165MO - Patient (pt) preference for the pertuzumab-trastuzumab fixed-dose combination for subcutaneous use (PH FDC SC) in HER2-positive early breast cancer (EBC): Primary analysis of the open-label, randomised crossover PHranceSCa study

Background

SC formulations of intravenous (IV) treatments (tx) are less invasive with shorter administration (admin) times; reducing pts’ clinic time, freeing up healthcare resources and potentially enabling admin outside of hospitals.

Methods

Pts completed neoadjuvant PH + chemotherapy + surgery and were randomised 1:1 to 3 cycles of PH IV followed by 3 cycles of PH FDC SC or vice-versa (crossover period). Pts then chose SC or IV to continue EBC tx up to 18 cycles (continuation period). Primary objective: to assess pt preference for PH FDC SC. Key secondary objectives: patient satisfaction, healthcare professional (HCP) perceptions on time/resource impact, and safety. ClinicalTrials.gov NCT03674112.

Results

At primary analysis, 160 pts were randomised; all pts completed crossover tx; 44% completed continuation tx at cut-off (24-02-20). 136 pts (85%; 95% CI 79–90%) preferred SC; 22 (14%) preferred IV; 2 (1%) had no preference. Main reasons for SC preference: reduced clinic time (n=119) and comfort during administration (n=73). 141 (88%) were very satisfied or satisfied with SC vs. 108 (68%) with IV. 87% chose SC to complete HER2-targeted therapy. HCPs’ perceptions on median pts’ time in the tx room across cycles 1–6 for SC vs. IV admin were 33–50 vs. 130–300 min, respectively. The rates of serious adverse events (AEs) and grade ≥3 AEs were low; the most common AEs were as expected (table). There were a higher number of injection site reactions with SC, mainly grade 1–2. AE rates before and after switching were similar (PH IV→PH FDC SC: 78%→73%; PH FDC SC→PH IV: 78%→64%), with no new safety signals. Table: 165MO

Conclusions

PHranceSCa clearly showed that the majority of pts preferred PH FDC SC over PH IV. PH FDC SC was generally well tolerated with no new safety signals. PH FDC SC offers a quicker alternative to PH IV and reduces patients’ time in the tx room.

Clinical trial identification

NCT03674112.

Editorial acknowledgement

Support for third-party writing assistance for this abstract, furnished by Daniel Clyde, PhD, of Health Interactions, was provided by F. Hoffmann-La Roche Ltd, Basel, Switzerland.

Legal entity responsible for the study

F. Hoffmann-La Roche Ltd.

Funding

F. Hoffmann-La Roche Ltd.

Disclosure

J. O'Shaughnessy: Advisory/Consultancy: 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; Non-remunerated activity/ies, Third-party writing assistance: F. Hoffmann-La Roche Ltd. S. Sousa: Advisory/Consultancy, Travel/Accommodation/Expenses, Also congresses and lectures: F. Hoffmann-La Roche Ltd, Novartis, Pfizer, Tesaro, AstraZeneca, MSD, Pierre Fabre and Eisai; Non-remunerated activity/ies, Third-party writing assistance: F. Hoffmann-La Roche Ltd. J. Cruz: Honoraria (self), Speaker: GSK, AstraZeneca, F. Hoffmann-La Roche Ltd, Novartis, PharmaMar, Eisai, Lilly, Celgene, Astellas, Amgen and Pfizer; Advisory/Consultancy: GSK, AstraZeneca, F. Hoffmann-La Roche Ltd, Novartis, PharmaMar, Eisai, Lilly, Celgene, Astellas, Amgen and Pfizer; Non-remunerated activity/ies, Third-party writing assistance: F. Hoffmann-La Roche Ltd. L. Fallowfield: Honoraria (self): Pfizer, AstraZeneca, BMS, Lilly, Novartis, Genomic Health and Nanostring; Non-remunerated activity/ies, Third-party writing assistance: F. Hoffmann-La Roche Ltd. P. Auvinen: Non-remunerated activity/ies, Third-party writing assistance. Funding for ESMO Breast Cancer Congress 2019: F. Hoffmann-La Roche Ltd. C. Pulido: Speaker Bureau/Expert testimony, Public speaking: AstraZeneca, Grunenthal and Novartis; Non-remunerated activity/ies, Third-party writing assistance: F. Hoffmann-La Roche Ltd; Non-remunerated activity/ies, Writing engagements: AstraZeneca. A. Cvetanovic: Non-remunerated activity/ies, Third-party writing assistance: F. Hoffmann-La Roche Ltd. S. Wilks: Advisory/Consultancy: Seattle Genetics; Non-remunerated activity/ies, Third-party writing assistance: F. Hoffmann-La Roche Ltd. L. Ribeiro: Advisory/Consultancy, Speaker Bureau/Expert testimony: Roche Pharmaceuticals, Merck Serono, MSD, BMS, AstraZeneca and Pfizer; Non-remunerated activity/ies, Personal medical education and participation in congresses: BMS, Roche Pharmaceuticals, Merck Serono, Pfizer, Amgen and Pierre Fabre; Non-remunerated activity/ies, Third-party writing assistance: F. Hoffmann-La Roche Ltd. M. Burotto: Advisory/Consultancy, Speaker Bureau/Expert testimony, Speaking at industry symposiums: F. Hoffmann-La Roche Ltd, MSD, BMS, AstraZeneca and Novartis; Non-remunerated activity/ies, Third-party writing assistance: F. Hoffmann-La Roche Ltd. D. Klingbiel: Shareholder/Stockholder/Stock options, Full/Part-time employment, Non-remunerated activity/ies, Third-party writing assistance: F. Hoffmann-La Roche Ltd. D. Messeri: Full/Part-time employment, Non-remunerated activity/ies, Third-party writing assistance: F. Hoffmann-La Roche Ltd. A. Alexandrou: Shareholder/Stockholder/Stock options, Non-remunerated activity/ies, Third-party writing assistance: F. Hoffmann-La Roche Ltd; Full/Part-time employment: Roche Products Limited. P. Trask: Non-remunerated activity/ies, Third-party writing assistance: F. Hoffmann-La Roche Ltd; Shareholder/Stockholder/Stock options, Full/Part-time employment: Genentech, Inc.. J. Fredriksson: Full/Part-time employment, Non-remunerated activity/ies, Third-party writing assistance: F. Hoffmann-La Roche Ltd. Z. Machackova: Shareholder/Stockholder/Stock options, Full/Part-time employment, Non-remunerated activity/ies, Third-party writing assistance: F. Hoffmann-La Roche Ltd. L. Stamatovic: Honoraria (self), Speaker: AstraZeneca, Novartis, Pfizer and F. Hoffmann-La Roche Ltd; Non-remunerated activity/ies, Third-party writing assistance: F. Hoffmann-La Roche Ltd.