2018 ASCO Annual Meeting!
Session: Breast Cancer—Local/Regional/Adjuvant
Type: Poster Session
Time: Saturday June 2, 8:00 AM to 11:30 AM
Location: Hall A
Patient (pt)-reported function and symptoms in APHINITY: A randomized comparison of chemotherapy (C) + trastuzumab (H) + placebo (Pla) versus C + H + pertuzumab (P) as adjuvant therapy in pts with HER2-positive early breast cancer (EBC).
2018 ASCO Annual Meeting
Poster Board Number:
Poster Session (Board #13)
J Clin Oncol 36, 2018 (suppl; abstr 521)
Author(s): Jose Baselga, Jennifer A. Petersen, Emma Clark, Claire Barton, Eleonora Restuccia, Marion Jennifer Procter, Amir Sonnenblick, Debora Fumagalli, Damian Parlier, Amal Arahmani, Giuseppe Viale, Linda L. Reaby, Elizabeth Frank, Richard D. Gelber, Martine J. Piccart-Gebhart, Jose Bines, Gunter von Minckwitz, Sabina McGarrahan Gasper; Memorial Sloan Kettering Cancer Center, New York, NY; Genentech, Inc., South San Francisco, CA; Roche Products Limited, Welwyn Garden City, United Kingdom; F. Hoffmann-La Roche Ltd, Basel, Switzerland; Frontier Science (Scotland), Kincraig, United Kingdom; Breast European Adjuvant Study Team (BrEAST) Data Center, Institut Jules Bordet, Brussels, Belgium, Institute of Oncology, Sourasky Medical Center, and Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel; Breast International Group, Brussels, Belgium; Breast European Adjuvant Study Team (BrEAST) Data Center, Institut Jules Bordet, Brussels, Belgium; European Institute of Oncology, University of Milan, Milan, Italy; Breast Cancer Trials, Newcastle, Australia; Dana-Farber Cancer Institute, Boston, MA; Dana-Farber Cancer Institute, Harvard Medical School, Harvard TH Chan School of Public Health, and Frontier Science and Technology Research Foundation, Boston, MA; Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium; Instituto Nacional de Câncer, Rio De Janeiro, Brazil; German Breast Group, Neu-Isenburg, Germany
Background: In APHINITY (NCT01358877), adding P to H + C significantly improved invasive disease-free survival in pts with HER2-positive EBC (von Minckwitz, NEJM 2017). Pt-reported health-related quality of life (HRQoL; symptoms of therapy, patient functioning, and global health status) was a secondary outcome, assessed by EORTC QLQ-C30, QLQ-BR23, and EQ-5D 3L questionnaires. Methods: Pts received 1 year (18 cycles) of P or Pla and H + standard adjuvant C (3–4 cycles of anthracycline-based C followed by 3–4 cycles of taxane, or 6 cycles of docetaxel + carboplatin). Pts completed measures until recurrence or 36 months post-randomization (whichever was first). Assessments were performed at screening, end of anthracycline, taxane, and HER2-targeted therapy, at Week 25, and at 6, 12, and 24 months following the end of HER2-targeted therapy. Mean and mean change from baseline (BL) scores were assessed in each arm and time point; results were defined as clinically meaningful if they differed by ± 10 points (Osoba, JCO 1998). Results: Questionnaire completion rates were > 85% throughout. Mean physical function scores (SD; 95% CI) decreased from BL to Week 13 (end of taxane): –10.7 (17.2; –11.4, –10.0) with P and –10.6 (17.7; –11.4, –9.9) with Pla during C. Scores returned to BL during HER2-targeted treatment. There was no clinically meaningful decline in role function from BL to Week 13 in either arm: –8.0 (28.6; –9.2, –6.8) with P and –8.5 (29.5; –9.8, –7.3) with Pla during C. Diarrhea symptom score differences from BL were clinically meaningful with P (at Week 13), and scores returned to BL at the end of targeted therapy (P + H). Diarrhea symptom scores were worst at Week 13 in both arms (P +22.3 [29.8; 21.0, 23.6]; Pla +9.2 [23.9; 8.2, 10.2]). Conclusions: In one of the largest HRQoL data sets reported to date in HER2-positive EBC, there was no clinically meaningful worsening of role function, indicating that patients’ abilities to conduct daily activities did not differ by treatment arm. Patient-reported diarrhea symptoms worsened to a greater extent in the P arm during both C and HER2-targeted treatment. Clinical trial information: NCT01358877
1. TAILORx: Phase III trial of chemoendocrine therapy versus endocrine therapy alone in hormone receptor-positive, HER2-negative, node-negative breast cancer and an intermediate prognosis 21-gene recurrence score.