Abstract 1202P
Background
Crizotinib is the first tyrosine kinase inhibitor authorized for the treatment of aNSCLC ALK+ or ROS1+, regardless of lines. Real-world (RW) data is scarce for these populations.
Methods
We conducted a non-interventional ambispective multicentric study on aNSCLC ALK+ or ROS1+ treated by crizotinib in collaboration with the CPHG (French College of General Hospital Respiratory Physician). The aim was first to describe patient’s characteristics, and second to evaluate effectiveness and safety of crizotinib in a RW setting in General Hospital in France.
Results
73 patients were included: 51 patients ALK+, 22 patients ROS1+. Median age was 65 -year-old [Q1-Q3: 52.0; 73.0], 45 (63.4%) female, 52 (82.5%) patients with ECOG < 2, 40 (56.3%) non-smokers. 70 (98.6%) adenocarcinoma, 62 (87.3%) stage IV. Bone and cerebral metastasis presented respectively in 46% and 12.7%. Diagnostic was usually histologic (90.1%) on primitive tumor (73.2%). The median delay between biopsy and positive result for ALK+ or ROS1+ was respectively 10 and 8 days. 26 (36.6%) patients had prior treatment before crizotinib, respectively 20 (28.2%) and 9 (13.6%) chemotherapy and radiotherapy. 70 (98.6%) patients initiated crizotinib at the recommended dose 250 mg bid and 47 (64.4 %) started crizotinib before inclusion (≤ 3 months). 24 (33.8%) patients had at least one dose reduction and 14 (19.7%) a treatment interruption. Objective Response Rate for ALK+ and ROS1+ was 62.7% and 55% respectively. Median progression-free survival (IC95) was ALK+ 9.4 months (7-16.1) and ROS1+ 6.6 months (4.3-14.3) median Overall Survival (IC95), not reach (NE-NE) and 13.7 months (5.0 e NE). According to the most recent safety analysis, 74 % and 37% had presented at least one adverse event (AE) and serious AE respectively. The most common AEs of any cause were diarrhea (24.7 %), nausea and oedema (16.4 % both) or vision disorders (12.3 %).
Conclusions
Our results are consistent with other RW in terms of effectiveness and safety. Crizotinib was effective in both ALK+ and ROS1+ aNSCLC in a real-life setting with no new safety concerns.
Clinical trial identification
NCT03718117.
Editorial acknowledgement
Legal entity responsible for the study
Pfizer SAS.
Funding
Pfizer.
Disclosure
D. Debieuvre: Financial Interests, Personal and Institutional, Principal Investigator: Pfizer; Financial Interests, Personal, Advisory Board: Pfizer. J. Grelier: Other, Personal, Full or part-time Employment: Pfizer. J. Le Treut: Financial Interests, Personal and Institutional, Advisory Board: Roche; Financial Interests, Personal and Institutional, Advisory Board: AstraZeneca; Financial Interests, Personal and Institutional, Advisory Board: Pfizer; Financial Interests, Personal and Institutional, Advisory Board: BMS; Financial Interests, Personal and Institutional, Advisory Board: MSF. All other authors have declared no conflicts of interest.