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

J. Gligorov, B. Ataseven, M. Verrill, M. De Laurentiis, K. H. Jung, H. A. Azim, N. Al-Sakaff, S. Lauer, M. Shing, X. Pivot, SafeHer Study Group, Francesco Cognetti

Research output: Contribution to journalArticle

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Abstract

AIM: To assess the safety and tolerability of adjuvant subcutaneous trastuzumab (Herceptin(R) 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 /= 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.
Original languageEnglish
Pages (from-to)237-246
JournalEuropean Journal of Cancer
Volume82
DOIs
Publication statusPublished - Jun 15 2017

Fingerprint

Breast Neoplasms
Safety
Drug Therapy
Therapeutics
human ERBB2 protein
Trastuzumab
Syringes
Heart Failure
Hand
Research Personnel
Equipment and Supplies
Injections

Keywords

  • Adjuvant
  • Breast cancer
  • HER2/neu
  • Herceptin
  • Subcutaneous
  • Trastuzumab

Cite this

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.; Laurentiis, M. De; Jung, K. H.; Azim, H. A.; Al-Sakaff, N.; Lauer, S.; Shing, M.; Pivot, X.; Group, SafeHer Study; Cognetti, Francesco.

In: European Journal of Cancer, Vol. 82, 15.06.2017, p. 237-246.

Research output: Contribution to journalArticle

Gligorov, J. ; Ataseven, B. ; Verrill, M. ; Laurentiis, M. De ; Jung, K. H. ; Azim, H. A. ; Al-Sakaff, N. ; Lauer, S. ; Shing, M. ; Pivot, X. ; Group, SafeHer Study ; Cognetti, Francesco. / 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. In: European Journal of Cancer. 2017 ; Vol. 82. pp. 237-246.
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abstract = "AIM: To assess the safety and tolerability of adjuvant subcutaneous trastuzumab (Herceptin(R) 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 /= 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.",
keywords = "Adjuvant, Breast cancer, HER2/neu, Herceptin, Subcutaneous, Trastuzumab",
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T1 - 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

AU - Gligorov, J.

AU - Ataseven, B.

AU - Verrill, M.

AU - Laurentiis, M. De

AU - Jung, K. H.

AU - Azim, H. A.

AU - Al-Sakaff, N.

AU - Lauer, S.

AU - Shing, M.

AU - Pivot, X.

AU - Group, SafeHer Study

AU - Cognetti, Francesco

N1 - LR: 20170619; CI: Copyright (c) 2017; JID: 9005373; OTO: NOTNLM; 2016/11/16 [received]; 2017/02/14 [revised]; 2017/05/04 [accepted]; aheadofprint

PY - 2017/6/15

Y1 - 2017/6/15

N2 - AIM: To assess the safety and tolerability of adjuvant subcutaneous trastuzumab (Herceptin(R) 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 /= 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(R) 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 /= 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 - Adjuvant

KW - Breast cancer

KW - HER2/neu

KW - Herceptin

KW - Subcutaneous

KW - Trastuzumab

U2 - S0959-8049(17)30961-9 [pii]

DO - S0959-8049(17)30961-9 [pii]

M3 - Article

VL - 82

SP - 237

EP - 246

JO - European Journal of Cancer

JF - European Journal of Cancer

SN - 0959-8049

ER -