Docetaxel and pegylated liposomal doxorubicin combination as first-line therapy for metastatic breast cancer patients: results of the phase II GINECO trial CAPYTTOLE

Background: This phase II study evaluated the clinical benefit of pegylated liposomal doxorubicin (PLD) and docetaxel (Taxotere) as first-line therapy for metastatic breast cancer (MBC). Patients and methods: MBC patients were enrolled to receive six cycles of PLD 35 mg/m 2 (day 1) and docetaxel 40 mg/m 2 (days 1 and 15), every 28 days (group A). Because of unacceptable toxic effects, doses were modified to PLD 30 mg/m 2 (day 1) and docetaxel 75 mg/m 2 (day 2), every 3 weeks (group B). The primary end point was clinical benefit. Results: Sixty-seven patients were included (group A, 53; group B, 14). In both groups, the median number of cycles delivered was 4 and the overall dose intensity was 82% for docetaxel and 71 % for PLD. In group A, main toxic effects were hematologic, palmar―plantar erythrodysesthesia (PPE), and stomatitis. In group B, higher rates of grade 3―4 PPE, febrile neutropenia, and hematologic toxic effects were reported. The rate of clinical benefit was 47%. Among patients with a measurable disease, 49% achieved a partial response, 27% had a stable disease, and 13% progressed, according to RECIST criteria. Conclusion: The combination of PLD and docetaxel delivered at planned doses in this study yields unacceptable toxicity and should not be used routinely in patients with MBC.