Randomized phase III trial of irinotecan plus cisplatin versus etoposide plus cisplatin in chemotherapy-naïve Korean patients with extensive-disease small cell lung cancer

Dong Wan Kim, Hoon Gu Kim, Joo Hang Kim, Keunchil Park, Hoon Kyo Kim, Joung Soon Jang, Bong Seog Kim, Jin Hyoung Kang, Kyung Hee Lee, Sang We Kim, Hun Mo Ryoo, Jin Soo Kim, Ki Hyeong Lee, Jung Hye Kwon, Jin Hyuk Choi, Sang Won Shin, Seokyung Hahn, Dae Seog Heo

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Abstract

Purpose This randomized phase III study was designed to compare the efficacy and safety of irinotecan plus cisplatin (IP) over etoposide plus cisplatin (EP) in Korean patients with extensive-disease small-cell lung cancer (SCLC). Materials and Methods Patients were randomly assigned to receive IP, composed of irinotecan 65 mg/m2 intravenously on days 1 and 8+cisplatin 70 mg/m2 intravenously on day 1 every 3 weeks, or EP, composed of etoposide 100 mg/m2 intravenously on days 1, 2, 3+cisplatin 70 mg/m2 intravenously on day 1, every 3 weeks for a maximum of six cycles, until disease progression, or until unacceptable toxicity occurred. The primary endpoint was overall survival. Results A total of 362 patients were randomized to IP (n=173) and EP (n=189) arms. There were no significant differences between IP and EP arms for the median overall survival (10.9 months vs. 10.3 months, p=0.120) and the median progression-free survival (6.5 months vs. 5.8 months, p=0.115). However, there was a significant difference in response rate (62.4% vs. 48.2%, p=0.006). The pre-planned subgroup analyses showed that IP was associated with longer overall survival in male (11.3 months vs. 10.1 months, p=0.036), < 65 years old (12.7 months vs. 11.3 months, p=0.024), and Eastern Cooperative Oncology Group performance status 0/1 (12.4 months vs. 10.9 months, p=0.040) patient groups. The severity of treatment-related adverse events such as grade 3/4 anemia, nausea and diarrhea was more frequent in patients treated with IP. Conclusion The IP chemotherapy did not significantly improve the survival compared with EP chemotherapy in Korean patients with extensive-disease SCLC.

Original languageEnglish
Pages (from-to)119-127
Number of pages9
JournalCancer Research and Treatment
Volume51
Issue number1
DOIs
Publication statusPublished - 2019 Jan 1

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irinotecan
Small Cell Lung Carcinoma
Etoposide
Cisplatin
Drug Therapy
Survival

Keywords

  • Cisplatin
  • Etoposide
  • Irinotecan
  • Korean
  • Small cell lung carcinoma

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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Randomized phase III trial of irinotecan plus cisplatin versus etoposide plus cisplatin in chemotherapy-naïve Korean patients with extensive-disease small cell lung cancer. / Kim, Dong Wan; Kim, Hoon Gu; Kim, Joo Hang; Park, Keunchil; Kim, Hoon Kyo; Jang, Joung Soon; Kim, Bong Seog; Kang, Jin Hyoung; Lee, Kyung Hee; Kim, Sang We; Ryoo, Hun Mo; Kim, Jin Soo; Lee, Ki Hyeong; Kwon, Jung Hye; Choi, Jin Hyuk; Shin, Sang Won; Hahn, Seokyung; Heo, Dae Seog.

In: Cancer Research and Treatment, Vol. 51, No. 1, 01.01.2019, p. 119-127.

Research output: Contribution to journalArticle

Kim, DW, Kim, HG, Kim, JH, Park, K, Kim, HK, Jang, JS, Kim, BS, Kang, JH, Lee, KH, Kim, SW, Ryoo, HM, Kim, JS, Lee, KH, Kwon, JH, Choi, JH, Shin, SW, Hahn, S & Heo, DS 2019, 'Randomized phase III trial of irinotecan plus cisplatin versus etoposide plus cisplatin in chemotherapy-naïve Korean patients with extensive-disease small cell lung cancer', Cancer Research and Treatment, vol. 51, no. 1, pp. 119-127. https://doi.org/10.4143/crt.2018.019
Kim, Dong Wan ; Kim, Hoon Gu ; Kim, Joo Hang ; Park, Keunchil ; Kim, Hoon Kyo ; Jang, Joung Soon ; Kim, Bong Seog ; Kang, Jin Hyoung ; Lee, Kyung Hee ; Kim, Sang We ; Ryoo, Hun Mo ; Kim, Jin Soo ; Lee, Ki Hyeong ; Kwon, Jung Hye ; Choi, Jin Hyuk ; Shin, Sang Won ; Hahn, Seokyung ; Heo, Dae Seog. / Randomized phase III trial of irinotecan plus cisplatin versus etoposide plus cisplatin in chemotherapy-naïve Korean patients with extensive-disease small cell lung cancer. In: Cancer Research and Treatment. 2019 ; Vol. 51, No. 1. pp. 119-127.
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abstract = "Purpose This randomized phase III study was designed to compare the efficacy and safety of irinotecan plus cisplatin (IP) over etoposide plus cisplatin (EP) in Korean patients with extensive-disease small-cell lung cancer (SCLC). Materials and Methods Patients were randomly assigned to receive IP, composed of irinotecan 65 mg/m2 intravenously on days 1 and 8+cisplatin 70 mg/m2 intravenously on day 1 every 3 weeks, or EP, composed of etoposide 100 mg/m2 intravenously on days 1, 2, 3+cisplatin 70 mg/m2 intravenously on day 1, every 3 weeks for a maximum of six cycles, until disease progression, or until unacceptable toxicity occurred. The primary endpoint was overall survival. Results A total of 362 patients were randomized to IP (n=173) and EP (n=189) arms. There were no significant differences between IP and EP arms for the median overall survival (10.9 months vs. 10.3 months, p=0.120) and the median progression-free survival (6.5 months vs. 5.8 months, p=0.115). However, there was a significant difference in response rate (62.4{\%} vs. 48.2{\%}, p=0.006). The pre-planned subgroup analyses showed that IP was associated with longer overall survival in male (11.3 months vs. 10.1 months, p=0.036), < 65 years old (12.7 months vs. 11.3 months, p=0.024), and Eastern Cooperative Oncology Group performance status 0/1 (12.4 months vs. 10.9 months, p=0.040) patient groups. The severity of treatment-related adverse events such as grade 3/4 anemia, nausea and diarrhea was more frequent in patients treated with IP. Conclusion The IP chemotherapy did not significantly improve the survival compared with EP chemotherapy in Korean patients with extensive-disease SCLC.",
keywords = "Cisplatin, Etoposide, Irinotecan, Korean, Small cell lung carcinoma",
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T1 - Randomized phase III trial of irinotecan plus cisplatin versus etoposide plus cisplatin in chemotherapy-naïve Korean patients with extensive-disease small cell lung cancer

AU - Kim, Dong Wan

AU - Kim, Hoon Gu

AU - Kim, Joo Hang

AU - Park, Keunchil

AU - Kim, Hoon Kyo

AU - Jang, Joung Soon

AU - Kim, Bong Seog

AU - Kang, Jin Hyoung

AU - Lee, Kyung Hee

AU - Kim, Sang We

AU - Ryoo, Hun Mo

AU - Kim, Jin Soo

AU - Lee, Ki Hyeong

AU - Kwon, Jung Hye

AU - Choi, Jin Hyuk

AU - Shin, Sang Won

AU - Hahn, Seokyung

AU - Heo, Dae Seog

PY - 2019/1/1

Y1 - 2019/1/1

N2 - Purpose This randomized phase III study was designed to compare the efficacy and safety of irinotecan plus cisplatin (IP) over etoposide plus cisplatin (EP) in Korean patients with extensive-disease small-cell lung cancer (SCLC). Materials and Methods Patients were randomly assigned to receive IP, composed of irinotecan 65 mg/m2 intravenously on days 1 and 8+cisplatin 70 mg/m2 intravenously on day 1 every 3 weeks, or EP, composed of etoposide 100 mg/m2 intravenously on days 1, 2, 3+cisplatin 70 mg/m2 intravenously on day 1, every 3 weeks for a maximum of six cycles, until disease progression, or until unacceptable toxicity occurred. The primary endpoint was overall survival. Results A total of 362 patients were randomized to IP (n=173) and EP (n=189) arms. There were no significant differences between IP and EP arms for the median overall survival (10.9 months vs. 10.3 months, p=0.120) and the median progression-free survival (6.5 months vs. 5.8 months, p=0.115). However, there was a significant difference in response rate (62.4% vs. 48.2%, p=0.006). The pre-planned subgroup analyses showed that IP was associated with longer overall survival in male (11.3 months vs. 10.1 months, p=0.036), < 65 years old (12.7 months vs. 11.3 months, p=0.024), and Eastern Cooperative Oncology Group performance status 0/1 (12.4 months vs. 10.9 months, p=0.040) patient groups. The severity of treatment-related adverse events such as grade 3/4 anemia, nausea and diarrhea was more frequent in patients treated with IP. Conclusion The IP chemotherapy did not significantly improve the survival compared with EP chemotherapy in Korean patients with extensive-disease SCLC.

AB - Purpose This randomized phase III study was designed to compare the efficacy and safety of irinotecan plus cisplatin (IP) over etoposide plus cisplatin (EP) in Korean patients with extensive-disease small-cell lung cancer (SCLC). Materials and Methods Patients were randomly assigned to receive IP, composed of irinotecan 65 mg/m2 intravenously on days 1 and 8+cisplatin 70 mg/m2 intravenously on day 1 every 3 weeks, or EP, composed of etoposide 100 mg/m2 intravenously on days 1, 2, 3+cisplatin 70 mg/m2 intravenously on day 1, every 3 weeks for a maximum of six cycles, until disease progression, or until unacceptable toxicity occurred. The primary endpoint was overall survival. Results A total of 362 patients were randomized to IP (n=173) and EP (n=189) arms. There were no significant differences between IP and EP arms for the median overall survival (10.9 months vs. 10.3 months, p=0.120) and the median progression-free survival (6.5 months vs. 5.8 months, p=0.115). However, there was a significant difference in response rate (62.4% vs. 48.2%, p=0.006). The pre-planned subgroup analyses showed that IP was associated with longer overall survival in male (11.3 months vs. 10.1 months, p=0.036), < 65 years old (12.7 months vs. 11.3 months, p=0.024), and Eastern Cooperative Oncology Group performance status 0/1 (12.4 months vs. 10.9 months, p=0.040) patient groups. The severity of treatment-related adverse events such as grade 3/4 anemia, nausea and diarrhea was more frequent in patients treated with IP. Conclusion The IP chemotherapy did not significantly improve the survival compared with EP chemotherapy in Korean patients with extensive-disease SCLC.

KW - Cisplatin

KW - Etoposide

KW - Irinotecan

KW - Korean

KW - Small cell lung carcinoma

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