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A Real-World Study: Therapeutic Outcomes of ROS1-Positive Advanced NSCLC
Hanqi Yuan1, Zihua Zou1,2, Xuezhi Hao1
1Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Background:
ROS1 gene rearrangement is an important target for NSCLC treatment. There is not yet sufficient real-world data on ROS1 diagnostic methods, treatment selection, and clinical outcomes in the Chinese population.
Methods:
A single-center retrospective collection of patients with a diagnosis of ROS1-positive advanced NSCLC from July 2011 to November 2021 was performed to document the method of ROS1 testing, treatment options, efficacy, and resistance to ROS1 inhibitors in these patients.
Results:
The method of ROS1 testing and initial treatment selection were significantly correlated with time. ROS1 testing shifted from FISH (67% pre-2019) to NGS (96.3% post-2019; p < 0.001). First-line ROS1-TKI use increased from 60.0% to 92.0% (p = 0.041). The vast majority of patients (90.0%) chose crizotinib as the initial ROS1 inhibitor, with objective response rates (for patients with target lesions) and median progression-free survival of 82.8% (95% CI: 68.1%-97.9%) and 18.7 months (95% CI: 8.9-28.4 months), respectively. CNS was the most common site of progression for crizotinib (60%, 13/26, including 11 intracranial progressions alone). Compared to patients who received a chemotherapy-based regimen (n = 8) as first-line therapy, patients who received ROS1-TKI (n = 32) as first-line therapy had significantly longer median PFS (18.3 months vs. 3.7 months, p < 0.001). For ROS1 inhibitor-resistant patients, 48.3% of patients underwent rebiopsy throughout the course of their disease, with G2032R being the most common secondary ROS1 mutation (7/8).
Conclusion:
With the innovation of diagnostic and therapeutic methods and the expansion of the scope of the health insurance coverage, more and more patients are benefiting from new technologies and targeted drugs. Although crizotinib has brought excellent therapeutic data for ROS1-positive patients, better brain protection strategies should be explored for ROS1-positive patients in the future. In addition, the low rate of rebiopsy in real-world ROS1-positive patients should also be emphasized in clinical practice.
Insights
Real-world data shows ROS1 testing shifted to NGS and ROS1-TKI use increased in Chinese NSCLC patients. Crizotinib demonstrated efficacy, but CNS progression necessitates better brain protection strategies.
Area of Science:
- Oncology
- Genetics
- Pharmacology
Background:
- ROS1 gene rearrangement is a key therapeutic target in non-small cell lung cancer (NSCLC).
- Limited real-world data exists on ROS1 diagnostic methods, treatment selection, and outcomes in the Chinese population.
Purpose of the Study:
- To analyze trends in ROS1 testing methods and treatment strategies for ROS1-positive advanced NSCLC in China.
- To evaluate the efficacy and resistance patterns of ROS1 inhibitors in a real-world setting.
Main Methods:
- Retrospective analysis of ROS1-positive advanced NSCLC patients treated between July 2011 and November 2021.
- Documentation of ROS1 testing methods (FISH vs. NGS), initial treatment choices (TKI vs. chemotherapy), efficacy, and resistance mechanisms.
Main Results:
- ROS1 testing evolved from FISH to NGS, with a significant increase in NGS use post-2019.
- First-line ROS1-TKI use rose significantly, with crizotinib being the primary choice (90%), achieving an 82.8% objective response rate and 18.7 months median PFS.
- Central nervous system (CNS) progression was common (60%) with crizotinib; rebiopsy revealed G2032R as the most frequent secondary mutation (48.3% of resistant cases).
Conclusions:
- Advancements in diagnostics and therapeutics, alongside expanded insurance coverage, are improving patient outcomes for ROS1-positive NSCLC.
- While crizotinib shows efficacy, improved CNS protection strategies are needed.
- Emphasis on increasing rebiopsy rates in clinical practice is crucial for managing resistance.
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