Tuberc Respir Dis.  2006 Jan;60(1):57-64.

Phase II Trial of Irinotecan plus Cisplatin Combination as First Line Therapy for Patients with Small cell Lung Cancer

• Jeong HC
• Lee SY
• Kim JH
• Ha ES
• Jung JY
• Lee KJ
• Lee SH
• Kim SJ
• Lee EJ
• Hur GY
• Lee SY
• Kim JH
• Shin C
• Shim JJ
• In KH
• Kang KH
• Yoo SH

Abstract

BACKGROUND: Recently, there have been several studies showing that irinotecan hydrochloride, a topoisomerase I inhibitor, is effective against extensive disease(ED) small cell lung cancer (SCLC). We conducted a phase II trial to evaluate the efficacy and toxicity of irinotecan plus cisplatin as a 1st line therapy for both limited and extensive disease SCLC.
METHODS
The study was conducted between January 2002 and June 2004. Patients were treated with 60mg/m2 irinotecan on day 1, 8, 15 and 60mg/m2 cisplatin on day 1, every 4 weeks. During concurrent thoracic irradiation for limited disease (LD)-SCLC patients, dose of irinotecan was reduced to 40mg/m2. Prophylactic cranial irradiation was given to patients with complete remission (CR) after chemotherapy.
RESULTS
Median ages of LD- and ED-SCLC were 64 years and performance status (PS) was 0-2. In patients with LD-SCLC, the response rate after concurrent chemoradiotherapy was 85% (CR, 6; Partial response [PR], 11). The median survival was 20 months (95% CIs, 15.6 to 24.4) with 1-and 2-year survival rates of 85% and 35%, respectively. Median progression free survival (PFS) was 12 months (95% CIs, 6.2 to 18.1) with 1-year PFS of 36%. In ED-SCLC, the response rate was 83.4% (CR, 1; PR, 14). The median survival was 14.5 months (95% CIs, 8.8 to 20.1) with 1-year survival rates of 75%. Median PFS was 6.3 months (95% CIs, 5.6 to 7.1) with 1-year PFS of 20%. The major toxicities (grade 3 or 4) of this regimen included leukopenia, anemia, thrombocytopenia, nausea/vomiting, and diarrhea without life threatening complication.
CONCLUSION
Our data shows that the combination of irinotecan plus cisplatin as a first line therapy is effective and tolerable in the treatment of both LD- and ED-SCLC.

Keyword

Small cell lung cancer; Irinotecan; Cisplatin; 1st line therapy

MeSH Terms

Anemia
Chemoradiotherapy
Cisplatin*
Cranial Irradiation
Diarrhea
Disease-Free Survival
DNA Topoisomerases, Type I
Drug Therapy
Humans
Leukopenia
Small Cell Lung Carcinoma*
Survival Rate
Thrombocytopenia
Cisplatin
DNA Topoisomerases, Type I

Figure

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  Figure 1 Kaplan-Meier Survival Curve of patients with LD-SCLC. Median survival of LD-SCLC was 20 months (95% CIs; 15.6 to 24.4) with 1- & 2-year survival rates of 85% and 35%, respectIvely.

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  Figure 2 Progression Free Survival (PFS) of patients with LD-SCLC. Median PFS was 12 months (95% CIs; 6.2 to 18.1) with 1 year PFS of 36%.

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  Figure 3 Kaplan-Meier Survival Curve of patients with ED-SCLC. Median survival of ED-SCLC was 14.5 months (95% CIs; 8.8 to 20.1) with 1 year survival rate of 75%.

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  Figure 4 Progression Free Survival (PFS) of patients with ED-SCLC. Median PFS was 6.3 months (95% CIs; 5.6 to 7.1) with 1 year PFS of 20%

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