Joyce O'Shaughnessy1, Susana Sousa2, Josefina Cruz3, Lesley Fallowfield4, Päivi Auvinen5, Catarina Pulido6, Ana Cvetanovic7, Sharon Wilks8, Leonor Ribeiro9, Mauricio Burotto10, Dirk Klingbiel11, Dimitri Messeri12, Ari Alexandrou13, Peter Trask14, Judy Fredriksson15, Zuzana Machackova16, Ljiljana Stamatovic17. 1. Baylor University Medical Center, Texas Oncology, US Oncology, 3410 Worth Street, Suite 400, Dallas, TX 75246, USA. Electronic address: Joyce.OShaughnessy@usoncology.com. 2. Department of Medical Oncology, Portuguese Oncology Institute of Porto, Porto, Portugal. Electronic address: susanapalmadesousa@gmail.com. 3. Department of Medical Oncology, Hospital Universitario de Canarias, La Laguna, S/C Tenerife, Spain. Electronic address: jcruzjurado@gmail.com. 4. Sussex Health Outcomes Research & Education in Cancer (SHORE-C), Brighton & Sussex Medical School, University of Sussex, Falmer, Brighton, BN1 9RR, UK. Electronic address: l.j.fallowfield@sussex.ac.uk. 5. Cancer Center, Kuopio University Hospital, Kuopio, Finland. Electronic address: paivi.auvinen@kuh.fi. 6. Hospital da Luz Lisboa, Avenida Lusíada, 100, 1500-650, Lisbon, Portugal. Electronic address: catarina.pulido@hospitaldaluz.pt. 7. Department of Medical Oncology, Medical Faculty Nis and Clinical Centre Nis, Bul.dr Zorana Djindjica 48, 18000, Nis, Serbia. Electronic address: ana.stankovic@yahoo.com. 8. Texas Oncology SA, Hematology/Medical Oncology, 2130 NE Loop 410 Suite 100, San Antonio, TX 78217, USA. Electronic address: sharon.wilks@usoncology.com. 9. Centro Hospitalar Universitário Lisboa Norte, Av. Prof. Egas Moniz, 1649-028, Lisbon, Portugal. Electronic address: leonor.ribeiro@chln.min-saude.pt. 10. Bradford Hill Clinical Research Center, Santiago, Chile. Electronic address: mauricioburotto@gmail.com. 11. Pharma Development Biometrics, Biostatistics, F. Hoffmann-La Roche Ltd, Hochstrasse 16, CH-4053 Basel, Switzerland. Electronic address: dirk.klingbiel@roche.com. 12. PDG Clinical Operations Oncology, F. Hoffmann-La Roche Ltd, Hochstrasse 16, CH-4053 Basel, Switzerland. Electronic address: dimitri.messeri@roche.com. 13. Portfolio Clinical Safety, Product Development Safety, Roche Products Limited, Hexagon Place, 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, UK. Electronic address: ari.alexandrou@roche.com. 14. Patient Centered Outcomes Research, Oncology, Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080, USA. Electronic address: trask.peter@gene.com. 15. Global Product Development/Medical Affairs Oncology, F. Hoffmann-La Roche Ltd, Grenzacherstrasse 124, 4070 Basel, Switzerland. Electronic address: judy.fredriksson@roche.com. 16. Global Product Development/Medical Affairs Oncology, F. Hoffmann-La Roche Ltd, Grenzacherstrasse 124, 4070 Basel, Switzerland. Electronic address: zuzana.machackova@roche.com. 17. Clinic for Medical Oncology, Institute for Oncology and Radiology of Serbia, Pasterova 14, 11000, Belgrade, Serbia. Electronic address: ljstamat@ncrc.ac.rs.
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 neoadjuvantP + 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.
RCT Entities:
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.