Universität zu Köln

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. and Subbiah, V. (2020). Efficacy of Selpercatinib in RET Fusion-Positive Non-Small-Cell Lung Cancer. N. Engl. J. Med., 383 (9). S. 813 - 825. WALTHAM: MASSACHUSETTS MEDICAL SOC. ISSN 1533-4406

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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.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Drilon, A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Oxnard, G. R. UNSPECIFIED UNSPECIFIED UNSPECIFIED Tan, D. S. W. UNSPECIFIED UNSPECIFIED UNSPECIFIED Loong, H. H. F. UNSPECIFIED UNSPECIFIED UNSPECIFIED Johnson, M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Gainor, J. UNSPECIFIED UNSPECIFIED UNSPECIFIED McCoach, C. E. UNSPECIFIED UNSPECIFIED UNSPECIFIED Gautschi, O. UNSPECIFIED UNSPECIFIED UNSPECIFIED Besse, B. UNSPECIFIED UNSPECIFIED UNSPECIFIED Cho, B. C. UNSPECIFIED UNSPECIFIED UNSPECIFIED Peled, N. UNSPECIFIED UNSPECIFIED UNSPECIFIED Weiss, J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Kim, Y. -J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Ohe, Y. UNSPECIFIED UNSPECIFIED UNSPECIFIED Nishio, M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Park, K. UNSPECIFIED UNSPECIFIED UNSPECIFIED Patel, J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Seto, T. UNSPECIFIED UNSPECIFIED UNSPECIFIED Sakamoto, T. UNSPECIFIED UNSPECIFIED UNSPECIFIED Rosen, E. UNSPECIFIED UNSPECIFIED UNSPECIFIED Shah, M. H. UNSPECIFIED UNSPECIFIED UNSPECIFIED Barlesi, F. UNSPECIFIED UNSPECIFIED UNSPECIFIED Cassier, P. A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Bazhenova, L. UNSPECIFIED UNSPECIFIED UNSPECIFIED De Braud, F. UNSPECIFIED UNSPECIFIED UNSPECIFIED Garralda, E. UNSPECIFIED UNSPECIFIED UNSPECIFIED Velcheti, V. UNSPECIFIED UNSPECIFIED UNSPECIFIED Satouchi, M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Ohashi, K. UNSPECIFIED UNSPECIFIED UNSPECIFIED Pennell, N. A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Reckamp, K. L. UNSPECIFIED UNSPECIFIED UNSPECIFIED Dy, G. K. UNSPECIFIED UNSPECIFIED UNSPECIFIED Wolf, J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Solomon, B. UNSPECIFIED UNSPECIFIED UNSPECIFIED Falchook, G. UNSPECIFIED UNSPECIFIED UNSPECIFIED Ebata, K. UNSPECIFIED UNSPECIFIED UNSPECIFIED Nguyen, M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Nair, B. UNSPECIFIED UNSPECIFIED UNSPECIFIED Zhu, E. Y. UNSPECIFIED UNSPECIFIED UNSPECIFIED Yang, L. UNSPECIFIED UNSPECIFIED UNSPECIFIED Huang, X. UNSPECIFIED UNSPECIFIED UNSPECIFIED Olek, E. UNSPECIFIED UNSPECIFIED UNSPECIFIED Rothenberg, S. M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Goto, K. UNSPECIFIED UNSPECIFIED UNSPECIFIED Subbiah, V. UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-322548
DOI:	10.1056/NEJMoa2005653
Journal or Publication Title:	N. Engl. J. Med.
Volume:	383
Number:	9
Page Range:	S. 813 - 825
Date:	2020
Publisher:	MASSACHUSETTS MEDICAL SOC
Place of Publication:	WALTHAM
ISSN:	1533-4406
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language TARGETING RET; OPEN-LABEL; LAROTRECTINIB; PHASE-2 Multiple languages Medicine, General & Internal Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/32254