Phase II study of camtobell inj. (belotecan) in combination with cisplatin in patients with previously untreated, extensive stage small cell lung cancer

Seungtaek Lim, Byoung Chul Cho, Ji Ye Jung, Gun Min Kim, Se Hyun Kim, Hye Ryun Kim, Han Sang Kim, Sun Min Lim, Ji Soo Park, Jun Ho Lee, Darae Kim, Eun Young Kim, Moo Suk Park, Young Sam Kim, Se Kyu Kim, Joon Chang, Joo Hang Kim

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Abstract

The aim of this study was to investigate the efficacy and safety of belotecan in combination with cisplatin in patients with previously non-treated extensive stage small cell lung cancer. A total of 42 patients were enrolled and treated with combination of belotecan 0.5mg/m2 on daily basis throughout day 1-4 and cisplatin 60mg/m2 on day 1 of a 3-week cycle, up to 6 cycles. Treatment was continued until the completion of 6 cycles of the chemotherapy, disease progression, detection of unacceptable toxicity, withdrawal of the consent, or death of the patient. Response was assessed every 2 cycles of chemotherapy by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. Toxicity was assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 3.0. The overall response rate was 73.8% in an intention to treat population and 83.9% in the evaluable patients. With the median follow up of 9.9 months, the median progression free survival was 6.9 months (95% CI, 6.6-7.2 months), and median overall survival was 11.2 months (95% CI, 9.9-12.5 months). The frequently reported grade≥3 toxicities were neutropenia (90.2%), thrombocytopenia (63.4%), and anemia (34.1%). Febrile neutropenia was reported in 16 patients (39.0%). Although most of non-hematologic toxicities were grade 1 or 2, there were 4 patient deaths caused by pneumonia complicated by septic shock. Belotecan and cisplatin combination chemotherapy demonstrated a promising efficacy in ED SCLC patients. But, the hematologic toxicity of this regimen requires considerable amount of attention.

Original languageEnglish
Pages (from-to)313-318
Number of pages6
JournalLung Cancer
Volume80
Issue number3
DOIs
Publication statusPublished - 2013 Jun 1

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Small Cell Lung Carcinoma
Cisplatin
Drug Therapy
Febrile Neutropenia
National Cancer Institute (U.S.)
Septic Shock
belotecan
Combination Drug Therapy
Neutropenia
Terminology
Thrombocytopenia
Disease-Free Survival
Disease Progression
Anemia
Pneumonia
Safety
Survival
Population

All Science Journal Classification (ASJC) codes

  • Oncology
  • Pulmonary and Respiratory Medicine
  • Cancer Research

Cite this

Lim, Seungtaek ; Cho, Byoung Chul ; Jung, Ji Ye ; Kim, Gun Min ; Kim, Se Hyun ; Kim, Hye Ryun ; Kim, Han Sang ; Lim, Sun Min ; Park, Ji Soo ; Lee, Jun Ho ; Kim, Darae ; Kim, Eun Young ; Park, Moo Suk ; Kim, Young Sam ; Kim, Se Kyu ; Chang, Joon ; Kim, Joo Hang. / Phase II study of camtobell inj. (belotecan) in combination with cisplatin in patients with previously untreated, extensive stage small cell lung cancer. In: Lung Cancer. 2013 ; Vol. 80, No. 3. pp. 313-318.
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title = "Phase II study of camtobell inj. (belotecan) in combination with cisplatin in patients with previously untreated, extensive stage small cell lung cancer",
abstract = "The aim of this study was to investigate the efficacy and safety of belotecan in combination with cisplatin in patients with previously non-treated extensive stage small cell lung cancer. A total of 42 patients were enrolled and treated with combination of belotecan 0.5mg/m2 on daily basis throughout day 1-4 and cisplatin 60mg/m2 on day 1 of a 3-week cycle, up to 6 cycles. Treatment was continued until the completion of 6 cycles of the chemotherapy, disease progression, detection of unacceptable toxicity, withdrawal of the consent, or death of the patient. Response was assessed every 2 cycles of chemotherapy by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. Toxicity was assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 3.0. The overall response rate was 73.8{\%} in an intention to treat population and 83.9{\%} in the evaluable patients. With the median follow up of 9.9 months, the median progression free survival was 6.9 months (95{\%} CI, 6.6-7.2 months), and median overall survival was 11.2 months (95{\%} CI, 9.9-12.5 months). The frequently reported grade≥3 toxicities were neutropenia (90.2{\%}), thrombocytopenia (63.4{\%}), and anemia (34.1{\%}). Febrile neutropenia was reported in 16 patients (39.0{\%}). Although most of non-hematologic toxicities were grade 1 or 2, there were 4 patient deaths caused by pneumonia complicated by septic shock. Belotecan and cisplatin combination chemotherapy demonstrated a promising efficacy in ED SCLC patients. But, the hematologic toxicity of this regimen requires considerable amount of attention.",
author = "Seungtaek Lim and Cho, {Byoung Chul} and Jung, {Ji Ye} and Kim, {Gun Min} and Kim, {Se Hyun} and Kim, {Hye Ryun} and Kim, {Han Sang} and Lim, {Sun Min} and Park, {Ji Soo} and Lee, {Jun Ho} and Darae Kim and Kim, {Eun Young} and Park, {Moo Suk} and Kim, {Young Sam} and Kim, {Se Kyu} and Joon Chang and Kim, {Joo Hang}",
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Lim, S, Cho, BC, Jung, JY, Kim, GM, Kim, SH, Kim, HR, Kim, HS, Lim, SM, Park, JS, Lee, JH, Kim, D, Kim, EY, Park, MS, Kim, YS, Kim, SK, Chang, J & Kim, JH 2013, 'Phase II study of camtobell inj. (belotecan) in combination with cisplatin in patients with previously untreated, extensive stage small cell lung cancer', Lung Cancer, vol. 80, no. 3, pp. 313-318. https://doi.org/10.1016/j.lungcan.2013.02.009

Phase II study of camtobell inj. (belotecan) in combination with cisplatin in patients with previously untreated, extensive stage small cell lung cancer. / Lim, Seungtaek; Cho, Byoung Chul; Jung, Ji Ye; Kim, Gun Min; Kim, Se Hyun; Kim, Hye Ryun; Kim, Han Sang; Lim, Sun Min; Park, Ji Soo; Lee, Jun Ho; Kim, Darae; Kim, Eun Young; Park, Moo Suk; Kim, Young Sam; Kim, Se Kyu; Chang, Joon; Kim, Joo Hang.

In: Lung Cancer, Vol. 80, No. 3, 01.06.2013, p. 313-318.

Research output: Contribution to journalArticle

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T1 - Phase II study of camtobell inj. (belotecan) in combination with cisplatin in patients with previously untreated, extensive stage small cell lung cancer

AU - Lim, Seungtaek

AU - Cho, Byoung Chul

AU - Jung, Ji Ye

AU - Kim, Gun Min

AU - Kim, Se Hyun

AU - Kim, Hye Ryun

AU - Kim, Han Sang

AU - Lim, Sun Min

AU - Park, Ji Soo

AU - Lee, Jun Ho

AU - Kim, Darae

AU - Kim, Eun Young

AU - Park, Moo Suk

AU - Kim, Young Sam

AU - Kim, Se Kyu

AU - Chang, Joon

AU - Kim, Joo Hang

PY - 2013/6/1

Y1 - 2013/6/1

N2 - The aim of this study was to investigate the efficacy and safety of belotecan in combination with cisplatin in patients with previously non-treated extensive stage small cell lung cancer. A total of 42 patients were enrolled and treated with combination of belotecan 0.5mg/m2 on daily basis throughout day 1-4 and cisplatin 60mg/m2 on day 1 of a 3-week cycle, up to 6 cycles. Treatment was continued until the completion of 6 cycles of the chemotherapy, disease progression, detection of unacceptable toxicity, withdrawal of the consent, or death of the patient. Response was assessed every 2 cycles of chemotherapy by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. Toxicity was assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 3.0. The overall response rate was 73.8% in an intention to treat population and 83.9% in the evaluable patients. With the median follow up of 9.9 months, the median progression free survival was 6.9 months (95% CI, 6.6-7.2 months), and median overall survival was 11.2 months (95% CI, 9.9-12.5 months). The frequently reported grade≥3 toxicities were neutropenia (90.2%), thrombocytopenia (63.4%), and anemia (34.1%). Febrile neutropenia was reported in 16 patients (39.0%). Although most of non-hematologic toxicities were grade 1 or 2, there were 4 patient deaths caused by pneumonia complicated by septic shock. Belotecan and cisplatin combination chemotherapy demonstrated a promising efficacy in ED SCLC patients. But, the hematologic toxicity of this regimen requires considerable amount of attention.

AB - The aim of this study was to investigate the efficacy and safety of belotecan in combination with cisplatin in patients with previously non-treated extensive stage small cell lung cancer. A total of 42 patients were enrolled and treated with combination of belotecan 0.5mg/m2 on daily basis throughout day 1-4 and cisplatin 60mg/m2 on day 1 of a 3-week cycle, up to 6 cycles. Treatment was continued until the completion of 6 cycles of the chemotherapy, disease progression, detection of unacceptable toxicity, withdrawal of the consent, or death of the patient. Response was assessed every 2 cycles of chemotherapy by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. Toxicity was assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 3.0. The overall response rate was 73.8% in an intention to treat population and 83.9% in the evaluable patients. With the median follow up of 9.9 months, the median progression free survival was 6.9 months (95% CI, 6.6-7.2 months), and median overall survival was 11.2 months (95% CI, 9.9-12.5 months). The frequently reported grade≥3 toxicities were neutropenia (90.2%), thrombocytopenia (63.4%), and anemia (34.1%). Febrile neutropenia was reported in 16 patients (39.0%). Although most of non-hematologic toxicities were grade 1 or 2, there were 4 patient deaths caused by pneumonia complicated by septic shock. Belotecan and cisplatin combination chemotherapy demonstrated a promising efficacy in ED SCLC patients. But, the hematologic toxicity of this regimen requires considerable amount of attention.

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