National Health and Medical Research Council Clinical Trials Centre and Sydney Medical School, University of Sydney, Sydney, New South Wales, Australia.
J Clin Oncol. 2011 Feb 1;29(4):456-63. doi: 10.1200/JCO.2010.30.2174. Epub 2010 Dec 28.
To estimate scenarios for survival for women with metastatic breast cancer (MBC) who are starting chemotherapy.
We sought randomized, first-line chemotherapy trials for MBC published from 1999 to 2009. We recorded median progression-free survival (PFS) and median overall survival (OS) and extracted the following percentiles (represented scenario) from each OS curve: 90th (worst-case), 75th (lower-typical), 25th (upper-typical), and 10th (best-case). We also estimated these scenarios for each OS curve by multiplying its median by four simple multiples: 0.25 (worst-case), 0.5 (lower-typical), 2 (upper-typical), and 3 (best-case). Estimates were deemed accurate if they were within 0.75 to 1.33 times the actual value.
From 36 trials (13,083 women), the mean for median PFS was 7.6 months (interquartile range [IQR], 6.0 to 9.0 months), the mean for median OS was 21.7 months (IQR,18.2 to 24.0 months), and the mean for the ratio of median OS to median PFS was 3.0 (IQR, 2.4 to 3.5). The mean for each OS scenario was worst-case, 6.3 months (IQR, 4.8 to 7.5 months); lower-typical, 11.9 months (IQR, 9.9 to 13.2 months); upper-typical, 36.2 months (IQR, 31.1 to 41.3 months); and best-case, 55.8 months (IQR, 47.5 to 60.2 months). Simple multiples of the median gave accurate estimates of the worst-case scenario in 73% of OS curves, lower-typical in 97%, upper-typical in 95%, and best-case in 96%. OS was longer in trials with higher proportions of estrogen receptor-positive tumors (P = .001) and in trials of trastuzumab-treated human epidermal growth factor receptor 2-positive tumors (P = .001).
Simple multiples of an OS curve's median can accurately estimate typical (half to double the median), best-case (triple the median), and worst-case (one quarter of the median) scenarios for survival.
评估 1999 年至 2009 年发表的转移性乳腺癌（MBC）一线化疗起始患者的生存情况。
我们检索了 MBC 一线化疗随机临床试验，记录中位无进展生存期（PFS）和中位总生存期（OS），并从每条 OS 曲线中提取以下百分位数（代表不同情景）：第 90 百分位（最差情况）、第 75 百分位（较低典型情况）、第 25 百分位（较高典型情况）和第 10 百分位（最佳情况）。我们还通过将每条 OS 曲线的中位数乘以四个简单倍数（0.25、0.5、2 和 3）来估计这些情景：最差情况（第 90 百分位）、较低典型情况（中位数的 0.5 倍）、较高典型情况（中位数的 2 倍）和最佳情况（中位数的 3 倍）。如果估计值在实际值的 0.75 至 1.33 倍范围内，则认为估计值是准确的。
从 36 项试验（13083 例女性）中，中位 PFS 的平均值为 7.6 个月（四分位距 [IQR]，6.0 至 9.0 个月），中位 OS 的平均值为 21.7 个月（IQR，18.2 至 24.0 个月），OS 与 PFS 比值的平均值为 3.0（IQR，2.4 至 3.5）。OS 每个情景的平均值分别为最差情况 6.3 个月（IQR，4.8 至 7.5 个月）、较低典型情况 11.9 个月（IQR，9.9 至 13.2 个月）、较高典型情况 36.2 个月（IQR，31.1 至 41.3 个月）和最佳情况 55.8 个月（IQR，47.5 至 60.2 个月）。中位数的简单倍数在 73%的 OS 曲线中准确估计了最差情况，在 97%的 OS 曲线中准确估计了较低典型情况，在 95%的 OS 曲线中准确估计了较高典型情况，在 96%的 OS 曲线中准确估计了最佳情况。雌激素受体阳性肿瘤比例较高的试验中 OS 更长（P =.001），曲妥珠单抗治疗人表皮生长因子受体 2 阳性肿瘤的试验中 OS 更长（P =.001）。
OS 曲线中位数的简单倍数可以准确估计生存的典型（中位数的一半到两倍）、最佳（中位数的三倍）和最差（中位数的四分之一）情况。
