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Selpercatinib治疗RET融合阳性非小细胞肺癌疗效显著

文章来源: 更新时间:2020-08-31 19:45

本期文章:《新英格兰医学杂志》:Vol.383 No.9

美国斯隆凯特林癌症纪念中心Alexander Drilon联合得克萨斯大学安德森肿瘤中心Vivek Subbiah团队研究了Selpercatinib治疗RET融合阳性非小细胞肺癌的疗效。2020年8月27日,《新英格兰医学杂志》发表了该成果。

RET融合是1-2%非小细胞肺癌(NSCLC)的致癌驱动因素。选择性RET抑制剂selpercatinib治疗RET融合阳性NSCLC患者的有效性和安全性尚不清楚。

在这项1-2期临床试验中,研究组招募先前接受过铂类化疗或未接受治疗的晚期RET融合阳性NSCLC患者,均接受selpercatinib治疗。主要终点为独立审核委员会确定的客观缓解(全部或部分缓解)。

在105名先前至少接受过铂类化疗的RET融合阳性NSCLC患者中,客观缓解率为64%。中位缓解时间为17.5个月,中位随访12.1个月后,63%的患者仍持续缓解。在39名先前未接受治疗的患者中,客观缓解率为85%,90%的缓解可持续6个月。

在检测出中枢神经系统转移的11例患者中,客观颅内缓解率为91%。3级及以上最常见不良事件包括高血压(14%)、丙氨酸氨基转移酶水平升高(12%)、天冬氨酸氨基转移酶水平升高(10%)、低钠血症(6%)和淋巴细胞减少症(6%)。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治疗先前接受过铂类化疗或未经治疗的RET融合阳性NSCLC患者,疗效显著持久,且毒副作用小。

附:英文原文

Title: Efficacy of Selpercatinib in RET Fusion–Positive Non–Small-Cell Lung Cancer

Author: Alexander Drilon, M.D.,, Geoffrey R. Oxnard, M.D.,, Daniel S.W. Tan, M.B., B.S., Ph.D.,, Herbert H.F. Loong, M.B., B.S.,, Melissa Johnson, M.D.,, Justin Gainor, M.D.,, Caroline E. McCoach, M.D., Ph.D.,, Oliver Gautschi, M.D.,, Benjamin Besse, M.D., Ph.D.,, Byoung C. Cho, M.D., Ph.D.,, Nir Peled, M.D., Ph.D.,, Jared Weiss, M.D.,, Yu-Jung Kim, M.D., Ph.D.,, Yuichiro Ohe, M.D., Ph.D.,, Makoto Nishio, M.D.,, Keunchil Park, M.D., Ph.D.,, Jyoti Patel, M.D.,, Takashi Seto, M.D.,, Tomohiro Sakamoto, M.D.,, Ezra Rosen, M.D., Ph.D.,, Manisha H. Shah, M.D.,, Fabrice Barlesi, M.D., Ph.D.,, Philippe A. Cassier, M.D.,, Lyudmila Bazhenova, M.D.,, Filippo De Braud, M.D.,, Elena Garralda, M.D.,, Vamsidhar Velcheti, M.D.,, Miyako Satouchi, M.D., Ph.D.,, Kadoaki Ohashi, M.D., Ph.D.,, Nathan A. Pennell, M.D., Ph.D.,, Karen L. Reckamp, M.D.,, Grace K. Dy, M.D.,, Jürgen Wolf, M.D.,, Benjamin Solomon, M.B., B.S., Ph.D.,, Gerald Falchook, M.D.,, Kevin Ebata, Ph.D.,, Michele Nguyen, B.S.,, Binoj Nair, Ph.D.,, Edward Y. Zhu, Ph.D.,, Luxi Yang, M.P.H.,, Xin Huang, Ph.D.,, Elizabeth Olek, M.D.,, S. Michael Rothenberg, M.D., Ph.D.,, Koichi Goto, M.D., Ph.D.,, and Vivek Subbiah, M.D.

Issue&Volume: 2020-08-26

Abstract: Background

RET fusions are oncogenic drivers in 1 to 2% of non–small-cell lung cancers (NSCLCs). In patients with RET fusion–positive NSCLC, the efficacy and safety of selective RET inhibition are unknown.

Methods

We enrolled patients with advanced RET fusion–positive NSCLC who had previously received platinum-based chemotherapy and those who were previously untreated separately 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 105 consecutively enrolled patients with RET fusion–positive NSCLC who had previously received at least platinum-based chemotherapy, the percentage with an objective response was 64% (95% confidence interval [CI], 54 to 73). The median duration of response was 17.5 months (95% CI, 12.0 to could not be evaluated), and 63% of the responses were ongoing at a median follow-up of 12.1 months. Among 39 previously untreated patients, the percentage with an objective response was 85% (95% CI, 70 to 94), and 90% of the responses were ongoing at 6 months. Among 11 patients with measurable central nervous system metastasis at enrollment, the percentage with an objective intracranial response was 91% (95% CI, 59 to 100). The most common adverse events of grade 3 or higher were hypertension (in 14% of the patients), an increased alanine aminotransferase level (in 12%), an increased aspartate aminotransferase level (in 10%), hyponatremia (in 6%), and lymphopenia (in 6%). A total of 12 of 531 patients (2%) discontinued selpercatinib because of a drug-related adverse event.

Conclusions

Selpercatinib had durable efficacy, including intracranial activity, with mainly low-grade toxic effects in patients with RET fusion–positive NSCLC who had previously received platinum-based chemotherapy and those who were previously untreated.

DOI: 10.1056/NEJMoa2005653

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2005653

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