Analysis of overall survival from a phase III study of ixabepilone plus capecitabine versus capecitabine in patients with MBC resistant to anthracyclines and taxanes

Autor: Henri Roché, Linda T. Vahdat, Pralay Mukhopadhyay, Xavier Pivot, Valorie F. Chan, Guillermo Lerzo, Fernando Hurtado de Mendoza, Luis Fein, Ronald Peck, Gabriel N. Hortobagyi, Rubi K. Li, Jacek Jassem, Hyun Cheol Chung, Binghe Xu, Henry L. Gomez
Přispěvatelé: Department of breast medical oncology, Texas State University, Instituto Nacional de Enfermedades Neoplasicas [Lima, Pérou] (INEN), St. Luke's Medical Center, Yonsei Cancer Center, Centro de Oncologia Rosario, Veterans Memorial Medical Center, Medical University of Gdansk, Hospital de oncologia Maria Curie, Service d'Oncologie Médicale [CHRU Besançon], Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon)-Université de Franche-Comté (UFC), Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC), Interactions hôte-greffon-tumeur, ingénierie cellulaire et génique - UFC (UMR INSERM 1098) (RIGHT), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Franche-Comté (UFC), Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC)-Etablissement français du sang [Bourgogne-Franche-Comté] (EFS [Bourgogne-Franche-Comté]), Hospital Nacional Edgardo Rebagliati Martins, The cancer hospital, Chinese Academy of Medical Sciences, The Weill medical college, Cornell University [New York], Research and development, BRISTOL-MYERS SQUIBB, Département d'oncologie médicale, Institut Claudius Regaud, Institut National de la Santé et de la Recherche Médicale (INSERM)-Etablissement français du sang [Bourgogne-Franche-Comté] (EFS [Bourgogne-Franche-Comté])-Université de Franche-Comté (UFC), Saas, Philippe
Jazyk: angličtina
Rok vydání: 2010
Předmět:
Oncology
Cancer Research
Time Factors
Kaplan-Meier Estimate
Pharmacology
Deoxycytidine
chemistry.chemical_compound
0302 clinical medicine
Risk Factors
Antineoplastic Combined Chemotherapy Protocols
Anthracyclines
0303 health sciences
Antibiotics
Antineoplastic
Ixabepilone
Middle Aged
Metastatic breast cancer
Tubulin Modulators
3. Good health
Europe
Treatment Outcome
030220 oncology & carcinogenesis
[SDV.IMM]Life Sciences [q-bio]/Immunology
Female
Taxoids
Breast disease
Fluorouracil
medicine.drug
Adult
medicine.medical_specialty
Antimetabolites
Antineoplastic
Asia
Anthracycline
[SDV.IMM] Life Sciences [q-bio]/Immunology
Breast Neoplasms
Epothilone
Risk Assessment
Disease-Free Survival
Capecitabine
03 medical and health sciences
Breast cancer
Internal medicine
medicine
Humans
030304 developmental biology
Aged
Proportional Hazards Models
Taxane
business.industry
South America
medicine.disease
United States
chemistry
Drug Resistance
Neoplasm
Epothilones
business
Zdroj: Breast Cancer Research and Treatment
Breast Cancer Research and Treatment, Springer Verlag, 2010, 122 (2), pp.409-18. ⟨10.1007/s10549-010-0901-4⟩
ISSN: 0167-6806
1573-7217
DOI: 10.1007/s10549-010-0901-4⟩
Popis: Limited proven treatment options exist for patients with metastatic breast cancer (MBC) resistant to anthracycline and taxane treatment. Ixabepilone, a novel semisynthetic analog of epothilone B, has demonstrated single-agent activity in MBC resistant to anthracyclines and taxanes. In combination with capecitabine in a phase III trial (CA163-046) in this setting, ixabepilone prolonged progression-free survival and increased objective response rate relative to capecitabine (Thomas et al. J Clin Oncol 25:5210–5217, 2007). Here, we report the results of overall survival (OS), a secondary efficacy endpoint from the CA163-046 trial. Seven hundred fifty-two patients with MBC resistant to anthracyclines and taxanes were randomized to ixabepilone (40 mg/m2 intravenously on day 1 of a 21-day cycle) plus capecitabine (2,000 mg/m2 orally on days 1 through 14 of a 21-day cycle) or capecitabine alone (2,500 mg/m2 on the same schedule). Patients receiving ixabepilone plus capecitabine treatment had a median survival of 12.9 months compared to 11.1 months for patients receiving capecitabine alone (HR = 0.9; 95%CI: 077–1.05; P = 0.19). This observed increase in median OS favored the combination; however, the difference was not statistically significant. Predefined subset analyses showed a clinically meaningful increase in OS in KPS 70–80 patients receiving ixabepilone plus capecitabine (HR = 0.75; 95% CI: 0.58–0.98). Ixabepilone plus capecitabine did not show a significant improvement in survival compared to capecitabine alone in patients with MBC resistant to anthracyclines and taxanes. The observed differences in survival favored the combination arm. A clinical benefit was also seen in patients in the KPS 70–80 subgroup (ClinicalTrials.gov number, NCT000080301).
Databáze: OpenAIRE
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