Fraser S C, Dobbs H J, Ebbs S R, Fallowfield L J, Bates T, Baum M
Department of Surgery, Kings College Hospital, London, UK.
Br J Cancer. 1993 Feb;67(2):402-6. doi: 10.1038/bjc.1993.74.
Forty patients with advanced breast cancer, randomised to receive CMF or weekly low dose Epirubicin, were evaluated by UICC criteria of response and WHO toxicity criteria, in addition to three QoL instruments: the 'Qualitator' daily diary card, 4 weekly Nottingham Health Profile (NHP) and Linear Analogue Self-Assessment (LASA). Response rates were 58% for CMF and 29% for epirubicin (chi 2 = 3.51, 1 d.f., P > 0.05). Median time to treatment failure was 24 weeks for CMF, 7 weeks for epirubicin (P < 0.05) but survival was similar in both groups. Survival was better for responders than for non-responders (medians 87 and 30 weeks, P = 0.02). CMF caused more objective alopecia (P < 0.001), nausea and vomiting (P < 0.001) and haematological toxicity (P < 0.02). However, QoL measures only recorded a significant difference in energy and pain, influenced primarily by the non-responders in each treatment group but with no difference in overall global scores. Scores for responders, irrespective of treatment, were better to start with (LASA P = 0.001); at 12 weeks, scores had improved (Qualitator P < 0.05; NHP P < 0.05). Scores in non-responders showed no change. In this small study aggressive chemotherapy gave better response and similar survival without impairing Quality of life overall. Detailed QoL measurement should be integral to all cancer chemotherapy trials.
40例晚期乳腺癌患者被随机分为接受CMF方案或每周低剂量表柔比星治疗组，除采用三种生活质量评估工具：“质量测定仪”每日日记卡、每4周一次的诺丁汉健康量表（NHP）和线性模拟自我评估法（LASA）外，还依据国际抗癌联盟（UICC）的疗效标准和世界卫生组织（WHO）的毒性标准进行评估。CMF方案的有效率为58%，表柔比星为29%（χ² = 3.51，自由度为1，P > 0.05）。CMF方案治疗失败的中位时间为24周，表柔比星为7周（P < 0.05），但两组的生存率相似。有效者的生存率优于无效者（中位生存期分别为87周和30周，P = 0.02）。CMF方案导致更多的客观脱发（P < 0.001）、恶心和呕吐（P < 0.001）以及血液学毒性（P < 0.02）。然而，生活质量评估仅记录到能量和疼痛方面存在显著差异，主要受各治疗组中无效者的影响，但总体综合评分无差异。无论接受何种治疗，有效者的评分一开始就更好（LASA，P = 0.001）；在12周时，评分有所改善（质量测定仪，P < 0.05；NHP，P < 0.05）。无效者的评分无变化。在这项小型研究中，积极的化疗方案疗效更佳且生存率相似，同时并未损害总体生活质量。详细的生活质量测量应成为所有癌症化疗试验不可或缺的一部分。
