Document Detail

Vinorelbine + mitomycin C as second-line treatment of metastatic breast cancer: a two-stage phase 2 study.
MedLine Citation:
PMID:  10644934     Owner:  NLM     Status:  MEDLINE    
Second-line treatment of patients with metastatic breast cancer resistant to anthracyclines is an important clinical issue. The aim of the present two-stage phase II study was to evaluate activity and toxicity of vinorelbine + mitomycin C (VM) in such patients. Fifty-five patients were entered and received vinorelbine 30 mg/m(2) on days 1 and 8 + mitomycin C 10 mg/m(2) on day 1, every 4 weeks, up to 9 cycles. Two complete and 23 partial responses were observed for an overall response rate of 45.4% (95% CI 32.0-59.4). Median survival was 13 months and probability of surviving after a 1-year follow-up was 58%. Toxicity was never life-threatening, but G-CSF was used in 45% of cycles to contrast neutropenia that was the most frequent side effect. These results are consistent with previous studies and strongly support VM being considered among the optimal polychemotherapy regimens for second-line treatment of metastatic breast cancer in clinical practice; for clinical research aims, VM should be used as control arm for randomized trials evaluating the activity of new drugs against breast cancer.
S De Placido; R Lauria; F Perrone; A Vernaglia Lombardi; C Carlomagno; E Varriale; R Costanzo; L Leo; M De Laurentiis; A R Bianco
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Publication Detail:
Type:  Clinical Trial; Clinical Trial, Phase II; Journal Article    
Journal Detail:
Title:  Oncology     Volume:  58     ISSN:  0030-2414     ISO Abbreviation:  Oncology     Publication Date:  2000  
Date Detail:
Created Date:  2000-03-01     Completed Date:  2000-03-01     Revised Date:  2006-04-24    
Medline Journal Info:
Nlm Unique ID:  0135054     Medline TA:  Oncology     Country:  SWITZERLAND    
Other Details:
Languages:  eng     Pagination:  8-14     Citation Subset:  IM    
Copyright Information:
Copyright 2000 S. Karger AG, Basel
Division of Medical Oncology, University of Naples Federico II, Naples, Italy.
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MeSH Terms
Antibiotics, Antineoplastic / administration & dosage
Antineoplastic Agents, Phytogenic / administration & dosage
Antineoplastic Combined Chemotherapy Protocols / adverse effects,  therapeutic use*
Breast Neoplasms / drug therapy*,  pathology
Disease-Free Survival
Drug Administration Schedule
Granulocyte Colony-Stimulating Factor / therapeutic use
Infusions, Intravenous
Middle Aged
Mitomycin / administration & dosage
Treatment Outcome
Vinblastine / administration & dosage,  analogs & derivatives
Reg. No./Substance:
0/Antibiotics, Antineoplastic; 0/Antineoplastic Agents, Phytogenic; 143011-72-7/Granulocyte Colony-Stimulating Factor; 50-07-7/Mitomycin; 71486-22-1/vinorelbine; 865-21-4/Vinblastine

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