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.