GFPC 03-2019: A Comprehensive National Analysis of the Management of Patients With ROS1-Positive Metastatic NSCLC

ROS1 translocation (ROS1-positive) represents a rare subset of non-small cell lung cancer (NSCLC), occurring in approximately 1% to 2% of individuals diagnosed with NSCLC. Limited information is available regarding the management strategies and outcomes for these patients in the real-world setting.

Explore ALK/ROS is a French, noninterventional multicenter study that was composed of 2 parts and included ALK-positive NSCLC patients treated with next-generation ALK inhibitors. This study sought to investigate the management practices and clinical outcomes of a national cohort of patients diagnosed with ROS1-positive NSCLC. The analysis included all ROS1-positive NSCLC patients treated at 28 centers from June 1, 2013, the date of access in France, to November 13, 2023. The evaluation focused on patient characteristics, duration of treatment across different lines, locally assessed progression-free survival (PFS), overall survival (OS), response rates, and the tolerability of treatments, all derived from medical documentation.

The study encompassed 141 patients with advanced NSCLC who tested positive for ROS1. Among these participants, 58.0% were women, and 86.5% were either nonsmokers or former smokers. A significant majority, 97.9%, had adenocarcinomas, with a median age of 58 years. At the time of diagnosis, 20.6% of patients presented with local or locally advanced stages, while 24.0% of patients had brain metastases. The median follow-up period was 33.3 months. On average, patients underwent 2 systemic treatments, with 98.6%, 63.8%, and 36.9% receiving at least 1 (L1), 2 (L2), or ≥3 (L3+) lines of treatment, respectively. In the first line of treatment, the median real-world progression-free survival (rwPFS) for patients treated with crizotinib (63%) was 16.9 months, compared with 11.9 months for those receiving platinum-based chemotherapy (28.3%). In L2, the median rwPFS for patients treated with crizotinib (21.2%) was 25.6 months, while those receiving lorlatinib (23.4%) had a median rwPFS of 26.5 months. In L3, the median rwPFS for patients undergoing chemotherapy was 8.1 months among 13.5% of patients, compared with 28.5 months for 10.6% of patients receiving lorlatinib. The median OS was 81.7 months, 55.9 and 94.2 in patients with and without cerebral metastasis at the time of diagnosis. Treatment-related side effects led to interruptions in therapy for 14.9% of patients in L1.

This extensive real-world cohort of unselected patients with advanced ROS1-positive NSCLC validates the favorable prognosis associated with this condition.

Source: Bussac GR, Guisier F, Veillon R, et al. A national real-world analysis of ROS1+ metastatic non-small cell lung cancer patients management (explore ALK, cohort 2, GFPC 03-2019). Barcelona, Spain, & online: presented at ESMO Congress 2024; abstract 1292P.