Randomized, open-label, phase II trial of oral capecitabine (Xeloda®) vs. a reference arm of intravenous CMF (cyclophosphamide, methotrexate and 5-fluorouracil) as first-line therapy for advanced/metastatic breast cancer
Randomized, open-label, phase II trial of oral capecitabine (Xeloda®) vs. a reference arm of intravenous CMF (cyclophosphamide, methotrexate and 5-fluorouracil) as first-line therapy for advanced/metastatic breast cancer
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DOI：
10.1023/a:1012281104865
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发表时间：
2001-09-01
影响因子：
50.5
通讯作者：
Laws, S
中科院分区：
文献类型：
--
作者：
O'Shaughnessy, JA;Blum, J;Laws, S
背景：对于年龄大于或等于 55 岁的晚期/转移性乳腺癌女性，口服卡培他滨作为一线治疗的总体反应率、安全性和耐受性进行了评估。 患者和方法：95 名患者被随机 (2:1) 接受间歇性口服卡培他滨 1255 mg/m(2) 每日两次（治疗两周，然后休息一周）或静脉注射 CMF（环磷酰胺、每三周给药一次甲氨蝶呤、5-氟尿嘧啶 [5-FU]）。结果：卡培他滨组的总体缓解率为 30%（95% 置信区间 (95% CI)：19%-43%），包括 3 例完全缓解 (5%)。 CMF 组观察到的缓解率为 16%（95% CI：5%-33%），没有完全缓解。卡培他滨至疾病进展的中位时间为 4.1 个月，CMF 为 3.0 个月。两个治疗组的生存期相似（卡培他滨组的中位生存期为 19.6 个月，CMF 组的中位生存期为 17.2 个月）。卡培他滨和 CMF 的安全性不同。然而，两种治疗方案通常都具有良好的耐受性，并且治疗中断和/或剂量调整可有效控制与卡培他滨相关的毒性。接受卡培他滨治疗的患者很少出现脱发和骨髓抑制，而腹泻和手足综合征则更为常见。 34% 的患者需要中断治疗和/或调整卡培他滨的个体剂量，并且通常可以有效地控制不良事件。卡培他滨组中有 16% 的患者因出现毒性而停止治疗。卡培他滨组和 CMF 组在研究治疗期间或停止研究治疗后 28 天内的死亡发生率分别为 8% 和 6%。 结论：对于患有晚期/转移性乳腺癌的老年患者（大于或等于 55 岁），每日两次口服卡培他滨方案作为一线化疗有效且耐受性良好，适合门诊治疗。
Background: Oral capecitabine was evaluated in terms of overall response rate, safety, and tolerability as first-line therapy in women aged greater than or equal to 55 years with advanced/metastatic breast cancer.Patients and methods: Ninety-five patients were randomized (2 : 1) to either intermittent oral capecitabine 1255 mg/m(2) twice daily (two weeks' treatment followed by a one-week rest period) or intravenous CMF (cyclophosphamide, methotrexate, 5-fluorouracil [5-FU]) administered every three weeks.Results: The overall response rate in the capecitabine group was 30% (95% confidence interval (95% CI): 19%-43%), including three complete responses (5%). The response rate observed in the CMF group was 16% (95% CI: 5%-33%), with no complete responses. Median time to disease progression was 4.1 months with capecitabine and 3.0 months with CMF. Survival was similar in the two treatment groups (median 19.6 months with capecitabine, 17.2 months with CMF). The safety profiles were different for capecitabine and CMF. However, both regimens were generally well tolerated and treatment interruption and/or dose modification was effective in managing toxicities associated with capecitabine. Alopecia and myelosuppression were rare in patients receiving capecitabine while diarrhea and hand-foot syndrome were more common. Treatment interruption and/or individual dose adjustment of capecitabine was required in 34% of patients and was generally effective in managing adverse events. Treatment was stopped owing to toxicity in 16% of patients in the capecitabine arm. The incidence of deaths during or within 28 days of stopping study treatment was 8% and 6% in the capecitabine and CMF arms, respectively.Conclusions: An oral, twice-daily regimen of capecitabine is effective and well tolerated when used as first-line chemotherapy in older patients (greater than or equal to 55 years) with advanced/metastatic breast cancer, and is suitable for outpatient therapy.