapaty, MD, PhD, of Memorial Sloan Kettering Cancer Center, New York, and his associates.
Frequency of ESR1 mutation did not differ by age, race, or site of metastatic disease. However, mutation prevalence was significantly associated with ECOG status (P = .04). Also, “there was a threefold increase in mutation prevalence in patients who had failed first-line therapy for metastatic disease (33% were mutant) compared with those who were initiating first-line treatment for MBC (11% were mutant), in whom exposure to AI therapy occurred only in the adjuvant setting,” the researchers wrote (JAMA Oncol. 2016 Aug 11. doi: 10.1001/jamaoncol.2016.1279).
Overall, patients with ESR1 mutations had shorter median overall survival times. Among patients with only D538G mutations, median overall survival was 25.99 months (95% CI, 19.19-32.36 months). Patients with only Y537S mutations had a median overall survival of 19.98 months (95% CI,13.01-29.31 months) whereas patients with neither mutation had an overall survival of 32.1 months (95% CI, 28.09-36.4 months). Patients carrying both mutations had an even further reduced median overall survival of 15.15 months (95% CI, 10.87-27.43).
Patients in BOLERO-2 had been randomized in a 2:1 ratio to receive either exemestane plus everolimus or exemestane plus placebo. For this secondary analysis, researchers found that patients who had received exemestane therapy and had the D538G mutation experienced a shorter median progression-free survival time (2.69 months; hazard ratio, 1.71; 95% CI, 1.09-2.68) compared with patients with no mutations who received exemestane therapy (3.94 months). Patients with no mutations who received everolimus had a median progression-free survival of 8.48 months, and patients with D538G mutations who received everolimus had a median progression-free survival of 5.78 months.
“One of the key findings of this work is the high prevalence of ER mutations in this patient population,” the investigators said.
The investigators also noted the ease, feasibility, and affordability with which cfDNA can be analyzed for these genetic mutations, and they believe the digital drop polymerase chain reaction assay used in this study could easily be implemented into regular clinical practice.
This study was funded by Novartis and supported by the Integrated Genomics Operation Core. Four of the investigators reported being employed by Novartis, and Dr. Chandarlapaty reported receiving financial compensation from AstraZeneca.
On Twitter @jessnicolecraig
FROM JAMA ONCOLOGY
Key clinical point: Estrogen receptor mutations in aromatase inhibitor–treated ER-positive metastatic breast cancer patients are common and are linked with worse outcomes.
Major finding: Estrogen receptor 1 mutations were detected in 156 patients (28.8% of 541 evaluable patients), with D538G mutations occurring in 114 patients (21.1%), Y537S mutations occurring in 72 patients (13.3%), and both mutations occurring in 30 patients (5.55%).
Data source: Plasma samples from 541 patients participating in BOLERO-2, a phase III trial of 724 women with postmenopausal ER-positive, HER2-nonamplified advanced breast cancer refractory to nonsteroidal aromatase inhibitors.
Disclosures: This study was funded by Novartis and supported by the Integrated Genomics Operation Core. Four of the investigators reported being employed by Novartis, and Dr. Chandarlapaty reported receiving financial compensation from AstraZeneca.
Salvage RT may reduce risk of prostate cancer metastasis even at low PSA levels
Increasing prostate-specific antigen (PSA) levels prior to salvage radiotherapy were significantly associated with an increased risk of distant metastasis and cause-specific mortality but not overall survival among men with detectable PSA following radical prostatectomy, according to a report published in the Journal of Clinical Oncology.
Investigators retrospectively studied 1,106 consecutive patients with surgically staged prostate cancer who received salvage radiotherapy (SRT) and who had a documented PSA of 0.1 ng/mL or greater. A total of 208 patients developed distant metastasis during median follow-up of 8.9 years.
In multivariate analysis, each doubling of pre-SRT PSA was associated with a 32% increased risk of distant metastasis (P less than .001), reported Bradley J. Stish, MD, and his associates at the Mayo Clinic (J Clin Oncol. 2016 Aug. doi: 10.1200/JCO.2016.68.3425).
Each pre-SRT PSA doubling also significantly increased the relative risk of cause-specific mortality (HR, 1.40; P less than .001) but not overall survival (HR, 1.12; P = .02).
More advanced tumor stages, higher Gleason scores, and higher PSA levels prior to salvage radiotherapy were significantly associated with an increased risk of biochemical recurrence. Salvage radiotherapy dose greater than 68 Gy and use of androgen suppression were associated with reduced risk of biochemical recurrence. Overall survival was 92.9% (95% confidence interval, 91.3%-94.5%) at 5 years and 77.3% (95% CI, 74.2%-80.5%) at 10 years. The cause-specific mortality rates were 3.0% (95% CI, 1.9%-4.0%) at 5 years and 10.4% (95% CI, 8.0%-12.6%) at 10 years.
“When taken together, these findings provide strong evidence supporting the clinical benefits attributable to early [salvage radiotherapy] in men with detectable PSA after [radical prostatectomy],” investigators wrote.
Beginning salvage radiotherapy treatment at the lowest PSA level is “most beneficial for long-term therapeutic efficacy,” they added.
On Twitter @jessnicolecraig
Increasing prostate-specific antigen (PSA) levels prior to salvage radiotherapy were significantly associated with an increased risk of distant metastasis and cause-specific mortality but not overall survival among men with detectable PSA following radical prostatectomy, according to a report published in the Journal of Clinical Oncology.
Investigators retrospectively studied 1,106 consecutive patients with surgically staged prostate cancer who received salvage radiotherapy (SRT) and who had a documented PSA of 0.1 ng/mL or greater. A total of 208 patients developed distant metastasis during median follow-up of 8.9 years.
In multivariate analysis, each doubling of pre-SRT PSA was associated with a 32% increased risk of distant metastasis (P less than .001), reported Bradley J. Stish, MD, and his associates at the Mayo Clinic (J Clin Oncol. 2016 Aug. doi: 10.1200/JCO.2016.68.3425).
Each pre-SRT PSA doubling also significantly increased the relative risk of cause-specific mortality (HR, 1.40; P less than .001) but not overall survival (HR, 1.12; P = .02).
More advanced tumor stages, higher Gleason scores, and higher PSA levels prior to salvage radiotherapy were significantly associated with an increased risk of biochemical recurrence. Salvage radiotherapy dose greater than 68 Gy and use of androgen suppression were associated with reduced risk of biochemical recurrence. Overall survival was 92.9% (95% confidence interval, 91.3%-94.5%) at 5 years and 77.3% (95% CI, 74.2%-80.5%) at 10 years. The cause-specific mortality rates were 3.0% (95% CI, 1.9%-4.0%) at 5 years and 10.4% (95% CI, 8.0%-12.6%) at 10 years.
“When taken together, these findings provide strong evidence supporting the clinical benefits attributable to early [salvage radiotherapy] in men with detectable PSA after [radical prostatectomy],” investigators wrote.
Beginning salvage radiotherapy treatment at the lowest PSA level is “most beneficial for long-term therapeutic efficacy,” they added.
On Twitter @jessnicolecraig
Increasing prostate-specific antigen (PSA) levels prior to salvage radiotherapy were significantly associated with an increased risk of distant metastasis and cause-specific mortality but not overall survival among men with detectable PSA following radical prostatectomy, according to a report published in the Journal of Clinical Oncology.
Investigators retrospectively studied 1,106 consecutive patients with surgically staged prostate cancer who received salvage radiotherapy (SRT) and who had a documented PSA of 0.1 ng/mL or greater. A total of 208 patients developed distant metastasis during median follow-up of 8.9 years.
In multivariate analysis, each doubling of pre-SRT PSA was associated with a 32% increased risk of distant metastasis (P less than .001), reported Bradley J. Stish, MD, and his associates at the Mayo Clinic (J Clin Oncol. 2016 Aug. doi: 10.1200/JCO.2016.68.3425).
Each pre-SRT PSA doubling also significantly increased the relative risk of cause-specific mortality (HR, 1.40; P less than .001) but not overall survival (HR, 1.12; P = .02).
More advanced tumor stages, higher Gleason scores, and higher PSA levels prior to salvage radiotherapy were significantly associated with an increased risk of biochemical recurrence. Salvage radiotherapy dose greater than 68 Gy and use of androgen suppression were associated with reduced risk of biochemical recurrence. Overall survival was 92.9% (95% confidence interval, 91.3%-94.5%) at 5 years and 77.3% (95% CI, 74.2%-80.5%) at 10 years. The cause-specific mortality rates were 3.0% (95% CI, 1.9%-4.0%) at 5 years and 10.4% (95% CI, 8.0%-12.6%) at 10 years.
“When taken together, these findings provide strong evidence supporting the clinical benefits attributable to early [salvage radiotherapy] in men with detectable PSA after [radical prostatectomy],” investigators wrote.
Beginning salvage radiotherapy treatment at the lowest PSA level is “most beneficial for long-term therapeutic efficacy,” they added.
On Twitter @jessnicolecraig
FROM THE JOURNAL OF CLINICAL ONCOLOGY
Key clinical point: Salvage radiotherapy should not be delayed by prolonged monitoring of detectable post radical prostatectomy PSA levels.
Major finding: A multivariate analysis revealed that prior to salvage radiotherapy, each doubling of prostate specific antigen was significantly associated with an increased risk of distant metastasis (hazard ratio, 1.32; 95% CI, 1.19-1.46; P less than .001) and cause-specific mortality (HR, 1.40; 95% CI, 1.21-1.63, P less than .001).
Data source: A retrospective study of 1,106 men with detectable prostate-specific antigen levels following radical prostatectomy for prostate cancer.
Disclosures: The Mayo Clinic funded this study. Six of the investigators had no disclosures to report; one investigator reported holding stock or ownership interest in Pfizer.
Zika virus RNA detected in serum beyond previously estimated time frame
Zika virus RNA was detected in the serum of five pregnant women beyond previously estimated time frames, according to a new case series study.
“This report adds to the existing evidence that Zika virus RNA in serum may be detected longer than previously expected, an observation now reported among at least eight pregnant women,” reported Dr. Dana Meaney-Delman of the Centers for Disease Control & Prevention, and her colleagues wrote. (Obstet Gynecol. 2016. doi: 10.1097/AOG.0000000000001625).
Five pregnant women who had traveled to or lived in one or more countries with active Zika virus transmission and had prolonged detection of Zika virus RNA in serum were reported to the U.S. Zika Pregnancy Registry, an enhanced surveillance initiative developed by the CDC to collect information on maternal exposure history, clinical presentation, laboratory testing, prenatal imaging, pregnancy screening and complications, fetal and neonatal outcomes, and infant development through the first year of life.
Prolonged detection was defined as the presence of Zika virus RNA detected in serum by real-time reverse transcription-polymerase chain reaction at 14 or more days after symptom onset for symptomatic pregnant women or 21 or more days after last possible exposure to Zika virus for asymptomatic pregnant women. A previous study reported a mean Zika viral RNA duration of 9.9 days, with 14 days being the longest duration of Zika virus RNA detection in a nonpregnant person.
Among the four symptomatic pregnant women, Zika virus RNA was detected in the serum at 17, 23, 44, and 46 days following symptom onset. In the one asymptomatic pregnant woman, Zika virus RNA was detected in serum at 53 days after her travel from an area with active Zika transmission.
Among the five pregnancies, one is ongoing, one was aborted and the fetus tested positive for fetal Zika virus infection, and three resulted in live births of healthy neonates with no reported abnormalities.
“Several questions remain regarding the findings of prolonged detection of Zika virus RNA. Most notably, the duration of Zika virus RNA in serum requires further investigation to determine whether there is a correlation between prolonged viral RNA detection and the presence of infectious virus,” the researchers wrote.
Read the study results here.
On Twitter @jessnicolecraig
Zika virus RNA was detected in the serum of five pregnant women beyond previously estimated time frames, according to a new case series study.
“This report adds to the existing evidence that Zika virus RNA in serum may be detected longer than previously expected, an observation now reported among at least eight pregnant women,” reported Dr. Dana Meaney-Delman of the Centers for Disease Control & Prevention, and her colleagues wrote. (Obstet Gynecol. 2016. doi: 10.1097/AOG.0000000000001625).
Five pregnant women who had traveled to or lived in one or more countries with active Zika virus transmission and had prolonged detection of Zika virus RNA in serum were reported to the U.S. Zika Pregnancy Registry, an enhanced surveillance initiative developed by the CDC to collect information on maternal exposure history, clinical presentation, laboratory testing, prenatal imaging, pregnancy screening and complications, fetal and neonatal outcomes, and infant development through the first year of life.
Prolonged detection was defined as the presence of Zika virus RNA detected in serum by real-time reverse transcription-polymerase chain reaction at 14 or more days after symptom onset for symptomatic pregnant women or 21 or more days after last possible exposure to Zika virus for asymptomatic pregnant women. A previous study reported a mean Zika viral RNA duration of 9.9 days, with 14 days being the longest duration of Zika virus RNA detection in a nonpregnant person.
Among the four symptomatic pregnant women, Zika virus RNA was detected in the serum at 17, 23, 44, and 46 days following symptom onset. In the one asymptomatic pregnant woman, Zika virus RNA was detected in serum at 53 days after her travel from an area with active Zika transmission.
Among the five pregnancies, one is ongoing, one was aborted and the fetus tested positive for fetal Zika virus infection, and three resulted in live births of healthy neonates with no reported abnormalities.
“Several questions remain regarding the findings of prolonged detection of Zika virus RNA. Most notably, the duration of Zika virus RNA in serum requires further investigation to determine whether there is a correlation between prolonged viral RNA detection and the presence of infectious virus,” the researchers wrote.
Read the study results here.
On Twitter @jessnicolecraig
Zika virus RNA was detected in the serum of five pregnant women beyond previously estimated time frames, according to a new case series study.
“This report adds to the existing evidence that Zika virus RNA in serum may be detected longer than previously expected, an observation now reported among at least eight pregnant women,” reported Dr. Dana Meaney-Delman of the Centers for Disease Control & Prevention, and her colleagues wrote. (Obstet Gynecol. 2016. doi: 10.1097/AOG.0000000000001625).
Five pregnant women who had traveled to or lived in one or more countries with active Zika virus transmission and had prolonged detection of Zika virus RNA in serum were reported to the U.S. Zika Pregnancy Registry, an enhanced surveillance initiative developed by the CDC to collect information on maternal exposure history, clinical presentation, laboratory testing, prenatal imaging, pregnancy screening and complications, fetal and neonatal outcomes, and infant development through the first year of life.
Prolonged detection was defined as the presence of Zika virus RNA detected in serum by real-time reverse transcription-polymerase chain reaction at 14 or more days after symptom onset for symptomatic pregnant women or 21 or more days after last possible exposure to Zika virus for asymptomatic pregnant women. A previous study reported a mean Zika viral RNA duration of 9.9 days, with 14 days being the longest duration of Zika virus RNA detection in a nonpregnant person.
Among the four symptomatic pregnant women, Zika virus RNA was detected in the serum at 17, 23, 44, and 46 days following symptom onset. In the one asymptomatic pregnant woman, Zika virus RNA was detected in serum at 53 days after her travel from an area with active Zika transmission.
Among the five pregnancies, one is ongoing, one was aborted and the fetus tested positive for fetal Zika virus infection, and three resulted in live births of healthy neonates with no reported abnormalities.
“Several questions remain regarding the findings of prolonged detection of Zika virus RNA. Most notably, the duration of Zika virus RNA in serum requires further investigation to determine whether there is a correlation between prolonged viral RNA detection and the presence of infectious virus,” the researchers wrote.
Read the study results here.
On Twitter @jessnicolecraig
FROM OBSTETRICS & GYNECOLOGY
Oxaliplatin boosts pCR in patients with locally advanced rectal cancer
Adding oxaliplatin to perioperative fluorouracil and radiotherapy was associated with a higher rate of pathologic complete response (pCR) in advanced rectal cancer patients, compared with single-agent fluorouracil plus radiotherapy, investigators report in the Journal of Clinical Oncology.
For the Neoadjuvant FOLFOX6 Chemotherapy With or Without Radiation in Rectal Cancer (FOWARC) study, 495 patients with locally advanced rectal cancer (LARC) who were undergoing total mesorectal excision were randomly assigned to one of three preoperative treatment arms: neoadjuvant therapy with fluorouracil plus radiotherapy (fluorouracil-radiotherapy group), fluorouracil chemotherapy with perioperative fluorouracil and oxaliplatin plus radiotherapy (mFOLFOX6-radiotherapy group), or fluorouracil chemotherapy with perioperative fluorouracil and oxaliplatin without radiotherapy (mFOLFOX6 group).The rates of pCR were 14.0%, 27.5%, and 6.6% for patients in the fluorouracil-radiotherapy, mFOLFOX6-radiotherapy, and mFOLFOX6 groups, respectively, Dr. Yanhong Deng of the Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou City, China, and her associates reported (J Clin Oncol. 2016. doi: 10.1200/JCO.2016.66.6198).
No patients died during neoadjuvant treatment. Grade 3 or 4 toxicities occurred in 55.5% (n = 86), 88% (n = 139), and 24.5% (n = 40) of patients in the fluorouracil-radiotherapy group, mFOLFOX6-radiotherapy, and mFOLFOX6 groups, respectively. The most common grade 3 to 4 toxicities were leukopenia, radiodermatitis, and radiation proctitis.
Initial analysis of this study showed that “compared with the single-agent fluorouracil, mFOLFOX6 concurrent with radiotherapy preoperatively results in a higher rate of pCR (14.0% vs. 27.5%), a higher good response rate, good compliance, and acceptable toxicity for patients with stage II/III rectal cancer,” the investigators wrote.
“These preliminary results suggest that a strategy of combining full-dose chemotherapy with radiation over chemosensitizing radiation may be a new option for neoadjuvant treatment in LARC,” they added.
Sun Yat-sen University funded this study. Dr. Deng and her associates did not have any disclosures to report.
On Twitter @jessnicolecraig
Adding oxaliplatin to perioperative fluorouracil and radiotherapy was associated with a higher rate of pathologic complete response (pCR) in advanced rectal cancer patients, compared with single-agent fluorouracil plus radiotherapy, investigators report in the Journal of Clinical Oncology.
For the Neoadjuvant FOLFOX6 Chemotherapy With or Without Radiation in Rectal Cancer (FOWARC) study, 495 patients with locally advanced rectal cancer (LARC) who were undergoing total mesorectal excision were randomly assigned to one of three preoperative treatment arms: neoadjuvant therapy with fluorouracil plus radiotherapy (fluorouracil-radiotherapy group), fluorouracil chemotherapy with perioperative fluorouracil and oxaliplatin plus radiotherapy (mFOLFOX6-radiotherapy group), or fluorouracil chemotherapy with perioperative fluorouracil and oxaliplatin without radiotherapy (mFOLFOX6 group).The rates of pCR were 14.0%, 27.5%, and 6.6% for patients in the fluorouracil-radiotherapy, mFOLFOX6-radiotherapy, and mFOLFOX6 groups, respectively, Dr. Yanhong Deng of the Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou City, China, and her associates reported (J Clin Oncol. 2016. doi: 10.1200/JCO.2016.66.6198).
No patients died during neoadjuvant treatment. Grade 3 or 4 toxicities occurred in 55.5% (n = 86), 88% (n = 139), and 24.5% (n = 40) of patients in the fluorouracil-radiotherapy group, mFOLFOX6-radiotherapy, and mFOLFOX6 groups, respectively. The most common grade 3 to 4 toxicities were leukopenia, radiodermatitis, and radiation proctitis.
Initial analysis of this study showed that “compared with the single-agent fluorouracil, mFOLFOX6 concurrent with radiotherapy preoperatively results in a higher rate of pCR (14.0% vs. 27.5%), a higher good response rate, good compliance, and acceptable toxicity for patients with stage II/III rectal cancer,” the investigators wrote.
“These preliminary results suggest that a strategy of combining full-dose chemotherapy with radiation over chemosensitizing radiation may be a new option for neoadjuvant treatment in LARC,” they added.
Sun Yat-sen University funded this study. Dr. Deng and her associates did not have any disclosures to report.
On Twitter @jessnicolecraig
Adding oxaliplatin to perioperative fluorouracil and radiotherapy was associated with a higher rate of pathologic complete response (pCR) in advanced rectal cancer patients, compared with single-agent fluorouracil plus radiotherapy, investigators report in the Journal of Clinical Oncology.
For the Neoadjuvant FOLFOX6 Chemotherapy With or Without Radiation in Rectal Cancer (FOWARC) study, 495 patients with locally advanced rectal cancer (LARC) who were undergoing total mesorectal excision were randomly assigned to one of three preoperative treatment arms: neoadjuvant therapy with fluorouracil plus radiotherapy (fluorouracil-radiotherapy group), fluorouracil chemotherapy with perioperative fluorouracil and oxaliplatin plus radiotherapy (mFOLFOX6-radiotherapy group), or fluorouracil chemotherapy with perioperative fluorouracil and oxaliplatin without radiotherapy (mFOLFOX6 group).The rates of pCR were 14.0%, 27.5%, and 6.6% for patients in the fluorouracil-radiotherapy, mFOLFOX6-radiotherapy, and mFOLFOX6 groups, respectively, Dr. Yanhong Deng of the Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou City, China, and her associates reported (J Clin Oncol. 2016. doi: 10.1200/JCO.2016.66.6198).
No patients died during neoadjuvant treatment. Grade 3 or 4 toxicities occurred in 55.5% (n = 86), 88% (n = 139), and 24.5% (n = 40) of patients in the fluorouracil-radiotherapy group, mFOLFOX6-radiotherapy, and mFOLFOX6 groups, respectively. The most common grade 3 to 4 toxicities were leukopenia, radiodermatitis, and radiation proctitis.
Initial analysis of this study showed that “compared with the single-agent fluorouracil, mFOLFOX6 concurrent with radiotherapy preoperatively results in a higher rate of pCR (14.0% vs. 27.5%), a higher good response rate, good compliance, and acceptable toxicity for patients with stage II/III rectal cancer,” the investigators wrote.
“These preliminary results suggest that a strategy of combining full-dose chemotherapy with radiation over chemosensitizing radiation may be a new option for neoadjuvant treatment in LARC,” they added.
Sun Yat-sen University funded this study. Dr. Deng and her associates did not have any disclosures to report.
On Twitter @jessnicolecraig
FROM JOURNAL OF CLINICAL ONCOLOGY
Key clinical point: Perioperative oxaliplatin administered in combination with fluorouracil and radiotherapy was associated with a higher rate of pathologic complete response in advanced rectal cancer patients compared with single-agent fluorouracil and radiotherapy.
Major finding: The rate of pathologic complete response was 27.5% for patients receiving oxaliplatin, fluorouracil, and radiotherapy vs. 14.0% for patients receiving single-agent fluorouracil and radiotherapy.
Data source: A multicenter, open-label, phase III trial involving 495 patients with locally advanced stage II/III rectal cancer.
Disclosures: Sun Yat-sen University funded this study. Dr. Deng and her associates did not have any disclosures to report.
First-in-class agent shows early promise in treating clear cell renal cell carcinoma
CHICAGO – Investigational agent PT2385, an inhibitor of hypoxia-inducible factor 2-alpha (HIF-2alpha), appears safe and tolerable and demonstrated early evidence of clinical activity in heavily pretreated patients with advanced clear cell renal cell carcinoma, investigators reported at the annual meeting of the American Society of Clinical Oncology.
In a small, phase I dose-escalation study, 39% of patients in the study achieved complete response, partial response, or stable disease lasting at least 16 weeks.
PT2385 is a first-in-class, orally administered selective small molecule inhibitor of HIF-2alpha, a transcription factor with a role in clear cell renal cell carcinoma.
“Hypoxia-inducible factor 2-alpha is a key oncogenic driver of clear cell renal cell carcinoma,” Kevin Courtney, MD, PhD, of the University of Texas Southwestern Medical Center, Dallas, said at the meeting.
A total of 51 patients (n = 26 for dose escalation cohort and n = 25 in dose expansion cohort) met the study’s eligibility requirements of having a diagnosis of clear cell renal cell carcinoma, an Eastern Cooperative Oncology Group score ranging from 0 to 1, and at least one prior anticancer therapy. The median age of the cohort was 65 years with the youngest participant being 29 years and the oldest being 80 years old. The majority of patients were male (71%), had received four or more prior systemic therapies (53%), and had undergone vascular endothelial growth factor therapy (98%). Patients were treated with continuous twice-daily oral dosing of PT2385 until progression or toxicity. A total of three patients were treated at the 100-mg dose, three at the 200-mg dose, four at the 400-mg dose, seven at the 800-mg dose, six at a dose of 1,200 mg, and three at a dose of 1,800 mg.
“No dose-limiting toxicity was observed at any dose level,” Dr. Courtney said.
Based on safety, pharmokinetic and pharmodynamic data, 800 mg twice daily was the selected dose for the expansion cohort, he reported.
Of 51 patients treated, 1 patient had a complete response, 3 achieved partial responses, and 16 patients achieved stable disease for at least 16 weeks. The most common grade one or two adverse events were anemia (n = 18), peripheral edema (n = 18), fatigue (n = 18), nausea (n = 15), and back pain (n = 12). Only two grade four adverse events (low lymphocyte count) were reported.
“Notably, hypertension was not seen,” Dr. Courtney said.
At the time the study concluded, the four patients who achieved complete or partial responses remained on the treatment, and five had received treatment for a year or longer.
The study was funded by Peloton Therapeutics. Dr. Courtney reported having stock and ownership interest in, serving in advisory roles for, or receiving research funding from multiple companies. Several coinvestigators reported receiving research funding from or holding patents with multiple companies including Peloton Therapeutics.
On Twitter @jessnicolecraig
CHICAGO – Investigational agent PT2385, an inhibitor of hypoxia-inducible factor 2-alpha (HIF-2alpha), appears safe and tolerable and demonstrated early evidence of clinical activity in heavily pretreated patients with advanced clear cell renal cell carcinoma, investigators reported at the annual meeting of the American Society of Clinical Oncology.
In a small, phase I dose-escalation study, 39% of patients in the study achieved complete response, partial response, or stable disease lasting at least 16 weeks.
PT2385 is a first-in-class, orally administered selective small molecule inhibitor of HIF-2alpha, a transcription factor with a role in clear cell renal cell carcinoma.
“Hypoxia-inducible factor 2-alpha is a key oncogenic driver of clear cell renal cell carcinoma,” Kevin Courtney, MD, PhD, of the University of Texas Southwestern Medical Center, Dallas, said at the meeting.
A total of 51 patients (n = 26 for dose escalation cohort and n = 25 in dose expansion cohort) met the study’s eligibility requirements of having a diagnosis of clear cell renal cell carcinoma, an Eastern Cooperative Oncology Group score ranging from 0 to 1, and at least one prior anticancer therapy. The median age of the cohort was 65 years with the youngest participant being 29 years and the oldest being 80 years old. The majority of patients were male (71%), had received four or more prior systemic therapies (53%), and had undergone vascular endothelial growth factor therapy (98%). Patients were treated with continuous twice-daily oral dosing of PT2385 until progression or toxicity. A total of three patients were treated at the 100-mg dose, three at the 200-mg dose, four at the 400-mg dose, seven at the 800-mg dose, six at a dose of 1,200 mg, and three at a dose of 1,800 mg.
“No dose-limiting toxicity was observed at any dose level,” Dr. Courtney said.
Based on safety, pharmokinetic and pharmodynamic data, 800 mg twice daily was the selected dose for the expansion cohort, he reported.
Of 51 patients treated, 1 patient had a complete response, 3 achieved partial responses, and 16 patients achieved stable disease for at least 16 weeks. The most common grade one or two adverse events were anemia (n = 18), peripheral edema (n = 18), fatigue (n = 18), nausea (n = 15), and back pain (n = 12). Only two grade four adverse events (low lymphocyte count) were reported.
“Notably, hypertension was not seen,” Dr. Courtney said.
At the time the study concluded, the four patients who achieved complete or partial responses remained on the treatment, and five had received treatment for a year or longer.
The study was funded by Peloton Therapeutics. Dr. Courtney reported having stock and ownership interest in, serving in advisory roles for, or receiving research funding from multiple companies. Several coinvestigators reported receiving research funding from or holding patents with multiple companies including Peloton Therapeutics.
On Twitter @jessnicolecraig
CHICAGO – Investigational agent PT2385, an inhibitor of hypoxia-inducible factor 2-alpha (HIF-2alpha), appears safe and tolerable and demonstrated early evidence of clinical activity in heavily pretreated patients with advanced clear cell renal cell carcinoma, investigators reported at the annual meeting of the American Society of Clinical Oncology.
In a small, phase I dose-escalation study, 39% of patients in the study achieved complete response, partial response, or stable disease lasting at least 16 weeks.
PT2385 is a first-in-class, orally administered selective small molecule inhibitor of HIF-2alpha, a transcription factor with a role in clear cell renal cell carcinoma.
“Hypoxia-inducible factor 2-alpha is a key oncogenic driver of clear cell renal cell carcinoma,” Kevin Courtney, MD, PhD, of the University of Texas Southwestern Medical Center, Dallas, said at the meeting.
A total of 51 patients (n = 26 for dose escalation cohort and n = 25 in dose expansion cohort) met the study’s eligibility requirements of having a diagnosis of clear cell renal cell carcinoma, an Eastern Cooperative Oncology Group score ranging from 0 to 1, and at least one prior anticancer therapy. The median age of the cohort was 65 years with the youngest participant being 29 years and the oldest being 80 years old. The majority of patients were male (71%), had received four or more prior systemic therapies (53%), and had undergone vascular endothelial growth factor therapy (98%). Patients were treated with continuous twice-daily oral dosing of PT2385 until progression or toxicity. A total of three patients were treated at the 100-mg dose, three at the 200-mg dose, four at the 400-mg dose, seven at the 800-mg dose, six at a dose of 1,200 mg, and three at a dose of 1,800 mg.
“No dose-limiting toxicity was observed at any dose level,” Dr. Courtney said.
Based on safety, pharmokinetic and pharmodynamic data, 800 mg twice daily was the selected dose for the expansion cohort, he reported.
Of 51 patients treated, 1 patient had a complete response, 3 achieved partial responses, and 16 patients achieved stable disease for at least 16 weeks. The most common grade one or two adverse events were anemia (n = 18), peripheral edema (n = 18), fatigue (n = 18), nausea (n = 15), and back pain (n = 12). Only two grade four adverse events (low lymphocyte count) were reported.
“Notably, hypertension was not seen,” Dr. Courtney said.
At the time the study concluded, the four patients who achieved complete or partial responses remained on the treatment, and five had received treatment for a year or longer.
The study was funded by Peloton Therapeutics. Dr. Courtney reported having stock and ownership interest in, serving in advisory roles for, or receiving research funding from multiple companies. Several coinvestigators reported receiving research funding from or holding patents with multiple companies including Peloton Therapeutics.
On Twitter @jessnicolecraig
AT THE 2016 ASCO ANNUAL MEETING
Key clinical point: The first-in-class oral HIF-2alpha inhibitor PT2385 demonstrated early evidence of clinical activity in patients with advanced clear cell renal cell carcinoma. The drug also appears safe and tolerable.
Major finding: Overall, one patient had a complete response, three achieved partial responses, and 16 patients achieved stable disease for at least 16 weeks.
Data source: A phase I dose-escalation and expansion study of 51 heavily pretreated patients with advanced clear cell renal cell carcinoma.
Disclosures: The study was funded by Peloton Therapeutics. Dr. Courtney reported having stock and ownership interest in, serving in advisory roles for, or receiving research funding from multiple companies. Several coinvestigators reported receiving research funding from or holding patents with multiple companies including Peloton Therapeutics.
Anthracycline benefit for high-risk breast cancer confirmed in joint analysis
CHICAGO – Docetaxel plus cyclophosphamide was significantly inferior to treatment with anthracycline/taxane-based chemotherapy, according to an interim joint analysis of the ABC (anthracyclines in early breast cancer) trials.
The ABC trials are three sequential trials from the US Oncology Research and National Surgical Adjuvant Breast and Bowel Project that randomized women with resected high-risk, early-stage breast cancer to receive docetaxel plus cyclophosphamide (TC) or one of several standard anthracycline/taxane-based chemotherapy (TaxAC) regimens.
A total of 4,130 patients met the ABC trials’ eligibility requirements and were randomly assigned to receive either TC therapy (n = 2,078) or TaxAC therapy (n = 2,052), Joanne Blum, MD, PhD, of the Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas, reported at the annual meeting of the American Society of Clinical Oncology.
Patient and tumor characteristics were balanced among the two treatment arms, and the median follow-up time was 3.2 years.
Inferiority was predefined as a Cox model hazard ratio (HR) score of 1.18 or higher when the cohort was stratified by nodal status, hormone-receptor status, and parent trial, Dr. Blum said.
The HR for the initial 334 events was 1.2, which exceeded the threshold and demonstrated that TC was inferior to TaxAC.
At the interim analysis, 399 events had occurred: 220 in the TC treatment arm and 179 in the TaxAC arm. Overall, the 4-year invasive disease-free survival was 88.2% for the TC treatment arm and 90.7% for the TaxAC treatment arm (HR, 1.23; 95% confidence interval, 1.01-1.50; P = .04). TaxAC was equal or superior to TC when the cohort was stratified by parent trial, hormone status, and nodal status. TC regimen was favored only in ER-positive patients with zero nodes.
There was no difference in overall survival between the two treatment arms.
Exploratory subgroup analyses suggest that TaxAC provides little benefit in ER-positive, node-negative cohorts, small benefit in ER-positive one-to-three node and ER-negative node-negative cohorts, and the most benefit for patients who were ER-positive with more than four nodes or ER-negative node-positive, Dr. Blum said.
Acute leukemia occurred in 0.24% of patients in the TaxAC group and in none of the patients in the TC treatment arm.
“Additional follow-up and correlative studies to identify biomarkers of anthracycline benefit will be crucial for fully determining the utility of anthracyclines across this heterogeneous patient population,” Dr. Blum concluded.
Dr. Blum had no disclosures to report. Sanofi, Genentech, and CTEP funded the ABC trials.
On Twitter @jessnicolecraig
CHICAGO – Docetaxel plus cyclophosphamide was significantly inferior to treatment with anthracycline/taxane-based chemotherapy, according to an interim joint analysis of the ABC (anthracyclines in early breast cancer) trials.
The ABC trials are three sequential trials from the US Oncology Research and National Surgical Adjuvant Breast and Bowel Project that randomized women with resected high-risk, early-stage breast cancer to receive docetaxel plus cyclophosphamide (TC) or one of several standard anthracycline/taxane-based chemotherapy (TaxAC) regimens.
A total of 4,130 patients met the ABC trials’ eligibility requirements and were randomly assigned to receive either TC therapy (n = 2,078) or TaxAC therapy (n = 2,052), Joanne Blum, MD, PhD, of the Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas, reported at the annual meeting of the American Society of Clinical Oncology.
Patient and tumor characteristics were balanced among the two treatment arms, and the median follow-up time was 3.2 years.
Inferiority was predefined as a Cox model hazard ratio (HR) score of 1.18 or higher when the cohort was stratified by nodal status, hormone-receptor status, and parent trial, Dr. Blum said.
The HR for the initial 334 events was 1.2, which exceeded the threshold and demonstrated that TC was inferior to TaxAC.
At the interim analysis, 399 events had occurred: 220 in the TC treatment arm and 179 in the TaxAC arm. Overall, the 4-year invasive disease-free survival was 88.2% for the TC treatment arm and 90.7% for the TaxAC treatment arm (HR, 1.23; 95% confidence interval, 1.01-1.50; P = .04). TaxAC was equal or superior to TC when the cohort was stratified by parent trial, hormone status, and nodal status. TC regimen was favored only in ER-positive patients with zero nodes.
There was no difference in overall survival between the two treatment arms.
Exploratory subgroup analyses suggest that TaxAC provides little benefit in ER-positive, node-negative cohorts, small benefit in ER-positive one-to-three node and ER-negative node-negative cohorts, and the most benefit for patients who were ER-positive with more than four nodes or ER-negative node-positive, Dr. Blum said.
Acute leukemia occurred in 0.24% of patients in the TaxAC group and in none of the patients in the TC treatment arm.
“Additional follow-up and correlative studies to identify biomarkers of anthracycline benefit will be crucial for fully determining the utility of anthracyclines across this heterogeneous patient population,” Dr. Blum concluded.
Dr. Blum had no disclosures to report. Sanofi, Genentech, and CTEP funded the ABC trials.
On Twitter @jessnicolecraig
CHICAGO – Docetaxel plus cyclophosphamide was significantly inferior to treatment with anthracycline/taxane-based chemotherapy, according to an interim joint analysis of the ABC (anthracyclines in early breast cancer) trials.
The ABC trials are three sequential trials from the US Oncology Research and National Surgical Adjuvant Breast and Bowel Project that randomized women with resected high-risk, early-stage breast cancer to receive docetaxel plus cyclophosphamide (TC) or one of several standard anthracycline/taxane-based chemotherapy (TaxAC) regimens.
A total of 4,130 patients met the ABC trials’ eligibility requirements and were randomly assigned to receive either TC therapy (n = 2,078) or TaxAC therapy (n = 2,052), Joanne Blum, MD, PhD, of the Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas, reported at the annual meeting of the American Society of Clinical Oncology.
Patient and tumor characteristics were balanced among the two treatment arms, and the median follow-up time was 3.2 years.
Inferiority was predefined as a Cox model hazard ratio (HR) score of 1.18 or higher when the cohort was stratified by nodal status, hormone-receptor status, and parent trial, Dr. Blum said.
The HR for the initial 334 events was 1.2, which exceeded the threshold and demonstrated that TC was inferior to TaxAC.
At the interim analysis, 399 events had occurred: 220 in the TC treatment arm and 179 in the TaxAC arm. Overall, the 4-year invasive disease-free survival was 88.2% for the TC treatment arm and 90.7% for the TaxAC treatment arm (HR, 1.23; 95% confidence interval, 1.01-1.50; P = .04). TaxAC was equal or superior to TC when the cohort was stratified by parent trial, hormone status, and nodal status. TC regimen was favored only in ER-positive patients with zero nodes.
There was no difference in overall survival between the two treatment arms.
Exploratory subgroup analyses suggest that TaxAC provides little benefit in ER-positive, node-negative cohorts, small benefit in ER-positive one-to-three node and ER-negative node-negative cohorts, and the most benefit for patients who were ER-positive with more than four nodes or ER-negative node-positive, Dr. Blum said.
Acute leukemia occurred in 0.24% of patients in the TaxAC group and in none of the patients in the TC treatment arm.
“Additional follow-up and correlative studies to identify biomarkers of anthracycline benefit will be crucial for fully determining the utility of anthracyclines across this heterogeneous patient population,” Dr. Blum concluded.
Dr. Blum had no disclosures to report. Sanofi, Genentech, and CTEP funded the ABC trials.
On Twitter @jessnicolecraig
AT THE 2016 ASCO ANNUAL MEETING
Key clinical point: Anthracyclines continue to have a role in the treatment of high-risk, HER2-negative breast cancer.
Major finding: 4-year invasive disease-free survival was 88.2% for the TC treatment arm and 90.7% for the TaxAC treatment arm (HR, 1.23; 95% CI, 1.01-1.50; P = .04).
Data source: An interim analysis of the ABC trials involved a total of 4,130 patients with breast cancer.
Disclosures: Dr. Blum had no disclosures to report. Sanofi, Genentech, and CTEP funded the ABC trials.