A phase Ii study of 5-fluorouracil/cisplatin in recurrent cervical cancer

Kaern, J.; Tropé, C.; Kjørstad, K.E.; Nordal, R.; Sundfør, K.; Vergote, I.; Vossli, S.; Abeler, V.; Sandvei, R.

Tidsskrift for den Norske Laegeforening Tidsskrift for Praktisk Medicin Ny Raekke 110(21): 2759-2762

1990


ISSN/ISBN: 0029-2001
PMID: 2219049
Document Number: 3705
50 patients with recurrent cervical carcinoma were included in a phase II study of cisplatinum and 5-fluorouracil. They were divided into patients with recurrent lesions outside the previously irradiated area (group 1) and those with at least one recurrent lesion inside this area (group 2). The treatment schedule consisted of 5-fluorouracil 1,000 mg/m2 intravenously during days 1 to 5, and cisplatinum 100 mg/m2 intravenously in day 1. 45 patients could be evaluated for response and toxicity with a median survival of 14+ months, (range 4-38+). In group 1 (29 patients) seven achieved complete response with a median duration of 14+ months, (range 3(+)-26+), median survival of 19+ months, (range 5(+)-28+), and 13 achieved partial response with a median duration of 8+ months, (range 3(+)-25+), median survival of 16 months, (range 6(+)-31+). In group 2 (16 patients) one patient achieved complete response and two partial response. One patient in this group with stationary disease is still alive after 38+ months. All the patients suffered from nausea and vomiting. The dose-limiting factor was bone marrow suppression. The response rate in group 1 of 69%, with a median survival of 19+ months, is higher than previously achieved with other cytostatic regimens. We found the regimen to be very toxic, however, for patients with central recurrences in previously irradiated areas, though some of these patients did achieve marked relief from pain.

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A phase Ii study of 5-fluorouracil/cisplatin in recurrent cervical cancer