KEY TAKEAWAYS
- The phase 3 RESILIENT study compared liposomal irinotecan to topotecan in SCLC patients who had deteriorated following their first platinum therapy.
- The study’s key endpoint was OS, and the secondary endpoints included PFS and the ORR.
- The study’s results suggested that while the OS wasn’t significantly better for those on liposomal irinotecan than for those on topotecan, the ORR for liposomal irinotecan was twice as effective.
The phase III RESILIENT study included patients (pts) who had been histologically or cytologically diagnosed with small cell lung cancer (SCLC) and showed disease progression post their initial platinum chemotherapy. In the study, pts were divided evenly. They were either administered liposomal irinotecan intravenously (70 mg/m2, bi-weekly for a 6-week cycle) or given topotecan (1.5 mg/m2/day over 5 days, tri-weekly in a 6-week cycle).
The main endpoint was overall survival (OS), analyzed using the log-rank test, considering factors like region and platinum sensitivity, with a one-sided significance of 0.023. The secondary goals were progression-free survival (PFS) and the objective response rate (ORR), as assessed by an independent central review.
In total, 461 pts, with a median age of 62 years, 67.9% being men and 74.2% having ECOG performance status 1, participated in the study. Of these, 229 received liposomal irinotecan, and 232 received topotecan, with a median follow-up of 18.4 months. The median OS and PFS were 7.9 and 4.0 months for those on liposomal irinotecan, respectively. In comparison, those on topotecan had 8.3 and 3.3 months, respectively.
While the primary endpoint of OS didn’t show significant improvement with liposomal irinotecan compared to topotecan, there was a noticeable doubling in ORR. The side effects observed for liposomal irinotecan were in line with what’s already known, with no new safety issues identified.
Clinical Trial: https://classic.clinicaltrials.gov/ct2/show/NCT03088813
Rudin, C.M., Dowlati, A., Chen, Y., Mendivil, A.F.N., Yang, J.C., Stojanovic, G., Rich, P., Andric, Z.G., Wu, Y., Chen, H., Zhang, L., Yeung, S., Benzaghou, F.M., Paz-Ares, L., Bunn, P.A. 161O – RESILIENT part 2: A randomized, open-label phase III study of liposomal irinotecan versus topotecan in adults with relapsed small cell lung cancer (SCLC). Journal of Thoracic Oncology (2023) 18 (4S): S129-S136.
