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Jeong, Lee, Kim, Ha, Jung, Lee, Lee, Kim, Lee, Hur, Lee, Kim, Shin, Shim, In, Kang, and Yoo: Phase II Trial of Irinotecan plus Cisplatin Combination as First Line Therapy for Patients with Small cell Lung Cancer
Original Article
Tuberculosis and Respiratory Diseases

Tuberculosis and Respiratory Diseases 2006; 60(1): 57-64.

Published online: 31 January 2006

DOI: https://doi.org/10.4046/trd.2006.60.1.57

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

Hye Cheol Jeong, M.D., Sang Yeub Lee, M.D., Jung Ha Kim, M.D., Eun Sil Ha, M.D., Jin Yong Jung, M.D., Kyung Ju Lee, M.D., Seung Hyeun Lee, M.D., Se Joong Kim, M.D., Eun Joo Lee, M.D., Gyu Young Hur, M.D., Sung Yong Lee, M.D., Je Hyeong Kim, M.D., Chol Shin, M.D., Jae Jeong Shim, M.D., Kwang Ho In, M.D., Kyung Ho Kang, M.D., Se Hwa Yoo, M.D.

Department of Internal Medicine, College of Medicine, Korea University, Seoul, Korea.

Address for correspondence: Kwang Ho In, M.D., Department of Internal Medicine, Korea University, Seoul, Korea 126-1, 5ga, Anam-Dong, Seongbuk-gu, Seoul, Korea. Phone: 02-920-5316, Fax: 02-929-2045, khin@korea.ac.kr

Received 31 August 2005       Accepted 12 December 2005

Copyright © 2006 The Korean Academy of Tuberculosis and Respiratory Diseases

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.

Keywords: Small cell lung cancer, Irinotecan, Cisplatin, 1st line therapy

Figures and Tables

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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Table 1
Baseline characterisitics of 38 patients with SCLC
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Abbreviation: ECOG, Eastern Cooperative Oncology Group LD, limited disease; ED, extensive disease

Table 2
Response of 38 patients with SCLC
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Abbreviation: CR, compleate response; PR, partial response; SD, stable disease; PD, progressive disease

Table 3
Tretment delivered
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Table 4
Number of treatment cycles by irinotecan doses and dose delivered to patients
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Table 5
Hematologic and nonhematologic toxicities of 20 patients with LD-SCLC
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Table 6
Hematologic and nonhematologic toxicities of patients with 18 ED-SCLC
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