title: Vinorelbine plus trastuzumab combination as first-line therapy for HER 2-positive metastatic breast cancer patients: an international phase II trial.
abstract: The aim of this international phase II trial was to determine the efficacy and safety profile of weekly vinorelbine plus trastuzumab as first-line chemotherapy for women with HER 2-overexpressing metastatic breast cancer. Sixty-nine patients with tumours overexpressing HER 2 received vinorelbine: 30 mg m-2 week-1 and trastuzumab: 4 mg kg-1 on day 1 as a loading dose followed by 2 mg kg-1 week-1 starting on day 8. Sixty-two patients were evaluable for response and 69 patients were evaluable for toxicity. The overall response rate was 62.9%. The median time to response was 8.4 weeks, the median duration of response was 17.5 months, the median progression-free survival was 9.9 months (95% CI, 5.6-12.1) and the one-year progression-free survival was 39.1%. The median survival for all patients was 23.7 months (95% CI, 18.4-32.6). This regimen was safe: grade 3-4 neutropenia were observed over 17.7% of courses in 83.8% of patients, with only two episodes of febrile neutropenia (0.1%) in two patients (2.9%). Only one patient discontinued treatment due to grade 3 symptomatic cardiac dysfunction that resolved with therapy. Vinorelbine plus trastuzumab is one of the most active treatment regimens for patients with HER 2-positive metastatic breast cancer and demonstrates a very favourable safety profile allowing prolonged treatment with long-term survival. This study has been presented in part at the following conferences: The San Antonio Breast Cancer Symposium, San Antonio, TX, USA, 2003; The American Society of Clinical Oncology, Orlando, FL, USA, 2005.
authors.affiliation: Mount Hospital, Perth, Australia, and Oncology Department, Medical University and Regional Cancer Centre, Bialystok, Poland. arlene.chan@bigpond.com
authors.forename: A
authors.initials: A
authors.lastname: Chan
authors.forename: M
authors.initials: M
authors.lastname: Martin
authors.forename: M
authors.initials: M
authors.lastname: Untch
authors.forename: M G
authors.initials: MG
authors.lastname: Gil
authors.forename: V
authors.initials: V
authors.lastname: Guillem-Porta
authors.forename: M
authors.initials: M
authors.lastname: Wojtukiewicz
authors.forename: P
authors.initials: P
authors.lastname: Kellokumpu-Lehtinen
authors.forename: H L
authors.initials: HL
authors.lastname: Sommer
authors.forename: V
authors.initials: V
authors.lastname: Georgoulias
authors.forename: N
authors.initials: N
authors.lastname: Battelli
authors.forename: M
authors.initials: M
authors.lastname: Pawlicki
authors.forename: D
authors.initials: D
authors.lastname: Aubert
authors.forename: T
authors.initials: T
authors.lastname: Bourlard
authors.forename: J
authors.initials: J
authors.lastname: Gasmi
authors.forename: G
authors.initials: G
authors.lastname: Villanova
authors.forename: L
authors.initials: L
authors.lastname: Petruzelka
mesh_terms: D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects; D061067:Antibodies, Monoclonal, Humanized; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage* / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000235:genetics / Q000378:metabolism; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D008875:Middle Aged; D009362:Neoplasm Metastasis / Q000188:drug therapy*; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000378:metabolism; D013318:Stroke Volume / Q000187:drug effects; D016019:Survival Analysis; D000068878:Trastuzumab; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D000077235:Vinorelbine
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000972:Antineoplastic Agents, Phytogenic; D018719:Erb-b2 Receptor Tyrosine Kinases; D000068878:Trastuzumab; D014747:Vinblastine; D000077235:Vinorelbine