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Selpercatinib治疗RET突变型甲状腺髓样癌患者疗效显

文章来源: 更新时间:2020-08-31 19:46

本期文章:《新英格兰医学杂志》:Vol.383 No.9

美国马萨诸塞州总医院Lori J. Wirth团队研究了selpercatinib治疗RET突变型甲状腺髓样癌患者的疗效。2020年8月27日,该研究发表在《新英格兰医学杂志》上。

RET突变发生在70%的甲状腺髓样癌中,而RET融合在其他甲状腺癌中很少发生。选择性RET抑制剂治疗RET突变甲状腺癌患者的有效性和安全性尚不清楚。

在一项1-2期临床试验中,研究组招募RET突变型甲状腺髓样癌患者,无论其是否接受过范德塔尼布或卡波赞尼布治疗,以及先前接受过治疗的RET融合阳性甲状腺癌患者,均接受selpercatinib治疗。主要终点为由独立审核委员会确定的客观缓解(全部或部分缓解)。

在55例先前接受过范德塔尼布和/或卡波赞尼布治疗的RET突变型甲状腺髓样癌患者中,缓解率为69%,1年无进展生存率为82%。在88例先前未接受过范德塔尼布或卡波赞尼布治疗的RET突变型甲状腺髓样癌患者中,缓解率为73%,一年无进展生存率为92%。

在19例先前接受过治疗的RET融合阳性甲状腺癌患者中,缓解率为79%,1年无进展生存率为64%。最常见的3级及以上不良事件为高血压(21%)、丙氨酸氨基转移酶水平升高(11%)、天冬氨酸氨基转移酶水平升高(9%)、低钠血症(8%)和腹泻(6%)。在所有接受治疗的531名患者中,有12名(2%)因药物相关不良事件而停用了selpercatinib。

总之,selpercatinib治疗曾接受过或未接受过范德塔尼布或卡波赞尼布治疗的甲状腺髓样癌患者,疗效持久,且毒副作用低。

附:英文原文

Title: Efficacy of Selpercatinib in RET-Altered Thyroid Cancers

Author: Lori J. Wirth, M.D.,, Eric Sherman, M.D.,, Bruce Robinson, M.D.,, Benjamin Solomon, M.B., B.S., Ph.D.,, Hyunseok Kang, M.D.,, Jochen Lorch, M.D.,, Francis Worden, M.D.,, Marcia Brose, M.D., Ph.D.,, Jyoti Patel, M.D.,, Sophie Leboulleux, M.D.,, Yann Godbert, M.D.,, Fabrice Barlesi, M.D., Ph.D.,, John C. Morris, M.D.,, Taofeek K. Owonikoko, M.D., Ph.D.,, Daniel S.W. Tan, M.B., B.S., Ph.D.,, Oliver Gautschi, M.D.,, Jared Weiss, M.D.,, Christelle de la Fouchardière, M.D.,, Mark E. Burkard, M.D., Ph.D.,, Janessa Laskin, M.D.,, Matthew H. Taylor, M.D.,, Matthias Kroiss, M.D.,, Jacques Medioni, M.D., Ph.D.,, Jonathan W. Goldman, M.D.,, Todd M. Bauer, M.D.,, Benjamin Levy, M.D.,, Viola W. Zhu, M.D.,, Nehal Lakhani, M.D., Ph.D.,, Victor Moreno, M.D., Ph.D.,, Kevin Ebata, Ph.D.,, Michele Nguyen, B.S.,, Dana Heirich, M.S.N.,, Edward Y. Zhu, Ph.D.,, Xin Huang, Ph.D.,, Luxi Yang, M.P.H.,, Jennifer Kherani, M.D.,, S. Michael Rothenberg, M.D., Ph.D.,, Alexander Drilon, M.D.,, Vivek Subbiah, M.D.,, Manisha H. Shah, M.D.,, and Maria E. Cabanillas, M.D.

Issue&Volume: 2020-08-26

Abstract: Background

RET mutations occur in 70% of medullary thyroid cancers, and RET fusions occur rarely in other thyroid cancers. In patients with RET-altered thyroid cancers, the efficacy and safety of selective RET inhibition are unknown.

Methods

We enrolled patients with RET-mutant medullary thyroid cancer with or without previous vandetanib or cabozantinib treatment, as well as those with previously treated RET fusion–positive thyroid cancer, in a phase 1–2 trial of selpercatinib. The primary end point was an objective response (a complete or partial response), as determined by an independent review committee. Secondary end points included the duration of response, progression-free survival, and safety.

Results

In the first 55 consecutively enrolled patients with RET-mutant medullary thyroid cancer who had previously received vandetanib, cabozantinib, or both, the percentage who had a response was 69% (95% confidence interval [CI], 55 to 81), and 1-year progression-free survival was 82% (95% CI, 69 to 90). In 88 patients with RET-mutant medullary thyroid cancer who had not previously received vandetanib or cabozantinib, the percentage who had a response was 73% (95% CI, 62 to 82), and 1-year progression-free survival was 92% (95% CI, 82 to 97). In 19 patients with previously treated RET fusion–positive thyroid cancer, the percentage who had a response was 79% (95% CI, 54 to 94), and 1-year progression-free survival was 64% (95% CI, 37 to 82). The most common adverse events of grade 3 or higher were hypertension (in 21% of the patients), increased alanine aminotransferase level (in 11%), increased aspartate aminotransferase level (in 9%), hyponatremia (in 8%), and diarrhea (in 6%). Of all 531 patients treated, 12 (2%) discontinued selpercatinib owing to drug-related adverse events.

Conclusions

In this phase 1–2 trial, selpercatinib showed durable efficacy with mainly low-grade toxic effects in patients with medullary thyroid cancer with and without previous vandetanib or cabozantinib treatment.

DOI: NJ202008273830909

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2005651

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