Randomized phase II trial comparing amrubicin with topotecan in patients with previously treated small-cell lung cancer: North Japan lung cancer study group trial 0402

Journal of Clinical Oncology

Volumn 26, Issue 33, 2008, Pages 5401-5406

  Inoue, Akira ^a   Sugawara, Shunichi ^b   Yamazaki, Koichi ^b   Maemondo, Makoto ^b   Suzuki, Toshiro ^b   Gomi, Kazunori ^b   Takanashi, Shingo ^b   Inoue, Chieko ^b   Inage, Minoru ^b   Yokouchi, Hiroshi ^b   Watanabe, Hiroshi ^b   Tsukamoto, Toumei ^b   Saijo, Yasuo ^b   Ishimoto, Osamu ^b   Hommura, Fumihiro ^b   Nukiwa, Toshihiro ^b  

^a TOHOKU UNIVERSITY HOSPITAL   (Japan)

^b NONE

Author keywords

[No Author keywords available]

Indexed keywords

AMRUBICIN; TOPOTECAN;

ADULT; AGED; ANEMIA; ANOREXIA; ARTICLE; CANCER RELAPSE; CHEMOTHERAPY INDUCED EMESIS; CLINICAL TRIAL; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DRUG EFFICACY; DRUG SAFETY; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; FEVER; HUMAN; INFECTION; JAPAN; LUNG SMALL CELL CANCER; MAJOR CLINICAL STUDY; MALE; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUTROPENIA; OVERALL SURVIVAL; PHASE 2 CLINICAL TRIAL; PNEUMONIA; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; RANDOMIZED CONTROLLED TRIAL; STOMATITIS; THROMBOCYTOPENIA; TREATMENT OUTCOME;

AGED; ANTHRACYCLINES; CARCINOMA, SMALL CELL; DISEASE PROGRESSION; DISEASE-FREE SURVIVAL; FEMALE; HUMANS; LUNG NEOPLASMS; MALE; MIDDLE AGED; SURVIVAL RATE; TOPOTECAN;

EID: 56749131841     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.2008.18.1974     Document Type: Article

References (28)

1. Govindan R, Page N, Morgensztern D, et al: Changing epidemiology of small-cell lung cancer in the United States over the last 30 years: Analysis of the surveillance, epidemiologic, and end results database. J Clin Oncol 24:4539-4544, 2006
2. Murren J, Glasten E, Pass H, et al: Small cell lung cancer, in Devita VT, Rosenberg SA, Hellman S (eds): Cancer: Principles and Practice of Oncology (ed 6). Philadelphia, PA, Lippincott-Raven, 2001, pp 983-1018
3. Schiller J, Kim K, Hutson P, et al: Phase II study of topotecan in patients with extensive stage small cell carcinoma of the lung: Cooperative Group Trial. J Clin Oncol 14:2345-2352, 1996
4. 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. J Clin Oncol 15:2090-2096, 1997
5. Depierre A, von Pawel J, Hans K, et al: Evaluation of topotecan (Hycamtin) in relapsed small-cell lung cancer (SCLC): A multicenter phase II study. Lung Cancer 18:35, 1997 (suppl 1)
6. Eckardt J, Gralla R, Palmer MC, et al: Topotecan (T) as second-line therapy in patients (pts) with small cell lung cancer (SCLC): A phase II study. Ann Oncol 7:107, 1996 (suppl 5)
7. von Pawel J, Schiller JH, Shepherd FA, et al: Topotecan versus cyclophosphamide, doxorubicin, and vincristine for the treatment of recurrent small-ell lung cancer. J Clin Oncol 17:658-667, 1999
8. Tiseo M, Ardizzoni A: Current status of second-line treatment and novel therapies for small cell lung cancer. J Thorac Oncol 2:764-772, 2007
9. Kubota K, Nishiwaki Y, Kakinuma R, et al: Dose-intensive weekly chemotherapy for treatment of relapsed small-cell lung cancer. J Clin Oncol 15:292-296, 1997
10. Ardizzoni A, Manegold C, Debruyne C, et al: European Organization for Research and Treatment of Cancer (EORTC) 08957 phase II study of topotecan in combination with cisplatin as second-line treatment of refractory and sensitive small cell lung cancer. Clin Cancer Res 9:143-150, 2003
11. Yana T, Negoro S, Takada M, et al: Phase II study of amrubicin in previously untreated patients with extensive-disease small cell lung cancer: West Japan Thoracic Oncology Group (WJTOG) study. Invest New Drugs 25:253-258, 2007
12. Kobayashi K, Hino M, Fukuoka M, et al: Phase I studies of nogitecan hydrochloride for Japanese. Int J Clin Oncol 7:177-186, 2002
13. Masuda N, Fukuoka M, Kusunoki Y, et al: CPT-11: A new derivative of camptothecin for the treatment of refractory or relapsed small-cell lung cancer. J Clin Oncol 10:1225-1229, 1992
14. Perez-Soler R, Glisson BS, Lee JS, et al: Treatment of patients with small-cell lung cancer refractory to etoposide and cisplatin with the topoisomerase I poison topotecan. J Clin Oncol 14:2785-2790, 1996
15. Smyth JF, Smith IE, Sessa C, et al: Activity of docetaxel (Taxotere) in small cell lung cancer: The Early Clinical Trials Group of the EORTC. Eur J Cancer 30A:1058-1060, 1994
16. van der Lee I, Smit EF, van Putten JW, et al: Single-agent gemcitabine in patients with resistant small-cell lung cancer. Ann Oncol 12:557-561, 2001
17. Masters GA, Declerck L, Blanke C, et al: Phase II trial of gemcitabine in refractory or relapsed small-cell lung cancer: Eastern Cooperative Oncology Group Trial 1597. J Clin Oncol 21:1550-1555, 2003
18. Hoang T, Kim K, Jaslowski A: Phase II study of second-line gemcitabine in sensitive or refractory small cell lung cancer. Lung Cancer 42:97-102, 2003
19. Jassem J, Karnicka-Mlodkowska H, van Pottelsberghe C, et al: Phase II study of vinorelbine (Navelbine) in previously treated small cell lung cancer patients: EORTC Lung Cancer Cooperative Group. Eur J Cancer 29A:1720-1722, 1993
20. Furuse K, Kubota K, Kawahara M, et al: Phase II study of vinorelbine in heavily previously treated small cell lung cancer: Japan Lung Cancer Vinorelbine Study Group. Oncology 53:169-172, 1996
21. Smit EF, Fokkema E, Biesma B, et al: A phase II study of paclitaxel in heavily pretreated patients with small-cell lung cancer. Br J Cancer 77:347-351, 1998
22. Hanna NH, Ansari R, Bhatia S, et al: Pemetrexed in patients with relapsed small cell lung cancer: A phase II study from the Hoosier Oncology Group. J Clin Oncol 24:379s, 2006 (suppl; abstr 7063)
23. Onoda S, Masuda N, Seto T, et al: Phase II trial of amrubicin for treatment of refractory or relapsed small-cell lung cancer: Thoracic Oncology Research Group Study 0301. J Clin Oncol 24:5448-5453, 2006
24. Kato T, Nokihara H, Ohe Y, et al: Phase II trial of amrubicin in patients with previously treated small cell lung cancer (SCLC). J Clin Oncol 24:379s, 2006 (suppl; abstr 7061)
25. Eckardt JR, von Pawel J, Pujol JL, et al: Phase III study of oral compared with intravenous topotecan as second-line therapy in small-cell lung cancer. J Clin Oncol 25:2086-2092, 2007
26. Jotte R, Conkling PR, Reynolds C, et al: A randomized phase II trial of amrubicin (AMR) vs topotecan as second-line treatment in extensive-disease small-cell lung cancer (SCLC) sensitive to platinum-based first-line chemotherapy. J Clin Oncol 26:433s, 2008 (suppl; abstr 8040)
27. Takeda K, Negoro S, Sawa T, et al: A phase II study of topotecan in patients with relapsed small-cell lung cancer. Clin Lung Cancer 4:224-228, 2003
28. Ettinger DS, Jotte R, Gupta V, et al: A phase 2 trial of single-agent amrubicin in patients with extensive-disease small cell lung cancer (ED-SCLC) that is refractory or progressive within 90 days of completion of first-line platinum-based chemotherapy. J Clin Oncol 26:xxx, 2008 (suppl; abstr 8041)