Role of survival post-progression in phase III trials of systemic chemotherapy in advanced non-small-cell lung cancer: a systematic review.
Role of survival post-progression in phase III trials of systemic chemotherapy in advanced non-small-cell lung cancer: a systematic review.
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DOI：
10.1371/journal.pone.0026646
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发表时间：
2011
期刊：
影响因子：
3.7
通讯作者：
Tanimoto M
中科院分区：
文献类型：
--
作者：
Hotta K;Kiura K;Fujiwara Y;Takigawa N;Hisamoto A;Ichihara E;Tabata M;Tanimoto M
在晚期非小细胞肺癌（NSCLC）中，随着救助环境中可用活性化合物数量的增加，进展到一线化疗后的生存率似乎有所提高。我们进行了一项文献调查，以研究进展后生存期（SPP）在过去几年中是否有所改善，以及SPP与总生存期（OS）的相关程度。在一线化疗治疗晚期NSCLC的III期试验中，提取了中位无进展生存期（MPFS）时间和中位生存期（MST）。SPP实际定义为MST减去MPFS的时间间隔。MPFS和MST之间的关系是一个线性函数。我们使用决定系数（r2）来评估它们之间的相关性。共确定了70项试验，145种化疗药物。总体而言，SPP的中位值为4.7个月，并且在20年中观察到SPP的稳定改善（每年增加9.414天，p<0.001），与MST的增加（每年增加11.253天，p<0.001）平行；MPFS改善不大（每年增加1.863天）。总的来说，MST和SPP之间的相关性（r 2 = 0.8917）比MST和MPFS时间（r 2 = 0.2563）更强，表明SPP和MPFS分别占MST变化的89%和25%。1988-1994年、1995-2001年和2002-2007年，MST与SPP的相关性逐渐增强（r 2分别为0.4428、0.7242和0.9081）。SPP与OS的关系更为密切，这可能是因为密集的研究后治疗。即使在晚期NSCLC中，由于SPP对OS的影响越来越大，PFS优势也不太可能与OS优势相关联，而且SPP的延长可能会限制OS在未来临床试验中评估早期化疗产生的真正疗效的最初作用。
In advanced non-small-cell lung cancer (NSCLC), with the increasing number of active compounds available in salvage settings, survival after progression to first-line chemotherapy seems to have improved. A literature survey was conducted to examine whether survival post-progression (SPP) has improved over the years and to what degree SPP correlates with overall survival (OS). Median progression-free survival (MPFS) time and median survival time (MST) were extracted in phase III trials of first-line chemotherapy for advanced NSCLC. SPP was pragmatically defined as the time interval of MST minus MPFS. The relationship between MPFS and MST was modeled in a linear function. We used the coefficient of determination (r 2) to assess the correlation between them. Seventy trials with 145 chemotherapy arms were identified. Overall, median SPP was 4.7 months, and a steady improvement in SPP was observed over the 20 years (9.414-day increase per year; p<0.001) in parallel to the increase in MST (11.253-day increase per year; p<0.001); MPFS improved little (1.863-day increase per year). Overall, a stronger association was observed between MST and SPP (r 2 = 0.8917) than MST and MPFS time (r 2 = 0.2563), suggesting SPP and MPFS could account for 89% and 25% of the variation in MST, respectively. The association between MST and SPP became closer over the years (r 2 = 0.4428, 0.7242, and 0.9081 in 1988–1994, 1995–2001, and 2002–2007, respectively). SPP has become more closely associated with OS, potentially because of intensive post-study treatments. Even in advanced NSCLC, a PFS advantage is unlikely to be associated with an OS advantage any longer due to this increasing impact of SPP on OS, and that the prolongation of SPP might limit the original role of OS for assessing true efficacy derived from early-line chemotherapy in future clinical trials.
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