Objective: Irinotecan in combination with cisplatin for extensive-stage disease small-cell lung cancer （ED-SCLC） patients has gained wide interest. Varying results for this treatment underpin the need for a synthesis of evidence. Methods: We conducted a literature-based meta-analysis to quantify the magnitude of the benefit comparing irinotecan in combination with cisplatin （IP） with etoposide in combination with cisplatin （EP） in ED-SCLC patients. The primary outcome was overall survival （OS） and progression-free survival （PFS）; secondary outcomes included overall response rate

1- and 2-year survival rates

disease control rate and toxicity. Results: Four trials including 1

541 patients were identified in the analysis. No positive results （P<0.05） were seen: OS （HR=0.85

CI95%=0.71-1.01; P=0.08） with high heterogeneity （Chi 2 =7.76

df=3 P=0.05]; I 2 =61%）

PFS （HR=0.91

CI95%=0.74-1.28; P=0.36） with high heterogeneity （Chi 2 =11.96

df=3 P=0.008]; I 2 =75%）

overall response rate（OR=1.16; CI95%=0.79-1.70; P=0.45）

disease control rate （OR=1.01; CI95%=0.74-1.38; P=0.95）

1-year survival rate （OR = 1.30; CI95%=0.98-1.72; P=0.07） and 2-year survival rate （OR=1.97; CI95%=0.95-4.09; P=0.07）. Fewer patients who received IP suffered severe hematologic toxicities （grade≥3）

such as neutropenia

thrombocytopenia and leucopenia. However

severe non-hematologic toxicities （grade≥3）

such as diarrhea

nausea

vomiting

fatigue

anorexia

and dehydration

were more common among patients who received IP. Conclusion: IP does not lengthen the overall survival or progression-free survival compared with EP in patients with ED-SCLC. Fewer patients receiving IP had grade ≥ 3 hematological toxicities of neutropenia

leucopenia and thrombocytopenia

but more had grade≥3 diarrhea

nausea

vomiting

fatigue

anorexia and dehydration.