TY - JOUR
TI - Final overall survival analysis of a phase II trial evaluating
vinorelbine and lapatinib in women with ErbB2 overexpressing metastatic
breast cancer
AU - Janni, Wolfgang
AU - Sarosiek, Tomasz
AU - Karaszewska, Boguslawa and
AU - Pikiel, Joanna
AU - Staroslawska, Elzbieta
AU - Potemski, Piotr
AU - Salat,
AU - Christoph
AU - Brain, Etienne
AU - Caglevic, Christian
AU - Briggs, Kathryn
AU - and Mahood, Kim
AU - DeSilvio, Michelle
AU - Marini, Luca and
AU - Papadimitriou, Christos
JO - Gastric and Breast Cancer
PY - 2015
VL - 24
TODO - 6
SP - 769-773
PB - Churchill Livingstone
SN - null
TODO - 10.1016/j.breast.2015.08.005
TODO - Breast cancer; HER2; Lapatinib; Vinorelbine; Capecitabine; Overall
survival
TODO - 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.
ER -