Phase II study of the modified regimen of etoposide, leucovorin and 5-fluorouracil for patients with advanced gastric cancer |
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Authors: | Chiou TJ; Tung SL; Hsieh RK; Wang WS; Yen CC; Fan FS; Liu JH; Chen PM |
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Institution: | Department of Medicine, Veterans General Hospital-Taipei, Taiwan. tjchiou@vghtpe.gov.tw |
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Abstract: | BACKGROUND: The efficacy of the treatment of advanced gastric cancer is not
very good. The response rate to the original
etoposide--leucovorin--5-fluorouracil (ELF) treatment is 53% with tolerable
side effects. Whether increasing the dose intensity by prolonging the
duration of infusion with 5-fluorouracil (5-FU) and leucovorin (LV) from 3
to 5 days for advanced or metastatic gastric cancer patients would enhance
the efficacy but not increase side effects is still unknown. METHODS:
Thirty-six advanced or metastatic gastric cancer and chemotherapy-naive
patients with measurable or evaluable diseases were scheduled to receive
intravenous etoposide 100 mg/m2/day on days 2-4, LV 300 mg/m2/day
intravenously and 5-FU 500 mg/m2/day intravenously on days 1-5, every 4
weeks. All patients who received at least two courses of chemotherapy were
evaluated for tumor response, survival and response duration and toxicity
according to the WHO criteria. RESULTS: Thirteen patients showed a
response, including five with complete response (CR). The overall response
rate was 36% (95% confidence interval, CI, 20-52%) in the whole group and
46% (95% CI 28-66%) in the 28 patients with measurable disease. The median
progression-free interval and overall median survival time were 5 and 7
months, respectively. The most frequent toxicity was alopecia (grade I/II
56.3%). The incidence of grade III or greater myelosuppression was 5.9%. No
treatment-related death occurred. CONCLUSIONS: The efficacy of the modified
ELF by increasing the dosages of 5-FU and LV is not superior to the results
of the original regimen, yet it is a relatively safe and tolerable
combination regimen for advanced gastric cancer.
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