Results from an observational trial with oral vinorelbine and trastuzumab in advanced breast cancer.
OBJECTIVE
We evaluated the efficacy and tolerability of oral vinorelbine plus trastuzumab (OV + T) in Her2 positive advanced breast cancer as first line chemotherapy or after progressing on earlier treatment.


METHODS
Thirty consecutive patients (median age: 59 years) were included. Patients received OV in a dose of 60 mg/m(2) on day 1 and 8, q=21, without dose escalation. Trastuzumab was administered every 3 weeks at a dose of 6 mg/kg bodyweight after a loading dose of 8 mg/kg. Response was evaluated every three cycles using UICC criteria. Time to progression (TTP) and overall survival (OS) were estimated using the Kaplan-Meier product limit method. A multivariate analysis was performed to evaluate factors potentially influencing response rate and TTP.


RESULTS
Median time of observation was 20 months. We observed a complete response in 18% of patients, partial remission in 50%, stable disease >or= 6 months in 21%, and progressive disease in 11%. TTP was median 9 months. OS was not reached. Response rate and TTP were influenced by line of treatment only. The main toxicities consisted of neutropenia and nausea.


CONCLUSIONS
OV + T appears to be an effective and safe treatment option in advanced breast cancer at the dose and schedule chosen.
Bartsch
Rupert
R
Department of Internal Medicine I, Division of Oncology, Medical University of Vienna, 18-20 Waehringer Guertel, A-1090, Vienna, Austria.
Wenzel
Catharina
C
Altorjai
Gabriela
G
Pluschnig
Ursula
U
Bachleitner-Hoffmann
Thomas
T
Locker
Gottfried J
GJ
Rudas
Margaretha
M
Mader
Robert
R
Zielinski
Christoph C
CC
Steger
Guenther G
GG
D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000911:Antibodies, Monoclonal / Q000008:administration & dosage; D061067:Antibodies, Monoclonal, Humanized; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D005260:Female; D018734:Genes, erbB-2; D006801:Humans; D007150:Immunohistochemistry; D017404:In Situ Hybridization, Fluorescence; D053208:Kaplan-Meier Estimate; D008875:Middle Aged; D016019:Survival Analysis; D000068878:Trastuzumab; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077235:Vinorelbine
D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D014747:Vinblastine; D000068878:Trastuzumab; D000077235:Vinorelbine