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Efficacy and safety of selpercatinib in Chinese patients with advanced RET-altered thyroid cancers: results from the phase II LIBRETTO-321 study.
Zheng, Xiangqian; Ji, Qinghai; Sun, Yuping; Ge, Minghua; Zhang, Bin; Cheng, Ying; Lei, Shangtong; Shi, Feng; Guo, Ye; Li, Linfa; Chen, Lu; Shao, Jingxin; Zhang, Wanli; Gao, Ming.
Afiliación
  • Zheng X; Department of Thyroid and Neck Tumor, Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin's Clinical Research Center for Cancer, Tianjin, China.
  • Ji Q; Department of Head and Neck Surgery, Fudan University Shanghai Cancer Center, Shanghai, China.
  • Sun Y; Department of Oncology, Jinan Central Hospital Affiliated to Shandong University, Jinan, China.
  • Ge M; Department of Head, Neck and Thyroid Surgery, Zhejiang Provincial People's Hospital, People's Hospital of Hangzhou Medical College, Hangzhou, China.
  • Zhang B; Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Head and Neck Surgery, Peking University Cancer Hospital and Institute, Beijing, China.
  • Cheng Y; Department of Thoracic Oncology, Jilin Cancer Hospital, Changchun, China.
  • Lei S; Department of General Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, China.
  • Shi F; Department of Nuclear Medicine, The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, and Hunan Cancer Hospital, Changsha, China.
  • Guo Y; Department of Oncology, Shanghai East Hospital, School of Medicine, Tongji University, Shanghai, China.
  • Li L; Department of Nuclear Medicine, Zhejiang Cancer Hospital, Hangzhou, China.
  • Chen L; Oncology, Eli Lilly and Company, Shanghai, China.
  • Shao J; Oncology, Eli Lilly and Company, Shanghai, China.
  • Zhang W; Oncology, Eli Lilly and Company, Shanghai, China.
  • Gao M; Department of Thyroid and Neck Tumor, Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin's Clinical Research Center for Cancer, Tianjin, China.
Ther Adv Med Oncol ; 14: 17588359221119318, 2022.
Article en En | MEDLINE | ID: mdl-36062046
Background: Selpercatinib, a highly selective and potent REarranged during Transfection (RET) kinase inhibitor, is effective in advanced RET-altered thyroid cancer (TC). However, the efficacy and safety in Chinese patients are unknown. Patients and methods: In the open-label, multi-center phase II LIBRETTO-321 (NCT04280081) study, Chinese patients with advanced solid tumors harboring RET alterations received selpercatinib 160 mg twice daily. The primary endpoint was objective response rate (ORR; RECIST v1.1) by independent review committee (IRC). Secondary endpoints included duration of response (DoR) and safety. Efficacy was assessed in the primary analysis set [PAS; treated patients with RET fusion-positive TC or RET-mutant medullary TC (MTC) confirmed by central laboratory] and all enrolled patients with MTC. Results: Of 77 enrolled patients, 29 had RET-mutant MTC and one had RET fusion-positive TC. In the PAS (n = 26), the ORR by IRC was 57.7% [95% confidence interval (CI), 36.9-76.6]. Median DoR was not reached and 93.3% of responses were ongoing at a median follow-up of 8.7 months. In all enrolled MTC patients (n = 29), the ORR by IRC was 58.6% (95% CI, 38.9-76.5). One RET fusion-positive TC patient treated for 23.4 weeks achieved a partial response at week 8 that was ongoing at cutoff. In the safety population (n = 77), 59.7% experienced grade ⩾3 treatment-emergent adverse events (TEAEs). TEAEs led to dose reductions in 32.5% (n = 25) and discontinuations in 5.2% [n = 4; 3.9% (n = 3) considered treatment related] of patients. Conclusions: Selpercatinib showed robust antitumor activity and was well tolerated in Chinese patients with advanced RET-altered TC, consistent with global data from LIBRETTO-001 (NCT04280081). ClinicalTrialsgov Identifier: NCT04280081 (first posted Feb 21, 2020).
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Tipo de estudio: Clinical_trials Idioma: En Revista: Ther Adv Med Oncol Año: 2022 Tipo del documento: Article País de afiliación: China Pais de publicación: Reino Unido

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Tipo de estudio: Clinical_trials Idioma: En Revista: Ther Adv Med Oncol Año: 2022 Tipo del documento: Article País de afiliación: China Pais de publicación: Reino Unido