Universität zu Köln

Felip, Enriqueta, Smit, Egbert F., Molina-Vila, Miguel A., Dafni, Urania, Massuti, Bartomeu, Berghmans, Thierry, de Marinis, Filippo, Passiglia, Francesco, Dingemans, Anne-Marie C., Cobo, Manuel, Viteri, Santiago ORCID: 0000-0002-7572-1123, Britschgi, Christian ORCID: 0000-0001-8831-1564, Cuffe, Sinead, Provencio, Mariano ORCID: 0000-0001-9053-9197, Merkelbach-Bruse, Sabine, Andriakopoulou, Charitini, Kammler, Roswitha, Ruepp, Barbara, Roschitzki-Voser, Heidi, Peters, Solange, Wolf, Juergen and Stahel, Rolf (2022). Alectinib for the treatment of pretreated RET-rearranged advanced NSCLC: Results of the ETOP ALERT-lung trial. Lung Cancer, 172. S. 94 - 100. CLARE: ELSEVIER IRELAND LTD. ISSN 1872-8332

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Abstract

Background: Alectinib, a highly selective next generation ALK-inhibitor, has exhibited potent anti-tumour activity in RET-rearranged NSCLC in the preclinical stage. Methods: ALERT-lung is a single-arm, phase II trial evaluating the activity of alectinib for the treatment of pretreated RET-rearranged advanced NSCLC. Alectinib was administered orally, 600 mg, twice per day until progression, refusal or unacceptable toxicity (treatment could continue beyond progression, if patient was deriving clinical benefit). Patient recruitment closed prematurely due to discouraging results for alectinib in a phase I/II study in the same indication. Results: All 14 patients who enrolled until the premature accrual closure, received at lease one dose of alectinib. Among them, median age was 61 years, majority (71 %) was female, never smokers, of ECOG PS 1. No objective response (complete or partial response) was recorded. Of the 13 evaluable patients, three (23 %) achieved and maintained disease stabilisation for 24 weeks. Up to 31 March 2021 (median follow-up 15.9 months), 12 PFS-events (92 %) were observed, with median PFS of 3.7 months (95 % C.I.: 1.8 - 7.3 months). Overall, three deaths (23 %) were reported. Seven patients (50 %) experienced grade = 3 adverse events, while three discontinued treatment due to erythema multiforme of grade 3, related to alectinib. No treatment-related serious adverse event was reported. Conclusions: Accrual into our trial was terminated early in response to other reports of limited activity of alectinib in patients with RET-fusion NSCLC and the emergence of more potent selective RET-inhibitors. Also in our trial, alectinib did not show the expected potential for anti-tumour activity in NSCLC.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Felip, Enriqueta UNSPECIFIED UNSPECIFIED UNSPECIFIED Smit, Egbert F. UNSPECIFIED UNSPECIFIED UNSPECIFIED Molina-Vila, Miguel A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Dafni, Urania UNSPECIFIED UNSPECIFIED UNSPECIFIED Massuti, Bartomeu UNSPECIFIED UNSPECIFIED UNSPECIFIED Berghmans, Thierry UNSPECIFIED UNSPECIFIED UNSPECIFIED de Marinis, Filippo UNSPECIFIED UNSPECIFIED UNSPECIFIED Passiglia, Francesco UNSPECIFIED UNSPECIFIED UNSPECIFIED Dingemans, Anne-Marie C. UNSPECIFIED UNSPECIFIED UNSPECIFIED Cobo, Manuel UNSPECIFIED UNSPECIFIED UNSPECIFIED Viteri, Santiago UNSPECIFIED orcid.org/0000-0002-7572-1123 UNSPECIFIED Britschgi, Christian UNSPECIFIED orcid.org/0000-0001-8831-1564 UNSPECIFIED Cuffe, Sinead UNSPECIFIED UNSPECIFIED UNSPECIFIED Provencio, Mariano UNSPECIFIED orcid.org/0000-0001-9053-9197 UNSPECIFIED Merkelbach-Bruse, Sabine UNSPECIFIED UNSPECIFIED UNSPECIFIED Andriakopoulou, Charitini UNSPECIFIED UNSPECIFIED UNSPECIFIED Kammler, Roswitha UNSPECIFIED UNSPECIFIED UNSPECIFIED Ruepp, Barbara UNSPECIFIED UNSPECIFIED UNSPECIFIED Roschitzki-Voser, Heidi UNSPECIFIED UNSPECIFIED UNSPECIFIED Peters, Solange UNSPECIFIED UNSPECIFIED UNSPECIFIED Wolf, Juergen UNSPECIFIED UNSPECIFIED UNSPECIFIED Stahel, Rolf UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-696633
DOI:	10.1016/j.lungcan.2022.08.008
Journal or Publication Title:	Lung Cancer
Volume:	172
Page Range:	S. 94 - 100
Date:	2022
Publisher:	ELSEVIER IRELAND LTD
Place of Publication:	CLARE
ISSN:	1872-8332
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language OPEN-LABEL; CANCER Multiple languages Oncology; Respiratory System Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/69663