A prospective multicenter phase II study of oral and i.v. vinorelbine plus trastuzumab as first-line therapy in HER2-overexpressing metastatic breast cancer.
BACKGROUND
To evaluate the efficacy and safety of oral and i.v. vinorelbine plus trastuzumab as first-line regimen in a patient-convenient application for human epidermal growth factor receptor 2 (HER2)-overexpressing patients with metastatic breast cancer.


METHODS
Forty-two women were enrolled in a multicenter study. The patients received i.v. vinorelbine at a dose of 25 mg/m(2) on day 1 followed by oral vinorelbine at a dose of 60 mg/m(2) on days 8 and 15 in a 3-week cycle. Standard dose trastuzumab was given at 3-week intervals.


RESULTS
Complete response was observed in 7 patients (18.9%) and partial response in 19 patients (51.4%), for an overall response rate of 70.3% [95% confidence interval (CI) 53.0-84.1]. The disease control rate reached 91.9% (95% CI 78.1-98.3). The median time to progression was 9.3 months, while median overall survival reached 35.6 months. Hematological and non-hematological toxic effects were acceptable with grade 3-4 leukopenia of 14% and neutropenia of 38%; cardiac toxicity did not reach the level of clinical relevance.


CONCLUSIONS
The combination of i.v. and oral vinorelbine plus trastuzumab demonstrates high activity and good tolerability in first-line treatment of HER2-overexpressing metastatic breast cancer. In addition, it offers convenience for the patients with only one i.v. treatment every 3 weeks.
Heinemann
V
V
Medical Department III, University of Munich, Munich. Electronic address: Volker.Heinemann@med.uni-muenchen.de.
Di Gioia
D
D
Medical Department III, University of Munich, Munich.
Vehling-Kaiser
U
U
Oncological Practice, Landshut.
Harich
H-D
HD
Oncological Practice, Hof.
Heinrich
B
B
Oncological Practice, Augsburg.
Welt
A
A
Department of Medicine (Cancer Research), West German Cancer Center, University Hospital Essen, Essen.
Ziske
C
C
Oncological Practice, Troisdorf.
Deutsch
G
G
Department of Gynecology, Diakonissenkrankenhaus Karlsruhe, Karlsruhe.
Pihusch
R
R
Oncological Practice, Rosenheim.
Kölbl
H
H
Department of Gynecology, University of Mainz, Mainz.
Hegewisch-Becker
S
S
Oncological Practice, Hamburg, Germany.
Michl
M
M
Medical Department III, University of Munich, Munich.
Stemmler
H J
HJ
Medical Department III, University of Munich, Munich.
D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000009:adverse effects; D061067:Antibodies, Monoclonal, Humanized; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000378:metabolism / Q000473:pathology*; D005260:Female; D006801:Humans; D007275:Injections, Intravenous; D053208:Kaplan-Meier Estimate; D008875:Middle Aged; D009362:Neoplasm Metastasis; D011446:Prospective Studies; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000378:metabolism*; D000068878:Trastuzumab; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077235:Vinorelbine
D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D018719:Erb-b2 Receptor Tyrosine Kinases; D000068878:Trastuzumab; D014747:Vinblastine; D000077235:Vinorelbine; C508053:ERBB2 protein, human