在常规临床实践中开始一线化疗的转移性乳腺癌女性与当代随机试验的生存时间。
Survival times of women with metastatic breast cancer starting first-line chemotherapy in routine clinical practice versus contemporary randomised trials.
机构信息
Macarthur Cancer Therapy Centre, Campbelltown Hospital, Sydney, Australia.
出版信息
Intern Med J. 2013 Aug;43(8):883-8. doi: 10.1111/imj.12178.
BACKGROUND
Survival times of women starting first-line chemotherapy for metastatic breast cancer (MBC) in routine clinical practice were determined and compared with those from a systematic review of randomised clinical trials.
METHODS
We identified women with MBC starting first-line chemotherapy from June 2003 to February 2011 and recorded their demographics, tumour and treatment characteristics, and survival times from the start of chemotherapy. Their survival distribution was summarised by the following percentiles (represented scenarios for survival): 90th (worst-case), 75th (lower-typical), 25th (upper-typical) and 10th (best-case), which were compared with the same percentiles from our systematic review of first-line chemotherapy trials.
RESULTS
The 273 women had a median age of 56 years, and a median time from diagnosis of MBC of 3 months. Eastern Cooperative Oncology Group performance status was 0-1 in 80%. Tumours were hormone receptor positive in 69%, human epidermal growth factor receptor 2 (HER2)-positive in 27% and triple negative in 13%. Survival times in months in routine clinical practice (vs the systematic review) were: 90th percentile 4 (6); 75th percentile 9 (12); median 20 (22); 25th percentile 36 (36) and 10th percentile 61 (56). Independent predictors of overall survival included HER2-positive disease (hazard ratio (HR) 0.49, P = 0.0002), hormone receptor positive disease (HR 0.51, P = 0.0004), Eastern Cooperative Oncology Group performance status 0-1 (HR 0.36, P < 0.0001) and adjuvant chemotherapy (HR 1.86, P = 0.0002).
CONCLUSION
Median and better survival times in routine practice were similar to those from randomised clinical trials; however, survival times worse than the median were shorter, likely reflecting patient selection in trials. Oncologists should adjust trial-based survival estimates for patients not meeting typical trial eligibility criteria.
背景
在常规临床实践中，确定了开始转移性乳腺癌（MBC）一线化疗的女性的生存时间，并将其与随机临床试验系统评价的结果进行了比较。
方法
我们从 2003 年 6 月至 2011 年 2 月确定了开始一线化疗的 MBC 女性，并记录了她们的人口统计学、肿瘤和治疗特征以及从化疗开始的生存时间。通过以下百分位数（代表生存情况）总结了她们的生存分布：第 90 百分位数（最差情况）、第 75 百分位数（较低典型情况）、第 25 百分位数（较高典型情况）和第 10 百分位数（最佳情况），并将其与我们对一线化疗试验的系统评价中的相同百分位数进行了比较。
结果
273 名女性的中位年龄为 56 岁，MBC 诊断后的中位时间为 3 个月。东部肿瘤协作组（ECOG）表现状态为 0-1 的占 80%。肿瘤中激素受体阳性占 69%，人表皮生长因子受体 2（HER2）阳性占 27%，三阴性占 13%。常规临床实践中的生存时间（vs 系统评价）分别为：第 90 百分位数 4 个月（6）；第 75 百分位数 9 个月（12）；中位数 20 个月（22）；第 25 百分位数 36 个月（36）；第 10 百分位数 61 个月（56）。总生存的独立预测因素包括 HER2 阳性疾病（风险比（HR）0.49，P=0.0002）、激素受体阳性疾病（HR 0.51，P=0.0004）、ECOG 表现状态 0-1（HR 0.36，P<0.0001）和辅助化疗（HR 1.86，P=0.0002）。
结论
常规实践中的中位和更好的生存时间与随机临床试验相似；然而，比中位数更差的生存时间更短，这可能反映了试验中的患者选择。肿瘤学家应根据不符合典型试验入选标准的患者调整基于试验的生存估计值。
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