Milvia Zambetti1, Filippo Montemurro2, Paolo Morandi3, Claudio Zamagni4, Alba A Brandes5, Giancarlo Bisagni6, Katia Cagossi7, Carmelo Bengala8, Stefania Gori9, Claudio Iannacone10, Alessia Stell11, Luca Gianni12. 1. Medical Oncology Dept, San Raffaele Scientific Institute, Via Olgettina, 60, 20132 Milan, Italy. Electronic address: milvia.zambetti2018@gmail.com. 2. Investigational and Clinical Oncology, Candiolo Cancer Institute, FPO-IRCCS, St. Prov. 142, 10060 Candiolo, Italy. Electronic address: filippo.montemurro@ircc.it. 3. Medical Oncology Dept., Azienda ULSS 12 "Veneziana", Ospedale Dell'Angelo, Via Paccagnella 11, 30174 Mestre-Venezia, Italy. Electronic address: Paolo.Morandi@aulss3.veneto.it. 4. SSD Medical Oncology Addari, Policlinico Sant'Orsola Malpighi, Via Pietro Albertoni, 15, 40138 Bologna, Italy. Electronic address: claudio.zamagni@aosp.bo.it. 5. Medical Oncology Dept, AUSL Bologna-ISNB, Via Altura, 3, 40139 Bologna, Italy. Electronic address: a.brandes@ausl.bologna.it. 6. IRCCS Arcispedale S. Maria Nuova Azienda Ospedaliera di Reggio Emilia, Viale Risorgimento, 80, 42123 Reggio Emilia, Italy. Electronic address: Giancarlo.Bisagni@asmn.re.it. 7. Division of Medical Oncology, "B.Ramazzini" Hospital, Via Molinari 2, 41012, Carpi, Italy. Electronic address: k.cagossi@ausl.mo.it. 8. Division of Medical Oncology, Department of Oncology, Misericordia Hospital, Via Senese, 169, 58100 Grosseto, Italy. Electronic address: c.bengala@usl9.toscana.it. 9. Oncology Dept. IRCCS Sacro Cuore Don Calabria Hospital, Via Don A. Sempreboni, 5, 37024 Negrar, Verona, Italy. Electronic address: stefania.gori@sacrocuore.it. 10. SPARC Consulting Srl, Via Archimede 94, 20129 Milan, Italy. Electronic address: claudio.iannacone@sparcconsulting.com. 11. Roche S.p.A., Viale G.B. Stucchi,110, 20900 Monza, Italy. Electronic address: alessia.stell@roche.com. 12. Medical Oncology Dept, San Raffaele Scientific Institute, Via Olgettina, 60, 20132 Milan, Italy. Electronic address: gianni.luca@hsr.it.
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.
BACKGROUND: Subcutaneous trastuzumab (H SC) is a valuable alternative to the intravenous formulation. This study assessed H SC safety and tolerability in humanepidermal 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.
Authors: Ross Mudgway; Carlos Chavez de Paz Villanueva; Ann C Lin; Maheswari Senthil; Carlos A Garberoglio; Sharon S Lum Journal: Ann Surg Oncol Date: 2020-03-10 Impact factor: 5.344