Phase II study of mFOLFOX6 in advanced gastric cancer patients with severe peritoneal metastases (WJOG10517G), including an individual patient data comparison with JCOG1108/WJOG7312G

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.

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Journal
Gastric Cancer
Published
2026-08-27
DOI
https://doi.org/10.1007/s10120-026-01790-3
Primary Topic
Gastric Cancer Management and Outcomes
Type
article
Field-Weighted Citation Impact
0.00

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article

Phase II study of mFOLFOX6 in advanced gastric cancer patients with severe peritoneal metastases (WJOG10517G), including an individual patient data comparison with JCOG1108/WJOG7312G

Takayuki Ando, Takako Eguchi Nakajima, Kenji Tsuchihashi, Takashi Inagaki et al.
Gastric Cancer
Gastric Cancer Management and Outcomes
article

Phase II study of mFOLFOX6 in advanced gastric cancer patients with severe peritoneal metastases (WJOG10517G), including an individual patient data comparison with JCOG1108/WJOG7312G

Takayuki Ando, Takako Eguchi Nakajima, Kenji Tsuchihashi, Takashi Inagaki, Masanori Terashima, Toshiki Masuishi, Hiroo Katsuya, Kenichi Yoshimura, Hiroki Hara, Yoshiyuki Yamamoto, Taito Esaki, Naotoshi Sugimoto, Takeshi Kawakami, Kei Muro, Chihiro Kondoh, Osamu Maeda, Seiichiro Mitani, Takao Tsuzuki, Yuriko Fujita, Hiroaki Sawai, Kentaro Kawakami, Yuji Negoro, Yudai Shinohara, Kazuhiro Shiraishi, Masato Nakamura
article en

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.

Gastric Cancer
University of Tsukuba (JP), Saga University (JP), Oita University (JP), University of Kochi (JP), Kyoto University (JP), Shizuoka Cancer Center (JP), Nagoya University Hospital (JP), National Hospital Organization Kyushu Cancer Center (JP), Kyushu University Hospital (JP), Kindai University Sakai Hospital (JP), Nagoya City University Hospital (JP), Kyushu Hospital (JP), Saitama Cancer Center (JP), Keiyukai Sapporo Hospital (JP), Japan Community Healthcare Organization (JP), Himeji Red Cross Hospital (JP), Aichi Cancer Center (JP), Yokohama Municipal Citizen's Hospital (JP), Osaka International Cancer Institute (JP), Nagoya Medical Center (JP), Aizawa Hospital (JP), Takatsuki General Hospital (JP), Toranomon Hospital (JP), University of Toyama (JP)
Yakult Honsha
Good health and well-being
Openalex Percentile: Top 11%
Gastric Cancer Management and Outcomes
DOIOpen Access PDFOpenAlex
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