The impact of actual body weight-based chemotherapy dosing and body size on adverse events and outcome in older patients with breast cancer: Results from Cancer and Leukemia Group B (CALGB) trial 49907 (Alliance A151436)

Vicki A. Morrison, Linda McCall, Hyman B. Muss, Aminah Jatoi, Harvey J. Cohen, Constance T. Cirrincione, Jennifer A. Ligibel, Jacqueline M. Lafky, Arti Hurria

Research output: Contribution to journalArticle

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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 ≥ 65 years 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).

Original languageEnglish (US)
JournalJournal of Geriatric Oncology
DOIs
StateAccepted/In press - Jan 1 2018

Fingerprint

Body Size
Leukemia
Body Weight
Breast Neoplasms
Drug Therapy
Neoplasms
Survival
Thinness
Practice Guidelines
Weights and Measures
Recurrence
Adjuvant Chemotherapy
Multivariate Analysis
Obesity
Safety

Keywords

  • Actual body weight-based chemotherapy dosing
  • Breast cancer
  • Elderly
  • Outcome
  • Toxicity

ASJC Scopus subject areas

  • Oncology
  • Geriatrics and Gerontology

Cite this

The impact of actual body weight-based chemotherapy dosing and body size on adverse events and outcome in older patients with breast cancer : Results from Cancer and Leukemia Group B (CALGB) trial 49907 (Alliance A151436). / Morrison, Vicki A.; McCall, Linda; Muss, Hyman B.; Jatoi, Aminah; Cohen, Harvey J.; Cirrincione, Constance T.; Ligibel, Jennifer A.; Lafky, Jacqueline M.; Hurria, Arti.

In: Journal of Geriatric Oncology, 01.01.2018.

Research output: Contribution to journalArticle

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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 ≥ 65 years 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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AU - Morrison, Vicki A.

AU - McCall, Linda

AU - Muss, Hyman B.

AU - Jatoi, Aminah

AU - Cohen, Harvey J.

AU - Cirrincione, Constance T.

AU - Ligibel, Jennifer A.

AU - Lafky, Jacqueline M.

AU - Hurria, Arti

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AB - 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 ≥ 65 years 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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KW - Elderly

KW - Outcome

KW - Toxicity

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