Efficacy and safety of subcutaneous trastuzumab and intravenous trastuzumab as part of adjuvant therapy for HER2-positive early breast cancer: Final analysis of the randomised, two-cohort PrefHer study
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Efficacy and safety of subcutaneous trastuzumab and intravenous trastuzumab as part of adjuvant therapy for HER2-positive early breast cancer: Final analysis of the randomised, two-cohort PrefHer study. / Pivot, X; Verma, S; Fallowfield, L; Müller, V; Lichinitser, M; Jenkins, V; Sánchez Muñoz, A; Machackova, Z; Osborne, S; Gligorov, J; PrefHer Study Group.
In: EUR J CANCER, Vol. 86, 11.2017, p. 82-90.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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TY - JOUR
T1 - Efficacy and safety of subcutaneous trastuzumab and intravenous trastuzumab as part of adjuvant therapy for HER2-positive early breast cancer: Final analysis of the randomised, two-cohort PrefHer study
AU - Pivot, X
AU - Verma, S
AU - Fallowfield, L
AU - Müller, V
AU - Lichinitser, M
AU - Jenkins, V
AU - Sánchez Muñoz, A
AU - Machackova, Z
AU - Osborne, S
AU - Gligorov, J
AU - PrefHer Study Group
N1 - Copyright © 2017 Elsevier Ltd. All rights reserved.
PY - 2017/11
Y1 - 2017/11
N2 - AIM: To assess efficacy (event-free survival, EFS) and safety in patients followed up for 3 years in the PrefHer study (NCT01401166).PATIENTS AND METHODS: Post surgery and post chemotherapy in the (neo)adjuvant setting, patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer were randomised to receive four cycles of the subcutaneous form of trastuzumab (Herceptin®SC [H SC] via single-use injection device [Cohort 1] or delivery via a hand-held syringe from an SC Vial [Cohort 2]; 600 mg fixed dose) followed by four of the intravenous form of trastuzumab (Herceptin®[H IV]; 8 mg/kg loading, 6 mg/kg maintenance doses) in the adjuvant setting or vice versa every 3 weeks. Patients could have received H before randomisation. H was then continued to complete a total of 18 cycles, including any cycles received before randomisation.RESULTS: A total of 488 patients were randomised across both cohorts. After median follow-up of 36.1 months, 3-year EFS across both groups in the evaluable intention-to-treat population (467 patients) was 90.6% overall, 89.9% in Cohort 1, and 91.1% in Cohort 2. No new safety signals were identified during long-term follow-up, with only one cardiac serious adverse event in the safety population (483 patients).CONCLUSIONS: Three-year EFS data following H SC and H IV treatment are consistent with those reported by previous trials for H in the adjuvant setting. The overall safety profile during adjuvant treatment was as expected.
AB - AIM: To assess efficacy (event-free survival, EFS) and safety in patients followed up for 3 years in the PrefHer study (NCT01401166).PATIENTS AND METHODS: Post surgery and post chemotherapy in the (neo)adjuvant setting, patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer were randomised to receive four cycles of the subcutaneous form of trastuzumab (Herceptin®SC [H SC] via single-use injection device [Cohort 1] or delivery via a hand-held syringe from an SC Vial [Cohort 2]; 600 mg fixed dose) followed by four of the intravenous form of trastuzumab (Herceptin®[H IV]; 8 mg/kg loading, 6 mg/kg maintenance doses) in the adjuvant setting or vice versa every 3 weeks. Patients could have received H before randomisation. H was then continued to complete a total of 18 cycles, including any cycles received before randomisation.RESULTS: A total of 488 patients were randomised across both cohorts. After median follow-up of 36.1 months, 3-year EFS across both groups in the evaluable intention-to-treat population (467 patients) was 90.6% overall, 89.9% in Cohort 1, and 91.1% in Cohort 2. No new safety signals were identified during long-term follow-up, with only one cardiac serious adverse event in the safety population (483 patients).CONCLUSIONS: Three-year EFS data following H SC and H IV treatment are consistent with those reported by previous trials for H in the adjuvant setting. The overall safety profile during adjuvant treatment was as expected.
KW - Adult
KW - Aged
KW - Aged, 80 and over
KW - Antineoplastic Agents, Immunological
KW - Breast Neoplasms
KW - Chemotherapy, Adjuvant
KW - Disease-Free Survival
KW - Drug Administration Schedule
KW - Female
KW - Humans
KW - Injections, Intravenous
KW - Injections, Subcutaneous
KW - Kaplan-Meier Estimate
KW - Middle Aged
KW - Neoadjuvant Therapy
KW - Protein Kinase Inhibitors
KW - Receptor, ErbB-2
KW - Time Factors
KW - Trastuzumab
KW - Treatment Outcome
KW - Journal Article
KW - Multicenter Study
KW - Randomized Controlled Trial
KW - Research Support, Non-U.S. Gov't
U2 - 10.1016/j.ejca.2017.08.019
DO - 10.1016/j.ejca.2017.08.019
M3 - SCORING: Journal article
C2 - 28963915
VL - 86
SP - 82
EP - 90
JO - EUR J CANCER
JF - EUR J CANCER
SN - 0959-8049
ER -