Vicki A Morrison1, Linda McCall2, Hyman B Muss3, Aminah Jatoi4, Harvey J Cohen5, Constance T Cirrincione6, Jennifer A Ligibel7, Jacqueline M Lafky8, Arti Hurria9. 1. Division of Hematology, Oncology and Transplantation, University of Minnesota, Hennepin County Medical Center, Minneapolis, MN, United States; Division of Infectious Disease, University of Minnesota, Hennepin County Medical Center, Minneapolis, MN, United States. Electronic address: morri002@umn.edu. 2. Alliance Statistics and Data Center, Duke University, Durham, NC, United States. Electronic address: linda.mccall@duke.edu. 3. UNC Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC, United States. Electronic address: hyman_muss@med.unc.edu. 4. Mayo Clinic, Rochester, MN, United States. Electronic address: Jatoi.Aminah@mayo.edu. 5. Duke University Medical Center, Durham, NC, United States. Electronic address: harvey.cohen@duke.edu. 6. Alliance Statistics and Data Center, Duke University, Durham, NC, United States. 7. Dana-Farber/Partners CancerCare, Boston, MA, United States. Electronic address: jennnifer_ligibel@dfci.harvard.edu. 8. Mayo Clinic, Rochester, MN, United States. Electronic address: lafky.jacqueline@mayo.edu. 9. City of Hope, Duarte, CA, United States. Electronic address: AHurria@coh.org.
Abstract
OBJECTIVE:Actual weight-based (AWB) chemotherapy dosing is recommended for obese patients in the 2012 ASCO Clinical Practice Guideline. CALGB 49907, which utilized ABW-based adjuvant chemotherapy dosing, was a phase 3 trial in women age≥65years with early stage breast cancer, providing the opportunity to examine impact of such dosing on toxicities and outcome in older patients with breast cancer. MATERIALS AND METHODS: Adverse event data were available for 615 of 633 enrolled patients. Objectives were to assess grade≥3 hematologic/non-hematologic toxicities by treatment arm, age, study entry BSA/BMI, and relapse-free (RFS) and overall survival (OS) by BSA/BMI. RESULTS: The 615 patients were sub-grouped by BSA (quartiles) and standard BMI categories, with BMI underweight/normal weight categories combined. Overall, grade≥3 non-hematologic and hematologic toxicities occurred in 39.8% and 28.3% of patients, respectively. There were no significant differences in grade≥3 toxicities among BSA quartiles. However, more grade≥3 hematologic toxicities occurred in the underweight/normal weight BMI subgroup compared to overweight/obese subgroups (p=0.048). Type of chemotherapy and age had no impact on toxicity occurrence by BSA/BMI categories. RFS was superior in the 25th-50th BSA percentile patients in univariate analysis (p=0.042), as was OS in both univariate and multivariate analyses (p=0.007, p=0.009, respectively). No differences in RFS or OS were found by BMI categories. CONCLUSION:Obesity was not correlated with adverse relapse or survival outcome, and grade≥3 toxicities were not greater with ABW-based dosing. This supports safety and efficacy of ABW-based dosing as per the 2012 ASCO clinical practice guideline. ClinicalTrials.gov Identifier: NCT00024102 (49907).
RCT Entities:
OBJECTIVE: Actual weight-based (AWB) chemotherapy dosing is recommended for obesepatients in the 2012 ASCO Clinical Practice Guideline. CALGB 49907, which utilized ABW-based adjuvant chemotherapy dosing, was a phase 3 trial in women age≥65years with early stage breast cancer, providing the opportunity to examine impact of such dosing on toxicities and outcome in older patients with breast cancer. MATERIALS AND METHODS: Adverse event data were available for 615 of 633 enrolled patients. Objectives were to assess grade≥3 hematologic/non-hematologic toxicities by treatment arm, age, study entry BSA/BMI, and relapse-free (RFS) and overall survival (OS) by BSA/BMI. RESULTS: The 615 patients were sub-grouped by BSA (quartiles) and standard BMI categories, with BMI underweight/normal weight categories combined. Overall, grade≥3 non-hematologic and hematologic toxicities occurred in 39.8% and 28.3% of patients, respectively. There were no significant differences in grade≥3 toxicities among BSA quartiles. However, more grade≥3 hematologic toxicities occurred in the underweight/normal weight BMI subgroup compared to overweight/obese subgroups (p=0.048). Type of chemotherapy and age had no impact on toxicity occurrence by BSA/BMI categories. RFS was superior in the 25th-50th BSA percentile patients in univariate analysis (p=0.042), as was OS in both univariate and multivariate analyses (p=0.007, p=0.009, respectively). No differences in RFS or OS were found by BMI categories. CONCLUSION:Obesity was not correlated with adverse relapse or survival outcome, and grade≥3 toxicities were not greater with ABW-based dosing. This supports safety and efficacy of ABW-based dosing as per the 2012 ASCO clinical practice guideline. ClinicalTrials.gov Identifier: NCT00024102 (49907).
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