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%). CONCLUSION: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.

journal_name

Oncology

journal_title

Oncology

authors

Matsubara J,Shimada Y,Kato K,Nagai Y,Iwasa S,Nakajima TE,Hamaguchi T,Yamada Y,Takagi S,Kobayashi K,Yoshioka A,Nakayama N,Tsuji A

doi

10.1159/000334462

subject

Has Abstract

pub_date

2011-01-01 00:00:00

pages

291-7

issue

5-6

eissn

0030-2414

issn

1423-0232

pii

000334462

journal_volume

81

pub_type

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