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


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.

SUBMITTER: Shaw AT 

PROVIDER: S-EPMC6637370 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature

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

Shaw A T AT   Riely G J GJ   Bang Y-J YJ   Kim D-W DW   Camidge D R DR   Solomon B J BJ   Varella-Garcia M M   Iafrate A J AJ   Shapiro G I GI   Usari T T   Wang S C SC   Wilner K D KD   Clark J W JW   Ou S-H I SI  

Annals of oncology : official journal of the European Society for Medical Oncology 20190701 7


<h4>Background</h4>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.<h4>Patients and methods</h4>ROS1 status was determined by FISH or reverse transcriptase-polymerase chain reaction. All patients received  ...[more]

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