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

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