title: Dose-dense biweekly docetaxel combined with 5-fluorouracil as first-line treatment in advanced gastric cancer: a phase II trial.
abstract: This study evaluated the efficacy, safety and impact on quality of life (QoL) of a dose-dense biweekly regimen of docetaxel and 5-fluorouracil in first-line treatment of advanced gastric cancer (AGC). Eligible patients received docetaxel 60 mg/m(2) and 5-fluorouracil (400 mg/m(2) bolus followed by 2,400 mg/m(2) 46-h infusion), fortnightly. Prophylactic use of G-CSF was adopted in all patients. The primary end point was response rate (RR). Secondary end points were progression-free survival (PFS), overall survival (OS), toxicity and QoL. Thirty-nine patients with a median age of 55 (28-80) were included. The RR was 51.3 %. Median PFS and OS were 6.7 and 14.0 months, respectively. The most common adverse events (all grades) were anemia (34, 87.2 %), fatigue (29, 74.4 %), neutropenia (26, 66.7 %), nail change (19, 48.7 %) and liver dysfunction (15, 38.5 %). In QoL analysis, improvements were obtained in seven scales, whereas drops were seen in three scales. Common Grade 3/4 toxicities included anemia (28.2 %), liver dysfunction (7.7 %) and fatigue (7.7 %). This novel regimen is a promising option for AGC, showing high RR, improvement on QoL and acceptable toxicity.
authors.affiliation: Department of Medical Oncology, The Sixth Affiliated Hospital, Sun Yat-sen University, 26 Yuancun Erheng Road, Guangzhou, 510655, China.
authors.forename: Jian
authors.initials: J
authors.lastname: Xiao
authors.forename: Yonghe
authors.initials: Y
authors.lastname: Chen
authors.forename: Wenyun
authors.initials: W
authors.lastname: Li
authors.forename: Jiaying
authors.initials: J
authors.lastname: Gong
authors.forename: Zhiyang
authors.initials: Z
authors.lastname: Zhou
authors.forename: Yanhong
authors.initials: Y
authors.lastname: Deng
authors.forename: Lei
authors.initials: L
authors.lastname: Wang
authors.forename: Donglin
authors.initials: D
authors.lastname: Ren
authors.forename: Jianping
authors.initials: J
authors.lastname: Wang
authors.forename: Junsheng
authors.initials: J
authors.lastname: Peng
authors.forename: Ping
authors.initials: P
authors.lastname: Lan
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000401:mortality; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D018572:Disease-Free Survival; D000077143:Docetaxel; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000401:mortality; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D005472:Fluorouracil