Randomized Phase III Trial of Irinotecan Plus Cisplatin versus Etoposide Plus Cisplatin in Chemotherapy-Naïve Korean Patients with Extensive-Disease Small Cell Lung Cancer
1
조회
0
다운로드
0
인용
0
참고문헌
키워드
초록
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 extensivedisease 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.
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 extensivedisease 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.
참고문헌 (24)
- Jemal A, "Global cancer statistics", CA Cancer J Clin, 61, pp.69~90 (2011)
- 정규원, "Cancer Statistics in Korea: Incidence, Mortality, Survival, and Prevalence in 2014", Cancer Research and Treatment, 49(2), pp.292~305 (2017), 대한암학회
- Sher T, "Small cell lung cancer", Mayo Clin Proc, 83, pp.355~367 (2008)
- Roth BJ, "Randomized study of cyclophosphamide, doxorubicin, and vincristine versus etoposide and cisplatin versus alternation of these two regimens in extensive smallcell lung cancer : a phase III trial of the Southeastern Cancer Study Group", J Clin Oncol, 10, pp.282~291 (1992)
- "Clinical practice guidelines in oncology: small cell lung cancer (version 1)" (2015)[URL]
- Fruh M, "Small-cell lung cancer (SCLC): ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up", Ann Oncol, 24(Suppl 6), pp.vi99~vi105 (2013)
- Lebeau B, "Six vs twelve cycles for complete responders to chemotherapy in small cell lung cancer: definitive results of a randomized clinical trial. The "Petites Cellules" Group", Eur Respir J, 5, pp.286~290 (1992)
- Masuda N, "CPT-11: a new derivative of camptothecin for the treatment of refractory or relapsed small-cell lung cancer", J Clin Oncol, 10, pp.1225~1229 (1992)
- Kudoh S, "West Japan Lung Cancer Group", J Clin Oncol, 16, pp.1068~1074 (1998)
- Negoro S, "A randomized phase III study of irinotecan and cisplatin (CP) versus etoposide and cisplatin (EP) in extensivedisease small-cell lung cancer (ED-SCLC): Japan Clinical Oncology Group Study (JCOG 9511)", Lung Cancer, 29(Suppl 1), pp.S30~ (2000)
- Noda K, "Irinotecan plus cisplatin compared with etoposide plus cisplatin for extensive small-cell lung cancer", N Engl J Med, 346, pp.85~91 (2002)
- Lara PN Jr, "Phase III trial of irinotecan", cisplatin compared with etoposide, J Clin Oncol, pp.2009, 27[DOI]
- Hanna N, "Randomized phase III trial comparing irinotecan", cisplatin with etoposide, J ClinOncol, pp.2006, 24[DOI]
- Lara PN Jr, "Common arm comparative outcomes analysis of phase 3 trials of cisplatin+irinotecan versus cisplatin+etoposide in extensive stage small cell lung cancer : final patientlevel results from Japan Clinical Oncology Group 9511 and Southwest Oncology Group 0124", Cancer, 116, pp.5710~5715 (2010)
- "Common Toxicity Criteria Manual, Common Toxicity Criteria, version 3" (2006)[URL]
- Therasse P, "New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada", J Natl Cancer Inst, 92, pp.205~216 (2000)
- Freedman LS, "Tables of the number of patients required in clinical trials using the logrank test", Stat Med, 1, pp.121~129 (1982)
- Shimoyama S, "Pharmacogenetics of irinotecan : An ethnicitybased prediction of irinotecan adverse events", World J Gastrointest Surg, 2, pp.14~21 (2010)
- de Jong FA, "ABCG2 pharmacogenetics : ethnic differences in allele frequency and assessment of influence on irinotecan disposition", Clin Cancer Res, 10, pp.5889~5894 (2004)
- Hoskins JM, "Irinotecan pharmacogenetics : influence of pharmacodynamic genes", Clin Cancer Res, 14, pp.1788~1796 (2008)
- Han JY, "Associations of ABCB1, ABCC2, and ABCG2 polymorphisms with irinotecan-pharmacokinetics and clinical outcome in patients with advanced non-small cell lung cancer", Cancer, 110, pp.138~147 (2007)
- Sohn JH, "Phase II trial of irinotecan and cisplatin with early concurrent radiotherapy in limited-disease small-cell lung cancer", Cancer, 109, pp.1845~1950 (2007)
- Han JY, "Phase II study of irinotecan plus cisplatin induction followed by concurrent twice-daily thoracic irradiation with etoposide plus cisplatin chemotherapy for limited-disease small-cell lung cancer", J Clin Oncol, 23, pp.3488~3494 (2005)
- Kubota K, "Etoposide and cisplatin versus irinotecan and cisplatin in patients with limited-stage small-cell lung cancer treated with etoposide and cisplatin plus concurrent accelerated hyperfractionated thoracic radiotherapy(JCOG0202) : a randomised phase 3 study", Lancet Oncol, 15, pp.106~113 (2014)