Abstract 382P
Background
The ALK inhibitors (ALKi) are the standard of care in metastatic NSCLC with EML4-ALK rearrangements. Different ALKi have been used in the clinics, however, not all eligible patients get to be treated with them for various reasons. We attempted to find out the real-world data on the treatment outcome in our country.
Methods
This is a retrospective, multi-institutional study, conducted under Network of Oncology Clinical Trials India (NOCI). A total of 67 ALK-positive metastatic lung cancer patients were included from 10 institutes across India. Median follow up duration was 23 months.
Results
In 1st line, ORR with ALKi was 63.6% [crizotinib: 60.7%, ceritinib: 70%, alectinib: 66.6%, p=0.508] and that with chemotherapy was 26.1%. ORR for patients who were started on ALKi up front was similar to those patients who were switched to ALKi after few chemotherapy cycles; [63.6% for both groups]. But 18.2% in the former group achieved CR whereas only 9.1% achieved CR in the latter group. The median PFS (mPFS) for 1st line ALKi group was better compared to chemotherapy [19 mos vs. 9 months p= 0.00, HR= 0.30, (95% CI 0.17-0.54)]. Median PFS for crizotinib, alectinib and ceritinib were 17, 22 and 19 months respectively; p= 0.48. Patients who received ALKi up front or after 1 to 3 cycles of chemotherapy or after 4 or more number of cycles of chemotherapy, had mPFS of 16 months, 22 months and 23 months respectively (p=0.47). Median PFS in 2nd line for ALKi and chemotherapy were 14 months and 5 months respectively; p= 0.002. In third line mPFS for the respective groups were 20 months and 4 months; p=0.009. The median OS was better in those who received ALKi in any lines (44 mos vs 14 mos, p<0.001,HR=0.10, (95%CI 0.04-0.23)] Progression in the brain was higher among those who didn’t receive ALKi (69.2% vs 31.5%).
Conclusions
Use of ALKi in 1st line in ALK positive metastatic NSCLC patients resulted in improved PFS. PFS or ORR did not vary between patients who received ALKi upfront or were shifted to ALKi after starting with chemotherapy. Patients who received ALKi in second or later lines fared much better in comparison to chemotherapy. Use of ALKi in any lines of therapy resulted in significantly prolonged OS.
Clinical trial identification
CTRI/2022/01/039233.
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.
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