Abstract |
To evaluate the single agent activity, pharmacokinetics and tolerability of the novel tubulin targeted agent vinflunine (VFL) (320 mg m(-2) q 21 days) as second-line chemotherapy in patients with metastatic breast carcinoma (MBC). All patients had disease progression after anthracycline/ taxane (A/T) therapy. They could have received a nonanthracycline adjuvant treatment and subsequently received a first-line A/T combination for advanced/metastatic disease; or relapsed >6 months after completion of adjuvant A/T therapy and were subsequently treated with the alternative agent; or relapsed within 6 months from an adjuvant A/T combination. Objective response was documented in 18 of 60 patients enrolled (RR: 30% (95% confidence interval (CI): 18.9-43.2%)). Among the responders, seven patients had relapsed during a period of <3 months from taxane-based regimen yielding a RR of 33.3%. The median duration of response was 4.8 months (95% CI: 4.2-7.2), median progression-free survival was 3.7 months (95% CI: 2.8-4.2) and median overall survival was 14.3 months (95% CI: 9.2-19.6). The most frequent adverse event was neutropenia (grade 3 in 28.3% and grade 4 in 36.7% of patients). No febrile neutropenia was observed. Fatigue (grade 3 in 16.7% of patients) and constipation (grade 3 in 11.7% of patients) were also common; these were non-cumulative and manageable permitting achievement of a good relative dose intensity of 93.5%. Vinflunine is an active agent with acceptable tolerance in the management of MBC patients previously treated with (A/T)-based regimens. These encouraging phase II results warrant further investigation of this novel agent in combination with other active agents in this setting or in earlier stages of disease.
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Authors | M Campone, H Cortes-Funes, D Vorobiof, M Martin, C F Slabber, E Ciruelos, E Bourbouloux, C Mendiola, F M Delgado, C Colin, V Aslanis, P Fumoleau |
Journal | British journal of cancer
(Br J Cancer)
Vol. 95
Issue 9
Pg. 1161-6
(Nov 06 2006)
ISSN: 0007-0920 [Print] England |
PMID | 17031408
(Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
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Chemical References |
- Anthracyclines
- Bridged-Ring Compounds
- Taxoids
- taxane
- vinflunine
- Vinblastine
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Topics |
- Adult
- Aged
- Anthracyclines
(administration & dosage)
- Antineoplastic Combined Chemotherapy Protocols
(adverse effects, therapeutic use)
- Breast Neoplasms
(drug therapy, metabolism, pathology)
- Bridged-Ring Compounds
(administration & dosage)
- Constipation
(chemically induced)
- Disease Progression
- Female
- Humans
- Leukopenia
(chemically induced)
- Middle Aged
- Nausea
(chemically induced)
- Neutropenia
(chemically induced)
- Survival Analysis
- Taxoids
(administration & dosage)
- Treatment Outcome
- Vinblastine
(analogs & derivatives, pharmacokinetics, therapeutic use)
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