Concurrent Lapatinib With Brain Radiation Therapy in Patients With HER2+ Breast Cancer With Brain Metastases: NRG Oncology-KROG/RTOG 1119 Phase 2 Randomized Trial.

Autor:	Kim IA; Department of Radiation Oncology, Seoul National University, Seoul, South Korea. Electronic address: inah228@snu.ac.kr., Winter KA; NRG Oncology Statistics and Data Management Center, Philadelphia, Pennsylvania., Sperduto PW; Radiation Oncologist, Minneapolis Radiation Oncology, Minneapolis, Minnesota., De Los Santos JF; Department of Radiation Oncology, Grandview Medical Center, Birmingham, Alabama., Peereboom DM; Brain Tumor & Neuro-Oncology Cleveland Clinic Main Campus, Cleveland, Ohio., Ogunleye T; Medical Physics Department, Northside Hospital Cancer Institute, Atlanta, Georgia., Boulter D; Department of Radiology, Ohio State University Wexner Medical Center, Columbus, Ohio., Fritz JM; Department of Radiology, Ohio State University Wexner Medical Center, Columbus, Ohio., Cho KH; Department of Radiation Oncology, Seoul National University, Seoul, South Korea., Shin KH; Department of Radiation Oncology, Seoul National University, Seoul, South Korea., Zoberi I; Department of Radiology Oncology, Washington University School of Medicine, St. Louis, Missouri., Choi S; Department of Radiation Oncology, University Hospitals Cleveland Medical Center and Case Comprehensive Cancer Center, Cleveland, Ohio., Palmer JD; Department of Radiology, Ohio State University Wexner Medical Center, Columbus, Ohio., Liem B; Department of Internal Medicine, Division of Hematology/Oncology, New Mexico Minority Underserved NCORP, Albuquerque, New Mexico., Kim YB; Department of Radiation Oncology, Yonsei University Health System-Severance Hospital, Seoul, South Korea., Anderson BM; Department of Human Oncology, University of Wisconsin Hospital and Clinics, Madison, Wisconsin., Thakrar AW; Department of Radiation Oncology, Stroger Hospital of Cook County Minority Underserved NCORP, Chicago, Illinois., Muanza TM; Department of Radiation Oncology, Jewish General Hospital, Montreal, Quebec, Canada., Kim MM; Department of Radiation Oncology, University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan., Choi DH; Department of Radiation Oncology, Samsung Medical Center, Seoul, South Korea., Mehta MP; Department of Radiation Oncology, Miami Cancer Institute, Miami, Florida., White JR; Department of Radiation Oncology, University of Kansas, Kansas City, Kansas.
Jazyk:	angličtina
Zdroj:	International journal of radiation oncology, biology, physics [Int J Radiat Oncol Biol Phys] 2024 Apr 01; Vol. 118 (5), pp. 1391-1401. Date of Electronic Publication: 2023 Jul 26.
DOI:	10.1016/j.ijrobp.2023.07.019
Abstrakt:	Purpose: Lapatinib plus whole brain radiation therapy (WBRT) or stereotactic radiosurgery (SRS) was hypothesized to improve the 12-week intracranial complete response (CR) rate compared with either option of radiation therapy (RT) alone for patients with brain metastases (BM) from human epidermal growth factor receptor 2-positive (HER2+) breast cancer. Methods and Materials: This study included patients with HER2+ breast cancer with ≥1 measurable, unirradiated BM. Patients were randomized to WBRT (37.5 Gy/3 wk)/SRS (size-based dosing) ± concurrent lapatinib (1000 mg daily for 6 weeks). Secondary endpoints included objective response rate (ORR), lesion-specific response, central nervous system progression-free survival, and overall survival. Results: From July 2012 to September 2019, 143 patients were randomized, with 116 analyzable for the primary endpoint. RT + lapatinib did not improve 12-week CR (0% vs 6% for RT alone, 1-sided P = .97), or ORR at 12 weeks. At 4 weeks, RT + lapatinib showed higher ORR (55% vs 42%). Higher graded prognostic assessment and ≤10 lesions were associated with higher 12-week ORR. Grade 3 and 4 adverse event rates were 8% and 0% for RT and 28% and 6% for RT + lapatinib. Conclusions: The addition of 6 weeks of concomitant lapatinib to WBRT/SRS did not improve the primary endpoint of 12-week CR rate or 12-week ORR. Adding lapatinib to WBRT/SRS showed improvement of 4-week ORR, suggesting a short-term benefit from concomitant therapy. (Copyright © 2023 Elsevier Inc. All rights reserved.)
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu