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

Beverly Moy*, Mafalda Oliveira, Cristina Saura, William Gradishar, Sung Bae Kim, Adam Brufsky, Sara A. Hurvitz, Larisa Ryvo, Daniele Fagnani, Sujith Kalmadi, Paula Silverman, Suzette Delaloge, Jesus Alarcon, Ava Kwong, Keun Seok Lee, Peter Cher Siang Ang, Samuel Guan Wei Ow, Sung Chao Chu, Richard Bryce, Kiana KeyvanjahJudith Bebchuk, Bo Zhang, Nina Oestreicher, Ron Bose, Nancy Chan

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish (US)
JournalBreast Cancer Research and Treatment
DOIs
StateAccepted/In press - 2021

Keywords

  • HER2-positive
  • Health-related quality of life
  • Metastatic breast cancer
  • Neratinib

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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