한빛사논문 | BRIC

한빛사 논문

조회109

서울대학교 의과대학

CV File 74 kb

Ann. Oncol., Apr 2022, 33 (4) S0923-7534(22)00005-9 | https://doi.org/10.1016/j.annonc.2021.12.014 Dabrafenib plus trametinib in patients with BRAF V600E-mutant anaplastic thyroid cancer: updated analysis from the phase II ROAR basket study.

V. Subbiah ¹, R.J. Kreitman ², Z.A. Wainberg ³, J.Y. Cho ⁴, J.H.M. Schellens ⁵, J.C. Soria ⁶, P.Y. Wen ⁷, C.C. Zielinski ⁸, M.E. Cabanillas ¹, A. Boran ⁹, P. Ilankumaran ⁹, P. Burgess ¹⁰, T. Romero Salas ⁹, B. Keam ¹¹

¹The University of Texas MD Anderson Cancer Center, Houston

²National Institutes of Health, Bethesda

³University of California, Los Angeles, USA

⁴Yonsei University College of Medicine, Gangnam Severance Hospital, Seoul, Republic of Korea

⁵Netherlands Cancer Institute, Amsterdam, the Netherlands

⁶Institut Gustave Roussy, University of Paris-Sud, and University of Paris-Saclay, Villejuif, France

⁷Dana-Farber Cancer Institute, Boston, USA

⁸Medical University of Vienna, Vienna, Austria

⁹Novartis Pharmaceuticals Corporation, East Hanover, USA

¹⁰Novartis Pharma AG, Basel, Switzerland

¹¹Seoul National University Hospital, Seoul, Republic of Korea

Correspondence to: Prof. Bhumsuk Keam

Abstract

Combined therapy with dabrafenib plus trametinib was approved in several countries for treatment of BRAF V600E-mutant anaplastic thyroid cancer (ATC) based on an earlier interim analysis of 23 response-assessable patients in the ATC cohort of the phase II Rare Oncology Agnostic Research (ROAR) basket study. We report an updated analysis describing the efficacy and safety of dabrafenib plus trametinib in the full ROAR ATC cohort of 36 patients with ∼4 years of additional study follow-up. ROAR (NCT02034110) is an open-label, nonrandomized, phase II basket study evaluating dabrafenib plus trametinib in BRAF V600E-mutant rare cancers. The ATC cohort comprised 36 patients with unresectable or metastatic ATC who received dabrafenib 150 mg twice daily plus trametinib 2 mg once daily orally until disease progression, unacceptable toxicity, or death. The primary endpoint was investigator-assessed overall response rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1. Secondary endpoints were duration of response (DOR), progression-free survival (PFS), overall survival (OS), and safety. At data cutoff (14 September 2020), median follow-up was 11.1 months (range, 0.9-76.6 months). The investigator-assessed ORR was 56% (95% confidence interval, 38.1% to 72.1%), including three complete responses; the 12-month DOR rate was 50%. Median PFS and OS were 6.7 and 14.5 months, respectively. The respective 12-month PFS and OS rates were 43.2% and 51.7%, and the 24-month OS rate was 31.5%. No new safety signals were identified with additional follow-up, and adverse events were consistent with the established tolerability of dabrafenib plus trametinib. These updated results confirm the substantial clinical benefit and manageable toxicity of dabrafenib plus trametinib in BRAF V600E-mutant ATC. Dabrafenib plus trametinib notably improved long-term survival and represents a meaningful treatment option for this rare, aggressive cancer.

논문정보

형식Research article
게재일2022년 04월 (BRIC 등록일 2023-09-18)
연구진국내(교신)+국외 연구진
분야 의약학 > 응용의학

댓글 작성 로그인

CV 열람하기

연락처 보기