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.

Anti-HER2 antibody prolongs overall survival disproportionally more than progression-free survival in HER2-Positive metastatic breast cancer patients

“…The pooled groups of drug differences between longer PFS and shorter PFS arms included seven anti-HER2 antibody studies [ [17] , [18] , [19] , [20] , [21] , [22] , [23] , 29 , 30 ] and 22 non-anti-HER2 antibody studies [ 12 , 16 , [31] , [32] , [33] , [34] , [35] , [36] , [37] , [38] , [39] , [40] , [41] , [42] , [43] , [44] , [45] , [46] , [47] , [48] , [49] , [50] , [51] , [52] ] (LACOG 0801, 31 which had three treatment arms, was analyzed as two separate studies) ( Table 1 ). Twenty-one studies (79%) were phase III, and the enrollment timeframe of all studies included were from 1995 to 2013.…”

A Systematic Review and Meta-analysis of the Combination of Vinorelbine and Lapatinib in Patients With Her2-positive Metastatic Breast Cancer

“…Reasons for exclusion of retrieved articles included review format (14 articles), articles reporting on other drugs or combinations (17 articles), phase I and pharmacokinetics studies (three articles), articles referring to policy and financial considerations (two articles) and studies concerning pre-clinical evaluations (two articles). From the eight remaining reports, two concerned the same study (11,12) and thus the total number of studies included in the analysis was seven (11,(13)(14)(15)(16)(17)(18).…”

SNORA71B promotes breast cancer cells across blood–brain barrier by inducing epithelial-mesenchymal transition

“…With the improvement of diagnosis and treatment of BC, the survival period of BC patients is significantly prolonged. Moreover, the incidence of BC metastasis to brain is gradually increasing [20]. Presently, the patients with BCBM urgently need novel molecular biomarkers for the diagnosis and prognosis.…”