title: A phase II study of modified FOLFOX as first-line chemotherapy in advanced small bowel adenocarcinoma.
abstract: This study aimed at assessing the efficacy and safety of biweekly oxaliplatin in combination with continuous infusional 5-fluorouracil and leucovorin (modified FOLFOX regimen) in patients with advanced small bowel adenocarcinoma (SBA). Thirty-three eligible patients with previously untreated SBA received 85 mg/m(2) of oxaliplatin intravenously over a 2-h period on day 1, together with 400 mg/m(2) of leucovorin over 2 h, followed by a 46-h infusion of 5-FU 2600 mg/m(2) every 2 weeks. All patients were evaluable for efficacy and toxicity. A median of nine cycles (range 3-18) was administered. The objective response rate was 48.5% [95% confidence interval (95% CI): 31-67%], with one complete response, 15 partial responses, 12 stable diseases, and five progressions. The median time to progression was 7.8 months (95% CI: 6.0-9.6) and the median overall survival was 15.2 months (95% CI: 11.0-19.4). Toxicity was fairly mild. Grade 3 toxicities included neutropenia (12.1%), thrombocytopenia (3.0%), nausea (6.1%), vomiting (3.0%), diarrhea (3.0%), peripheral neuropathy (9.1%), and fatigue (3.0%), and grade 4 toxicities occurred in none of the patients. The modified FOLFOX regimen is highly active and well tolerated as first-line chemotherapy for advanced SBA patients.
authors.affiliation: Department of Oncology, First Affiliated Hospital of Nanchang University, China.
authors.forename: Xiao Jun
authors.initials: XJ
authors.lastname: Xiang
authors.forename: Ya Wen
authors.initials: YW
authors.lastname: Liu
authors.forename: Ling
authors.initials: L
authors.lastname: Zhang
authors.forename: Feng
authors.initials: F
authors.lastname: Qiu
authors.forename: Feng
authors.initials: F
authors.lastname: Yu
authors.forename: Zheng Yu
authors.initials: ZY
authors.lastname: Zhan
authors.forename: Miao
authors.initials: M
authors.lastname: Feng
authors.forename: Jun
authors.initials: J
authors.lastname: Yan
authors.forename: Jian Guo
authors.initials: JG
authors.lastname: Zhao
authors.forename: Jian Ping
authors.initials: JP
authors.lastname: Xiong
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D018572:Disease-Free Survival; D004379:Duodenal Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D006801:Humans; D007078:Ileal Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D007580:Jejunal Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D053208:Kaplan-Meier Estimate; D002955:Leucovorin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009944:Organoplatinum Compounds / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use
chemical_list: D009944:Organoplatinum Compounds; D002955:Leucovorin; D005472:Fluorouracil