ROS1 mutation occurs in approximately 1-2% of patients with NSCLC. There are limited data on the efficacy of crizotinib therapy in the treatment of ROS1-positive advanced stage NSCLC. The survival results of two studies evaluating the efficacy of crizotinib in these patients are contradictory. In the study, we aimed to evaluate real life data of the patients with ROS1 positive advanced stage NSCLC treated with crizotinib in Turkey.
In this multicenter study, patients with ROS1-positive NSCLC treated with crizotinib were retrospectively analyzed. Clinical and demographic characteristics of the disease, response rates median PFS and side effects with crizotinib were evaluated in 42 patients.
Twenty-two of the patients (52.4%) were female, and 23 (54.8%) were non-smoker. The median age at the time of diagnosis was 51 (20-80) years. The most common histology was adenocarcinoma (n ve %). At baseline, 12 (28.6%) patients had pleural effusion, 11 (26.2%) had brain metastasis, and 17 (40.5%) had bone metastasis. The baseline ECOG performance score was "0" in 28.6% and “1” in 64.3%. Crizotinib was used in 45.2% of patients at the first line, 42.9% at the second line, and 12.0% in the next steps. The most common side effect was fatigue (43%). In 4 patients vascular event developed (3 thromboemboli, 1 acute MI). Brain metastasis developed in 31% of the patients at the follow-up. The overall response rate with crizotinib was 59.5% with 9.5% complete remission and 50.0% partial remission. The disease control rate was 83.3%. The median PFS was 13.2 months and the 12-month PFS was 53%. Twelve-month OS was 62%, the median OS was 25 months. Two patients who developed progression were treated with lorlatinib and one patient was treated with ceritinib and and then alectinib. Overall survival in these patients were 24 months, 28 months and 13.7 months, respectively.
In 2 published studies, median PFS in patients with ROS1-positive NSCLC with treated crizotinib were reported as 9.1 and 19.2 months independently of the treatment step. In our study, the median PFS was 13.2 months in patients as a result of real-life data of patients in Turkey. The clinical features of the disease are compatible with the literature.
Clinical trial identification
Legal entity responsible for the study
Turkish Oncology Group, Lung Cancer Subgrup.
Has not received any funding.
S. Kilickap: Pfizer. All other authors have declared no conflicts of interest.