SALVAGE CHEMOTHERAPY FOR GASTRIC CANCER

J Clin Oncol. 2012 Mar 12. [Epub ahead of print]

Salvage Chemotherapy for Pretreated Gastric Cancer: A Randomized Phase III Trial Comparing Chemotherapy Plus Best Supportive Care With Best Supportive Care Alone.

Kang JH, Lee SI, Lim DH, Park KW, Oh SY, Kwon HC, Hwang IG, Lee SC, Nam E, Shin DB, Lee J, Park JO, Park YS, Lim HY, Kang WK, Park SH.

Source

Jung Hun Kang, Gyeongsang National University Hospital, Jinju; Soon Il Lee, Do Hyoung Lim, and Keon-Woo Park, Dankook University Hospital, Cheonan; Sung Yong Oh and Hyuk-Chan Kwon, Dong-A University Hospital, Busan; In Gyu Hwang, Chung-Ang University College of Medicine; Sang-Cheol Lee, Soonchunhyang University Hospital; Eunmi Nam, Ewha Women's University Hospital; Jeeyun Lee, Joon Oh Park, Young Suk Park, Ho Yeong Lim, Won Ki Kang, and Se Hoon Park, Sungkyunkwan University Samsung Medical Center, Seoul; and Dong Bok Shin, Gachon University Gil Hospital, Incheon, Korea.

Abstract

PURPOSEWhen designing this trial, there was no evidence that salvage chemotherapy (SLC) in advanced gastric cancer (AGC) resulted in substantial prolongation of survival when compared with best supportive care (BSC). However, SLC is often offered to pretreated patients with AGC for anecdotal reasons. PATIENTS AND METHODSPatients with AGC with one or two prior chemotherapy regimens involving both fluoropyrimidines and platinum and with an Eastern Cooperative Oncology Group performance status (PS) 0 or 1 were randomly assigned in a ratio of 2:1 to SLC plus BSC or BSC alone. Choice of SLC-either docetaxel 60 mg/m(2) every 3 weeks or irinotecan 150 mg/m(2) every 2 weeks-was left to the discretion of investigators. Primary end point was overall survival (OS).ResultsMedian OS was 5.3 months among 133 patients in the SLC arm and 3.8 months among 69 patients in the BSC arm (hazard ratio, 0.657; 95% CI, 0.485 to 0.891; one-sided P = .007). OS benefit for SLC was consistent in most of the prospectively defined subgroups, including age, PS, number of prior treatments, metastatic sites, hemoglobin levels, and response to prior chemotherapy. SLC was generally well tolerated, and adverse events were similar in the SLC and BSC arms. We found no median OS difference between docetaxel and irinotecan (5.2 v 6.5 months; P = .116). CONCLUSIONTo our knowledge, this is the largest phase III trial comparing SLC plus BSC with BSC alone in AGC. In pretreated patients, SLC is tolerated and significantly improves OS when added to BSC.