RT Journal Article
T1 Alectinib for the treatment of pretreated RET-rearranged advanced NSCLC: Results of the ETOP ALERT-lung trial.
A1 Felip, Enriqueta
A1 Smit, Egbert F
A1 Molina-Vila, Miguel A
A1 Dafni, Urania
A1 Massuti, Bartomeu
A1 Berghmans, Thierry
A1 de Marinis, Filippo
A1 Passiglia, Francesco
A1 Dingemans, Anne-Marie C
A1 Cobo, Manuel
A1 Viteri, Santiago
A1 Britschgi, Christian
A1 Cuffe, Sinead
A1 Provencio, Mariano
A1 Merkelbach-Bruse, Sabine
A1 Andriakopoulou, Charitini
A1 Kammler, Roswitha
A1 Ruepp, Barbara
A1 Roschitzki-Voser, Heidi
A1 Peters, Solange
A1 Wolf, Jürgen
A1 Stahel, Rolf
A1 ETOP 12-17 ALERT-lung Collaborators, 
AB Alectinib, a highly selective next generation ALK-inhibitor, has exhibited potent anti-tumour activity in RET-rearranged NSCLC in the preclinical stage. 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. 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. 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.
YR 2022
FD 2022-08-12
LK http://hdl.handle.net/10668/22354
UL http://hdl.handle.net/10668/22354
LA en
DS RISalud
RD Apr 6, 2025