Phase II study of cisplatin/etoposide and endostar for extensive-stage small-cell lung cancer

Purpose To investigate the efficacy and safety of endostar, a novel recombinant human endostatin, plus cisplatin, and etoposide in patients with extensive-stage small-cell lung cancer (ED-SCLC). Patients and methods Chemotherapy-naive patients with histologically confirmed, measurable ED-SCLC were enrolled. Treatment consisted of cisplatin (25 mg/m(2)) administered intravenously (IV) on days 1-3; etoposide (120 mg/m(2)) administered intravenously (IV) on days 1-3; endostar (15 mg) administered intravenously (IV) on days 1-14 every 21 days for up to four cycles. The primary objective was to assess the progression-free survival (FPS). Secondary objectives were to assess the objective response rate, median overall survival (OS), and treatment-related toxicity. Results Thirty-three patients were enrolled, the median age of the patients was 53 years (range, 29-74), twenty-three patients (69.7%) were men and 10 patients were women. Eastern Cooperative Oncology Group performance status scores were 0, 1, and 2 in 30.3, 60.6, and 9.1% of the patients, respectively. The overall response rate was 69.7%, one patient (3%) had a complete response, and 22 patients (66.7%) had partial responses. Five patients (15.1%) had stable disease; the median PFS was 5.0 months (95% CI, 4.2-5.6 months), and the 6-month PFS was 33.3%. The median OS was 11.5 months (95% CI, 9.6-13.4 months), and the 1-year OS was 38.1% (95% CI, 26-50.1%). Sixteen patients (48.5%) had at least one grade 3/4 adverse events; the most common grade 3/4 hematologic toxicity included neutropenia in 57.6%, thrombocytopenia in 12.1% of patients. The most common grade 3/4 non-hematologic toxicities included fatigue in 15.2%, nausea/vomiting in 9.1%, diarrhea in 6.1%, anorexia in 6.1%, mucositis in 6.1% of patients. Conclusion The addition of rh-endostain to cisplatin and etoposide in patients with ED-SCLC results in slightly improved PFS and OS relative to historical controls who received this chemotherapy regimen alone. This regimen appears to be well tolerated; the promising results suggest the further randomized phase III trial to define endostar's impact on SCLC treatment.