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

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Version 2 2023-06-12, 09:50
Version 1 2023-06-09, 23:47
journal contribution
posted on 2023-06-12, 09:50 authored by Joyce O'Shaughnessy, Susana Sousa, Josefina Cruz, Lesley FallowfieldLesley Fallowfield, Päivi Auvinen, Catarina Pulido, Ana Cvetanovic, Sharon Wilks, Leonor Ribeiro, Mauricio Burotto, Dirk Klingbie, Dimitri Messer, Ari Alexandrou, Peter Trask, Judy Fredriksson, Zuzana Machackova, Ljiljana Stamatovic
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.

History

Publication status

  • Published

File Version

  • Published version

Journal

European Journal of Cancer

ISSN

0959-8049

Publisher

Elsevier

Volume

152

Page range

223-232

Department affiliated with

  • Sussex Health Outcomes Research & Education in Cancer (SHORE-C) Publications

Full text available

  • Yes

Peer reviewed?

  • Yes

Legacy Posted Date

2021-05-06

First Open Access (FOA) Date

2021-06-17

First Compliant Deposit (FCD) Date

2021-05-05

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