WS13-3 - Postprogression Survival for First-Line Chemotherapy in Patients with Advanced Gastric Cancer

Abstract

ABSTRACT Purpose With the increasing availability of active agents, the importance of postprogression survival (PPS) in clinical trials has been recognized for several malignancies. However, little is known about PPS in advanced gastric cancer (AGC). Methods A literature search identified 43 randomized trials in chemotherapy-naive patients with AGC. We partitioned overall survival (OS) into progression-free survival (PFS) and PPS, and then examined the correlation between median OS and either median PFS or median PPS. The correlation between differences in OS (ΔOS) and those in PFS (ΔPFS) between trial arms was also investigated. We examined whether any association might be affected by year of completion of trial enrollment. Results The average median OS was significantly longer in recent (2006 and later) trials than in older (2005 and earlier) trials (10.60 versus 8.64 months, P Conclusion PPS is highly correlated with OS for first-line chemotherapy in AGC, especially in recent trials, likely because of the incremental use of second-line chemotherapy. Currently, OS is accepted as the gold standard for efficacy evaluation in phase III trials for AGC. However, as PPS increases, OS can become skewed, and a statistically significant benefit in terms of PFS will likely become masked with OS as the end point.