title: Phase II study of bolus 5-fluorouracil and leucovorin combined with weekly paclitaxel as first-line therapy for advanced gastric cancer.
abstract: OBJECTIVE
  We evaluated the efficacy and safety of bolus 5-fluorouracil (5-FU) and leucovorin combined with weekly paclitaxel (FLTAX) in advanced gastric cancer (GC) patients.
  
  
  METHODS
  Patients with untreated stage IV GC received paclitaxel 80 mg/m(2) as a 1-hour infusion, followed by 5-FU 600 mg/m(2) as a bolus infusion and L-leucovorin 250 mg/m(2) as a 2-hour infusion on days 1, 8 and 15. Treatment cycles were repeated every 28 days. The primary endpoint was response rate.
  
  
  RESULTS
  Thirty-five patients were enrolled. The median age was 62 years (range 34-75). Twenty-one patients (60%) had diffuse-type cancer and 11 had peritoneal metastasis. The confirmed response rate was 43% (95% CI 26-61) with 15 partial responses. Stable disease was observed in 16 (46%) patients. Median progression-free survival and overall survival were 6.8 months (95% CI 5.8-7.4) and 16.2 months (95% CI 10.0-22.8), respectively. Grade 3-4 adverse events were: neutropenia (54%), febrile neutropenia (3%), diarrhea (6%) and sensory neuropathy (11%).
  
  
  CONCLUSIONS
  FLTAX showed a desirable safety profile, and the efficacy against advanced GC was encouraging. FLTAX may be a good option for GC patients with deteriorated general condition, and a randomized clinical trial in such patients is currently underway.
authors: Gastrointestinal Oncology Division, National Cancer Center Hospital, Tokyo, Japan. jmatsuba@kuhp.kyoto-u.ac.jp
authors: Junichi
authors: J
authors: Matsubara
authors: Yasuhiro
authors: Y
authors: Shimada
authors: Ken
authors: K
authors: Kato
authors: Yushi
authors: Y
authors: Nagai
authors: Satoru
authors: S
authors: Iwasa
authors: Takako E
authors: TE
authors: Nakajima
authors: Tetsuya
authors: T
authors: Hamaguchi
authors: Yasuhide
authors: Y
authors: Yamada
authors: Seiichi
authors: S
authors: Takagi
authors: Kazuma
authors: K
authors: Kobayashi
authors: Akira
authors: A
authors: Yoshioka
authors: Norisuke
authors: N
authors: Nakayama
authors: Akihito
authors: A
authors: Tsuji
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D018572:Disease-Free Survival; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009367:Neoplasm Staging; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000473:pathology
chemical_list: D017239:Paclitaxel; D002955:Leucovorin; D005472:Fluorouracil