Patient-reported function, health-related quality of life, and symptoms in APHINITY: pertuzumab plus trastuzumab and chemotherapy in HER2-positive early breast cancer

José Bines, Emma Clark, Claire Barton, Eleonora Restuccia, Marion Procter, Amir Sonnenblick, Debora Fumagalli, Damien Parlier, Amal Arahmani, José Baselga, Giuseppe Viale, Linda L. Reaby, Elizabeth Frank, Richard D. Gelber, Martine Piccart, Christian Jackisch, Jennifer A. Petersen

Research output: Contribution to journalArticlepeer-review

Abstract

Background: We assessed health-related quality of life (symptoms of therapy/patient functioning/global health status), in APHINITY (pertuzumab/placebo, trastuzumab, and chemotherapy as adjuvant HER2-positive early breast cancer therapy). Methods: Patients received 1 year/18 cycles of pertuzumab/placebo with trastuzumab and chemotherapy and completed EORTC QLQ-C30 and BR23 questionnaires until 36 months post-randomisation/disease recurrence. Changes ≥10 points from baseline were considered clinically meaningful. Results: 87–97% of patients completed questionnaires. In the pertuzumab versus placebo arms, mean decrease in physical function scores (baseline → end of taxane) was −10.7 (95% CI −11.4, −10.0) versus −10.6 (−11.4, −9.9), mean decrease in global health status was −11.2 (−12.2, −10.2) versus −10.2 (−11.1, −9.2), and mean increase in diarrhoea scores (baseline → end of taxane) was +22.3 (21.0, 23.6) versus +9.2 (8.2, 10.2). Diarrhoea scores remained elevated versus baseline in the pertuzumab arm throughout HER2-targeted treatment (week 25: +13.2; end of treatment: +12.2). Role functioning was maintained in both arms. Conclusions: Improved invasive disease-free survival achieved by adding pertuzumab to trastuzumab and chemotherapy did not adversely affect the ability to conduct activities of daily living versus trastuzumab and chemotherapy alone. Patient-reported diarrhoea worsened during taxane therapy in both arms, persisting during HER2-targeted treatment in the pertuzumab arm. ClinicalTrials.gov: NCT01358877.

Original languageEnglish
Pages (from-to)38-47
Number of pages10
JournalBritish Journal of Cancer
Volume125
Issue number1
DOIs
Publication statusPublished - Jul 6 2021

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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