Coates A, Gebski V, Bishop J F, Jeal P N, Woods R L, Snyder R, Tattersall M H, Byrne M, Harvey V, Gill G
Ludwig Institute for Cancer Research (Sydney Branch), University of Sydney, N.S.W., Australia.
N Engl J Med. 1987 Dec 10;317(24):1490-5. doi: 10.1056/NEJM198712103172402.
Since chemotherapy for metastatic breast cancer is not curative, consideration of the quality of life is important in selecting a treatment regimen. We conducted a randomized trial comparing continuous chemotherapy, administered until disease progression was evident, with intermittent therapy, whereby treatment was stopped after three cycles and then repeated for three more cycles only when there was evidence of disease progression. Each approach was tested with doxorubicin combined with cyclophosphamide or with cyclophosphamide combined with methotrexate, fluorouracil, and prednisone. Intermittent therapy resulted in a significantly worse response (P = 0.02 by Mann-Whitney test), a significantly shorter time to disease progression (relative risk based on proportional-hazards model, 1.8; 95 percent confidence interval, 1.4 to 2.4), and a trend toward shorter survival (relative risk, 1.3; confidence interval, 0.99 to 1.6). The quality of life was expressed as linear-analogue self-assessment scores for physical well-being, mood, pain, and appetite and as a quality-of-life index. It improved significantly during the first three cycles, when all patients received treatment. Thereafter, intermittent therapy was associated with worse scores for physical well-being (by 23 percent of scale; 95 percent confidence interval, 11 to 35 percent), mood (25 percent; 13 to 37 percent), and appetite (12 percent; 0 to 24 percent) and for the quality-of-life index as indicated by the patient (14 percent; 5 to 23 percent) and the physician (16 percent; 7 to 26 percent). Changes in the quality of life were independent prognostic factors in proportional-hazards models of subsequent survival. We conclude that, as tested, continuous chemotherapy is better than intermittent chemotherapy for advanced breast cancer.
由于转移性乳腺癌的化疗无法治愈,因此在选择治疗方案时考虑生活质量很重要。我们进行了一项随机试验,比较持续化疗(持续给药直至疾病进展明显)与间歇疗法(治疗三个周期后停药,仅在有疾病进展证据时再重复三个周期)。每种方法都使用阿霉素联合环磷酰胺或环磷酰胺联合甲氨蝶呤、氟尿嘧啶和泼尼松进行测试。间歇疗法导致反应明显更差(曼-惠特尼检验P = 0.02),疾病进展时间明显更短(基于比例风险模型的相对风险为1.8;95%置信区间为1.4至2.4),以及生存时间有缩短趋势(相对风险为1.3;置信区间为0.99至1.6)。生活质量用身体状况、情绪、疼痛和食欲的线性模拟自我评估分数以及生活质量指数来表示。在所有患者接受治疗的前三个周期中,生活质量显著改善。此后,间歇疗法与身体状况评分更差(量表的23%;95%置信区间为11%至35%)、情绪评分更差(25%;13%至37%)、食欲评分更差(12%;0%至24%)以及患者(14%;5%至23%)和医生(16%;7%至26%)所指出的生活质量指数更差相关。生活质量的变化是后续生存比例风险模型中的独立预后因素。我们得出结论,如测试所示,对于晚期乳腺癌,持续化疗优于间歇化疗。