A phase II study of gemcitabine plus cisplatin in previously untreated advanced ovarian cancer.
BACKGROUND
The primary objective was the evaluation of the effects of gemcitabine plus cisplatin on the overall response rate (ORR) of patients with advanced ovarian cancer; the secondary assessments included toxicity, time to progressive disease (TtPD) and the duration of response.


METHODS
Chemonaive patients with stage III/IV ovarian cancer received gemcitabine 1250 mg/m2 (d 1,8) and cisplatin 75 mg/m2 (d 1), every 21 days for a maximum of six cycles.


RESULTS
Between March 1999 and June 2003, 28 patients (median age 52 years, range 23-72) had received chemotherapy. Of 26 assessable patients, the ORR was 57.7% (95% CI, 42.7%-83.6%) based on four complete responses and eleven partial responses, six patients experienced stable disease, while five had progressive disease. The median survival was 28.1 months (95% CI, 11.4-33.4 months), the median TtPD was 10.5 months (95% CI, 1.4-44.2 months) and the median duration of response was 24.3 months (95% CI, 12.3-33.4 months). The most common grade 3/4 toxicities were nausea/vomiting (15.2%) and neutropenia (10.7%). There was no grade 3 or 4 thrombocytopenia.


CONCLUSIONS
Gemcitabine plus cisplatin exhibited activity in advanced ovarian cancer with an acceptable toxicity profile.
Gallardo
Dolores
D
Instituto Nacional de Cancerología, Av. San Fernando # 22 Del. Tlalpan, México.
Calderillo
German
G
Serrano
Alberto
A
Alexander
Francisco
F
Rodríguez
Gerardo
G
Pérez
Leonel
L
de la Garza
Jaime
J
Orate-Ocaña
Luis
L
Otero
Jorge
J
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D005260:Female; D006801:Humans; D008875:Middle Aged; D009367:Neoplasm Staging; D010051:Ovarian Neoplasms / Q000188:drug therapy* / Q000473:pathology; D000093542:Gemcitabine
D003841:Deoxycytidine; D002945:Cisplatin; D000093542:Gemcitabine