63P - Phase III SafeHer study subgroup analyses: Safety and tolerability of subcutaneous trastuzumab for HER2-positive early breast cancer in patients wi...

Date 20 December 2015
Event ESMO Asia 2015 Congress
Session Poster presentation 2
Topics Anticancer Agents
Breast Cancer
Biological Therapy
Presenter Mona Shing
Citation Annals of Oncology (2015) 26 (suppl_9): 16-33. 10.1093/annonc/mdv519
Authors K.H. Jung1, B. Ataseven2, M. Verrill3, M. De Laurentiis4, H.A. Azim5, X. Pivot6, N. Al-Sakaff7, S. Lauer8, M. Shing9, J. Gligorov10
  • 1Asan Medical Center, University of Ulsan College of Medicine, 138-736 - Seoul/KR
  • 2Department Of Obstetrics And Gynaecology, Kliniken Essen-Mitte, 45136 - Essen/DE
  • 3Medical Oncology Department, Northern Centre for Cancer Care, NE7 7DN - Newcastle upon Tyne/GB
  • 4Breast Oncology Department, National Cancer Institute “Fondazione Pascale”, Naples/IT
  • 5Clinical Oncology Department, Cairo University, Cairo/EG
  • 6Chemotherapy - Oncology, CHU Jean Minjoz, 25030 - BesanÃÂon/FR
  • 7Global Pharma Development, F. Hoffmann-La Roche Ltd., CH-4070 - Basel/CH
  • 8Biostatistics, F. Hoffmann-La Roche Ltd., CH-4070 - Basel/CH
  • 9Global Pharma Development, Genentech Inc., 94080 - San Francisco/US
  • 10Aphp Hôpital Tenon And Upmc, Institut Universitaire de Cancérologie, Université Paris-Sorbonne, 75020 - Paris/FR



To explore safety and tolerability of 600 mg fixed-dose subcutaneous (SC) trastuzumab (Herceptin® SC [H SC]), administered every 3 weeks (q3w) for 18 cycles via hand-held syringe, as adjuvant therapy for HER2-positive early breast cancer (EBC) in patients (pts) with lower body weight and in Asian pts in Cohort A of the SafeHer study. Pts in Cohort B receive H SC via single-use injection device and treatment was ongoing at the time of clinical cutoff.


Adverse events (AEs) and serious AEs (SAEs) were recorded/graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) 4.0; congestive heart failure (CHF), according to NCI-CTCAE 4.0/New York Heart Association functional classification. Lower-weight subgroups were pts weighing <45 kg, ≤53 kg (lowest weight decile) and ≤59 kg (lowest weight quartile). Results are from a planned interim analysis; follow-up will continue for 5 years.


SafeHer interim results are from the first dose until 4 weeks after the last H SC dose (13 months' follow-up for pts who received 18 H SC cycles). Cohort A's safety population comprises 1864 pts; 1563 (84%) received 18 H SC cycles and 295 (16%) are Asian. Among the 31 pts weighing <45 kg, the 226 pts weighing ≤53 kg and the 501 pts weighing ≤59 kg, there was a greater proportion of Asian pts compared with the overall population (55%, 43% and 34%, respectively, compared with 16%). Overall safety, safety in lower-weight groups and safety in Asian pts are shown in the table.

Pts, n (%) Cohort A overall n = 1864 <45 kg n = 31 Lowest weight decile: ≤53 kg n = 226 Lowest weight quartile: ≤59 kg n = 501 Asian pts n = 295
Any grade AE 1628 (87) 27 (87) 197 (87) 428 (85) 254 (86)
≥grade 3 AE 432 (23) 8 (26) 40 (18) 89 (18) 48 (16)
SAE 235 (13) 3 (10) 25 (11) 51 (10) 33 (11)
Cardiac AE 310 (17) 5 (16) 24 (11) 58 (12) 38 (13)
CHF 10 (1) 0 2 (1) 4 (1) 4 (1)


In this SafeHer Phase III study subgroup analysis, the safety results were similar for the H SC 600 mg q3w fixed dose among lower-weight and Asian pts, relative to the overall population. Thus, safety and tolerability of the H SC 600 mg q3w fixed dose is confirmed as adjuvant therapy for these important HER2-positive EBC pt populations.

Clinical trial identification



M. Shing: Other Substantive Relationships - Genentech employee. K.H. Jung: Corporate-sponsored Research - Eisai Korea. B. Ataseven, H.A. Azim, J. Gligorov: Advisory Board - Roche; Corporate-sponsored Research – Roche. M. Verrill: Advisory Board ‐ Fees from Roche; Corporate‐sponsored Research ‐ Institutional funding from Roche; Other Substanstve Relationships ‐ Fees from speaking for Roche. M. De Laurentiis: Advisory Board - Novartis, Roche, Celgene, AstraZeneca, Genomic Health. N. Al-Sakaff: Ownership - Roche shares; Other Substantive Relationships - Roche employee. S. Lauer: Other Substantive Relationships - Roche contractor. All other authors have declared no conflicts of interest.