RESILIENT Part 2: A Randomized, Open-Label Phase III Study of Liposomal Irinotecan Versus Topotecan in Adults With
David R Spigel1, Afshin Dowlati2, Yuanbin Chen3
1Sarah Cannon Research Institute/Tennessee Oncology, Nashville, TN.
Summary
Second-line liposomal irinotecan and topotecan showed similar overall survival and progression-free survival in small cell lung cancer (SCLC). Liposomal irinotecan achieved a higher objective response rate but had fewer severe adverse events than topotecan.
Area of Science:
- Oncology
- Clinical Trials
- Pharmacology
Background:
- Small cell lung cancer (SCLC) is an aggressive malignancy with limited treatment options after first-line therapy.
- Relapsed SCLC necessitates effective second-line treatment strategies to improve patient outcomes.
- Topotecan has been a standard of care in the second-line setting for SCLC.
Purpose of the Study:
- To compare the efficacy and safety of second-line liposomal irinotecan versus topotecan in patients with SCLC.
- To evaluate overall survival (OS) as the primary endpoint in the RESILIENT trial.
- To assess secondary endpoints including progression-free survival (PFS) and objective response rate (ORR).
Main Methods:
- A phase III, randomized, open-label trial (RESILIENT) enrolled 461 patients with SCLC progressing on or after first-line platinum-based chemotherapy.
- Patients were randomized 1:1 to receive intravenous liposomal irinotecan (70 mg/m² every 2 weeks) or intravenous topotecan (1.5 mg/m² daily for 5 days every 3 weeks).
- Primary endpoint was OS; secondary endpoints included PFS and ORR, assessed by blinded independent central review (BICR).
Main Results:
- Median OS was 7.9 months for liposomal irinotecan vs. 8.3 months for topotecan (HR 1.11; P=.31).
- Median PFS was 4.0 months for liposomal irinotecan vs. 3.3 months for topotecan (HR 0.96; P=.71).
- Objective response rate (ORR) was significantly higher with liposomal irinotecan (44.1%) compared to topotecan (21.6%). Grade ≥3 treatment-emergent adverse events were less frequent with liposomal irinotecan (42.0%) than topotecan (83.4%).
Conclusions:
- Liposomal irinotecan and topotecan showed comparable median OS and PFS in patients with relapsed SCLC.
- While the primary endpoint of OS was not met, liposomal irinotecan demonstrated a superior ORR.
- The safety profile of liposomal irinotecan was consistent with known data, with fewer severe adverse events compared to topotecan.
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