Phase II study of mFOLFOX6 in advanced gastric cancer patients with severe peritoneal metastases (WJOG10517G), including an individual patient data comparison with JCOG1108/WJOG7312G
Year: 2026
Type: article
Study design: Clinical Trial
Abstract: BACKGROUND: Advanced gastric cancer patients with severe peritoneal metastases, defined as massive ascites throughout the abdominal cavity and/or inadequate oral intake requiring intravenous infusion support, have been excluded from pivotal clinical trials. METHODS: This phase II trial evaluated mFOLFOX6 in HER2-negative, chemotherapy-naive advanced gastric cancer patients with severe peritoneal metastases. The primary endpoint was overall survival (OS); secondary endpoints included ascites response rate among patients with massive ascites and oral intake improvement rate. A sample size of 50 was planned to detect a median OS of 9 months, with a threshold of 6 months (one-sided α = 0.05; β = 0.2). A prespecified individual patient data comparative analysis was performed using data from patients treated with 5-fluorouracil/l-leucovorin (FL) or FL plus paclitaxel (FLTAX) in JCOG1108/WJOG7312G. RESULTS: Among 51 patients, Eastern Cooperative Oncology Group performance status was 0/1/2 in 3/40/8 patients. Median OS and progression-free survival were 7.4 (lower limit of one-sided 95% confidence interval [CI], 6.5) and 3.8 months, respectively. Among 25 patients with massive ascites, the ascites response rate was 36%. Of 33 patients with inadequate oral intake, 46% achieved improved oral intake. The most frequent grade 3-4 adverse event was neutropenia (51%), and febrile neutropenia occurred in one patient (2%). No treatment-related deaths occurred. In propensity score-weighted analysis, OS hazard ratios with mFOLFOX6 versus FL and FLTAX were 0.76 (95% CI 0.56-1.03) and 0.87 (95% CI 0.64-1.18), respectively. CONCLUSIONS: mFOLFOX6 was tolerable and may be a treatment option for advanced gastric cancer patients with severe peritoneal metastases. CLINICAL TRIAL REGISTRATION: jRCTs041180007.
Source: Gastric Cancer
Authors: Toshiki Masuishi, Hiroki Hara, Takayuki Ando, Takeshi Kawakami, Yoshiyuki Yamamoto, Naotoshi Sugimoto, Kazuhiro Shiraishi, Taito Esaki, Yuji Negoro, Takao Tsuzuki, Hiroaki Sawai, Masato Nakamura, Takashi Inagaki, Yudai Shinohara, Kentaro Kawakami, Seiichiro Mitani, Kenji Tsuchihashi, Chihiro Kondoh, Hiroo Katsuya, Osamu Maeda, Yuriko Fujita, Kenichi Yoshimura, Masanori Terashima, Takako Eguchi Nakajima, Kei Muro
Institutions: Aichi Cancer Center, Saitama Cancer Center, University of Toyama, Shizuoka Cancer Center, University of Tsukuba, Osaka International Cancer Institute, Nagoya Medical Center, National Hospital Organization Kyushu Cancer Center, Kochi Health Sciences Center, Himeji Red Cross Hospital, Takatsuki General Hospital, Aizawa Hospital, Oita University, Kyushu Hospital, Japan Community Healthcare Organization, Keiyukai Sapporo Hospital, Kindai University, Kyushu University Hospital, Toranomon Hospital, Saga University, Nagoya University Hospital, Yokohama Municipal Citizen's Hospital, Nagoya City University, Kyoto University
Language: English
Subfield: Pulmonary and Respiratory Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $3,590
Funder: Yakult Honsha
OpenAlex ID: W7204482492