Relationship between toxicity and obesity in women receiving adjuvant chemotherapy for breast cancer: Results from cancer and leukemia group B study 8541
Relationship between toxicity and obesity in women receiving adjuvant chemotherapy for breast cancer: Results from cancer and leukemia group B study 8541
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DOI：
10.1200/jco.1996.14.11.3000
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发表时间：
1996-11-01
影响因子：
45.3
通讯作者：
Schilsky, RL
中科院分区：
文献类型：
--
作者：
Rosner, GL;Hargis, JB;Schilsky, RL
目的：我们检查了一项大型临床试验的数据，以确定根据实际体重的化疗剂量是否会使肥胖患者面临更大的毒性风险。患者和方法：癌症和白血病 B 组 (CALGB) 研究 8541，这是一项针对局部淋巴结阳性 II 期乳腺癌患者的辅助环磷酰胺、阿霉素和氟尿嘧啶 (CAF) 的时间表和剂量的随机研究，提供了 1,435 名女性的数据进行分析。根据体重指数 (BMI)，如果女性 BMI 大于或等于 27.3 kg/m(2)，我们就将其归类为肥胖；如果剂量与实际体重计算值的误差在 5% 以内，则认为剂量是基于体重的。我们的主要分析涉及第 1 周期期间的毒性风险。 结果：在接受基于体重的最剂量密集型 CAF 方案的女性中，47% 的肥胖女性和 51% 的非肥胖女性在第 1 周期期间经历了严重的血液学毒性（级别大于或等于 3）（P=.51，双尾）。在第 1 周期接受基于体重的剂量的女性中，治疗失败的总体风险比（肥胖与非肥胖）为 1.02（95% 置信区间，0.83 至 1.26），按治疗分层并根据阳性淋巴结数量、绝经状态、激素受体状态和肿瘤大小进行调整。肥胖女性的总体调整后失败风险比（基于体重与减少的初始剂量）为 0.73（95% 置信区间，0.53 至 1.00）。结论：与接受类似剂量的非肥胖女性相比，按实际体重初始给药（5% 以内）的肥胖患者并未出现过量的第 1 周期毒性或更差的结果。数据表明，在第 1 周期中接受减少剂量的肥胖女性的无失败生存率较差。我们建议CAF的初始剂量根据实际体重计算。 (C) 1996 年，美国临床肿瘤学会。
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 greater than or equal to 27.3 kg/m(2); 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 greater than or equal to 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. (C) 1996 by American Society of Clinical Oncology.