Τίτλος:
Final overall survival analysis of a phase II trial evaluating
vinorelbine and lapatinib in women with ErbB2 overexpressing metastatic
breast cancer
Γλώσσες Τεκμηρίου:
Αγγλικά
Περίληψη:
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. (C) 2015 The Authors. Published by Elsevier Ltd.
Συγγραφείς:
Janni, Wolfgang
Sarosiek, Tomasz
Karaszewska, Boguslawa and
Pikiel, Joanna
Staroslawska, Elzbieta
Potemski, Piotr
Salat,
Christoph
Brain, Etienne
Caglevic, Christian
Briggs, Kathryn
and Mahood, Kim
DeSilvio, Michelle
Marini, Luca and
Papadimitriou, Christos
Περιοδικό:
Gastric and Breast Cancer
Εκδότης:
Churchill Livingstone
Λέξεις-κλειδιά:
Breast cancer; HER2; Lapatinib; Vinorelbine; Capecitabine; Overall
survival
DOI:
10.1016/j.breast.2015.08.005
