Epirubicin and paclitaxel (EPI-TAX regimen) for advanced ovarian cancer after failure of platinum-containing regimens.

Background: The place of anthracyclines in the treatment of advanced ovarian cancer remains a matter of debate. We have assessed the feasibility and evaluated the tolerance of epirubicin (EPI) combined with paclitaxel (TAX) in heavily pretreated ovarian cancer patients.

Methods: Between March 1996 and March 1998, 34 patients with ovarian cancer in relapse after platinum-based chemotherapy received EPI (75 mg/m(2)/day, iv) and TAX (175 mg/m(2)/day, 3-h infusion). Cycles were repeated every 3 weeks. This treatment was second-line for 10 patients and third/fourth-line for 24.

Results: Of the 34 assessable patients, 15 (44%) (95% confidence interval 27-60%) achieved objective response (3 complete and 12 partial responses). The number of previous lines of chemotherapy or previous anthracycline treatments did not influence response rates. Responders to previous paclitaxel-based regimens had a significantly higher response rate to EPI-TAX combination (57%) than nonresponders (11%) (P = 0.05). Median response duration was 40 weeks (range 12-94). Median survival from inclusion was 10.7 months (range 1-40). Myelosuppression was the most frequent side effect. Grade 3/4 neutropenia occurred in 31 patients (91%), febrile neutropenia episodes in 17%, and grade 3/4 anemia and thrombopenia in 27 and 24%, respectively. The main nonhematological toxicities included alopecia and grade 2 peripheral neuropathy (12%). Cardiac dysfunction was observed in one patient after the fourth treatment cycle.

Conclusions: Toxicity of the EPI-TAX regimen was acceptable in this population of heavily pretreated ovarian cancer patients. The regimen was effective and it is considered an option for patients previously responding to paclitaxel-based therapy.