Back to Search Start Over

Crizotinib in ROS1 -rearranged advanced non-small-cell lung cancer (NSCLC): updated results, including overall survival, from PROFILE 1001.

Authors :
Shaw, A T
Riely, G J
Bang, Y -J
Kim, D -W
Camidge, D R
Solomon, B J
Varella-Garcia, M
Iafrate, A J
Shapiro, G I
Usari, T
Wang, S C
Wilner, K D
Clark, J W
Ou, S -H I
Source :
Annals of Oncology. Jul2019, Vol. 30 Issue 7, p1121-1126. 6p. 4 Charts, 2 Graphs.
Publication Year :
2019

Abstract

Background In the ongoing phase I PROFILE 1001 study, crizotinib showed antitumor activity in patients with ROS1 -rearranged advanced non-small-cell lung cancer (NSCLC). Here, we present updated antitumor activity, overall survival (OS) and safety data (additional 46.2 months follow-up) for patients with ROS1 -rearranged advanced NSCLC from PROFILE 1001. Patients and methods ROS1 status was determined by FISH or reverse transcriptase–polymerase chain reaction. All patients received crizotinib at a starting dose of 250 mg twice daily. Results Fifty-three patients received crizotinib, with a median duration of treatment of 22.4 months. At data cut-off, treatment was ongoing in 12 patients (23%). The objective response rate (ORR) was 72% [95% confidence interval (CI), 58% to 83%], including six confirmed complete responses and 32 confirmed partial responses; 10 patients had stable disease. Responses were durable (median duration of response 24.7 months; 95% CI, 15.2–45.3). ORRs were consistent across different patient subgroups. Median progression-free survival was 19.3 months (95% CI, 15.2–39.1). A total of 26 deaths (49%) occurred (median follow-up period of 62.6 months), and of the remaining 27 patients (51%), 14 (26%) were in follow-up at data cut-off. Median OS was 51.4 months (95% CI, 29.3 to not reached) and survival probabilities at 12, 24, 36, and 48 months were 79%, 67%, 53%, and 51%, respectively. No correlation was observed between OS and specific ROS1 fusion partner. Treatment-related adverse events (TRAEs) were mainly grade 1 or 2, per CTCAE v3.0. There were no grade ≥4 TRAEs and no TRAEs associated with permanent discontinuation. No new safety signals were reported with long-term crizotinib treatment. Conclusions These findings serve as a new benchmark for OS in ROS1 -rearranged advanced NSCLC, and continue to show the clinically meaningful benefit and safety of crizotinib in this molecular subgroup. Trial Registration Number ClinicalTrials.gov identifier NCT00585195 [ABSTRACT FROM AUTHOR]

Details

Language :
English
ISSN :
09237534
Volume :
30
Issue :
7
Database :
Academic Search Index
Journal :
Annals of Oncology
Publication Type :
Academic Journal
Accession number :
137648123
Full Text :
https://doi.org/10.1093/annonc/mdz131