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E-Poster Display

223P - Safety and tolerability of subcutaneous trastuzumab (H SC) self-administered at home via single-use injection device (SID) in patients (pts) with HER2-positive early breast cancer (EBC): Primary and final analysis of the open-label, phase IIIB HOMERUS study

Date

17 Sep 2020

Session

E-Poster Display

Presenters

Albert ten Tije

Citation

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

Authors

A.J. ten Tije1, S. van Steenis2, J. Briers2, E.M.P. Elsten1

Author affiliations

  • 1 Department Of Medical Oncology, Amphia Hospital, 4818 CK - Breda/NL
  • 2 Medical Affairs, Roche Netherlands B.V., Woerden/NL
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Resources

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.

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