ELCC 2023: Liposomal Irinotecan Not Superior to Topotecan in Phase 3 Trial for Relapsed Small Cell Lung Cancer
No benefit seen for overall survival or progression-free survival, though doubling of objective response rate was seen
THURSDAY, April 6, 2023 (HealthDay News) -- Liposomal irinotecan does not increase overall survival (OS) versus topotecan for patients with relapsed small cell lung cancer (SCLC), according to study presented at the annual meeting of the European Lung Cancer Congress, held from March 29 to April 1 in Copenhagen, Denmark.
“Every time a randomized phase 3 trial fails, it is a big disappointment, especially in SCLC where second-line treatment is not especially effective and has a lot of side effects,” Paul Bunn, M.D., from the University of Colorado Denver, told Elsevier’s PracticeUpdate.
In the phase 3 RESILIENT trial, Bunn and colleagues randomly assigned 461 patients with SCLC who had progressed on or after receiving 1L platinum-based therapy to receive intravenous liposomal irinotecan (229 patients; 70 mg/m2 every two weeks in a six-week cycle) or topotecan (232 patients; 1.5 mg/m2/day for five days, every three weeks in a six-week cycle).
The researchers found that during a median follow-up of 18.4 months, median OS was 7.9 months with liposomal irinotecan versus 8.3 months with topotecan (hazard ratio [HR] for death, 1.11; 95 percent confidence interval [CI], 0.90 to 1.37; P = 0.3094), while progression-free survival was 4.0 and 3.3 months, respectively (HR for disease progression or death, 0.96; 95 percent CI, 0.77 to 1.20; nominal P = 0.7053). However, the objective response rate (based on blinded independent central reviews) was twice as high with liposomal irinotecan (44.1 percent versus 21.6 percent with topotecan).
The percentage of patients experiencing a grade 3 or higher treatment-related, treatment-emergent adverse event was twice as high with topotecan (42.0 percent for liposomal irinotecan versus 83.4 for topotecan).
“So obviously [these findings are] not going to change practice, but what will happen next is unknown,” Bunn told Elsevier’s PracticeUpdate. “There are many agents still being used in this space, and the hope is that something new will come along [and] be better.”
Several authors disclosed financial ties to the pharmaceutical industry, including IPSEN Bioscience, Inc., which funded the study.
Click on any of these tags to subscribe to Topic Alerts. Once subscribed, you can get a single, daily email any time PracticeUpdate publishes content on the topics that interest you.
Visit your Preferences and Settings section to Manage All Topic Alerts