Abstract 1338
Background
The Phase III, non-randomised, multinational, open-label SafeHer study (NCT01566721) confirmed the safety and tolerability profile of 600 mg fixed-dose subcutaneous trastuzumab (Herceptin® SC [H SC]), administered every 3 weeks (q3w) for 18 cycles/1 year from an H SC Vial via hand-held syringe or from a single-use injection device (SID), as adjuvant therapy for HER2-positive early breast cancer (Gligorov J, et al. EBCC 2016; P326). The safety and tolerability of H SC 600 mg fixed-dose therapy may be affected by patients' body weights and active medical conditions, especially in patients with lower body weights. We assessed these factors in an exploratory analysis of SafeHer.
Methods
Adverse events (AEs) and serious AEs (SAEs) were recorded/graded per National Cancer Institute – Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.0. Congestive heart failure (CHF) was assessed by NCI-CTCAE v4.0/New York Heart Association functional classification. Results are descriptive. Data are from the combined H SC Vial and H SC SID cohorts, from the first H SC dose until 28 days after the last dose (plus a 5-day window). SafeHer study follow-up will continue for 5 years.
Results
Safety and active medical conditions of interest by weight subgroup are shown in the table.
| Patients, n (%) | Overall N = 2573 | Very- low weight 59– ≤ 67 kg n = 641 | Quartile 3 >67– ≤ 77 kg n = 625 | Quartile 4 >77 kg n = 623 | |||
|---|---|---|---|---|---|---|---|
| Any grade AE | 2282 (89)1 | 36 (90) | 258 (88) | 590 (87) | 566 (88) | 558 (89) | 561 (90) |
| Grade ≥3 AE | 596 (23)1 | 8 (20) | 54 (18) | 121 (18) | 152 (24) | 155 (25) | 167 (27) |
| Cardiac disorder | 24 (1)1 | 0 | 3 (1) | 6 (1) | 5 (1) | 7 (1) | 6 (1) |
| CHF | 8 (ConclusionsIn this SafeHer subgroup analysis, the safety results were comparable for the H SC 600 mg q3w fixed dose among the lower-body-weight subgroups and the overall patient population. In the higher-body-weight subgroup, grade ≥3 AE and SAE rates were slightly higher than the overall patient population, which may be influenced by the higher rate of active medical conditions in the higher-body-weight subgroups; nevertheless, grade ≥3 and serious cardiac disorders remained comparable across all weight subgroups. Clinical trial identificationNCT01566721 Legal entity responsible for the studyF. Hoffmann-La Roche Ltd. FundingF. Hoffmann-La Roche Ltd. DisclosureB. Ataseven: Membership of an advisory board (Roche). Other substantive relationships (honorarium for lectures: Roche, AstraZeneca; Travel expenses support: Roche). M. Verrill: Stock ownership (Roche, Bayer); Membership of an advisory board (Roche, Celgene, AstraZeneca, Novartis, Pfizer, Teva, Chugai); Corporate-sponsored research (Roche, Novartis, Amgen). X. Pivot: Consultant with honorarium for Roche, Amgen, Novartis, Eisai, Pierre Fabre. M. De Laurentiis: Membership of an advisory board (Roche, Novartis, Celgene, Pfizer, Eisai). N. Al-Sakaff: Stock ownership (Roche). Employee of Roche. S. Lauer: Other substantive relationships (contract work for F. Hoffmann-La Roche). M. Shing: Other substantive relationships (Employee of Genentech, Inc.). J. Gligorov: Consultancy: Roche-Genentech; Eisai Honoraria: Teva; Novartis-GSK; GenomicHealth. H.A. Azim: Membership of an advisory board (Roche, Pfizer, Novartis & Amgen); Corporate-sponsored research (Bayer & Pfizer). All other authors have declared no conflicts of interest. Resources from the same session2354 - The clinicopathologic features and treatment of 607 hindgut neuroendocrine tumor (NET) patients at a single institutionPresenter: Seung Tae Kim Session: Poster Display Resources: Abstract 2594 - Neuroendocrine carcinomas of the colorectal origin - Polish experiencePresenter: Agnieszka Kolasińska-Ćwikła Session: Poster Display Resources: Abstract 2539 - Neuroendocrine neoplasms of the appendix including goblet cell carcinoidsPresenter: Agnieszka Kolasinska-Cwikla Session: Poster Display Resources: Abstract 1245 - Prognostic validity of AJCC staging system in neuroendocrine tumors of the appendixPresenter: Amir Mehrvarz Sarshekeh Session: Poster Display Resources: Abstract 3902 - Enhancer of zest homolog 2 (EZH2) expression in well and moderately differentiated pancreatic neuroendocrine tumor (pNET)Presenter: Riccardo Marconcini Session: Poster Display Resources: Abstract 3882 - Differential clinical and pathological characteristics of hereditary neuroendocrine pancreatic tumours (NEPT)Presenter: Gema Marín Zafra Session: Poster Display Resources: Abstract 2296 - Natural course of thyroid cancer nodules compared with benign thyroid nodulesPresenter: Kyung-Jin Yun Session: Poster Display Resources: Abstract 4083 - Reassessment of proliferative activity at disease progression in neuroendocrine neoplasmsPresenter: Noemi Cicchese Session: Poster Display Resources: Abstract 3866 - 18F-FDG-PET to predict disease progression in advanced digestive neuroendocrine neoplasmsPresenter: Maria Rinzivillo Session: Poster Display Resources: Abstract 3651 - UK phase IV, observational study to assess quality of life in patients (pts) with pancreatic neuroendocrine tumours (pNETS) receiving treatment with everolimus: The “real-world” OBLIQUE studyPresenter: John Ramage Session: Poster Display Resources: Abstract 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.
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