Safety and tolerability of subcutaneous trastuzumab for the adjuvant treatment of human epidermal growth factor receptor 2-positive early breast cancer
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Safety and tolerability of subcutaneous trastuzumab for the adjuvant treatment of human epidermal growth factor receptor 2-positive early breast cancer : SafeHer phase III study's primary analysis of 2573 patients. / Gligorov, J; Ataseven, B; Verrill, M; De Laurentiis, M; Jung, K H; Azim, H A; Al-Sakaff, N; Lauer, S; Shing, M; Pivot, X; SafeHer Study Group.
In: EUR J CANCER, Vol. 82, 09.2017, p. 237-246.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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TY - JOUR
T1 - Safety and tolerability of subcutaneous trastuzumab for the adjuvant treatment of human epidermal growth factor receptor 2-positive early breast cancer
T2 - SafeHer phase III study's primary analysis of 2573 patients
AU - Gligorov, J
AU - Ataseven, B
AU - Verrill, M
AU - De Laurentiis, M
AU - Jung, K H
AU - Azim, H A
AU - Al-Sakaff, N
AU - Lauer, S
AU - Shing, M
AU - Pivot, X
AU - SafeHer Study Group
AU - Muller , Volkmar
N1 - Copyright © 2017 Elsevier Ltd. All rights reserved.
PY - 2017/9
Y1 - 2017/9
N2 - AIM: To assess the safety and tolerability of adjuvant subcutaneous trastuzumab (Herceptin®SC, H SC), delivered from an H SC Vial via hand-held syringe (Cohort A) or single-use injection device (Cohort B), with or without chemotherapy, for human epidermal growth factor receptor 2 (HER2)-positive stage I to IIIC early breast cancer (EBC) in the phase III SafeHer study (NCT01566721).METHODS: Patients received 600 mg fixed-dose H SC every 3 weeks for 18 cycles. The chemotherapy partner was at the investigators' discretion (H SC monotherapy was limited to ≤10% of the population). Data from the first H SC dose until 28 days (plus a 5-day window) after the last dose are presented. Results are descriptive.RESULTS: In the overall population, 2282/2573 patients (88.7%) experienced adverse events (AEs). Of the above, 128 (5.0%) patients experienced AEs leading to study drug discontinuation; 596 (23.2%) experienced grade ≥ 3 AEs and 326 (12.7%) experienced serious AEs. Grade ≥ 3 cardiac disorders were reported in 24 patients (0.9%), including congestive heart failure in eight (0.3%). As expected, the AE rates varied according to the timing of chemotherapy in both cohorts, with higher rates in concurrent versus sequential chemotherapy subgroups. In the concurrent chemotherapy subgroup, AEs were more common during the actual period of concurrent chemotherapy compared with the period when patients did not receive concurrent chemotherapy.CONCLUSION: SafeHer confirms the safety and tolerability of the H SC 600 mg fixed dose for 1 year (every 3 weeks for 18 cycles) as adjuvant therapy with concurrent or sequential chemotherapy for HER2-positive EBC. These primary analysis results are consistent with the known safety profile for intravenous H and H SC.
AB - AIM: To assess the safety and tolerability of adjuvant subcutaneous trastuzumab (Herceptin®SC, H SC), delivered from an H SC Vial via hand-held syringe (Cohort A) or single-use injection device (Cohort B), with or without chemotherapy, for human epidermal growth factor receptor 2 (HER2)-positive stage I to IIIC early breast cancer (EBC) in the phase III SafeHer study (NCT01566721).METHODS: Patients received 600 mg fixed-dose H SC every 3 weeks for 18 cycles. The chemotherapy partner was at the investigators' discretion (H SC monotherapy was limited to ≤10% of the population). Data from the first H SC dose until 28 days (plus a 5-day window) after the last dose are presented. Results are descriptive.RESULTS: In the overall population, 2282/2573 patients (88.7%) experienced adverse events (AEs). Of the above, 128 (5.0%) patients experienced AEs leading to study drug discontinuation; 596 (23.2%) experienced grade ≥ 3 AEs and 326 (12.7%) experienced serious AEs. Grade ≥ 3 cardiac disorders were reported in 24 patients (0.9%), including congestive heart failure in eight (0.3%). As expected, the AE rates varied according to the timing of chemotherapy in both cohorts, with higher rates in concurrent versus sequential chemotherapy subgroups. In the concurrent chemotherapy subgroup, AEs were more common during the actual period of concurrent chemotherapy compared with the period when patients did not receive concurrent chemotherapy.CONCLUSION: SafeHer confirms the safety and tolerability of the H SC 600 mg fixed dose for 1 year (every 3 weeks for 18 cycles) as adjuvant therapy with concurrent or sequential chemotherapy for HER2-positive EBC. These primary analysis results are consistent with the known safety profile for intravenous H and H SC.
KW - Adult
KW - Aged
KW - Aged, 80 and over
KW - Antineoplastic Agents
KW - Breast Neoplasms
KW - Chemotherapy, Adjuvant
KW - Female
KW - Humans
KW - Injections, Subcutaneous
KW - Middle Aged
KW - Receptor, ErbB-2
KW - Survival Analysis
KW - Trastuzumab
KW - Young Adult
KW - Clinical Trial, Phase III
KW - Journal Article
KW - Multicenter Study
KW - Research Support, Non-U.S. Gov't
U2 - 10.1016/j.ejca.2017.05.010
DO - 10.1016/j.ejca.2017.05.010
M3 - SCORING: Journal article
C2 - 28625777
VL - 82
SP - 237
EP - 246
JO - EUR J CANCER
JF - EUR J CANCER
SN - 0959-8049
ER -
