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 session

80O - Patient (pt) preference and satisfaction with the subcutaneous fixed-dose combination of pertuzumab (P) and trastuzumab (H) in pts with HER2-positive early breast cancer (HER2+ eBC): Interim analysis of the open-label, randomised cross-over PHranceSCa study

Date

23 May 2020

Session

Mini Oral session

Presenters

Joyce O'Shaughnessy

Citation

Annals of Oncology (2020) 31 (suppl_2): S42-S47. 10.1016/annonc/annonc118

Authors

J. O'Shaughnessy1, S.P. Sousa2, J. Cruz3, L.J. Fallowfield4, P. Auvinen5, C. Pulido6, A. Cvetanovic7, S. Wilks8, L. Ribeiro9, M. Burotto10, D. Klingbiel11, D. Messeri11, A. Alexandrou12, P. Trask13, J. Fredriksson11, L. Stamatovic14

Author affiliations

  • 1 Baylor University Medical Center, Texas Oncology, US Oncology, TX 75246 - Dallas, Texas/US
  • 2 Department Of Medical Oncology, Portuguese Oncology Institute of Porto, Porto/PT
  • 3 Hospital Universitario De Canarias, La Laguna, Medical Oncology, Santa Cruz de Tenerife, Tenerife/ES
  • 4 Brighton And Sussex Medical School, Sussex Health Outcomes Research & Education in Cancer, Falmer/GB
  • 5 Cancer Center, Kuopio University Hospital, Kuopio/FI
  • 6 Centro De Oncologia, Hospital Da Luz Lisboa, Lisbon/PT
  • 7 Medical Faculty, Nis and Clinical Centre, Nis/RS
  • 8 Texas Oncology, San Antonio, Texas/US
  • 9 Centro Hospitalar Universitário Lisboa Norte, Hospital Santa Maria (CHULN/HSM), Lisbon/PT
  • 10 Bradford Hill, Clinical Research Center, Santiago/CL
  • 11 F. Hoffman-la Roche Ltd, Global Product Development, Basel/CH
  • 12 Roche Products Ltd, Product Development Safety, Welwyn Garden City/GB
  • 13 Genentech Inc, Patient Centered Outcomes Research - Oncology, San Francisco, California/US
  • 14 Clinic For Medical Oncology, Institute for Oncology and Radiology of Serbia, Belgrade/RS
More

Resources

Login to access the resources on OncologyPRO.

Abstract 80O

Background

A subcutaneous fixed-dose combination of P + H (PH FDC SC) may offer pts less invasive, faster administration vs intravenous P + H (PH IV). PHranceSCa is an open-label, randomised cross-over study evaluating pt preference and satisfaction with PH FDC SC vs PH IV.

Methods

Pts with histologically confirmed, HER2+ eBC who completed neoadjuvant therapy with P + H + chemotherapy and had surgery are enrolled and 1:1 randomised to Group A: 3 cycles of PH IV every 3 weeks (q3w) (P: 840 mg loading dose, 420 mg maintenance; H: 8 mg/kg loading; 6 mg/kg maintenance) then 3 cycles of PH FDC SC q3w (loading: 1200 mg P, 600 mg H; maintenance: 600 mg P, 600 mg H); or Group B: 3 cycles of PH FDC SC q3w then 3 cycles of PH IV q3w. Pts then choose PH FDC SC or PH IV to complete anti-HER2 therapy (up to 18 cycles). The primary objective is to evaluate patient preference for PH FDC SC.

Results

At clinical cut-off (19-08-19), 118 patients were randomised (Group A, n = 56; Group B, n = 62). All were female; median age was 49 years. 42/51 pts (82%; 95% CI 69–92%) who completed the cross-over therapy preferred PH FDC SC. Main reasons for PH FDC SC preference were “less time in clinic” (n = 38) and “more comfortable therapy administration” (n = 22). 46/51 (90%) pts were “very satisfied” or “satisfied” with PH FDC SC vs 34/51 (67%) with PH IV. 84% pts chose PH FDC SC to complete their therapy. 81/116 pts had ≥1 adverse event (AE), 1 had a serious AE (PH IV; pyrexia) and 5 had a Grade 3 AE (PH FDC SC, n = 3: ejection fraction [EF] decrease, diarrhoea, device-related infection; PH IV, n = 2: EF decrease, lymphopenia); there were no deaths and no AEs led to study discontinuation. 16/116 (13.8%) pts had diarrhoea, mainly low grade. Systemic administration-related reaction rates were 2/116 (1.7%) for PH FDC SC and 3/116 (2.6%) for PH IV. 21/116 (18.1%) pts had local injection site reactions; there were no local infusion-related reactions.

Conclusions

In the PHranceSCa interim analysis, 82% (95% CI 69–92%) of pts preferred PH FDC SC. PH FDC SC was generally well tolerated; the safety profile was consistent with PH IV and no new safety signals were seen.

Clinical trial identification

NCT03674112.

Editorial acknowledgement

Support for third-party writing assistance for this manuscript, furnished by Rachel Johnson, PhD, of Health Interactions, was provided by F. Hoffman-La Roche Ltd.

Legal entity responsible for the study

F. Hoffman-La Roche.

Funding

F. Hoffman-La Roche.

Disclosure

J. O'Shaughnessy: Honoraria (self), Advisory/Consultancy: AbbVie; Honoraria (self), Advisory/Consultancy: Agendia; Honoraria (self), Advisory/Consultancy: Amgen Biotechnology; Honoraria (self), Advisory/Consultancy: AstraZeneca; Honoraria (self), Advisory/Consultancy: Bristol-Myers Squibb; Honoraria (self), Advisory/Consultancy: Celgene Corporation; Honoraria (self), Advisory/Consultancy: Eisai; Honoraria (self), Advisory/Consultancy: Genentech; Honoraria (self), Advisory/Consultancy: Genomic Health; Honoraria (self), Advisory/Consultancy: GRAIL; Honoraria (self), Advisory/Consultancy: Immunomedics; Honoraria (self), Advisory/Consultancy: Heron Therapeutics; Honoraria (self), Advisory/Consultancy: Ipsen Biopharmaceuticals; Honoraria (self), Advisory/Consultancy: Jounce Therapeutics; Honoraria (self), Advisory/Consultancy: Lilly; Honoraria (self), Advisory/Consultancy: Merck; Honoraria (self), Advisory/Consultancy: Myriad; Honoraria (self), Advisory/Consultancy: Novartis; Honoraria (self), Advisory/Consultancy: Ondonate Therapeutics; Honoraria (self), Advisory/Consultancy: Pfizer; Honoraria (self), Advisory/Consultancy: Puma Biotechnology; Honoraria (self), Advisory/Consultancy: Prime Oncology; Honoraria (self), Advisory/Consultancy: Seattle Genetics; Honoraria (self), Advisory/Consultancy: Syndax Pharmaceuticals; Honoraria (self), Advisory/Consultancy: Takeda; Honoraria (self), Advisory/Consultancy, Non-remunerated activity/ies, Support for third-party writing assistance for this manuscript, furnished by Rachel Johnson, PhD, of Health Interactions, was provided by F. Hoffman-La Roche Ltd. S.P. Sousa: Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Novartis; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Pfizer; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Tesaro; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: AstraZeneca/MSD; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Pierre Fabre; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Eisai; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses, Non-remunerated activity/ies, Support for third-party writing assistance for this manuscript, furnished by Rachel Johnson, PhD, of Health Interactions, was provided by F. Hoffman-La Roche Ltd. J. Cruz: Honoraria (self), Advisory/Consultancy: Glaxo; Honoraria (self), Advisory/Consultancy: AstraZeneca; Honoraria (self), Advisory/Consultancy: Novartis; Honoraria (self), Advisory/Consultancy: PharmaMar; Honoraria (self), Advisory/Consultancy: Eisai; Honoraria (self), Advisory/Consultancy: Lilly; Honoraria (self), Advisory/Consultancy: Celgene; Honoraria (self), Advisory/Consultancy: Astellas; Honoraria (self), Advisory/Consultancy: Amgen; Honoraria (self), Advisory/Consultancy: Pfizer; Honoraria (self), Advisory/Consultancy, Non-remunerated activity/ies, Support for third-party writing assistance for this manuscript, furnished by Rachel Johnson, PhD, of Health Interactions, was provided by F. Hoffman-La Roche Ltd. L.J. Fallowfield: Honoraria (self): Pfizer; Honoraria (self): AstraZeneca; Honoraria (self): BMS; Honoraria (self): Lilly; Honoraria (self): Novartis; Honoraria (self): Genomic Health; Honoraria (self): NanoString; Non-remunerated activity/ies, Support for third-party writing assistance for this manuscript, furnished by Rachel Johnson, PhD, of Health Interactions, was provided by F. Hoffman-La Roche Ltd. P. Auvinen: Non-remunerated activity/ies, Support for third-party writing assistance for this manuscript, furnished by Rachel Johnson, PhD, of Health Interactions, was provided by F. Hoffman-La Roche Ltd. C. Pulido: Non-remunerated activity/ies, Support for third-party writing assistance for this manuscript, furnished by Rachel Johnson, PhD, of Health Interactions, was provided by F. Hoffman-La Roche Ltd. A. Cvetanovic: Non-remunerated activity/ies, Support for third-party writing assistance for this manuscript, furnished by Rachel Johnson, PhD, of Health Interactions, was provided by F. Hoffman-La Roche Ltd. S. Wilks: Non-remunerated activity/ies, Support for third-party writing assistance for this manuscript, furnished by Rachel Johnson, PhD, of Health Interactions, was provided by F. Hoffman-La Roche Ltd. L. Ribeiro: Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Pfizer; Honoraria (self), Advisory/Consultancy: AstraZeneca; Honoraria (self), Advisory/Consultancy, Personal Education: Bristol-Myers Squibb; Honoraria (self), Advisory/Consultancy: MSD; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Merck Serono; Travel/Accommodation/Expenses: Amgen; Travel/Accommodation/Expenses: Pierre Fabre; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses, Non-remunerated activity/ies, Support for third-party writing assistance for this manuscript, furnished by Rachel Johnson, PhD, of Health Interactions, was provided by F. Hoffman-La Roche Ltd. M. Burotto: Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: MSD; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: BMS; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: AstraZeneca; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: Novartis; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Non-remunerated activity/ies, Support for third-party writing assistance for this manuscript, furnished by Rachel Johnson, PhD, of Health Interactions, was provided by F. Hoffman-La Roche Ltd. D. Klingbiel: Shareholder/Stockholder/Stock options, Full/Part-time employment, Non-remunerated activity/ies, Support for third-party writing assistance for this manuscript, furnished by Rachel Johnson, PhD, of Health Interactions, was provided by F. Hoffman-La Roche Ltd. D. Messeri: Full/Part-time employment, Non-remunerated activity/ies, Support for third-party writing assistance for this manuscript, furnished by Rachel Johnson, PhD, of Health Interactions, was provided by F. Hoffman-La Roche Ltd. A. Alexandrou: Shareholder/Stockholder/Stock options: Pfizer; Full/Part-time employment, Non-remunerated activity/ies, Support for third-party writing assistance for this manuscript, furnished by Rachel Johnson, PhD, of Health Interactions, was provided by F. Hoffman-La Roche Ltd. P. Trask: Shareholder/Stockholder/Stock options, Full/Part-time employment: Genentech Inc; Non-remunerated activity/ies, Support for third-party writing assistance for this manuscript, furnished by Rachel Johnson, PhD, of Health Interactions, was provided by F. Hoffman-La Roche Ltd. J. Fredriksson: Shareholder/Stockholder/Stock options, Full/Part-time employment, Non-remunerated activity/ies, Support for third-party writing assistance for this manuscript, furnished by Rachel Johnson, PhD, of Health Interactions, was provided by F. Hoffman-La Roche Ltd. L. Stamatovic: Non-remunerated activity/ies, Support for third-party writing assistance for this manuscript, furnished by Rachel Johnson, PhD, of Health Interactions, was provided by F. Hoffman-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