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Cited by 828

The DOI matches its Crossref record; 4 of the 4 references it cites were found in a registry or an index.

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

Open access
Drilon, Alexander, Oxnard, Geoffrey R., Tan, Daniel S.W., Loong, Herbert H.F., Johnson, Melissa, Gainor, Justin, McCoach, Caroline E., Gautschi, Oliver, Besse, Benjamin, Cho, Byoung C., Peled, Nir, Weiss, Jared, Kim, Yu-Jung, Ohe, Yuichiro, Nishio, Makoto, Park, Keunchil, Patel, Jyoti, Seto, Takashi, Sakamoto, Tomohiro, Rosen, Ezra, Shah, Manisha H., Barlesi, Fabrice, Cassier, Philippe A., Bazhenova, Lyudmila, De Braud, Filippo, Garralda, Elena, Velcheti, Vamsidhar, Satouchi, Miyako, Ohashi, Kadoaki, Pennell, Nathan A., Reckamp, Karen L., Dy, Grace K., Wolf, Jürgen, Solomon, Benjamin, Falchook, Gerald, Ebata, Kevin, Nguyen, Michele, Nair, Binoj, Zhu, Edward Y., Yang, Luxi, Huang, Xin, Olek, Elizabeth, Rothenberg, S. Michael, Goto, Koichi, Subbiah, Vivek·2020·New England Journal of Medicine
DOI 10.1056/nejmoa2005653
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Abstract

BACKGROUND: fusion-positive NSCLC, the efficacy and safety of selective RET inhibition are unknown. METHODS: 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: 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: fusion-positive NSCLC who had previously received platinum-based chemotherapy and those who were previously untreated. (Funded by Loxo Oncology and others; LIBRETTO-001 ClinicalTrials.gov number, NCT03157128.).

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Metadata

Authors
Drilon, A., Oxnard, G. R., Tan, D. S. W., Loong, H. H. F., Johnson, M., Gainor, J., McCoach, C. E., Gautschi, O., Besse, B., Cho, B. C., Peled, N., Weiss, J., Kim, Y.-J., Ohe, Y., Nishio, M., Park, K., Patel, J., Seto, T., Sakamoto, T., Rosen, E., Shah, M. H., Barlesi, F., Cassier, P. A., Bazhenova, L., De Braud, F., Garralda, E., Velcheti, V., Satouchi, M., Ohashi, K., Pennell, N. A., Reckamp, K. L., Dy, G. K., Wolf, J., Solomon, B., Falchook, G., Ebata, K., Nguyen, M., Nair, B., Zhu, E. Y., Yang, L., Huang, X., Olek, E., Rothenberg, S. M., Goto, K., & Subbiah, V.
Venue
New England Journal of Medicine
Publisher
Massachusetts Medical Society
Published
2020-08-27
Volume
383
Issue
9
Pages
813-824
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
DOI
10.1056/nejmoa2005653
OpenAlex
W3081278682
Cited by
828
References
4
FWCI
64.15
Type
journal article
Language
en
Open access
bronze

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