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).

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.

• Authors: 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
• Journal: British journal of cancer (Br J Cancer) Vol. 121 Issue 12 Pg. 985-990 (12 2019) ISSN: 1532-1827 [Electronic] England
• PMID: 31690831 (Publication Type: Clinical Trial, Phase II, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Lapatinib
• ERBB2 protein, human
• Receptor, ErbB-2
• Trastuzumab
• Vinorelbine

Topics

• Adult
• Aged
• Antineoplastic Combined Chemotherapy Protocols (administration & dosage)
• Breast Neoplasms (drug therapy, genetics, pathology)
• Disease Progression
• Disease-Free Survival
• Female
• Humans
• Lapatinib (administration & dosage)
• Middle Aged
• Neoplasm Metastasis
• Receptor, ErbB-2 (genetics)
• Trastuzumab (administration & dosage)
• Vinorelbine (administration & dosage)