A randomized phase III study comparing three anthracycline-free taxane-based regimens, as first line chemotherapy, in metastatic breast cancer: a Hellenic Cooperative Oncology Group study

Autor: Anna Kalogera-Fountzila, Christos Papadimitriou, Epaminontas Samantas, Dimitris Bafaloukos, E. Briasoulis, Maria Karina, Urania Dafni, Nikos Maniadakis, George Fountzilas, H. P. Kalofonos, Meletios A. Dimopoulos, Angelos Koutras, Gerassimos Aravantinos, P. Kosmidis, D.V. Skarlos, D.G. Pectasides, F. Matsiakou, Helen Gogas, Pavlos Papakostas, C. Christodoulou
Jazyk: angličtina
Rok vydání: 2009
Předmět:
Oncology
Cancer Research
medicine.medical_treatment
Paclitaxel/administration & dosage/therapeutic use
Docetaxel
Deoxycytidine
Carboplatin
chemistry.chemical_compound
Carboplatin/therapeutic use
Antineoplastic Combined Chemotherapy Protocols
Neoplasm Metastasis
Aged
80 and over

Antibodies
Monoclonal

Middle Aged
Metastatic breast cancer
Taxoids/administration & dosage/*therapeutic use
Breast Neoplasms/*drug therapy/*pathology
Taxoids
Female
medicine.drug
Adult
medicine.medical_specialty
Paclitaxel
Antineoplastic Agents
Breast Neoplasms
Antibodies
Monoclonal/therapeutic use

Antibodies
Monoclonal
Humanized

Breast cancer
Internal medicine
medicine
Deoxycytidine/administration & dosage/analogs & derivatives
Humans
Aged
Chemotherapy
Taxane
Performance status
business.industry
Antineoplastic Agents/therapeutic use
Trastuzumab
medicine.disease
Gemcitabine
Surgery
chemistry
Antineoplastic Combined Chemotherapy Protocols/therapeutic use
business
Popis: BACKGROUND: Effective anthracycline-free combinations need to be evaluated in metastatic breast cancer (MBC), due to the increased number of patients treated with anthracycline-based adjuvant chemotherapy. PATIENTS AND METHODS: Patients with MBC were randomized to paclitaxel and carboplatin (PCb) every 3 weeks or docetaxel and gemcitabine (GDoc) every 3 weeks or weekly paclitaxel (Pw). Trastuzumab was given to patients with HER-2 over-expressing tumors. The primary endpoint of the study was survival. Quality of life (QoL) and cost were assessed. RESULTS: Totally, 416 eligible patients entered the study. Median survival times were 29.9 months for PCb, 26.9 for GDoc and 41.0 for Pw (P = 0.037). According to multivariate analysis, adjuvant chemotherapy, >1 metastatic sites, lack of maintenance hormonal therapy, and worse performance status (PS) were significant adverse prognostic factors for survival, while Pw when compared to GDoc improved survival (P = 0.03), as well as when compared to PCb in the subgroup of patients with PS = 1 (P = 0.01, treatment by PS interaction P = 0.03). No significant differences in terms of time to progression were found. Severe myelotoxicity and mucositis were more frequent with GDoc, while severe neuropathy with PCb and Pw. QoL changes did not differ significantly between treatment groups, while cost analysis favored Pw. CONCLUSIONS: Pw appears to be the most preferable choice among the 3 anthracycline-free taxanes-based regimens tested in the present study. Breast Cancer Res Treat
Databáze: OpenAIRE