A phase II trial of paclitaxel, 5-fluorouracil (5-FU) and cisplatin in patients with metastatic or recurrent gastric cancer.
OBJECTIVE
We wanted to assess the effectiveness and safety of combination chemotherapy with paclitaxel, 5-fluorouracil (5-FU) and cisplatin for treating advanced gastric cancer.


METHODS
Patients with metastatic or recurrent gastric cancer were entered into this study. Paclitaxel at a dose of 135 mg/m(2) on day 1, 5-FU 1 g/m(2)/day in a 24 hour continuous infusion from day 1 to day 4 and cisplatin 60 mg/m(2) on day 1 were administered. This regimen was repeated every 3 weeks.


RESULTS
A total of 34 patients were enrolled in this study. Among them, 33 patients were finally evaluable for their response. 17 (51.5%) patients had a partial response (95% CI: 26.0 approximately 77.0%). The median duration of overall survival was 13.2 months. Grade 3 or 4 neutropenia and thrombocytopenia were observed in 15.2% and 1.1% of all the cycles, respectively. Grade 3 stomatitis and neurotoxicity were observed in 20.6% and 1.1% of all patients, respectively. Grade 4 non-hematologic toxicity was not observed.


CONCLUSIONS
The regimen of paclitaxel, 5-FU and cisplatin demonstrated activity and acceptable toxicity for treating metastatic gastric cancer.
Kang
Gun Hi
GH
Department of Internal Medicine, College of Medicine, Inje University, Sanggye Paik Hospital, Seoul, Korea.
Kim
Gwang Sil
GS
Lee
Hyo Rak
HR
Yuh
Young Jin
YJ
Kim
Sung Rok
SR
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