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Clinical Trial
. 2021 Jul:152:223-232.
doi: 10.1016/j.ejca.2021.03.047. Epub 2021 Jun 16.

Preference for the fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection in patients with HER2-positive early breast cancer (PHranceSCa): A randomised, open-label phase II study

Joyce O'Shaughnessy  1 , Susana Sousa  2 , Josefina Cruz  3 , Lesley Fallowfield  4 , Päivi Auvinen  5 , Catarina Pulido  6 , Ana Cvetanovic  7 , Sharon Wilks  8 , Leonor Ribeiro  9 , Mauricio Burotto  10 , Dirk Klingbiel  11 , Dimitri Messeri  12 , Ari Alexandrou  13 , Peter Trask  14 , Judy Fredriksson  15 , Zuzana Machackova  16 , Ljiljana Stamatovic  17 ; PHranceSCa study group
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Free article
Clinical Trial

Preference for the fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection in patients with HER2-positive early breast cancer (PHranceSCa): A randomised, open-label phase II study

Joyce O'Shaughnessy et al. Eur J Cancer. 2021 Jul.
Free article

Abstract

Aim: The aim of the study was to assess patient preference for the fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection (PH FDC SC) in patients with HER2-positive early breast cancer in PHranceSCa (NCT03674112).

Materials and methods: Patients who completed neoadjuvant P + H + chemotherapy + surgery were randomised 1:1 to three intravenous (IV) P + H cycles followed by three cycles of PH FDC SC or vice versa (crossover) and then chose subcutaneous (SC) injection or IV infusion to continue up to 18 cycles (continuation). Assessments were via patient and healthcare professional (HCP) questionnaires.

Results: One hundred and sixty patients were randomised (cut-off: 24 February 2020); 136 (85.0%, 95% confidence interval: 78.5-90.2%) preferred SC; 22 (13.8%) preferred IV; 2 (1.3%) had no preference. The main reasons for SC preference were reduced clinic time (n = 119) and comfort during administration (n = 73). One hundred and forty-one patients (88.1%) were very satisfied/satisfied with SC injection versus 108 (67.5%) with IV infusion; 86.9% chose PH FDC SC continuation. HCP perceptions of median patient treatment room time ranged from 33.0-50.0 min with SC and 130.0-300.0 min with IV. Most adverse events (AEs) were grade 1/2 (no 4/5s); serious AE rates were low. AE rates before and after switching were similar (cycles 1-3 IV → cycles 4-6 SC: 77.5% → 72.5%; cycles 1-3 SC → cycles 4-6 IV: 77.5% → 63.8%).

Conclusion: Most patients strongly preferred PH FDC SC over P + H IV. PH FDC SC was generally well tolerated, with no new safety signals (even when switching), and offers a quicker alternative to IV infusion.

Keywords: Adjuvant; Early breast cancer; Fixed dose; Healthcare resource; Patient preference; Patient-reported outcomes; Pertuzumab; Quality of life; Subcutaneous; Trastuzumab.

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Conflict of interest statement

Conflict of interest statement J.O.'S. reports consultancy/advisory roles for AbbVie, Agendia, Amgen, AstraZeneca, BMS, Celgene, Eisai, Genentech, Inc., Immunomedics, Ipsen, Lilly, Merck, Novartis, Odonate, Pfizer, Puma, Prime Oncology, F. Hoffmann-La Roche Ltd, Seattle Genetics and Daiichi Sankyo. S.S. reports funding for travelling, congresses, lectures and advisory boards from F. Hoffmann-La Roche Ltd, Novartis, Pfizer, Tesaro, AstraZeneca, MSD, Pierre Fabre and Eisai. J.C. reports speaker honoraria from GSK, AstraZeneca, F. Hoffmann-La Roche Ltd, Novartis, PharmaMar, Eisai, Lilly, Celgene, Astellas, Amgen and Pfizer and consultant/advisory roles for GSK, AstraZeneca, F. Hoffmann-La Roche Ltd, Novartis, PharmaMar, Eisai, Lilly, Celgene, Astellas, Amgen and Pfizer. L.F. reports honoraria from Pfizer, AstraZeneca, BMS, Lilly, Novartis, Exact Sciences and Veracyte. P.A. reports funding for the ESMO Breast Cancer Congress 2019. C.P. reports public speaking for AstraZeneca, Grunenthal and Novartis and writing engagements from AstraZeneca. A.C. reports speaker honoraria from Novartis, Pfizer, AstraZeneca and F. Hoffmann-La Roche Ltd. S.W. reports payment for an advisory board from Seattle Genetics. L.R. reports payments for speaking and advisory boards from Roche Pharmaceuticals, Merck Serono, MSD, BMS, AstraZeneca and Pfizer and for personal medical education and participation in congresses from BMS, Roche Pharmaceuticals, Merck Serono, Pfizer, Amgen and Pierre Fabre. M.B. reports payments for advisory boards, speaking at industry symposiums and consulting roles from F. Hoffmann-La Roche Ltd, MSD, BMS, AstraZeneca and Novartis. D.K. is an employee of, and owns stocks in, F. Hoffmann-La Roche Ltd. D.M. is an employee of F. Hoffmann-La Roche Ltd. A.A. is an employee of Roche Products Limited and owns stocks in F. Hoffmann-La Roche Ltd. P.T. is an employee of, and owns stocks in, Genentech, Inc. J.F. is an employee of F. Hoffmann-La Roche Ltd. Z.M. is an employee of, and owns stocks in, F. Hoffmann-La Roche Ltd. L.S. reports speaker honoraria from AstraZeneca, Novartis, Pfizer and F. Hoffmann-La Roche Ltd. All authors have received research support in the form of third-party writing assistance for this manuscript from F. Hoffmann-La Roche Ltd.

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