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Concurrent Lapatinib With Brain Radiation Therapy in Patients With HER2+ Breast Cancer With Brain Metastases: NRG Oncology-KROG/RTOG 1119 Phase 2 Randomized Trial.
Kim, In Ah; Winter, Kathryn A; Sperduto, Paul W; De Los Santos, Jennifer F; Peereboom, David M; Ogunleye, Tomi; Boulter, Daniel; Fritz, Joel M; Cho, Kwan Ho; Shin, Kyung Hwan; Zoberi, Imran; Choi, Serah; Palmer, Joshua D; Liem, Ben; Kim, Yong Bae; Anderson, Bethany M; Thakrar, Anupama W; Muanza, Thierry M; Kim, Michelle M; Choi, Doo Ho; Mehta, Minesh P; White, Julia R.
Afiliación
  • 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.
Int J Radiat Oncol Biol Phys ; 118(5): 1391-1401, 2024 Apr 01.
Article en En | MEDLINE | ID: mdl-37506981
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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Neoplasias Encefálicas / Neoplasias de la Mama / Radiocirugia Tipo de estudio: Clinical_trials / Prognostic_studies Límite: Female / Humans Idioma: En Revista: Int J Radiat Oncol Biol Phys Año: 2024 Tipo del documento: Article Pais de publicación: Estados Unidos
Texto completo
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XML
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Neoplasias Encefálicas / Neoplasias de la Mama / Radiocirugia Tipo de estudio: Clinical_trials / Prognostic_studies Límite: Female / Humans Idioma: En Revista: Int J Radiat Oncol Biol Phys Año: 2024 Tipo del documento: Article Pais de publicación: Estados Unidos