A phase II study of 5-fluorouracil/L-leucovorin/oxaliplatin (mFOLFOX6) in Japanese patients with metastatic or unresectable small bowel adenocarcinoma |
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| Authors: | Takahiro Horimatsu Norisuke Nakayama Toshikazu Moriwaki Yoshinori Hirashima Mikio Fujita Masako Asayama Ichiro Moriyama Koji Nakashima Eishi Baba Hiroshi Kitamura Takao Tamura Ayumu Hosokawa Kenichi Yoshimura Manabu Muto |
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| Affiliation: | 1.Department of Therapeutic Oncology,Kyoto University Hospital,Kyoto,Japan;2.Department of Gastroenterology,Kanagawa Cancer Center,Kanazawa,Japan;3.Division of Gastroenterology,University of Tsukuba,Tsukuba,Japan;4.Department of Medical Oncology and Hematology, Faculty of Medicine,Oita University,Oita,Japan;5.Department of Gastroenterology and Hepetology,Kobe City Medical Center General Hospital,Kobe,Japan;6.Department of Gastroenterology,Saitama Cancer Center Hospital,Saitama,Japan;7.Division of Clinical Study of Oncology, School of Medicine,Shimane University,Matsue,Japan;8.First Department of Internal Medicine, Faculty of Medicine,University of Miyazaki,Miyazaki,Japan;9.Department of Comprehensive Clinical Oncology, Faculty of Medical Sciences,Kyushu University,Fukuoka,Japan;10.Department of Internal Medicine, Medical Oncology, School of Medicine,Kyorin University,Tokyo,Japan;11.Department of Medical Oncology, Faculty of Medicine,Kinki University,Higashiosaka,Japan;12.Department of Gastroenterology and Hematology, Faculty of Medicine,University of Toyama,Toyama,Japan;13.Innovative Clinical Research Center (ICREK),Kanazawa University Hospital,Kanazawa,Japan |
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| Abstract: | BackgroundSeveral studies have suggested that chemotherapy prolonged survival in patients with metastatic or recurrent small bowel adenocarcinoma (SBA); however, there is still no standard chemotherapy regimen. Here, we evaluated the efficacy and safety of a 5-fluorouracil (5-FU)/L-leucovorin (l-LV)/oxaliplatin (mFOLFOX6) protocol as a first-line therapy for patients with SBA.Patients and methodsThis was a multicenter, single-arm, open-label phase II study. Eligibility criteria included histologically confirmed adenocarcinoma, age 20–80 years, and an Eastern Cooperative Oncology Group performance status (PS) of 0–2. The primary endpoint was 1-year progression-free survival (PFS). The secondary endpoints included overall response rate (ORR), overall survival (OS), overall PFS, and safety.ResultsBetween April 2010 and November 2012, 24 patients were enrolled from 12 institutions. The median age of the patients was 63 years (range 31–79) and there was a male/female ratio of 18/6. The number of PS 0/1 patients was 17/7 and locally advanced/metastatic disease was seen in 2/22 patients, respectively. The primary tumor site was the duodenum in 14 patients (58%) and jejunum in 10 patients (42%). The median follow-up time was 14.7 months (3.7–40.3). The 1-year PFS was 23.3%. The ORR was 9/20 (45%). The median PFS and OS times were 5.9 months (95% confidence interval [CI] 3.0–10.2) and 17.3 months (95% CI 11.7–19.0), respectively. Major grade 3/4 toxicities were neutropenia (38%), anemia/peripheral neuropathy (25%), and stenosis (17%). There were no treatment-related deaths.ConclusionsAlthough the primary endpoint was not met, mFOLFOX6 showed effective and good tolerance as a first-line treatment for SBA. |
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