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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

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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, Jahrgang 86, 11.2017, S. 82-90.

Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung

Harvard

Pivot, X, Verma, S, Fallowfield, L, Müller, V, Lichinitser, M, Jenkins, V, Sánchez Muñoz, A, Machackova, Z, Osborne, S, Gligorov, J & PrefHer Study Group 2017, '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', EUR J CANCER, Jg. 86, S. 82-90. https://doi.org/10.1016/j.ejca.2017.08.019

APA

Pivot, X., Verma, S., Fallowfield, L., Müller, V., Lichinitser, M., Jenkins, V., Sánchez Muñoz, A., Machackova, Z., Osborne, S., Gligorov, J., & PrefHer Study Group (2017). 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. EUR J CANCER, 86, 82-90. https://doi.org/10.1016/j.ejca.2017.08.019

Vancouver

Pivot X, Verma S, Fallowfield L, Müller V, Lichinitser M, Jenkins V et al. 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. EUR J CANCER. 2017 Nov;86:82-90. https://doi.org/10.1016/j.ejca.2017.08.019

Bibtex

@article{87e6b1d50b9e414c89b97f14f121bd4f,
title = "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",
abstract = "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{\textregistered}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{\textregistered}[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.",
keywords = "Adult, Aged, Aged, 80 and over, Antineoplastic Agents, Immunological, Breast Neoplasms, Chemotherapy, Adjuvant, Disease-Free Survival, Drug Administration Schedule, Female, Humans, Injections, Intravenous, Injections, Subcutaneous, Kaplan-Meier Estimate, Middle Aged, Neoadjuvant Therapy, Protein Kinase Inhibitors, Receptor, ErbB-2, Time Factors, Trastuzumab, Treatment Outcome, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't",
author = "X Pivot and S Verma and L Fallowfield and V M{\"u}ller and M Lichinitser and V Jenkins and {S{\'a}nchez Mu{\~n}oz}, A and Z Machackova and S Osborne and J Gligorov and {PrefHer Study Group}",
note = "Copyright {\textcopyright} 2017 Elsevier Ltd. All rights reserved.",
year = "2017",
month = nov,
doi = "10.1016/j.ejca.2017.08.019",
language = "English",
volume = "86",
pages = "82--90",
journal = "EUR J CANCER",
issn = "0959-8049",
publisher = "Elsevier Limited",

}

RIS

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 -