Subcutaneous vs Intravenous Trastuzumab/Pertuzumab: A Time and Motion Substudy of a Phase II Trial of Adjuvant Trastuzumab/Pertuzumab for Stage I HER2+ Breast Cancer (ADEPT trial).

Autor:	Waks AG; Medical Oncology, Dana-Farber Cancer Institute, Boston, MA.; Breast Oncology Program, Dana-Farber Brigham Cancer Center, Boston, MA.; Harvard Medical School, Boston, MA., Chen EL; Brigham and Women's Hospital, Boston, MA., Graham N; Data Sciences, Dana-Farber Cancer Institute, Boston, MA., Frey AM; Medical Oncology, Dana-Farber Cancer Institute, Boston, MA.; Breast Oncology Program, Dana-Farber Brigham Cancer Center, Boston, MA.; Harvard Medical School, Boston, MA., Almeida K; Pharmacy and Clinical Support, Dana-Farber Cancer Institute, Boston, MA., Attaya V; Medical Oncology, Dana-Farber Cancer Institute, Boston, MA.; Current Affiliation: Olema Oncology, San Francisco, CA., Ryding C; Medical Oncology, Dana-Farber Cancer Institute, Boston, MA., Abbass I; Genentech, Inc, South San Francisco, CA., Fung A; Genentech, Inc, South San Francisco, CA., Sussell J; Genentech, Inc, South San Francisco, CA., Cortazar P; Genentech, Inc, South San Francisco, CA., Harvey C; Pharmacy and Clinical Support, Dana-Farber Cancer Institute, Boston, MA., Leth D; Pharmacy and Clinical Support, Dana-Farber Cancer Institute, Boston, MA., Faggen M; Dana-Farber Brigham Cancer Center in Clinical Affiliation With South Shore Hospital, Weymouth, MA., Sinclair N; Dana-Farber Brigham Cancer Center-Foxborough and Milford, Foxborough, MA., Walsh J; Dana-Farber/New Hampshire Oncology-Hematology, Londonderry, NH., Tung N; Harvard Medical School, Boston, MA.; Beth Israel Deaconess Medical Center, Boston, MA., Sinclair S; Eastern Maine Medical Center, Brewer, ME., Lo S; Bennett Cancer Center, Stamford Health, Stamford, CT., Yardley D; Sarah Cannon Research Institute, Nashville, TN., Valero V; The University of Texas MD Anderson Cancer Center, Houston, TX., Meisel J; Winship Cancer Institute at Emory University, Atlanta, GA., Ballinger TJ; Indiana University School of Medicine, Indianapolis, IN., Adams S; Perlmutter Cancer Center, NYU Langone Health, New York, NY., Carey LA; Department of Medicine, Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC., Rauch JK; UNC Health, Garner, NC., Abramson VG; Vanderbilt University Medical Center, Nashville, TN., Williams NO; Ohio State University Wexner Medical Center, Columbus, OH., Chen WY; Medical Oncology, Dana-Farber Cancer Institute, Boston, MA.; Breast Oncology Program, Dana-Farber Brigham Cancer Center, Boston, MA.; Harvard Medical School, Boston, MA., Leone JP; Medical Oncology, Dana-Farber Cancer Institute, Boston, MA.; Breast Oncology Program, Dana-Farber Brigham Cancer Center, Boston, MA.; Harvard Medical School, Boston, MA., Schumer ST; Medical Oncology, Dana-Farber Cancer Institute, Boston, MA.; Breast Oncology Program, Dana-Farber Brigham Cancer Center, Boston, MA.; Harvard Medical School, Boston, MA., Tayob N; Harvard Medical School, Boston, MA.; Data Sciences, Dana-Farber Cancer Institute, Boston, MA., Tolaney SM; Medical Oncology, Dana-Farber Cancer Institute, Boston, MA.; Breast Oncology Program, Dana-Farber Brigham Cancer Center, Boston, MA.; Harvard Medical School, Boston, MA.
Jazyk:	angličtina
Zdroj:	JCO oncology practice [JCO Oncol Pract] 2024 Jul 19, pp. OP2400021. Date of Electronic Publication: 2024 Jul 19.
DOI:	10.1200/OP.24.00021
Abstrakt:	Purpose: The time required for in-clinic drug administration can substantially affect breast cancer patients' quality of life. Subcutaneous (SC) drug administration, as opposed to intravenous (IV), may reduce this time commitment. This study sought to estimate the difference in time burden between IV and SC administration of trastuzumab and pertuzumab (HP). Methods: We prospectively enrolled a subcohort of patients participating in the ADEPT trial (ClinicalTrials.gov identifier: NCT04569747, investigating adjuvant HP plus endocrine therapy for stage I human epidermal growth factor receptor 2-positive breast cancer) to this single-arm crossover time and motion substudy. Patients received two cycles of IV HP followed by two cycles of SC HP. During each cycle, time points in drug preparation and administration were captured. The primary end point was total patient time in the treatment chair. Additional end points included total patient treatment experience time and total pharmacy workflow time. A sample size of 22 patients was estimated to provide 90.7% power with two-sided alpha .05 to detect a difference of 70 minutes in the primary end point by treatment arm (IV v SC). Results: Twenty-two patients were enrolled. The mean total patient time in the treatment chair was 61.8 minutes shorter with SC versus IV HP (22.5 v 84.3 minutes; P < .0001). The mean total patient treatment experience time (incorporating time spent waiting for treatment initiation and time spent in the treatment chair) was 81.8 minutes shorter for SC administration (96 v 177.8 minutes; P < .0001). The pharmacy workflow time was 78.2 minutes shorter for SC versus IV formulation (41 v 119.2 minutes; P < .0001). Conclusion: SC administration of HP shortened patient time burden by approximately 1 hour. SC drug administration can facilitate faster workflows for health care professionals and improve patients' breast cancer treatment experience.
Databáze:	MEDLINE
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