A phase II trial of capecitabine plus cisplatin (XP) for patients with advanced gastric cancer with early relapse after S-1 adjuvant therapy: XParTS-I trial |
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| Authors: | Kazuhiro Nishikawa Akira Tsuburaya Takaki Yoshikawa Masazumi Takahashi Kazuaki Tanabe Kensei Yamaguchi Shigefumi Yoshino Tsutomu Namikawa Toru Aoyama Yasushi Rino Junji Kawada Akihito Tsuji Koichi Taira Yutaka Kimura Yasuhiro Kodera Yoshinori Hirashima Hiroshi Yabusaki Naoki Hirabayashi Kazumasa Fujitani Yumi Miyashita Satoshi Morita Junichi Sakamoto |
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| Institution: | 1.Department of Surgery,Osaka National Hospital,Osaka,Japan;2.Department of Surgery,Tsuboi Cancer Center Hospital,Koriyama,Japan;3.Department of Gastrointestinal Surgery,Kanagawa Cancer Center,Yokohama,Japan;4.Department of Surgery,Yokohama Municipal Citizen’s Hospital,Yokohama,Japan;5.Department of Gastroenterological and Transplant Surgery,Hiroshima University,Hiroshima,Japan;6.Division of Gastroenterology,Saitama Cancer Center,Kita-Adachi-Gun,Japan;7.Oncology Center,Yamaguchi University Hospital,Ube,Japan;8.Department of Surgery I,Kochi Medical School,Nankoku,Japan;9.Department of Surgery,Yokohama City University,Yokohama,Japan;10.Department of Surgery,Osaka General Medical Center,Osaka,Japan;11.Department of Clinical Oncology,Kobe City Medical Center General Hospital,Kobe,Japan;12.Department of Gastroenterology,Osaka City University Graduate School of Medicine,Osaka,Japan;13.Department of Surgery, Faculty of Medicine,Kindai University,Osakasayama,Japan;14.Department of Gastroenterological Surgery,Nagoya University Graduate School of Medicine,Nagoya,Japan;15.Department of Medical Oncology and Hematology, Faculty of Medicine,Oita University,Oita,Japan;16.Department of Gastroenterological Surgery,Niigata Cancer Center Hospital,Niigata,Japan;17.Department of Surgery,Hiroshima City Asa Hospital,Hiroshima,Japan;18.Epidemiological and Clinical Research Information Network (ECRIN),Okazaki,Japan;19.Department of Biomedical Statistics and Bioinformatics, Graduate School of Medicine,Kyoto University,Kyoto,Japan;20.Tokai Central Hospital,Kakamigahara,Japan |
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| Abstract: | BackgroundsIn Japan, standard regimens for advanced gastric cancer (AGC) include S-1 chemotherapy. The standard treatment for early relapse after adjuvant chemotherapy with fluoropyrimidine alone is platinum-based chemotherapy, while the standard treatment for early relapse after adjuvant chemotherapy with fluoropyrimidine plus platinum is second-line chemotherapy. To evaluate the efficacy and safety of capecitabine plus cisplatin (XP) treatment for AGC patients who relapse within 6 months after S-1-based therapy, we conducted a multicenter phase II trial (NCT01412294).MethodsHER2-negative gastric cancer patients treated with adjuvant chemotherapy including S-1 for more than 12 weeks and relapsed within 6 months were treated with capecitabine 1000 mg/m2 bid for 14 days plus cisplatin 80 mg/m2 on day 1 of a 3-week cycle. The primary endpoint was PFS; secondary endpoints were OS, time to treatment failure, overall response rate (ORR) and safety.ResultsForty patients (median age 64) were enrolled; of those, 37 (92.5%) received adjuvant S-1 monotherapy. Median PFS was 4.4 months (95% CI 3.6–5.1), which was longer than the 2-month protocol-specified threshold (p < 0.001). Median OS was 13.7 months (95% CI 9.0–17.7) and ORR was 8/30 (26.7%) (95% CI 14.2–44.4). Most common grade ≥ 3 adverse events were neutropenia (23%), anemia (18%), elevated serum creatinine (18%), fatigue (13%), diarrhea (7.5%), and anorexia (7.5%).ConclusionsXP was safe and effective in patients with early relapse after S-1 adjuvant chemotherapy for curatively resected gastric cancers. XP may be a good option for the treatment of patients after early failure after adjuvant S-1.Trial registrationNCT01412294. |
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