Pegylated liposomal doxorubicin and gemcitabine in the front-line treatment of recurrent/metastatic breast cancer: a multicentre phase II study

摘要: This multicentre phase II study was aimed at investigating the activity and safety of pegylated liposomal doxorubicin (PLD) gemcitabine (GEM) as front-line therapy in a large series chemotherapy-naive recurrent/metastatic breast cancer patients. From June 2003 to December 2006, total 71 patients were enrolled. Median age 63 years (range=37–79), 31 (43.7%) ⩾65 old. Patients received PLD, 25 mg m−2, day 1, followed by GEM, 800 mg m−2, days 1 8, q21. Response evaluable 64 cases. Eight complete (12.5%) 17 partial responses (26.6%) registered, with an overall response rate 39.1%. Thirty (46.9%) experienced stable disease, clinical benefit 85.9%. time progression (TTP) 11 months, whereas median survival (OS) not reached. The 1- 2-year OS 79 61%, respectively. A 443 courses for toxicity: grade 3 4 neutropaenia affected 14 (20.3%) (4.3%), Grade palmar-plantar erythrodysesthesia syndrome documented five cases (7.2%) one case (1.4%), mucositis occurred six (8.7%) two (2.9%), 2 cardiac toxicity observed only case. Interestingly enough, there no difference percentage severity either haematological or non-haematological according (<65 vs years). We confirmed large, very homogenous sample efficacy PLD/GEM combination, providing rates, TTP values comparable those achieved more toxic combinations.