Non-pegylated liposomal doxorubicin and docetaxel as front line treatment in HER2-neu negative metastatic breast cancer: Safety and efficacy results

Abstract

10659 Background: First line docetaxel (D) and doxorubicin (DXR) yield up to 55% response rates in controlled studies, in relapse situation for patients who have received anthracyclin in adjuvant setting, with the risk to run on cardiotoxicity regarding anthracyclin cumulative dose.The objective of the study is to determine efficacy and tolerance of Myocet (M) and D as frontline chemotherapy in her2-neu negative metastatic breast cancer (MBC) patients (pts) who have received anthracyclin in adjuvant setting. Methods: Eligible pts were above 18 years, with MBC relapsing at least 12 month after anthracyclin given in adjuvant setting. WHO = 0–1-2, normal left ejection fraction (LEF), measurable targets, cumulative dose of DXR or epirubicin or mitoxantron previously administred respectively under 300, 600, 75 mg/m2. Ongoing hormonotherapy or radiotherapy had to be stop at least 4 weeks before treatment: M = 60 mg/m2 was given as 90 minutes infusion, followed by D = 75 mg/m2 given as 60 minutes infusion, the both 21 days cycles for 6 cycles. Clinical adverse event review, haematology was performed each cycle, LEF each two cycles, tumor assessment, at day 50 and day 120. Results: Between 04/04 and 05/05: 21 pts with median age 55 (33–72) entered the study. All pts were metastatic (liver 10 pts, bone 9, lung 4, soft tissue 2, skin 2, pleural 1, multiples 6). Premenopausal 6 pts , negative oestrogen receptor: 5 pts. A total of 108 MD infusion has been given, infusions delayed 11, omitted 1, reduced dose 15. Use of neutrophils growth factors 11 pts. No treatment related death has been reported. Grade 3/4 toxicity: febrile neutropenia 6 pts (28%), thrombocytopenia 1, alopecia 21, nausea-vomiting 0, gastritis 1, dental infection 1, one cardiac heart failure grade 3 was observed 6 month after the end of 9 cycles of MD, responsive to angiotensin conversion inhibitor. Efficacy: 10 partials responses, 5 completes responses and 2 progressive disease. RR = 71% Binomial 95% CI (53–85). Conclusions: MD is clinically well tolerated with however 28 % grade 3/4 neutropenia and a large use of neutrophils growth factors, no life threatening aplasia was observed. The high response rate had to be confirm with the safety results at the end of the accrual (50 pts planed). No significant financial relationships to disclose.