Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

Mini Oral - Breast cancer, early stage

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

Date

18 Sep 2020

Session

Mini Oral - Breast cancer, early stage

Presenters

Joyce O'Shaughnessy

Citation

Annals of Oncology (2020) 31 (suppl_4): S303-S339. 10.1016/annonc/annonc267

Authors

J. O'Shaughnessy1, S. Sousa2, J. Cruz3, L. Fallowfield4, P. Auvinen5, C. Pulido6, A. Cvetanovic7, S. Wilks8, L. Ribeiro9, M. Burotto10, D. Klingbiel11, D. Messeri12, A. Alexandrou13, P. Trask14, J. Fredriksson15, Z. Machackova15, L. Stamatovic16

Author affiliations

  • 1 Baylor University Medical Center, Texas Oncology, US Oncology, 75246 - Dallas/US
  • 2 Department Of Medical Oncology, Portuguese Oncology Institute of Porto, NA - Porto/PT
  • 3 Department Of Medical Oncology, Hospital Universitario de Canarias, NA - La Laguna, S/C Tenerife/ES
  • 4 Sussex Health Outcomes Research & Education In Cancer (shore-c), Brighton and Sussex Medical School, BN1 9PX - Falmer/GB
  • 5 Cancer Center, Kuopio University Hospital, NA - Kuopio/FI
  • 6 Centro De Oncologia, Hospital Da Luz Lisboa, NA - Lisbon/PT
  • 7 Department Of Medical Oncology, Medical Faculty Nis and Clinical Centre Nis, NA - Nis/RS
  • 8 Department Of Hematology & Medical Oncology, Texas Oncology San Antonio, NA - San Antonio/US
  • 9 Centro Hospitalar Universitário Lisboa Norte, Hospital Santa Maria (CHULN/HSM), NA - Lisbon/PT
  • 10 Medical Oncology Department, Bradford Hill Clinical Research Center, 8420383 - Santiago/CL
  • 11 Pharma Development Biometrics, Biostatistics, F. Hoffmann-La Roche Ltd, NA - Basel/CH
  • 12 Pdg Clinical Operations Oncology, F. Hoffmann-La Roche Ltd, NA - Basel/CH
  • 13 Portfolio Clinical Safety And Product Development Safety, Roche Products Limited, NA - Welwyn Garden City/GB
  • 14 Patient Centered Outcomes Research, Oncology, Genentech, Inc., NA - South San Francisco/US
  • 15 Global Product Development/medical Affairs Oncology, F. Hoffmann-La Roche Ltd, NA - Basel/CH
  • 16 Clinic For Medical Oncology, Institute for Oncology and Radiology of Serbia, NA - Belgrade/RS
More

Resources

Login to access the resources on OncologyPRO.

Abstract 165MO

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

% of pts PH IV pooled crossover n=160 PH FDC SC pooled crossover n=160 PH IV pooled continuation n=21 PH FDC SC pooled continuation n=137 All pts n=160
AE 71 75 62 51 90
Common AEs (≥5% of pts)
- Radiation skin injury 17 11 0 1 28
- Injection site reaction 0 23 0 7 26
- Diarrhoea 10 8 19 10 22
- Fatigue 6 6 5 3 11
- Arthralgia 4 5 10 1 11
- Hot flush 4 6 0 2 10
- Headache 2 3 10 1 6
- Myalgia 3 2 10 0 6
- Rash 1 1 10 1 5
- Bone pain 0 0 10 0 1
AE with fatal outcome 0 0 0 0 0
Grade ≥3 AE 4 3 10 3 8
Serious AE 4 1 0 2 6
AE leading to any study tx discontinuation 0 1 5 0 1

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.

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings