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, Susana Sousa, Josefina Cruz, Lesley Fallowfield, Päivi Auvinen, Catarina Pulido, Ana Cvetanović, Sharon Wilks, Leonor Ribeiro, Mauricio Burotto, Dirk Klingbiel, Dimitri Messeri, Ari Alexandrou, Peter C. Trask, J. Fredriksson, Z. Machackova, Ljiljana Stamatović, Ernesto Korbenfeld, Jorge Nadal, Hélio Pinczowski, Felipe José Silva Melo Cruz, Gustavo Mota de Sousa, Aline Coelho Gonçalves, Gisah Guilgen, Mauricio Burotto, Antti Jekunen, Päivi Auvinen, Winne Yeo, Eric C. K. Cheng, Hikmat A. Razeq, Fadi Rafic El Karak, Fadi Farhat, Servando C. Huerta, Brizio M. Jaime, Juan P. Feregrino, O. Castillo, Juan Carlos Alcedo, Leonor Ribeiro, Maria Rita Dionísio, Susana Sousa, Catarina Pulido, Salha Bujassoum, Hatoon Bakhraibah, Ana Cvetanović, Ljiljana Stamatović, Álvaro Rodríguez Lescure, Josefina Cruz, Camilla Wendt, Sara Margolin, Helena Granstam Björneklett, Michelina Cairo, Shaker R. Dakhil, Nguyet Le‐Lindqwister, Ling Ma, Kristi McIntyre, Joyce O’Shaughnessy, Svetislava J. Vukelja, Donald Richards, Sharon Wilks, John M. Wallmark
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.