P48.08 Phase IV Clinical Study on the Safety and Efficacy of Lobaplatin-Based Regimen With Small Cell Lung Cancer

Abstract

Previous phase III studies have confirmed a similar efficacy of lobaplatin /etoposide (EL) to that of cisplatin /etoposide (EP) and more favorable safety profile including less gastrointestinal toxicity and nephrotoxicity as first-line treatment for extensive-stage SCLC(ED-SCLC). Based upon the evidence of this study, Chinese Society Of Clinical Oncology (CSCO) guidelines for SCLC have added EL regimen as an option for the first line treatment of ED-SCLC. We further carried out a phase IV study to systematically evaluate the safety and effectiveness of lobaplatin (LBP)-based regimen for widespread use in SCLC population. Patients diagnosed with SCLC were enrolled without therapeutic history limitation. The chemotherapy regimen was decided by the investigator with LBP administration required. The primary end point was safety and the secondary study endpoints included PFS, OS, ORR, and DCR. 1211 patients were enrolled from 30 centers in China. 780 patients were newly diagnosed with 96.18% treated with LBP plus etoposide; 431 were relapsed patients with 46.27% treated with LBP plus etoposide, 31.33% with LBP plus irinotecan and 21.69% with LBP alone. The average treatment cycle of treatment-naïve patients and relapsed patients were 3.9 and 3.6 cycles, respectively. The median follow-up period was 36 months. The efficacy of LBP-based treatment was similar to previous studies. The ORR, DCR, mPFS and mOS were shown in the table below. The overall and grade III/IV incidence of AE were 90.22% and 48.46%, respectively. The highest incidence of AE were leukopenia, neutropenia, thrombopenia, and anemia, with incidences of 66.7%, 61.7%, 42.3%, and 55.1%, and grade III/IV incidences were 24.1%, 36.0%, 14.8%, and 11.5%. The incidence of SAE was 8.04%, mainly because of myelosuppression which prolonged the hospital stays. There was no treatment-related death and no significant difference in the overall and grade III/IV incidence of AE between newly treated and relapsed patients. Besides, the total and grade III/IV incidence of thrombocytopenia were lower in both treatment-naïve and relapsed patients whose creatinine clearance > 80 ml/min.Tabled 1Treatment-naïve patientsRelapsed patientsOverall (n=780)LS-SCLC (n=322)ED-SCLC (n=458)Overall (n=431)LS-SCLC (n=122)ED-SCLC (n=309)ORR(%)66.1%69.1%64.0%33.438.731.1DCR(%)89.5%92.4%87.5%70.974.569.3mPFS(m)676453mOS(m)12.113.311.39.212.07.6 Open table in a new tab The LBP regimen is effective and safe for Chinese patients with SCLC. Clinical trial information: ChiCTR-ONC-13003470.