Weekly combination of non-pegylated liposomal doxorubicin and taxane in first-line breast cancer: wALT trial (phase I-II)
| Autor: | Giulia Baciarello, E. Petrelli, Paolo Grassi, M. Girolami, M. Di Seri, Maria Sofia Rosati, Luigi Frati, Maria Luisa Basile, Cristina Raimondi, S. Giovannoni |
|---|---|
| Rok vydání: | 2010 |
| Předmět: |
Oncology
medicine.medical_specialty Anthracycline Antineoplastic Agents Breast Neoplasms Neutropenia chemistry.chemical_compound Breast cancer Internal medicine medicine Humans Neoplasm Metastasis Aged Taxane business.industry Dose dense First-line breast cancer NPLD Doxorubicin Female Middle Aged Taxoids Hematology medicine.disease Metastatic breast cancer Surgery Clinical trial Paclitaxel chemistry Docetaxel business medicine.drug |
| Zdroj: | Annals of oncology : official journal of the European Society for Medical Oncology. 22(2) |
| ISSN: | 1569-8041 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|