Relationship between toxicity and obesity in women receiving adjuvant chemotherapy for breast cancer: Results from Cancer and Leukemia Group B study 8541

Gary Rosner, J. B. Hargis, D. R. Hollis, D. R. Budman, R. B. Weiss, I. C. Henderson, R. L. Schilsky

Research output: Contribution to journalArticle

Abstract

Purpose: We examined data from a large clinical trial to determine if chemotherapy dosing according to actual body weight places obese patients at greater risk of toxicity. Patients and Methods: Cancer and Leukemia Group B (CALGB) study 8541, a randomized study of schedule and dose of adjuvant cyclophosphamide, doxorubicin, and fluorouracil (CAF) for stage II breast cancer patients with positive regional lymph nodes, provided data on 1,435 women for analysis. Using body-mass index (BMI), we classified a woman as obese if her BMI was ≤ 27.3 kg/m2; doses were considered weight-based if within 5% of values calculated using actual weight. Our primary analysis concerned toxicity risks during cycle 1. Results: Among women who received weight-based doses of the most dose-intensive CAF regimen, 47% of obese and 51% of nonobese women experienced severe hematologic toxicity (grade ≤ 3) during cycle 1 (P = .51, two-tailed). The overall risk ratio (obese v nonobese) of treatment failure among women who received weight-based doses during cycle 1 was 1.02 (95% confidence interval, 0.83 to 1.26), stratified by treatment and adjusted for number of positive nodes, menopausal status, hormone receptor status, and tumor size. The overall adjusted failure risk ratio (weight-based v reduced initial doses) was 0.73 (95% confidence interval, 0.53 to 1.00) among obese women. Conclusion: Obese patients initially dosed (within 5%) by actual weight did not experience excess cycle 1 toxicity or worse outcome compared with nonobese women dosed similarly. The data suggest that obese women who received reduced doses in cycle 1 experienced worse failure-free survival. We recommend that initial doses of CAF be computed according to actual body weight.

Original languageEnglish (US)
Pages (from-to)3000-3008
Number of pages9
JournalJournal of Clinical Oncology
Volume14
Issue number11
StatePublished - 1996
Externally publishedYes

Fingerprint

Adjuvant Chemotherapy
Leukemia
Obesity
Breast Neoplasms
Weights and Measures
Neoplasms
Fluorouracil
Doxorubicin
Cyclophosphamide
Body Mass Index
Odds Ratio
Body Weight
Confidence Intervals
Treatment Failure
Appointments and Schedules
Lymph Nodes
Clinical Trials
Hormones
Drug Therapy
Survival

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Rosner, G., Hargis, J. B., Hollis, D. R., Budman, D. R., Weiss, R. B., Henderson, I. C., & Schilsky, R. L. (1996). Relationship between toxicity and obesity in women receiving adjuvant chemotherapy for breast cancer: Results from Cancer and Leukemia Group B study 8541. Journal of Clinical Oncology, 14(11), 3000-3008.

Relationship between toxicity and obesity in women receiving adjuvant chemotherapy for breast cancer : Results from Cancer and Leukemia Group B study 8541. / Rosner, Gary; Hargis, J. B.; Hollis, D. R.; Budman, D. R.; Weiss, R. B.; Henderson, I. C.; Schilsky, R. L.

In: Journal of Clinical Oncology, Vol. 14, No. 11, 1996, p. 3000-3008.

Research output: Contribution to journalArticle

Rosner, Gary ; Hargis, J. B. ; Hollis, D. R. ; Budman, D. R. ; Weiss, R. B. ; Henderson, I. C. ; Schilsky, R. L. / Relationship between toxicity and obesity in women receiving adjuvant chemotherapy for breast cancer : Results from Cancer and Leukemia Group B study 8541. In: Journal of Clinical Oncology. 1996 ; Vol. 14, No. 11. pp. 3000-3008.
@article{56ca0df05cd640ea94912cb58d9c0962,
title = "Relationship between toxicity and obesity in women receiving adjuvant chemotherapy for breast cancer: Results from Cancer and Leukemia Group B study 8541",
abstract = "Purpose: We examined data from a large clinical trial to determine if chemotherapy dosing according to actual body weight places obese patients at greater risk of toxicity. Patients and Methods: Cancer and Leukemia Group B (CALGB) study 8541, a randomized study of schedule and dose of adjuvant cyclophosphamide, doxorubicin, and fluorouracil (CAF) for stage II breast cancer patients with positive regional lymph nodes, provided data on 1,435 women for analysis. Using body-mass index (BMI), we classified a woman as obese if her BMI was ≤ 27.3 kg/m2; doses were considered weight-based if within 5{\%} of values calculated using actual weight. Our primary analysis concerned toxicity risks during cycle 1. Results: Among women who received weight-based doses of the most dose-intensive CAF regimen, 47{\%} of obese and 51{\%} of nonobese women experienced severe hematologic toxicity (grade ≤ 3) during cycle 1 (P = .51, two-tailed). The overall risk ratio (obese v nonobese) of treatment failure among women who received weight-based doses during cycle 1 was 1.02 (95{\%} confidence interval, 0.83 to 1.26), stratified by treatment and adjusted for number of positive nodes, menopausal status, hormone receptor status, and tumor size. The overall adjusted failure risk ratio (weight-based v reduced initial doses) was 0.73 (95{\%} confidence interval, 0.53 to 1.00) among obese women. Conclusion: Obese patients initially dosed (within 5{\%}) by actual weight did not experience excess cycle 1 toxicity or worse outcome compared with nonobese women dosed similarly. The data suggest that obese women who received reduced doses in cycle 1 experienced worse failure-free survival. We recommend that initial doses of CAF be computed according to actual body weight.",
author = "Gary Rosner and Hargis, {J. B.} and Hollis, {D. R.} and Budman, {D. R.} and Weiss, {R. B.} and Henderson, {I. C.} and Schilsky, {R. L.}",
year = "1996",
language = "English (US)",
volume = "14",
pages = "3000--3008",
journal = "Journal of Clinical Oncology",
issn = "0732-183X",
publisher = "American Society of Clinical Oncology",
number = "11",

}

TY - JOUR

T1 - Relationship between toxicity and obesity in women receiving adjuvant chemotherapy for breast cancer

T2 - Results from Cancer and Leukemia Group B study 8541

AU - Rosner, Gary

AU - Hargis, J. B.

AU - Hollis, D. R.

AU - Budman, D. R.

AU - Weiss, R. B.

AU - Henderson, I. C.

AU - Schilsky, R. L.

PY - 1996

Y1 - 1996

N2 - Purpose: We examined data from a large clinical trial to determine if chemotherapy dosing according to actual body weight places obese patients at greater risk of toxicity. Patients and Methods: Cancer and Leukemia Group B (CALGB) study 8541, a randomized study of schedule and dose of adjuvant cyclophosphamide, doxorubicin, and fluorouracil (CAF) for stage II breast cancer patients with positive regional lymph nodes, provided data on 1,435 women for analysis. Using body-mass index (BMI), we classified a woman as obese if her BMI was ≤ 27.3 kg/m2; doses were considered weight-based if within 5% of values calculated using actual weight. Our primary analysis concerned toxicity risks during cycle 1. Results: Among women who received weight-based doses of the most dose-intensive CAF regimen, 47% of obese and 51% of nonobese women experienced severe hematologic toxicity (grade ≤ 3) during cycle 1 (P = .51, two-tailed). The overall risk ratio (obese v nonobese) of treatment failure among women who received weight-based doses during cycle 1 was 1.02 (95% confidence interval, 0.83 to 1.26), stratified by treatment and adjusted for number of positive nodes, menopausal status, hormone receptor status, and tumor size. The overall adjusted failure risk ratio (weight-based v reduced initial doses) was 0.73 (95% confidence interval, 0.53 to 1.00) among obese women. Conclusion: Obese patients initially dosed (within 5%) by actual weight did not experience excess cycle 1 toxicity or worse outcome compared with nonobese women dosed similarly. The data suggest that obese women who received reduced doses in cycle 1 experienced worse failure-free survival. We recommend that initial doses of CAF be computed according to actual body weight.

AB - Purpose: We examined data from a large clinical trial to determine if chemotherapy dosing according to actual body weight places obese patients at greater risk of toxicity. Patients and Methods: Cancer and Leukemia Group B (CALGB) study 8541, a randomized study of schedule and dose of adjuvant cyclophosphamide, doxorubicin, and fluorouracil (CAF) for stage II breast cancer patients with positive regional lymph nodes, provided data on 1,435 women for analysis. Using body-mass index (BMI), we classified a woman as obese if her BMI was ≤ 27.3 kg/m2; doses were considered weight-based if within 5% of values calculated using actual weight. Our primary analysis concerned toxicity risks during cycle 1. Results: Among women who received weight-based doses of the most dose-intensive CAF regimen, 47% of obese and 51% of nonobese women experienced severe hematologic toxicity (grade ≤ 3) during cycle 1 (P = .51, two-tailed). The overall risk ratio (obese v nonobese) of treatment failure among women who received weight-based doses during cycle 1 was 1.02 (95% confidence interval, 0.83 to 1.26), stratified by treatment and adjusted for number of positive nodes, menopausal status, hormone receptor status, and tumor size. The overall adjusted failure risk ratio (weight-based v reduced initial doses) was 0.73 (95% confidence interval, 0.53 to 1.00) among obese women. Conclusion: Obese patients initially dosed (within 5%) by actual weight did not experience excess cycle 1 toxicity or worse outcome compared with nonobese women dosed similarly. The data suggest that obese women who received reduced doses in cycle 1 experienced worse failure-free survival. We recommend that initial doses of CAF be computed according to actual body weight.

UR - http://www.scopus.com/inward/record.url?scp=0029824018&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0029824018&partnerID=8YFLogxK

M3 - Article

C2 - 8918498

AN - SCOPUS:0029824018

VL - 14

SP - 3000

EP - 3008

JO - Journal of Clinical Oncology

JF - Journal of Clinical Oncology

SN - 0732-183X

IS - 11

ER -