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Weekly combination of non-pegylated liposomal doxorubicin and taxane in first-line breast cancer: wALT trial (phase I-II).

Author(s): Rosati MS, Raimondi C, Baciarello G, Grassi P, Giovannoni S, Petrelli E, Basile ML, Girolami M, Di Seri M, Frati L

Affiliation(s): Department of Oncology A, Policlinico Umberto, Sapienza University of Rome, 155 V.le del Policlinico, 00161 Rome, Italy. sofiarosati@tiscali.it

Publication date & source: 2011-02, Ann Oncol., 22(2):315-20. Epub 2010 Aug 6.

Publication type: Clinical Trial, Phase I; Clinical Trial, Phase II; Randomized Controlled Trial

BACKGROUND: Through different pharmacodynamic-kinetic interactions, weekly administration of proved efficacy agents can overcome resistance with lower toxicity and greater benefit. Based on this assumption, we designed a phase I-II trial with weekly non-pegylated liposomal anthracycline and taxane in first-line breast cancer patients. PATIENTS AND METHODS: We enrolled 56 previously untreated metastatic breast cancer patients; they were randomly assigned to receive paclitaxel (Taxol) (50 mg/mq) or docetaxel (Taxotere) (30 mg/mq) combined with non-pegylated liposomal anthracycline (25 mg/mq) on days 1, 8 and 15 every 4 weeks. The primary end points were the clinical benefit and treatment-related toxic effects assessment. Secondary end points were time-to-disease progression (TTP) and overall survival (OS). RESULTS: The overall clinical benefit was 87.04%. World Health Organization G3-4 toxic effects included neutropenia (45%), anemia (44%), complete alopecia (83%), severe onycholysis and neuropathy. The 24% of patients developed left ventricular ejection fraction reduction but none >10% with recover after treatment completion. The median absolute decrease from baseline was 1%. Median TTP was 11 months and median OS was 23 months. CONCLUSIONS: Combined weekly administration of taxane and non-pegylated liposomal anthracycline is well tolerated and clinical benefit data encourage phase III study design.

Page last updated: 2011-12-09

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