A phase II study of 5-fluorouracil/L-leucovorin/oxaliplatin (mFOLFOX6) in Japanese patients with metastatic or unresectable small bowel adenocarcinoma

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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Abstract

Background: Several 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 methods: This 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. Results: Between 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. Conclusions: Although the primary endpoint was not met, mFOLFOX6 showed effective and good tolerance as a first-line treatment for SBA.

Original languageEnglish
Pages (from-to)905-912
Number of pages8
JournalInternational Journal of Clinical Oncology
Volume22
Issue number5
DOIs
Publication statusPublished - Oct 1 2017

All Science Journal Classification (ASJC) codes

  • Surgery
  • Hematology
  • Oncology

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    Horimatsu, T., Nakayama, N., Moriwaki, T., Hirashima, Y., Fujita, M., Asayama, M., Moriyama, I., Nakashima, K., Baba, E., Kitamura, H., Tamura, T., Hosokawa, A., Yoshimura, K., & Muto, M. (2017). A phase II study of 5-fluorouracil/L-leucovorin/oxaliplatin (mFOLFOX6) in Japanese patients with metastatic or unresectable small bowel adenocarcinoma. International Journal of Clinical Oncology, 22(5), 905-912. https://doi.org/10.1007/s10147-017-1138-6