All-oral combination of lapatinib and capecitabine in patients with brain metastases from HER2-positive breast cancer : a phase II study

الملخص EN

Approximately one-third of patients with advanced, HER2+ve breast cancer (BC) develop brain metastases (BMs).

The aim of this study is to investigate efficacy and tolerability of the combination of lapatinib and capecitabine (LC) in HER2+ve BC patients with brain metastases (BCBM).

Patients and methods : Between January 2011 and January 2013, 21 patients with HER2+ve BCBM were included.

Sixteen patients (76.19 %) progressed after whole brain radiotherapy (WBRT) and 5 patients (23.81 %) were treatment-naı¨ve for BM.

Patients received lapatinib (1250 mg / day continuously) and capecitabine (2000 mg / m2 on days 1-14 of a 21-day cycle).

All patients were treated with trastuzumab either in the adjuvant or metastatic setting.

No patients had received prior lapatinib and / or capecitabine.

End-points were response rate (RR), progression free survival (PFS), overall survival (OS) and toxicity.

Results : The overall response rate (ORR) was 33.3 % (7 / 21) and all were partial response.

For patients receiving prior WBRT and patients receiving LC as first line treatment for BCBM the ORR was 31.2 % (5 / 16) and 40.0 % (2 / 5) respectively.

Median PFS was 5.5 months.

Median OS was 11 months.

Treatment-related adverse events were manageable.

Grade 3-4 toxicities were hand-foot syndrome (14.3 %), diarrhea (14.3 %), nausea / vomiting (9.5 %), mucositis (4.8 %), and skin rash (4.8 %).

Conclusion : The combination of LC is active and well-tolerated treatment in patients with HER2+ve BCBM.