A Randomized Phase III Study of Patients With Advanced Gastric Adenocarcinoma Without Progression After Six Cycles of XELOX (Capecitabine Plus Oxaliplatin) Followed by Capecitabine Maintenance or Clinical Observation

심병용; Guk Jin Lee; Hyunho Kim; Sung Shim Cho; Hyung Soon Park; Ho Jung An; In Sook Woo; Jae Ho Byun; Ji Hyung Hong; Yoon Ho Ko; Der Sheng Sun; Hye Sung Won; Jong Youl Jin; Ji Chan Park; In-Ho Kim; Sang Young Roh

doi:10.5230/jgc.2023.23.e16

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자료유형: 학술저널

저자정보: 심병용 (가톨릭대학교) Guk Jin Lee (Bucheon St. Mary’s Hospital College of Medicine The Catholic University of Korea Seoul Korea) Hyunho Kim (Division of Medical Oncology Department of Internal Medicine St. Vincent’s Hospital College of Medicine The Catholic University of Korea Seoul Korea) Sung Shim Cho (Division of Medical Oncology Department of Internal Medicine St. Vincent’s Hospital College of Medicine The Catholic University of Korea Seoul Korea) Hyung Soon Park (Division of Medical Oncology Department of Internal Medicine St. Vincent’s Hospital College of Medicine The Catholic University of Korea Seoul Korea) Ho Jung An (Division of Medical Oncology Department of Internal Medicine St. Vincent’s Hospital College of Medicine The Catholic University of Korea Seoul Korea) In Sook Woo (Division of Medical Oncology Department of Internal Medicine Yeouido St. Mary’s Hospital College of Medicine The Catholic University of Korea Seoul Korea) Jae Ho Byun (Department of Internal Medicine College of Medicine Incheon St. Mary’s Hospital The Catholic University of Korea) Ji Hyung Hong (Division of Medical Oncology Department of Internal Medicine Eunpyeong St. Mary’s Hospital College of Medicine The Catholic University of Korea Seoul Korea) Yoon Ho Ko (Department of Internal Medicine Eunpyeong St. Mary’s Hospital College of Medicine The Catholic University of Korea Seoul) Der Sheng Sun (Department of Internal Medicine College of Medicine Uijeongbu St. Mary's Hospital The Catholic University of Korea) Hye Sung Won (Department of Internal Medicine College of Medicine Uijeongbu St. Mary's Hospital The Catholic University of Korea) Jong Youl Jin (Bucheon St. Mary’s Hospital College of Medicine The Catholic University of Korea) Ji Chan Park (Division of Medical Oncology Department of Internal Medicine Daejeon St. Mary’s Hospital College of Medicine The Catholic University of Korea) In-Ho Kim (Division of Medical Oncology Department of Internal Medicine Seoul St. Mary’s Hospital College of Medicine The Catholic University of Korea) Sang Young Roh (Division of Medical Oncology Department of Internal Medicine College of Medicine Seoul St. Mary’s Hospital The Catholic University of Korea)

저널정보: 대한위암학회 Journal of Gastric Cancer Journal of Gastric Cancer 제23권 제2호

발행연도: 2023.4

수록면: 315 - 327 (13page)

DOI: 10.5230/jgc.2023.23.e16

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Purpose: Oxaliplatin, a component of the capecitabine plus oxaliplatin (XELOX) regimen, has a more favorable toxicity profile than cisplatin in patients with advanced gastric cancer (GC). However, oxaliplatin can induce sensory neuropathy and cumulative, dose-related toxicities. Thus, the capecitabine maintenance regimen may achieve the maximum treatment effect while reducing the cumulative neurotoxicity of oxaliplatin. This study aimed to compare the survival of patients with advanced GC between capecitabine maintenance and observation after 1st line XELOX chemotherapy. Materials and Methods: Sixty-three patients treated with six cycles of XELOX for advanced GC in six hospitals of the Catholic University of Korea were randomized 1:1 to receive capecitabine maintenance or observation. The primary endpoint was progression-free survival (PFS), analyzed using a two-sided log-rank test stratified at a 5% significance level. Results: Between 2015 and 2020, 32 and 31 patients were randomized into the maintenance and observation groups, respectively. After randomization, the median number of capecitabine maintenance cycles was 6. The PFS was significantly higher in the maintenance group than the observation group (6.3 vs. 4.1 months, P=0.010). Overall survival was not significantly different between the 2 groups (18.2 vs. 16.5 months, P=0.624). Toxicities, such as hand-foot syndrome, were reported in some maintenance group patients. Maintenance treatment was a significant factor associated with PFS in multivariate analysis (hazard ratio, 0.472; 95% confidence interval, 0.250–0.890; P=0.020). Conclusions: After 6 cycles of XELOX chemotherapy, capecitabine maintenance significantly prolonged PFS compared with observation, and toxicity was manageable. Maintenance treatment was a significant prognostic factor associated with PFS.

#Stomach neoplasm #Capecitabine #Maintenance chemotherapy #Clinical trial

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