Centre Alexis Vautrin and Nancy University, EA 4360, Vandoeuvre-lès-Nancy 54511, France.
Br J Cancer. 2010 Jan 5;102(1):59-67. doi: 10.1038/sj.bjc.6605442. Epub 2009 Nov 17.
A phase-III trial showed the non-inferiority of oral capecitabine plus oxaliplatin (XELOX) vs 5-fluorouracil/leucovorin plus oxaliplatin (FOLFOX-6) in terms of efficacy in first-line treatment of metastatic colorectal cancer. A secondary objective was to compare the quality of life (QoL) and health-care satisfaction of patients.
Patients were randomised to receive XELOX (n=156) or FOLFOX-6 (n=150) for 6 months. Quality of life and satisfaction were assessed by the Quality of Life Questionnaire-C30 (QLQ-C30) and Functional Assessment of Chronic Illness Therapy Chemotherapy Convenience and Satisfaction Questionnaire (FACIT-CCSQ), respectively. Patients completed questionnaires at baseline, at Cycle3 (C3) and Cycle (C6) (XELOX) or at C4 and C8 visits (FOLFOX-6) and at their final visit.
A total of 245 and 225 patients were assessed using QLQ-C30 and FACIT-CCSQ, respectively. The completion rates were >80%. Global QoL scores did not differ significantly between groups during the study. According to FACIT-CCSQ, XELOX seemed more convenient (C3/C4, P<0.001; C6/C8, P=0.009) and satisfactory to patients (C6/C8, P=0.003) than FOLFOX-6. At the final visit, XELOX patients spent fewer days on hospital visits (3.3 vs 5.3 days, P=0.045) and lost fewer hours of work/daily activities (10.2 vs 37.1 h lost, P=0.007).
XELOX has a similar QoL profile, but seemed to be more convenient in terms of administration at certain time points and reduced time lost for work or other activities compared with FOLFOX-6.
一项 III 期临床试验表明，在转移性结直肠癌的一线治疗中，卡培他滨联合奥沙利铂（XELOX）与 5-氟尿嘧啶/亚叶酸钙联合奥沙利铂（FOLFOX-6）在疗效方面无差异。次要目标是比较患者的生活质量（QoL）和医疗保健满意度。
患者被随机分配接受 XELOX（n=156）或 FOLFOX-6（n=150）治疗 6 个月。生活质量和满意度分别通过生活质量问卷-C30（QLQ-C30）和慢性疾病治疗化疗便利和满意度问卷（FACIT-CCSQ）进行评估。患者在基线、第 3 周期（C3）和第 6 周期（XELOX）或第 4 周期和第 8 周期（FOLFOX-6）就诊时以及最后一次就诊时完成问卷。
共有 245 名和 225 名患者分别使用 QLQ-C30 和 FACIT-CCSQ 进行评估。完成率均>80%。研究期间，两组的总体 QoL 评分无显著差异。根据 FACIT-CCSQ，XELOX 在便利性（C3/C4，P<0.001；C6/C8，P=0.009）和患者满意度（C6/C8，P=0.003）方面似乎优于 FOLFOX-6。在最后一次就诊时，XELOX 患者的住院就诊天数（3.3 天 vs 5.3 天，P=0.045）和每天工作/日常活动的损失时间（10.2 小时 vs 37.1 小时，P=0.007）更少。
XELOX 具有相似的 QoL 特征，但在某些时间点给药时似乎更方便，并且与 FOLFOX-6 相比，工作或其他活动的损失时间更少。
