Weekly docetaxel versus CMF as adjuvant chemotherapy for older women with early breast cancer: final results of the randomized phase III ELDA trial
Weekly docetaxel versus CMF as adjuvant chemotherapy for older women with early breast cancer: final results of the randomized phase III ELDA trial
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DOI：
10.1093/annonc/mdu564
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发表时间：
2015-04-01
影响因子：
50.5
通讯作者：
de Matteis, A.
中科院分区：
文献类型：
--
作者：
Perrone, F.;Nuzzo, F.;de Matteis, A.
背景：老年女性乳腺癌辅助化疗的证据不足。我们测试是否每周多西他赛是更有效的比标准chemotherapy.Patients和方法：我们进行了一项多中心，随机III期研究。年龄65-79岁的乳腺癌手术女性，复发风险从平均到高，根据激素受体状态，以1：1的比例分配CMF（环磷酰胺600 mg/m2，甲氨蝶呤40 mg/m2，氟尿嘧啶600 mg/m2，第1、8天）或多西他赛（35 mg/m2，第1、8、15天），每4周一次，持续4或6个周期。主要终点为无病生存期（DFS）。进行了老年评估。采用EORTC C-30和BR-23问卷评估生活质量（QoL）。结果：从2003年7月至2011年4月，302例患者被随机分配，299例（152例分配CMF和147例分配多西他赛）符合条件。中位随访70个月后，观察到109例DFS事件。多西他赛与CMF的DFS未校正风险比（HR）为1.21 [95%置信区间（CI）0.83-1.76，P = 0.32]; CMF组5年DFS估计值为0.69，多西他赛组为0.65。死亡的HR为1.34（95% CI 0.80-2.22，P = 0.26）。治疗组与测量患者能力或合并症的老年量表之间无相互作用。CMF组的血液学毒性、粘膜炎和恶心更严重;多西他赛组的过敏、疲乏、脱发、甲病、味觉障碍、腹泻、腹痛、神经病变、心脏和皮肤毒性更严重。1例死亡归因于CMF，2例归因于多西他赛。年龄增加、工具性日常生活活动受损、合并症数量和多西他赛治疗与重度非血液学毒性独立相关。多西他赛的恶心呕吐，食欲不振，腹泻，身体形象，未来的前景，治疗副作用和脱发items.Conclusions：每周多西他赛是不是更有效的辅助治疗老年妇女乳腺癌和乳腺癌的生活质量和毒性比标准CMF。
Background: Evidence on adjuvant chemotherapy in older women with breast cancer is poor. We tested whether weekly docetaxel is more effective than standard chemotherapy.Patients and methods: We carried out a multicenter, randomized phase III study. Women aged 65-79, operated for breast cancer, with average to high risk of recurrence, were allocated 1 : 1 to CMF (cyclophosphamide 600 mg/m(2), methotrexate 40 mg/m(2), fluorouracil 600 mg/m(2), days 1, 8) or docetaxel (35 mg/m2 days 1, 8, 15) every 4 weeks, for four or six cycles according to hormone receptor status. Primary end point was disease-free survival (DFS). A geriatric assessment was carried out. Quality of life (QoL) was assessed with EORTC C-30 and BR-23 questionnaires.Results: From July 2003 to April 2011, 302 patients were randomized and 299 (152 allocated CMF and 147 docetaxel) were eligible. After 70-month median follow-up, 109 DFS events were observed. Unadjusted hazard ratio (HR) of DFS for docetaxel versus CMF was 1.21 [95% confidence interval (CI) 0.83-1.76, P = 0.32]; DFS estimate at 5 years was 0.69 with CMF and 0.65 with docetaxel. HR of death was 1.34 (95% CI 0.80-2.22, P = 0.26). There was no interaction between treatment arms and geriatric scales measuring patients' ability or comorbidities. Hematological toxicity, mucositis and nausea were worse with CMF; allergy, fatigue, hair loss, onychopathy, dysgeusia, diarrhea, abdominal pain, neuropathy, cardiac and skin toxicity were worse with docetaxel. One death was attributed to CMF and two to docetaxel. Increasing age, impairment in instrumental daily living activities, number of comorbidities and docetaxel treatment were independently associated with severe nonhematological toxicity. QoL was worse with docetaxel for nausea-vomiting, appetite loss, diarrhea, body image, future perspective, treatment side-effects and hair loss items.Conclusions: Weekly docetaxel is not more effective than standard CMF as adjuvant treatment of older women with breast cancer and worsens QoL and toxicity.