Amrubicin Plus Irinotecan Demonstrates Promising Efficacy, Safety for Chemotherapy-Naïve Patients With Extensive-Disease Small Cell Lung Cancer
According to results from the phase 2 LC 08-01 trial, amrubicin plus irinotecan demonstrated promising efficacy and safety compared to cisplatin plus irinotecan among chemotherapy-naïve patients with extensive-disease small cell lung cancer (SCLC).
In this study, researchers randomized 100 patients on a 1-to-1 basis to receive either 90 mg/m2 of amrubicin on day 1 plus 50 mg/m2 of irinotecan on days 1 and 8 of a 21 day cycle (n = 50) or 60 mg/m2 of cisplatin on day 1 plus 60 mg/m2 of irinotecan on days 1, 8, and 15 of a 28 day cycle (n = 50). The primary end point was 1-year overall survival (OS). Key secondary end points included progression-free survival (PFS), objective response rate (ORR), and safety.
At analysis, the 1-year OS rate was 68% in the amrubicin arm and 59.2% in the cisplatin arm (P = .18) with a median survival time of 14.8 months and 13.5 months, respectively (hazard ratio [HR], 0.618; confidence interval [CI], 0.398 to 0.961; P = .31). The median PFS was 4.8 months in the amrubicin arm and 5.4 months in the cisplatin arm (P = .54). The ORR was 70% in the amrubicin arm and 55.1% in the cisplatin arm (P = .15).
Patients in the cisplatin arm experienced greater instances of vomiting, loss of appetite, diarrhea, and elevated serum creatinine. Grade 2/3 interstitial lung disease occurred in 5 patients in the amrubicin arm and 1 patient in the cisplatin arm. No treatment-related deaths occurred.
As Dr Yoshioka et al concluded, “Although the study did not meet its primary endpoint, [amrubicin plus irinotecan] showed promising efficacy and good tolerability in chemo-naïve patients with [extensive-disease]-SCLC.”
Source:
Yoshioka H, Ishida T, Atagi S, et al. Randomized phase II trial of amrubicin plus irinotecan versus cisplatin plus irinotecan in chemo-naïve patients with extensive-disease small-cell lung cancer: Results of the Japan multinational trial organization (JMTO) LC 08-01. Clin Lung Cancer. Published online: September 30, 2024. doi: 10.1016/j.cllc.2024.09.004
