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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
biochemistry, genetics and molecular biology
Phase 2 study of single-agent IV vinflunine as third-line treatment of metastatic breast cancer after failure of anthracycline-/taxane-based chemotherapy
American Journal of Clinical Oncology: Cancer Clinical Trials, Volume 32, No. 4, Year 2009
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Description
OBJECTIVE: A multicenter, open-label, phase 2 study evaluated the efficacy and safety of intravenous vinflunine as third-line treatment in patients with progressing metastatic breast cancer (MBC) after failure of anthracycline- and taxane-based chemotherapy. PATIENTS AND METHODS: Fifty-six patients with MBC, relapsing after receiving 2 previous treatments for advanced disease, including both anthracyclines and taxanes, received 320 mg/m of vinflunine once every 3 weeks (median number of 2.5 cycles, range: 1-13). RESULTS: According to an independent radiologist, the response rate was 12.5% (95% CI: 5.2-24.1) and 14% (95% CI: 5.3-27.9) (6 partial responses) in the treated and evaluable populations, respectively. Disease control was achieved in 42.9% and 51.2% of the patients, respectively. Median progression-free survival was 2.6 months (95% CI: 1.6-4.0 months) with a median overall survival of 11.4 months (95% CI: 7.4-14.2 months). Duration of response was 6.8 months (95% CI: 5.6 months, upper limit not reached). Leukopenia was the most frequent hematologic toxicity, with grade 3/4 severity in 49.1% of the patients. Grade 3 neutropenia in 30.9%, grade 4 in 40.0% of patients, febrile neutropenia (5.4%), and 1 case of neutropenia infection (1.8%) were reported. Other grade 3 toxicities included anemia (5.5%), fatigue (14.3%), and constipation (7.1%), which were noncumulative. The adverse events associated with vinflunine were predictable and manageable. CONCLUSIONS: Vinflunine is an active and well-tolerated agent as third-line treatment of patients with MBC after failure of anthracycline- and taxane-based therapy. These results warrant further investigation of vinflunine monotherapy or in combination for the treatment of MBC. © 2009 Lippincott Williams & Wilkins, Inc.
Authors & Co-Authors
Fumoleau, Pierre
France, Dijon
Centre Georges-françois Leclerc
Cortés-Funés, Hernán
Spain, Madrid
Hospital Universitario 12 de Octubre
Taleb, Amina B.
France, Castres
Pierre Fabre Recherche et Devéloppement
Chan, Stephen Y.T.
United Kingdom, Nottingham
Nottingham City Hospital
Campone, Mario
France, Saint-herblain
Clcc Nantes Atlantique Centre René gauducheau
Pouget, Jean Christophe
France, Castres
Pierre Fabre Recherche et Devéloppement
Tubiana-Hulin, Michèle
France, Saint-cloud
Centre René Huguenin
Slabber, Coenraad Frederik
South Africa, Pretoria
Steve Biko Academic Hospital
Caroff-Paraïso, Isabelle
France, Castres
Pierre Fabre Recherche et Devéloppement
Alberts, Alberts S.
South Africa, Pretoria
Wilgers Hospital
Ben-Ayed, Farhat
Tunisia, Tunis
Institut Salah Azaiez de Tunis
Statistics
Citations: 32
Authors: 11
Affiliations: 9
Identifiers
Doi:
10.1097/COC.0b013e31818f2d2f
ISSN:
02773732
e-ISSN:
1537453X
Research Areas
Cancer