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Cancer Res Treat. 2019 Jan;51(1):119-127. doi: 10.4143/crt.2018.019. Epub 2018 Mar 12.

Randomized Phase III Trial of Irinotecan Plus Cisplatin versus Etoposide Plus Cisplatin in Chemotherapy-Naïve Korean Patients with Extensive-Disease Small Cell Lung Cancer.

Author information

1
Department of Internal Medicine, Seoul National University Hospital, Seoul, Korea.
2
Division of Hematology-Oncology, Department of Internal Medicine, Gyeongsang National University Hospital, Jinju, Korea.
3
Department of Internal Medicine, Division of Medical Oncology, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Korea.
4
Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Seoul, Korea.
5
Department of Internal Medicine, St. Vincent's Hospital, The Catholic University of Korea, Suwon, Korea.
6
Division of Hematology/Oncology, Department of Internal Medicine, Chung-Ang University College of Medicine, Seoul, Korea.
7
Division of Hemato-Oncology, Department of Internal Medicine, Veterans Health Service Medical Center, Seoul, Korea.
8
Division of Medical Oncology, Department of Internal Medicine, Seoul St. Mary's Hospital, Seoul, Korea.
9
Department of Hematology-Oncology, Yeungnam University Medical Center, Daegu, Korea.
10
Division of Oncology, Department of Internal Medicine, Asan Medical Center, Seoul, Korea.
11
Department of Internal Medicine, Daegu Catholic University Hospital, Daegu, Korea.
12
Department of Internal Medicine, SMG-SNU Boramae Medical Center, Seoul, Korea.
13
Division of Medical Oncology, Chungbuk National University Hospital, Chungju, Korea.
14
Division of Hematology-Oncology, Department of Internal Medicine, Hallym University College of Medicine, Kangdong Sacred Heart Hospital, Seoul, Korea.
15
Department of Hematology-Oncology, Ajou University Hospital, Suwon, Korea.
16
Division of Oncology/Hematology, Department of Internal Medicine, Korea University Anam Hospital, Seoul, Korea.
17
Medical Research Collaborating Center, Seoul National University College of Medicine, Seoul, Korea.

Abstract

PURPOSE:

This randomized phase III study was designed to compare the efficacy and safety of irinote-can 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

PMID:
29529858
PMCID:
PMC6334001
DOI:
10.4143/crt.2018.019
[Indexed for MEDLINE]
Free PMC Article

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