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

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

doi:2006.60.1.57

Tuberc Respir Dis > Volume 60(1); 2006 > Article

Original Article

Tuberculosis and Respiratory Diseases 2006;60(1):57-64.
DOI: https://doi.org/10.4046/trd.2006.60.1.57 Published online January 1, 2006.

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

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

Department of Internal Medicine, College of Medicine, Korea University, Seoul, Korea. khin@korea.ac.kr

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.

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