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 sessionZUMA-3: A phase 1/2 multi-center study evaluation the safety and efficacy of KTE-C19 anti-CD19 CAR T cells in adult patients with relapsed/refractory B precursor acute lymphoblastic leukemia (R/R ALL)Presenter: Bijal Shah Session: Poster display Resources: Abstract ZUMA-2: A phase 2 multi-center study evaluating the efficacy of KTE-C19 (Anti-CD19 CAR T cells) in patients with relapsed/refractory Mantle cell lymphoma (R/R MCL)Presenter: Michael Wang Session: Poster Display Resources: Abstract ZUMA-1: A phase 2 multi-center study evaluating anti-CD19 chimeric antigen receptor (CAR) T cells in patients with refractory aggressive non-Hodgkin lymphoma (NHL)Presenter: Sattva Neelapu Session: Poster Display Resources: Abstract Younger age as a prognostic indicator in breast cancer: Correlation between clinical-pathologic factors and miRNAs and long-term follow-upPresenter: Maria Teresa Martinez Session: Poster display Resources: Abstract Window study of the PARP inhibitor rucaparib in patients with primary triple negative or BRCA1/2 related breast cancer (RIO)Presenter: Christy Toms Session: Poster display Resources: Abstract Whole exome sequencing (WES) and RNA sequencing (RNA-seq) in routine clinical practice for colorectal cancer (CRC) and non-small cell lung cancer (NSCLC) patients (pts)Presenter: Géraldine Perkins Session: Poster display Resources: Abstract What is the optimal annual interpretive volume for a radiologist reading screening mammograms?Presenter: Asli Uluturk Session: Poster display Resources: Abstract What decides breast conservation versus mastectomy in the background of diverse sociocultural environment, an Indian studyPresenter: Poonamalle Padmanabhan Bapsy Session: Poster display Resources: Abstract Waiting time to diagnosis and treatment of the head and neck cancer in four institutions in PortugalPresenter: Ana Castro Session: Poster display Resources: Abstract Wait times for diagnosis and treatment of lung cancer: a single centre experiencePresenter: Catherine Labbe 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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