Dana-Farber Cancer Institute, Boston, MA, USA.
J Clin Oncol. 2011 Mar 10;29(8):1022-8. doi: 10.1200/JCO.2010.29.9859. Epub 2011 Feb 7.
A phase III trial (Cancer and Leukemia Group B CALGB-49907) was conducted to test whether older patients with early-stage breast cancer would have equivalent relapse-free and overall survival with capecitabine compared with standard chemotherapy. The quality of life (QoL) substudy tested whether capecitabine treatment would be associated with a better QoL than standard chemotherapy.
QoL was assessed in 350 patients randomly assigned to either standard chemotherapy (cyclophosphamide, methotrexate, and fluorouracil [CMF] or doxorubicin and cyclophosphamide [AC]; n = 182) or capecitabine (n = 168). Patients were interviewed by telephone before treatment (baseline), midtreatment, within 1 month post-treatment, and at 12, 18, and 24 months postbaseline by using questionnaires from the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30), a breast systemic adverse effects scale (EORTC BR23), and the Hospital Anxiety and Depression Scale (HADS).
Compared with patients who were treated with standard chemotherapy, patients who were treated with capecitabine had significantly better QoL, role function, and social function, fewer systemic adverse effects, less psychological distress, and less fatigue during and at the completion of treatment (P ≤ .005). Capecitabine treatment was associated with less nausea, vomiting, and constipation and with better appetite than standard treatment (P ≤ .004), but worse hand-foot syndrome and diarrhea (P < .005). These differences all resolved by 12 months.
Standard chemotherapy was superior to capecitabine in improving relapse-free and overall survival for older women with early-stage breast cancer. Although capecitabine was associated with better QoL during treatment, QoL was similar for both groups at 1 year. The brief period of poorer QoL with standard treatment is a modest price to pay for a chance at improved survival.
一项 III 期临床试验（癌症和白血病组 B 临床试验 CALGB-49907）旨在检验卡培他滨与标准化疗相比，是否能使早期乳腺癌老年患者具有同等的无复发生存率和总生存率。该质量生活（QoL）子研究检验了卡培他滨治疗是否与标准化疗相比能产生更好的 QoL。
共有 350 例患者随机分为标准化疗组（环磷酰胺、甲氨蝶呤和氟尿嘧啶[CMF]或阿霉素和环磷酰胺[AC]；n=182）或卡培他滨组（n=168）。患者在治疗前（基线）、治疗中期、治疗后 1 个月内、基线后 12、18 和 24 个月通过欧洲癌症研究与治疗组织生活质量问卷 C30（EORTC QLQ-C30）、乳腺全身不良效应量表（EORTC BR23）和医院焦虑抑郁量表（HADS）进行电话访谈。
与接受标准化疗的患者相比，接受卡培他滨治疗的患者 QoL、角色功能和社会功能显著更好，全身不良反应更少，心理困扰更少，治疗期间和治疗结束时疲劳更少（P≤0.005）。卡培他滨治疗与标准治疗相比，恶心、呕吐和便秘更少，食欲更好（P≤0.004），但手足综合征和腹泻更严重（P<0.005）。这些差异在 12 个月时均得到缓解。
标准化疗在改善早期乳腺癌老年女性的无复发生存率和总生存率方面优于卡培他滨。虽然卡培他滨治疗期间 QoL 更好，但两组在 1 年时 QoL 相似。标准治疗期间 QoL 短暂下降是提高生存率的适度代价。
