Résumé
Retrospective analysis and comparison of the side effects, efficacy and feasibility of cisplatin and carboplatin each in combination with paclitaxel as front-line therapy in advanced epithelial ovarian cancer. Between January 2001 and January 2006, 39 patients with advanced epithelial ovarian cancer were allocated to receive paclitaxel 175mg/m[2] intravenously as a 3-hour infusion followed by either cisplatin 75mg/m[2] or carboplalin [area under the plasma concentration-time curve of 5] both on day [1]. The schedule was repeated every 3 weeks for at least six cycles to the majority of the patients. The primary endpoint was the proportion of patients without progression at 2 years. Secondary endpoints included toxicity, tolerability, response to treatment, and overall and progression-free survival time. Kaplan-Meier method estimated overall and time to disease progression. Log rank test compared survival curves with p value 230 had 92.3% sensitivity and 100% specificity [p=<0.001] and tumor size at start of chemotherapy had 96.3% sensitivity and 100% specificity [p<0.001]. The 2-years progression-free survival [PFS] of all patients was 39.4% and the median time to disease progression was 23.3 months. While the median overall survival time of all patients was 37.5 months and the 2-years overall survival [OAS] was 62.9%. The 2-years PFS and OAS were 35.2% and 44.4%, respectively, for TC arm compared with 44.4% and 83.3%, respectively, for paclitaxel-cisplatin [TP] arm. The relative risk [RR] of progression for patients with incomplete response was 6.9 [95%- CI, 2.052 to 23.11] and the RR of death for TC arm was 6.3 [95% CI, 1.7 to 9.0]. The small number of patients entered onto the study caused wide CI around the hazards ratio for RR of death with delayed treatment [hazards ratio, 4.0; 95% CI, 1.7 to 23.3] and did not allow conclusions about efficacy. Age >60 [p=0.05], stage IIIB, IIIC and IV disease [p=0.02], and delayed treatment [0.001] had statistically significant adverse effect on the OAS, while response to chemotherapy [p=0.03] had statistically significant effect on prolonging the OAS. Presence of residual disease >1cm had borderline significance [p=0.06] on the OAS. However elevated level of CA[125] >230, tumor grade, pathological subtype, Karnofsky performance status [KPS] had no statistically significant effect on the OAS [all p=NS]. Univariate analysis of factors that might affect PFS showed that patients with a residual tumor of less than 1cm before chemotherapy [p=0.0003], KPS [p=0.0268], FIGO stage II or IIIa [p=0.0018], had statistically significant longer PFS while CA125 >230 [p=0.0012] and incomplete response [p=0.002] had a significant adverse impact on PFS. In patients with advanced ovarian cancer, a chemotherapy regimen consisting of TC results in less toxicity, is easier to administer, and has similar median time to disease progression [23.3 months], when compared with TP regimen, however a longer follow-up is required for a definitive statement on survival