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Abstract
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.

Affiliations

In Ah Kim 1, Kathryn A Winter 2, Paul W Sperduto 3, Jennifer F De Los Santos 4, David M Peereboom 5, Tomi Ogunleye 6, Daniel Boulter 7, Joel M Fritz 7, Kwan Ho Cho 8, Kyung Hwan Shin 8, Imran Zoberi 9, Serah Choi 10, Joshua D Palmer 7, Ben Liem 11, Yong Bae Kim 12, Bethany M Anderson 13, Anupama W Thakrar 14, Thierry M Muanza 15, Michelle M Kim 16, Doo Ho Choi 17, Minesh P Mehta 18, Julia R White 19
1Department of Radiation Oncology, Seoul National University, Seoul, South Korea. Electronic address: inah228@snu.ac.kr.
2NRG Oncology Statistics and Data Management Center, Philadelphia, Pennsylvania.
3Radiation Oncologist, Minneapolis Radiation Oncology, Minneapolis, Minnesota.
4Department of Radiation Oncology, Grandview Medical Center, Birmingham, Alabama.
5Brain Tumor & Neuro-Oncology Cleveland Clinic Main Campus, Cleveland, Ohio.
6Medical Physics Department, Northside Hospital Cancer Institute, Atlanta, Georgia.
7Department of Radiology, Ohio State University Wexner Medical Center, Columbus, Ohio.
8Department of Radiation Oncology, Seoul National University, Seoul, South Korea.
9Department of Radiology Oncology, Washington University School of Medicine, St. Louis, Missouri.
10Department of Radiation Oncology, University Hospitals Cleveland Medical Center and Case Comprehensive Cancer Center, Cleveland, Ohio.
11Department of Internal Medicine, Division of Hematology/Oncology, New Mexico Minority Underserved NCORP, Albuquerque, New Mexico.
12Department of Radiation Oncology, Yonsei University Health System-Severance Hospital, Seoul, South Korea.
13Department of Human Oncology, University of Wisconsin Hospital and Clinics, Madison, Wisconsin.
14Department of Radiation Oncology, Stroger Hospital of Cook County Minority Underserved NCORP, Chicago, Illinois.
15Department of Radiation Oncology, Jewish General Hospital, Montreal, Quebec, Canada.
16Department of Radiation Oncology, University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan.
17Department of Radiation Oncology, Samsung Medical Center, Seoul, South Korea.
18Department of Radiation Oncology, Miami Cancer Institute, Miami, Florida.
19Department of Radiation Oncology, University of Kansas, Kansas City, Kansas.