Neratinib + capecitabine sustains health-related quality of life in patients with HER2-positive metastatic breast cancer and ≥ 2 prior HER2-directed regimens

Abstract

Purpose To characterize health-related quality of life (HRQoL) in patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC) from the NALA phase 3 study. Methods In NALA (NCT01808573), patients were randomized 1:1 to neratinib + capecitabine (N + C) or lapatinib + capecitabine (L + C). HRQoL was assessed using seven prespecified scores from the European Organisation for Research and Treatment of Cancer Quality Of Life Questionnaire core module (QLQ-C30) and breast cancer-specific questionnaire (QLQ-BR23) at baseline and every 6 weeks. Descriptive statistics summarized scores over time, mixed models evaluated differences between treatment arms, and Kaplan–Meier methods were used to assess time to deterioration in HRQoL scores of ≥ 10 points. Results Of the 621 patients randomized in NALA, patients were included in the HRQoL analysis if they completed baseline and at least one follow-up questionnaire. The summary, global health status, physical functioning, fatigue, constipation, and systemic therapy side effects scores were stable over time with no persistent differences between treatment groups. There were no differences in time to deterioration (TTD) for the QLQ-C30 summary score between treatment arms; the hazard ratio (HR) for N + C vs. L + C was 0.94 (95% CI 0.63–1.40). Only the diarrhea score worsened significantly more in the N + C arm as compared to the L + C arm, and this remained over time (HR for TTD for N + C vs. L + C was 1.71 [95% CI 1.32–2.23]). Conclusion In NALA, patients treated with N + C maintained their global HRQoL over time, despite a worsening of the diarrhea-related scores. These results may help guide optimal treatment selection for HER2-positive MBC.

Bilateral inflammatory recurrence of HER-2 positive breast cancer: a unique case report and literature review

“…Moving forward, we are now considering the next step of treatment, which involves choosing between targeted maintenance therapy alone or combining targeted therapy with other drugs. Capecitabine, a well-established oral chemotherapy drug, has demonstrated positive maintenance treatment effects in numerous studies when combined with other therapies (27)(28)(29). For the follow-up maintenance treatment, we decided to use capecitabine in combination with trastuzumab and pertuzumab.…”

A comprehensive clinical evaluation of HER2-TKIs in patients with previously treated HER2-positive metastatic breast cancer

“…As regards life quality, we retrieved PubMed and NCKI to obtain five studies [18,[26][27][28][29]. The quality of life between neratinib + capecitabine and lapatinib + capecitabine was similar, with mean Core Quality of Life questionnaire summary and global health status/HRQoL scores being similar [18,26,27]. Compared with chemotherapy, pyrotinib could significantly improve the life quality of patients (P < 0.05) [28].…”