Safety profile of subcutaneous trastuzumab for the treatment of patients with HER2-positive early or locally advanced breast cancer

primary analysis of the SCHEARLY study

Milvia Zambetti, Filippo Montemurro, Paolo Morandi, Claudio Zamagni, Alba A Brandes, Giancarlo Bisagni, Katia Cagossi, Carmelo Bengala, Stefania Gori, Claudio Iannacone, Alessia Stell, Luca Gianni

Research output: Contribution to journalArticle

Abstract

BACKGROUND: Subcutaneous trastuzumab (H SC) is a valuable alternative to the intravenous formulation. This study assessed H SC safety and tolerability in human epidermal growth factor receptor 2 (HER2)+ early/locally advanced breast cancer (EBC/LABC).

METHODS: SCHEARLY is a prospective, two-cohort, non-randomised, multicentre Italian trial included in the umbrella study UmbHER1, planning a 1-year treatment with H SC 600 mg in HER2+ EBC/LABC. Patients were sequentially assigned to cohort A (N = 121) and B (N = 119) to receive H SC via a handheld syringe and a single-use injection device, respectively. Adjuvant or neoadjuvant treatment included anthracycline-containing regimens followed by H SC plus taxanes and then alone for 18 cycles totally.

RESULTS: Two hundred forty patients were enrolled (adjuvant therapy: 81.7%; neoadjuvant therapy: 18.3%), and 201 completed the treatment (early discontinuation was mainly due to intercurrent adverse events [AEs], 7.5%). Overall, the two cohorts displayed similar safety profiles. From H SC start, the rate of treatment-related AEs in the safety population (N = 228) was 3.9% for grade ≥3 AEs; 0.9% for serious AEs (one pleuropericarditis and one anaphylactic shock, both resolved) and 14.5% for cardiac AEs, the most common being the decreased left ventricular ejection fraction (7.9%; mean reduction from the screening to the follow-up visit was 2.9%). No cases of congestive heart failure occurred. The rate of systemic administration-related reactions and local injection site reactions was 68.0% and 21.9%, respectively, mostly of grade 1-2.

CONCLUSIONS: H SC 600 mg confirmed to be a safe and tolerable option as adjuvant/neoadjuvant therapy in patients with HER2+ EBC and LABC. CLINICALTRIALS.

GOV IDENTIFIER: NCT01940497.

Original languageEnglish
Pages (from-to)61-70
Number of pages10
JournalEuropean Journal of Cancer
Volume105
DOIs
Publication statusPublished - Dec 2018

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Neoadjuvant Therapy
Breast Neoplasms
Safety
Taxoids
Injections
Pericarditis
Anthracyclines
Syringes
Anaphylaxis
Therapeutics
Stroke Volume
Multicenter Studies
Heart Failure
Equipment and Supplies
human ERBB2 protein
Trastuzumab
Population

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Safety profile of subcutaneous trastuzumab for the treatment of patients with HER2-positive early or locally advanced breast cancer : primary analysis of the SCHEARLY study. / Zambetti, Milvia; Montemurro, Filippo; Morandi, Paolo; Zamagni, Claudio; Brandes, Alba A; Bisagni, Giancarlo; Cagossi, Katia; Bengala, Carmelo; Gori, Stefania; Iannacone, Claudio; Stell, Alessia; Gianni, Luca.

In: European Journal of Cancer, Vol. 105, 12.2018, p. 61-70.

Research output: Contribution to journalArticle

Zambetti, Milvia ; Montemurro, Filippo ; Morandi, Paolo ; Zamagni, Claudio ; Brandes, Alba A ; Bisagni, Giancarlo ; Cagossi, Katia ; Bengala, Carmelo ; Gori, Stefania ; Iannacone, Claudio ; Stell, Alessia ; Gianni, Luca. / Safety profile of subcutaneous trastuzumab for the treatment of patients with HER2-positive early or locally advanced breast cancer : primary analysis of the SCHEARLY study. In: European Journal of Cancer. 2018 ; Vol. 105. pp. 61-70.
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abstract = "BACKGROUND: Subcutaneous trastuzumab (H SC) is a valuable alternative to the intravenous formulation. This study assessed H SC safety and tolerability in human epidermal growth factor receptor 2 (HER2)+ early/locally advanced breast cancer (EBC/LABC).METHODS: SCHEARLY is a prospective, two-cohort, non-randomised, multicentre Italian trial included in the umbrella study UmbHER1, planning a 1-year treatment with H SC 600 mg in HER2+ EBC/LABC. Patients were sequentially assigned to cohort A (N = 121) and B (N = 119) to receive H SC via a handheld syringe and a single-use injection device, respectively. Adjuvant or neoadjuvant treatment included anthracycline-containing regimens followed by H SC plus taxanes and then alone for 18 cycles totally.RESULTS: Two hundred forty patients were enrolled (adjuvant therapy: 81.7{\%}; neoadjuvant therapy: 18.3{\%}), and 201 completed the treatment (early discontinuation was mainly due to intercurrent adverse events [AEs], 7.5{\%}). Overall, the two cohorts displayed similar safety profiles. From H SC start, the rate of treatment-related AEs in the safety population (N = 228) was 3.9{\%} for grade ≥3 AEs; 0.9{\%} for serious AEs (one pleuropericarditis and one anaphylactic shock, both resolved) and 14.5{\%} for cardiac AEs, the most common being the decreased left ventricular ejection fraction (7.9{\%}; mean reduction from the screening to the follow-up visit was 2.9{\%}). No cases of congestive heart failure occurred. The rate of systemic administration-related reactions and local injection site reactions was 68.0{\%} and 21.9{\%}, respectively, mostly of grade 1-2.CONCLUSIONS: H SC 600 mg confirmed to be a safe and tolerable option as adjuvant/neoadjuvant therapy in patients with HER2+ EBC and LABC. CLINICALTRIALS.GOV IDENTIFIER: NCT01940497.",
author = "Milvia Zambetti and Filippo Montemurro and Paolo Morandi and Claudio Zamagni and Brandes, {Alba A} and Giancarlo Bisagni and Katia Cagossi and Carmelo Bengala and Stefania Gori and Claudio Iannacone and Alessia Stell and Luca Gianni",
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TY - JOUR

T1 - Safety profile of subcutaneous trastuzumab for the treatment of patients with HER2-positive early or locally advanced breast cancer

T2 - primary analysis of the SCHEARLY study

AU - Zambetti, Milvia

AU - Montemurro, Filippo

AU - Morandi, Paolo

AU - Zamagni, Claudio

AU - Brandes, Alba A

AU - Bisagni, Giancarlo

AU - Cagossi, Katia

AU - Bengala, Carmelo

AU - Gori, Stefania

AU - Iannacone, Claudio

AU - Stell, Alessia

AU - Gianni, Luca

N1 - Copyright © 2018 Elsevier Ltd. All rights reserved.

PY - 2018/12

Y1 - 2018/12

N2 - BACKGROUND: Subcutaneous trastuzumab (H SC) is a valuable alternative to the intravenous formulation. This study assessed H SC safety and tolerability in human epidermal growth factor receptor 2 (HER2)+ early/locally advanced breast cancer (EBC/LABC).METHODS: SCHEARLY is a prospective, two-cohort, non-randomised, multicentre Italian trial included in the umbrella study UmbHER1, planning a 1-year treatment with H SC 600 mg in HER2+ EBC/LABC. Patients were sequentially assigned to cohort A (N = 121) and B (N = 119) to receive H SC via a handheld syringe and a single-use injection device, respectively. Adjuvant or neoadjuvant treatment included anthracycline-containing regimens followed by H SC plus taxanes and then alone for 18 cycles totally.RESULTS: Two hundred forty patients were enrolled (adjuvant therapy: 81.7%; neoadjuvant therapy: 18.3%), and 201 completed the treatment (early discontinuation was mainly due to intercurrent adverse events [AEs], 7.5%). Overall, the two cohorts displayed similar safety profiles. From H SC start, the rate of treatment-related AEs in the safety population (N = 228) was 3.9% for grade ≥3 AEs; 0.9% for serious AEs (one pleuropericarditis and one anaphylactic shock, both resolved) and 14.5% for cardiac AEs, the most common being the decreased left ventricular ejection fraction (7.9%; mean reduction from the screening to the follow-up visit was 2.9%). No cases of congestive heart failure occurred. The rate of systemic administration-related reactions and local injection site reactions was 68.0% and 21.9%, respectively, mostly of grade 1-2.CONCLUSIONS: H SC 600 mg confirmed to be a safe and tolerable option as adjuvant/neoadjuvant therapy in patients with HER2+ EBC and LABC. CLINICALTRIALS.GOV IDENTIFIER: NCT01940497.

AB - BACKGROUND: Subcutaneous trastuzumab (H SC) is a valuable alternative to the intravenous formulation. This study assessed H SC safety and tolerability in human epidermal growth factor receptor 2 (HER2)+ early/locally advanced breast cancer (EBC/LABC).METHODS: SCHEARLY is a prospective, two-cohort, non-randomised, multicentre Italian trial included in the umbrella study UmbHER1, planning a 1-year treatment with H SC 600 mg in HER2+ EBC/LABC. Patients were sequentially assigned to cohort A (N = 121) and B (N = 119) to receive H SC via a handheld syringe and a single-use injection device, respectively. Adjuvant or neoadjuvant treatment included anthracycline-containing regimens followed by H SC plus taxanes and then alone for 18 cycles totally.RESULTS: Two hundred forty patients were enrolled (adjuvant therapy: 81.7%; neoadjuvant therapy: 18.3%), and 201 completed the treatment (early discontinuation was mainly due to intercurrent adverse events [AEs], 7.5%). Overall, the two cohorts displayed similar safety profiles. From H SC start, the rate of treatment-related AEs in the safety population (N = 228) was 3.9% for grade ≥3 AEs; 0.9% for serious AEs (one pleuropericarditis and one anaphylactic shock, both resolved) and 14.5% for cardiac AEs, the most common being the decreased left ventricular ejection fraction (7.9%; mean reduction from the screening to the follow-up visit was 2.9%). No cases of congestive heart failure occurred. The rate of systemic administration-related reactions and local injection site reactions was 68.0% and 21.9%, respectively, mostly of grade 1-2.CONCLUSIONS: H SC 600 mg confirmed to be a safe and tolerable option as adjuvant/neoadjuvant therapy in patients with HER2+ EBC and LABC. CLINICALTRIALS.GOV IDENTIFIER: NCT01940497.

U2 - 10.1016/j.ejca.2018.09.034

DO - 10.1016/j.ejca.2018.09.034

M3 - Article

VL - 105

SP - 61

EP - 70

JO - European Journal of Cancer

JF - European Journal of Cancer

SN - 0959-8049

ER -