拉帕蒂尼
医学
临床终点
放射外科
相伴的
内科学
肿瘤科
乳腺癌
放射治疗
癌症
不利影响
转移性乳腺癌
随机对照试验
曲妥珠单抗
作者
In Ah Kim,Kathryn Winter,Paul W. Sperduto,Jennifer F. De Los Santos,David Peereboom,Tomi Ogunleye,Daniel Boulter,Joel Fritz,Kwan Ho Cho,Kyung Hwan Shin,Imran Zoberi,Serah Choi,Joshua D. Palmer,Ben Liem,Yong Bae Kim,Bethany Anderson,Anu Thakrar,Thierry Muanza,Michelle M. Kim,Doo Ho Choi,Minesh P. Mehta,Julia White
标识
DOI:10.1016/j.ijrobp.2023.07.019
摘要
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.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.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.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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