Annals of Oncology 14:1258-1263, 2003
© 2003 European Society for Medical Oncology
Original Paper |
Cisplatin, epirubicin, leucovorin and 5-fluorouracil (PELF) is more active than 5-fluorouracil, doxorubicin and methotrexate (FAMTX) in advanced gastric carcinoma
1 Medical Oncology Division, Azienda Ospedaliera Universitaria, Parma; 2 Regina Elena Institute, Rome; 3 Medical Oncology Service, Azienda Sanitaria Locale, Terni; 4 Medical Oncology Service, Azienda Sanitaria Locale, Piacenza; 5 Medical Oncology Division, Azienda Osperdaliera Universitaria, Modena; 6 Medical Oncology Service, Azienda Osperdaliera, Reggio Emilia; 7 Medical Oncology Division, Azienda Osperdaliera Universitaria, Perugia, Italy
Received 11 October 2002, revised 9 January 2003, accepted 8 April 2003;
Background:
5-Fluorouracil (5-FU), doxorubicin and methotrexate (FAMTX) and cisplatin, epirubicin, leucovorin and 5-FU (PELF) have both been reported to be superior to the combination 5-FU, doxorubicin and mitomycin C (FAM) in advanced gastric carcinoma. On the basis of the presence and dose intensity of the included agents, we hypothesised that PELF would be superior to FAMTX.
Patients and methods:
Two hundred patients with untreated advanced gastric carcinoma were randomised to receive PELF or FAMTX for a maximum of six cycles or until disease progression.
Results:
The complete response (CR) rates to PELF and FAMTX were, respectively, 13% [95% confidence intervals (CI) 6% to 20%] and 2% (95% CI 0% to 5%; P = 0.003), and the objective response rates [CR plus partial response (PR) rates] 39% (95% CI 29% to 49%) and 22% (95% CI 13% to 30%; P = 0.009), thus significantly favouring the PELF combination. The survival rates after 12 months (30.8% versus 22.4%) and 24 months (15.7% versus 9.5%) were also higher among patients receiving PELF, but these differences were not statistically significant. The toxicities were qualitatively different but quantitatively similar. Both regimens seem to be feasible provided that careful patient monitoring is assured.
Conclusions:
PELF is significantly more active than FAMTX and deserves further research in the adjuvant setting.
Key words: advanced gastric carcinoma, chemotherapy, FAMTX combination, PELF combination
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