Seiichiro Mitani1,2, Shigenori Kadowaki3, Azusa Komori1,4, Chihiro Kondoh1,5, Isao Oze6, Kyoko Kato1, Toshiki Masuishi1, Kazunori Honda1, Yukiya Narita1, Hiroya Taniguchi1,7, Masashi Ando1, Tsutomu Tanaka8, Masahiro Tajika8, Kei Muro1. 1. Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan. 2. Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka-Sayama, Japan. 3. Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan. skadowaki@aichi-cc.jp. 4. Department of Medical Oncology and Hematology, Oita University Faculty of Medicine, Oita, Japan. 5. Department of Medical Oncology, Toranomon Hospital, Tokyo, Japan. 6. Division of Cancer Epidemiology and Prevention, Aichi Cancer Center, Nagoya, Japan. 7. Department of Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan. 8. Department of Endoscopy, Aichi Cancer Center Hospital, Nagoya, Japan.
Abstract
INTRODUCTION: In patients with advanced gastric cancer refractory tochemotherapy, the treatment options are limited. Via this phase II study, we aimed to assess the efficacy and safety of oxaliplatin in combination with 5-fluorouracil and l-leucovorin (modified FOLFOX6). METHODS:Patients who had histologically confirmed metastatic gastric cancer refractory to ≥ two previous chemotherapy regimens were included. The primary endpoint was the overall response rate (ORR) by an independent central review. According to an assumption of a threshold ORR of 10% and expected ORR of 25%, with α = 0.05 and β = 0.20, at least 33 patients were required. The secondary endpoints included overall survival (OS), progression-free survival (PFS), quality of life measured by EQ-5D, and safety. RESULTS: Among the 35 enrolled patients, 33 were included in the primary analysis. All patients previously received fluoropyrimidines, cisplatin, and taxanes, and 24 (73%) were pretreated with irinotecan. The confirmed ORR was 27% [95% confidence interval (CI) 13-46]. The median PFS and OS were 2.2 (95% CI 1.2-3.2) and 5.6 (95% CI 4.1-7.0) months, respectively. In the multivariate analyses, immunotherapy within 90 days and a Glasgow Prognostic Score of 0 were associated with better treatment outcomes. The most common grade ≥ 3 adverse event was neutropenia (36%), and no febrile neutropenia was observed. The median EQ-5D scores did not change from baseline at 2, 4, and 8 weeks (p value = 0.38, 0.79, and 0.98, respectively). CONCLUSION:Modified FOLFOX6 (mFOLFOX6) showed substantial activity and acceptable toxicity for chemotherapy-refractory advanced gastric cancer. TRIAL REGISTRATION: UMIN Clinical Trial Registry (UMIN000016416).
RCT Entities:
INTRODUCTION: In patients with advanced gastric cancer refractory to chemotherapy, the treatment options are limited. Via this phase II study, we aimed to assess the efficacy and safety of oxaliplatin in combination with 5-fluorouracil and l-leucovorin (modified FOLFOX6). METHODS:Patients who had histologically confirmed metastatic gastric cancer refractory to ≥ two previous chemotherapy regimens were included. The primary endpoint was the overall response rate (ORR) by an independent central review. According to an assumption of a threshold ORR of 10% and expected ORR of 25%, with α = 0.05 and β = 0.20, at least 33 patients were required. The secondary endpoints included overall survival (OS), progression-free survival (PFS), quality of life measured by EQ-5D, and safety. RESULTS: Among the 35 enrolled patients, 33 were included in the primary analysis. All patients previously received fluoropyrimidines, cisplatin, and taxanes, and 24 (73%) were pretreated with irinotecan. The confirmed ORR was 27% [95% confidence interval (CI) 13-46]. The median PFS and OS were 2.2 (95% CI 1.2-3.2) and 5.6 (95% CI 4.1-7.0) months, respectively. In the multivariate analyses, immunotherapy within 90 days and a Glasgow Prognostic Score of 0 were associated with better treatment outcomes. The most common grade ≥ 3 adverse event was neutropenia (36%), and no febrile neutropenia was observed. The median EQ-5D scores did not change from baseline at 2, 4, and 8 weeks (p value = 0.38, 0.79, and 0.98, respectively). CONCLUSION: Modified FOLFOX6 (mFOLFOX6) showed substantial activity and acceptable toxicity for chemotherapy-refractory advanced gastric cancer. TRIAL REGISTRATION: UMIN Clinical Trial Registry (UMIN000016416).
Entities:
Keywords:
Chemotherapy; FOLFOX regimen; Gastric cancer; Phase II clinical trial
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