title: Final overall survival analysis of a phase II trial evaluating vinorelbine and lapatinib in women with ErbB2 overexpressing metastatic breast cancer.
abstract: Lapatinib plus capecitabine (lap+cap) is approved as treatment for patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC), who have progressed on prior trastuzumab in the metastatic setting. We previously reported progression-free survival (PFS), overall survival (OS) and safety results from this open-label, multicentre, phase II study (VITAL; NCT01013740) conducted in women with HER2 positive MBC, to evaluate the efficacy and safety of lap plus vinorelbine (lap+vin), an important chemotherapy option for MBC, compared with lap+cap. In total, 112 patients were randomised 2:1 to treatment with lap+vin (N = 75) or lap+cap (N = 37). Results showed that the median PFS (primary endpoint) and OS (secondary endpoint) post-randomisation were comparable between treatment arms, with no new safety signals detected. Here, we assessed the final OS in this study at 40 months post-randomisation. At the time of final analyses, 24 (32%) patients were ongoing in the lap+vin arm, compared with 14 (38%) patients in the lap+cap arm (92% in both arms had discontinued treatment). Median OS in the lap+vin arm was 23.3 months (95% confidence intervals [CI]: 18.5, 31.1), compared with 20.3 months (95% CI: 16.4, 31.8) in the lap+cap arm. The median follow-up in the lap+vin arm was 18.86 months (95% CI: 10.68, 26.02), compared with 19.38 (95% CI: 25.56) months in the lap+cap arm. Similar rates of death (56-57%) were observed in both arms. The final OS was consistent with the previously reported data and suggest that lap+vin offers an effective treatment option for women with HER2-positive MBC.
authors.affiliation: Universitätsklinikum Ulm, Prittwitzstr 43, 89075 Ulm, Germany. Electronic address: wolfgang.janni@uniklinik-ulm.de.
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Janni
authors.affiliation: NZOZ Magodent, Fieldorfa 40, 04-0125 Warsaw, Poland.
authors.forename: Tomasz
authors.initials: T
authors.lastname: Sarosiek
authors.affiliation: Przychodnia Lekarska NZOZ KOMED, Ul Wojska Polskiego 6, 62-500 Konin, Poland.
authors.forename: Boguslawa
authors.initials: B
authors.lastname: Karaszewska
authors.affiliation: Wojewodzkie Centrum Onkologii, Aleja Zwycięstwa 31, 80-219 Gdansk, Poland.
authors.forename: Joanna
authors.initials: J
authors.lastname: Pikiel
authors.affiliation: Centrum Onkologii Ziemi Lubelskieij, Doktor Kazimierza Jaczewskiego 7, 20-090 Lublin, Poland.
authors.forename: Elzbieta
authors.initials: E
authors.lastname: Staroslawska
authors.affiliation: Uniwersytet Medyczny w Łodzi, Wojewodzki Szpital Specjalistyczny im. M.Kopernika, Pabianicka 62, 93-513 Lodz, Poland.
authors.forename: Piotr
authors.initials: P
authors.lastname: Potemski
authors.affiliation: Hämato-Onkologische Gemeinschaftspraxis, Franz-Schrank-Str 2, 80638 Munich, Germany.
authors.forename: Christoph
authors.initials: C
authors.lastname: Salat
authors.affiliation: Hôpital René Huguenin/Institut Curie, 35 Rue Dailly, Saint Cloud 92210, France.
authors.forename: Etienne
authors.initials: E
authors.lastname: Brain
authors.affiliation: Fundacion Arturo Lopez Perez, Rancagua 878, Providencia, Santiago 7500921 Chile.
authors.forename: Christian
authors.initials: C
authors.lastname: Caglevic
authors.affiliation: Novartis Pharma AG, Basel, Switzerland.
authors.forename: Kathryn
authors.initials: K
authors.lastname: Briggs
authors.affiliation: Novartis Pharma AG, Basel, Switzerland.
authors.forename: Kim
authors.initials: K
authors.lastname: Mahood
authors.affiliation: Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
authors.forename: Michelle
authors.initials: M
authors.lastname: DeSilvio
authors.affiliation: Novartis Pharma AG, Basel, Switzerland.
authors.forename: Luca
authors.initials: L
authors.lastname: Marini
authors.affiliation: Department of Clinical Therapeutics, Alexandra Hospital, University of Athens School of Medicine, V.Sophias 80, 11528 Athens, Greece.
authors.forename: Christos
authors.initials: C
authors.lastname: Papadimitriou
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D001943:Breast Neoplasms / Q000737:chemistry / Q000188:drug therapy / Q000401:mortality* / Q000473:pathology; D018572:Disease-Free Survival; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D000077341:Lapatinib; D008207:Lymphatic Metastasis; D008875:Middle Aged; D011799:Quinazolines / Q000008:administration & dosage*; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000032:analysis*; D016019:Survival Analysis; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D000077235:Vinorelbine
chemical_list: D000077341:Lapatinib; D011799:Quinazolines; D018719:Erb-b2 Receptor Tyrosine Kinases; D014747:Vinblastine; D000077235:Vinorelbine; C508053:ERBB2 protein, human
keywords: Breast cancer; Capecitabine; HER2; Lapatinib; Overall survival; Vinorelbine