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A phase II study of 5-fluorouracil/L-leucovorin/oxaliplatin (mFOLFOX6) in Japanese patients with metastatic or unresectable small bowel adenocarcinoma.
- Source :
-
International journal of clinical oncology [Int J Clin Oncol] 2017 Oct; Vol. 22 (5), pp. 905-912. Date of Electronic Publication: 2017 May 23. - Publication Year :
- 2017
-
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.<br />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.<br />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.<br />Conclusions: Although the primary endpoint was not met, mFOLFOX6 showed effective and good tolerance as a first-line treatment for SBA.
- Subjects :
- Adenocarcinoma mortality
Adenocarcinoma pathology
Adenocarcinoma surgery
Adult
Aged
Antineoplastic Combined Chemotherapy Protocols adverse effects
Asian People
Disease-Free Survival
Female
Fluorouracil administration & dosage
Fluorouracil therapeutic use
Humans
Intestinal Neoplasms mortality
Intestinal Neoplasms pathology
Intestine, Small pathology
Leucovorin administration & dosage
Leucovorin therapeutic use
Male
Middle Aged
Neutropenia chemically induced
Organoplatinum Compounds administration & dosage
Organoplatinum Compounds therapeutic use
Oxaliplatin
Treatment Outcome
Adenocarcinoma drug therapy
Antineoplastic Combined Chemotherapy Protocols therapeutic use
Intestinal Neoplasms drug therapy
Subjects
Details
- Language :
- English
- ISSN :
- 1437-7772
- Volume :
- 22
- Issue :
- 5
- Database :
- MEDLINE
- Journal :
- International journal of clinical oncology
- Publication Type :
- Academic Journal
- Accession number :
- 28536826
- Full Text :
- https://doi.org/10.1007/s10147-017-1138-6