Abstract 223P
Background
HOMERUS (NCT02040935) assessed safety and tolerability of H SC monotherapy; self-administered at home by trained healthcare professionals (HCPs; or the trained pt under supervision, if the pt was deemed competent) via SID, in pts with HER2-positive EBC.
Methods
Pts were ≥18 years, had ECOG 0/1, acceptable LVEF and completed surgery and chemotherapy (if applicable). H SC (600 mg fixed dose) was given via SID into the thigh over ∼5 minutes for 3 cycles (C) at hospital by an HCP, followed by up to 15 C via SID at home. After 3 C at home, pts chose to continue at home or return to the hospital. Primary objective: safety and tolerability. Short Form Health Survey (SF-36) and mood and anxiety questionnaire (MASQ) were given at C3 and C9. H trough concentrations (Ctrough) were assessed at C2, 3 and 9, and 10, 12 or 13. Analyses are descriptive and exploratory.
Results
125 pts were enrolled and assessed for safety. Treatment-emergent adverse events are shown in the table; 0 were of special interest or grade 4/5. Two deaths were reported, both due to disease recurrence and unrelated to H SC. Median SF-36 physical score improved by 4.4 points from C3 to C9. No effect on SF-36 mental scores or MASQ was seen. Most pts (≥96%) chose to continue home administration post-C6. Observed Ctrough was slightly higher than reported simulations (Quartino et al. Cancer Chemother Pharmacol 2016) but similar when adjusted for 19% lower estimated clearance, regardless of location. There was no difference in exposure between locations. Table: 223P
| Adverse events | Pts, n/125 (%) |
| Any | 121 (97) |
| Grade 3 | 23 (18) |
| Serious | 10 (8) |
| Related | 84 (67) |
| Leading to dose delay/interruption | 20 (16) |
| Leading to discontinuation | 9 (7) |
| Selected | |
| - Suspected cardiac origin | 35 (28) |
| - LVEF decrease | 14 (11) |
| - SID complaint | 28 (22) |
| Unresolved | 79 (63) |
Conclusions
H SC administered by SID in the hospital followed by home administration was well tolerated, with findings in line with the known H safety profile. No new safety signals or problems with multiple home administrations were identified, and most pts chose continued home administration. H exposure was comparable in each setting.
Clinical trial identification
NCT02040935.
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. We would like to thank Dr Jeske Timmermans-van Boxtel of Roche Netherlands B.V. for protocol writing.
Legal entity responsible for the study
Roche Nederland B.V., Woerden, Netherlands.
Funding
Roche Nederland B.V., Woerden, Netherlands.
Disclosure
A.J. ten Tije: Honoraria (self): Roche Nederland B.V.; Research grant / Funding (institution): Roche Nederland B.V.; Travel / Accommodation / Expenses: Roche Nederland B.V.; Non-remunerated activity/ies, Support for third-party writing assistance for this abstract: F. Hoffmann-La Roche Ltd. S. van Steenis: Non-remunerated activity/ies, Support for third-party writing assistance for this abstract: F. Hoffmann-La Roche Ltd; Full/Part-time employment: Roche Nederland B.V. J. Briers: Non-remunerated activity/ies, Support for third-party writing assistance for this abstract: F. Hoffmann-La Roche Ltd; Full/Part-time employment: Roche Nederland B.V.; Shareholder/Stockholder/Stock options: F.Hoffmann-La Roche Ltd. E.M.P. Elsten: Non-remunerated activity/ies, Support for third-party writing assistance for this abstract: F. Hoffmann-La Roche Ltd.