Topotecan for Small Cell Lung Cancer: A Systematic Review_Chinese Journal of Evidence-Based Medicine

Authors：

WANG Xiaoshan ¹ ,  WU Taixiang ² , HOU Mei ¹

1. Clinical Oncology Center, West China Hospital, Sichuan University, Chengdu 610041, China; 2. Chinese Evidence-Based Medicine Center/INCLEN CERTC, West China Hospital, Sichuan University, Chengdu 610041, China;

Corresponding author：

WU Taixiang, Email: xiaoshanwangxue@163.com

Keywords：

Topotecan; Small cell lung cancer; Treatment; Systematic review

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Objective 　To evaluate the role of topotecan in the treatment of small cell lung cancer (SCLC).
Methods 　Up to 2006, we searched The Cochrane Library, MEDLINE, EMbase, Cancerlit, CBM, CNKI and VIP. Handsearch and additional search were also conducted. The quality of included studies was evaluated and meta-analyses were performed for the results of homogeneous studies by RevMan 4.2.8 software.
Results 　Fourteen studies involving 2 099 participants with SCLC were included. All included studies were adequate in reporting randomization, while inadequate in allocation concealment and blinding. Meta-analyses showed that the response rate of TP (topotecan + cisplatin) regimen had no significant difference compared with EP regimen (etoposide + cisplatin) with OR 0.83 and 95%CI 0.63 to 1.09, but myelo-suppression such as leucopenia and thrombopenia was more severe with TP regimen; the response rate of monotherapy with topotecan was similar with that of CE (carboplatin + etoposide) regimen with OR 0.59 and 95%CI 0.22 to 1.60; the response rate of TEP (topotecan + etoposide + cisplatin) regimen was comparable with that of EP regimen with OR 1.37 and 95%CI 0.82 to –2.28, but myelosuppression and anemia were more severe with TEP regimen; the response rate with OR 0.97 and 95％CI 0.60 to –1.57, median time to progression with WMD –2.32 and 95％CI –5.72 to 1.09 and median survival time with WMD –1.65 and 95％CI –7.13 to 3.83 of IV topotecan were similar to those of oral topotecan, while neutropenia was more severe with IV topotecan. Forty-five treatment-related deaths were reported in all included studies.
Conclusions 　Topotecan is an effective agent for SCLC when used as monotherapy or in combined treatment, but myelosuppression such as leucopenia and thrombopenia was relatively severe. Although it has been recommended as a second-line agent for recurrence of sensitive SCLC, more clinical trials are needed to define its role in first-line treatment. Due to a high risk of selection bias and detection bias in included studies, the evidence is insufficient to determine the effect of topotecan. Further large-scale trials are required to define the role of topotecan in the treatment of SCLC.

Citation： WANG Xiaoshan,WU Taixiang,HOU Mei. Topotecan for Small Cell Lung Cancer: A Systematic Review. Chinese Journal of Evidence-Based Medicine, 2007, 07(3): 189-203. doi: Copy

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1. Chinese Society of Clinical Oncology. 2006. http://www.csco.net.cn. (Updated yearly).
2. Tang ZY, Zhu SN, Cao SL. Editor-in-Chief. Modern Oncology. 2nd Edition. Shanghai: Publishing Company of Shanghai Medical University, 2000. 876.
3. Kang P, Yu QT, Li ZG. Clinical observation of topotecan and cisplatin combination chemotherapy for small cell lung cancer. Guangxi Medical Journal, 2002, 24(10): 1541–1542.
4. Liu W, Liu Y, Gu ZP, et al. Comparative study on topotecan plus cisplatin as preoperative neoadjuvant chemotherapy for small cell lung cancer. Chinese Journal of Misdiagnostics, 2004, 4(11): 1790–1792.
5. Gao YJ, Liu JW, Ban LY, et al. Clinical study of domestic topotecan hydrochloride in the treatment of small cell lung cancer. Chinese Journal of Current Practical Medicine, 2004, 3(16): 11–12.
6. Li R, Yang J, Li EX, et al. Phase Ⅱ clinical trial of domestic TPT (topotecan) hydrochloride. Chinese New Drugs Journal, 2001, 10(10): 760–763.
7. Su YQ, Chou JR, Liu Lk, et al. Clinical observation of topotecan and etoposide plus cisplatin in treating small cell lung cancer. Chinese Clinical Oncology, 2004, 9(1): 5–7.
8. Qi YE, Liu YH, Zheng MZ, et al. Clinical comparative study of topotecan/etoposide vs. etoposide/cisplatin as first-line treatment in patients with small cell lung cancer. Journal of China Medical University, 2005, 34(3): 269–270.
9. Ma SR. Topotecan hydrochloride in combination with Cisplatin in patients with small cell lung cancer. Journal of Medical Forum, 2003, 24(6): 41.
10. Shi HL, Zhu YZ, Liu Z, et al. Study on topotecan in the treatment of small-cell lung cancer. Beijing Medical Journal, 2002, 24(4): 251–253.
11. Xu JH, J Zhou JT, Zhou WW, et al. Clinical study of topotecan plus cisplatin in patients with small cell lung cancer. Cancer Research and Clinic, 2005, 17(1): 35–36.
12. American Cancer Society: Cancer Facts and Figures 2006. Atlanta, Ga; American Cancer Society, 2006. [2006-08-07]. http://www.cancer.org,Last accessed August 7, 2006.
13. 中国抗癌协会临床肿瘤学协作专业委员会. 2006年. http://www.csco.net.cn. (常规每年更新).
14. 汤钊猷, 朱世能, 曹世龙. 主编. 现代肿瘤学. 第2版. 上海: 上海医科大学出版社, 2000. 876.
15. Okuno SH, Jett JR. Small cell lung cancer: current therapy and promising new regimens. The Oncologist, 2002, 7: 234–238.
16. Schiller JH. Current standards of care in small-cell and non-small-cell lung cancer. Oncology, 2001, 61(Suppl 1): 3–13.
17. von Pawel J. The role of topotecan in treating small cell lung cancer: second-line treatment. Lung Cancer, 2003, 41(Suppl 4): S3–S8.
18. Topotecan. An Oncologist’ View.Centre Francois Baclesse, Centre Régional de Lutte Contre le Cancer, Caen, France. The Oncologist, 1998, 3: 390–402.
19. Depierre A, von Pawel J, Hans K, et al. Evaluation of topotecan (Hycam-tin(TM)) in relapsed small cell lung cancer (SCLC). A multicentre phase II study. Lung Cancer, 1997, 18(Suppl 1): 35.
20. Ardizzoni A, Hansen H, Dombernowsky P, et al. Topotecan, a new active drug in the second-line treatment of small-cell lung cancer: a phase II study in patients with refractory and sensitive disease. The European Organization for Research and Treatment of Cancer Early Clinical Stud-ies Group and New Drug Development Office, and the Lung Cancer Cooperative Group. J Clin Oncol, 1997, 15: 2090–2096.
21. Perez-Soler R, Glisson BS, Lee JS, et al. Treatment of patients with small-cell lung cancer refractory to etoposide and cisplatin with the topoisomer-ase I poison topotecan. J Clin Oncol, 1996, 14: 2785–2790.
22. Sandler AB. Chemotherapy for small cell lung cancer. Semin Oncol, 2003, 30: 9–25.
23. Ardizzoni A, Hansen H, Dombernowsky P, et al. Topotecan, a new active drug in the second-line treatment of small-cell lung cancer: a phase II study in patients with refractory and sensitive disease. The European Organization for Research and Treatment of Cancer Early Clinical Studies Group and New Drug Development Office, and the Lung Cancer Cooperative Group. J Clin Oncol, 1997, 15: 2090–2096.
24. Depierre A, von Pawel J, Hans K, et al. Evaluation of topotecan in relapsed small cell lung cancer (SCLC). A (Hycamtin multicentre phase II study. Lung Cancer, 1997, 18(Suppl 1): 35.
25. Eckardt J, Gralla R, Palmer MC, et al. Topotecan (T) as secondline therapy in patients (Pts) with small cell lung cancer(SCLC): a phase II study. Ann Oncol, 1996, 7(Suppl 5): 107.
26. von Pawel J, Schiller JH, Shepherd FA, et al. Topotecan versus cyclophosphamide, doxorubicin, and vincristine for the treatment of recurrent small-cell lung cancer. J Clin Oncol, 1999, 17: 658–667.
27. Korfel A, Oehm C, von Pawel J, et al. Response to topotecan of symptomatic brain metastases of small-cell lung cancer also after whole-brain irradiation: a multicentre phase II study. Eur J Cancer, 2002, 38: 1724–1729.
28. Wong ET, Berkenblit A. The role of topotecan in the treatment of brain metastases. The Oncologist, 2004, 9: 68–79.
29. Bahadori HR, Green MR, Catapano CV. Synergistic interaction between topotecan and microtubule-interfering agents. Cancer Chemother Pharmacol, 2001, 48: 188–196.
30. Nagourney RA, Sommers BL, Harper SM, et al. Ex vivo analysis of topotecan: advancing the application of laboratory-based clinical therapeutics. Br J Cancer, 2003, 89: 1789–1795.
31. Jonsson E, Fridborg H, Nygren P, et al. Synergistic interactions of combinations of topotecan with standard drugs in primary cultures of human tumor cells from patients. Eur J Clin Pharmacol, 1998, 54: 509–514.
32. Greco FA. Topotecan as first-line therapy for small cell lung cancer. Lung Cancer, 2003, 41(Suppl 4): S9–S16.
33. Alderson P, Green S, Higgins JPT, editors. Cochrane Reviewer’s Handbook 4.2.2 (updated March 2004). The Cochrane Library. Chichester, UK: John Wiley & Sons, Ltd, 2004.
34. Higgins JPT, Thompson SG. Quantifying heterogeneity in a meta-analysis. Stat Med, 2002, 21(11): 1539–1558.
35. Egger M, Davey Smith G, Schneider M, et al. Bias in meta-analysis detected by a simple,graphical test. BMJ, 1997, 315(7109): 629–634.
36. 康平, 于起涛, 李志革. 拓扑替康联合顺铂治疗小细胞肺癌临床观察. 广西医学, 2002, 24(10): 1541~1542.
37. 刘文, 刘勇, 谷仲平, 等. 拓扑替康联合顺铂在小细胞肺癌术前新辅助化疗效果和耐受性. 中国误诊学杂志, 2004, 4(11): 1790~1792.
38. 高亚杰, 刘基巍, 班丽英, 等. 国产盐酸拓扑替康治疗小细胞肺癌的临床研究. 中国现代实用医学杂志, 2004, 3(16): 11~12.
39. 李蓉, 杨谨, 李恩孝, 等. 国产盐酸拓扑替康治疗小细胞肺癌Ⅱ期临床试验. 中国新药杂志, 2001, 10(10): 760~763.
40. 束永前, 仇金荣, 刘连科, 等. 拓扑替康、依托泊甙联合顺铂治疗小细胞肺癌的临床观察. 临床肿瘤学杂志, 2004, 9(1): 5~7.
41. 膝月娥, 刘云鹤, 郑美珍, 等. 拓扑替康联合顺铂与足叶乙甙联合顺铂一线治疗小细胞肺癌的临床比较研究. 中国医科大学学报, 2005, 34(3): 269~270.
42. 马书仁. 盐酸拓扑替康顺铂治疗小细胞肺癌. 医药论坛杂志, 2003, 24(6): 41.
43. 史鹤玲, 朱允中, 刘哲, 等. 盐酸拓扑替康治疗小细胞肺癌临床研究. 北京医学, 2002, 24(4): 251~253.
44. 徐建华, 周均田, 周文伟, 等. 拓扑替康联合顺铂治疗小细胞肺癌的临床研究. 肿瘤研究与临床, 2005, 17(1): 35~36.
45. Eckardt JR, von Pawel J, Papai Z, et al. Open-label, multicenter, randomized, phase Ⅲ study comparing oral topotecan/ cispl atin versus etoposide/ cisplatin as treatment for chemotherapy-naive patients with extensive-disease small-cell lung cancer. J Clin Oncol, 2006, 24(13): 2044–2051.
46. Ignatiadis M, Mavroudis D, Veslemes M, et al. Sequential versus alternating administration of cisplatin/ etoposide and topotecan as first-line treatment in extensive-stage small-cell lung cancer: preliminary results of a Phase III Trial of the Hellenic Oncology Research Group. Clin Lung Cancer, 2005, 7(3): 183–189.
47. Greco FA, Thompson DS, Morrissey LH, et al. Paclitaxel/ carboplatin/ etoposide versus paclitaxel/ topotecan for extensive-stage small cell lung cancer: a Minnie Pearl Cancer Research Network randomized, prospective phase II trial. Oncologist, 2005, 10(9): 728–733.
48. Quoix E, Breton JL, Gervais R, et al. A randomised phase II study of the efficacy and safety of intravenous topotecan in combination with either cisplatin or etoposide in patients with untreated extensive disease small-cell lung cancer. Lung Cancer, 2005, 49(2): 253–261.
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Chinese Journal of Evidence-Based Medicine

Topotecan for Small Cell Lung Cancer: A Systematic Review

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