Randomised Phase 2 study of lapatinib and vinorelbine vs vinorelbine in patients with HER2 + metastatic breast cancer after lapatinib and trastuzumab treatment (KCSG BR11-16)

Sung Hoon Sim, In Hae Park, Kyung Hae Jung, Sung Bae Kim, Jin Hee Ahn, Kyung Hun Lee, Seock Ah Im, Young Hyuck Im, Yeon Hee Park, Joohyuk Sohn, Yu Jung Kim, Suee Lee, Hee Jun Kim, Yee Soo Chae, Kyong Hwa Park, Byung Ho Nam, Keun Seok Lee, Jungsil Ro

Research output: Contribution to journalArticle

Abstract

Background: The continuum of anti-HER2 agents is a standard treatment of HER2 + metastatic breast cancer (MBC). This study evaluated the efficacy of lapatinib plus vinorelbine in patients progressed on both trastuzumab and lapatinib treatments. Methods: A total of 149 patients were randomly assigned to lapatinib with vinorelbine (LV) (n = 75; lapatinib, 1000 mg daily; vinorelbine 20 mg/m2 D1, D8 q3w) or vinorelbine (V) (n = 74; 30 mg/m2 D1, D8 q3w). The primary endpoint was progression-free survival (PFS) rate at 18 weeks. Results: The median number of previous anti-HER2 therapies was 2 (range 2–5). There was no significant difference in PFS rate at 18 weeks between LV and V arms (45.9% vs 38.9%, p = 0.40). ORR was 19.7% in LV arm, and 16.9% in V arm (p = 0.88). PFS and OS did not differ between two arms (LV vs V; median PFS, 16 vs 12 weeks, HR = 0.86, 95% CI 0.61–1.22; median OS, 15.0 vs 18.9 months, HR = 1.07, 95% CI 0.72–1.58). Toxicity profiles were similar in both arms and all were manageable. Conclusions: Lapatinib plus vinorelbine treatment was tolerable; however, it failed to demonstrate the clinical benefits over vinorelbine alone in patients with HER2 + MBC after progression on both trastuzumab and lapatinib. Clinical trial registration: ClinicalTrials.gov number NCT01730677.

Original languageEnglish
Pages (from-to)985-990
Number of pages6
JournalBritish Journal of Cancer
Volume121
Issue number12
DOIs
Publication statusPublished - 2019 Dec 10

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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    Sim, S. H., Park, I. H., Jung, K. H., Kim, S. B., Ahn, J. H., Lee, K. H., Im, S. A., Im, Y. H., Park, Y. H., Sohn, J., Kim, Y. J., Lee, S., Kim, H. J., Chae, Y. S., Park, K. H., Nam, B. H., Lee, K. S., & Ro, J. (2019). Randomised Phase 2 study of lapatinib and vinorelbine vs vinorelbine in patients with HER2 + metastatic breast cancer after lapatinib and trastuzumab treatment (KCSG BR11-16). British Journal of Cancer, 121(12), 985-990. https://doi.org/10.1038/s41416-019-0618-z