Journal List > Tuberc Respir Dis > v.61(2) > 1000981

Hwang, Kim, Jung, Park, Park, Kim, Kim, Yang, and Jeong: Phase II Study of Irinotecan Plus Cisplatin as First Line therapy in Extensive Small-Cell Lung Cancer



Irinotecan (topoisomerase I inhibitor) is effective as a monotherapy against small-cell lung cancer(SCLC). Cisplatin is also an important drug against SCLC. A phase II study of irinotecan combined with cisplatin was carried out to evaluate the efficacy and toxicity of this combined regimen as a first line treatment in patients with extensive SCLC.


Thirty-nine patients with previously untreated extensive SCLC were enrolled in this study. Irinotecan 60mg/m2 was administered intravenously on days 1, 8 and 15, and in combination with cisplatin 60mg/m2 on day 1 and every 28 days thereafter. Four cycles of chemotherapy were given to the patients.


The overall response rate was 77% with a complete response (CR) rate of 8%. The median survival time, 1- and 2-year survival rate were 14.8 months, 60.9% and 27.6%, respectively. The median progression free survival time, 6-and 12-month progression free survival rate were 8.4 months, 75% and 18.8%, respectively. The WHO grade 3 or more toxicity encountered were leukopenia (23%), diarrhea (26%). Two patients changed their chemotherapeutic regimen and one patient died from severe diarrhea.


The combination of irinotecan and cisplatin is effective as a first line therapy in extensive SCLC is effective , but has severe or fatal diarrhea as toxicity.

Figures and Tables

Figure 1
Kaplan-Meier survival curve
MST: median survival time
CI: confidence interval
Figure 2
Progression free survival curve
MPFS: median progression free survival time
CI: confidence interval
Table 1
Patients characteristics
Table 2
Toxic effects according to WHO grading


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