Tuberc Respir Dis.  2006 Aug;61(2):143-149.

Phase II Study of Irinotecan Plus Cisplatin as First Line therapy in Extensive Small-Cell Lung Cancer

• Hwang KE
• Kim SY
• Jung JH
• Park SH
• Park JH
• Kim HJ
• Kim HR
• Yang SH
• Jeong ET

Abstract

BACKGROUND: 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.
METHODS
Thirty-nine patients with previously untreated extensive SCLC were enrolled in this study. Irinotecan 60mg/m(2) was administered intravenously on days 1, 8 and 15, and in combination with cisplatin 60mg/m(2) on day 1 and every 28 days thereafter. Four cycles of chemotherapy were given to the patients.
RESULTS
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.
CONCLUSION
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.

Keyword

Small-cell lung cancer; Irinotecan; Cisplatin

MeSH Terms

Cisplatin*
Diarrhea
Disease-Free Survival
Drug Therapy
Humans
Leukopenia
Lung Neoplasms*
Lung*
Survival Rate
Cisplatin

Figure

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  Figure 1 Kaplan-Meier survival curve MST: median survival time CI: confidence interval

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  Figure 2 Progression free survival curve MPFS: median progression free survival time CI: confidence interval

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