Phase II study of amrubicin at a dose of 45 mg/m2 in patients with previously treated small-cell lung cancer

Japanese Journal of Clinical Oncology

Volumn 45, Issue 10, 2015, Pages 941-946

  Asao, Tetsuhiko ^a   Nokihara, Hiroshi ^a   Yoh, Kiyotaka ^b   Niho, Seiji ^b   Goto, Koichi ^b   Ohmatsu, Hironobu ^b   Kubota, Kaoru ^a,c   Yamamoto, Noboru ^a   Sekine, Ikuo ^a,d   Kunitoh, Hideo ^a,e   Fujiwara, Yutaka ^a   Ohe, Yuichiro ^a  

^a NATIONAL CANCER CENTER HOSPITAL   (Japan)

^b NATIONAL CANCER CENTER HOSPITAL EAST   (Japan)

^c NIPPON MEDICAL SCHOOL   (Japan)

^d UNIVERSITY OF TSUKUBA   (Japan)

^e JAPANESE RED CROSS MEDICAL CENTER   (Japan)

Author keywords

Amrubicin; Phase II; Salvage chemotherapy; Small cell lung cancer

Indexed keywords

ALANINE AMINOTRANSFERASE; AMRUBICIN; ASPARTATE AMINOTRANSFERASE; BILIRUBIN; CREATININE; ANTHRACYCLINE; ANTINEOPLASTIC AGENT;

ABNORMAL LABORATORY RESULT; ADULT; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ANGINA PECTORIS; ANOREXIA; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BILIRUBIN BLOOD LEVEL; CANCER RECURRENCE; CLINICAL ARTICLE; CONSTIPATION; CREATININE BLOOD LEVEL; DIARRHEA; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG SAFETY; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; HEART ARRHYTHMIA; HUMAN; HYPOKALEMIA; HYPONATREMIA; INCIDENCE; INFECTION; INJECTION SITE REACTION; LEUKOPENIA; MALAISE; MALE; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUTROPENIA; PHASE 2 CLINICAL TRIAL; PNEUMONIA; PROGRESSION FREE SURVIVAL; SMALL CELL LUNG CANCER; STOMATITIS; SURVIVAL RATE; SURVIVAL TIME; THROMBOCYTOPENIA; TREATMENT DURATION; TREATMENT RESPONSE; VOMITING; CLINICAL TRIAL; DISEASE FREE SURVIVAL; LUNG NEOPLASMS; MIDDLE AGED; SMALL CELL LUNG CARCINOMA; TUMOR RECURRENCE; YOUNG ADULT;

ADULT; AGED; ANTHRACYCLINES; ANTINEOPLASTIC AGENTS; DISEASE-FREE SURVIVAL; FEMALE; HUMANS; INCIDENCE; LUNG NEOPLASMS; MALE; MIDDLE AGED; NEOPLASM RECURRENCE, LOCAL; NEUTROPENIA; PNEUMONIA; SMALL CELL LUNG CARCINOMA; SURVIVAL RATE; THROMBOCYTOPENIA; YOUNG ADULT;

EID: 84944383571     PISSN: 03682811     EISSN: 14653621     Source Type: Journal    
DOI: 10.1093/jjco/hyv107     Document Type: Article

References (18)

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 2006;24:4539-44.
2. O'Brien ME, Ciuleanu TE, Tsekov H, et al. Phase III trial comparing supportive care alone with supportive care with oral topotecan in patients with relapsed small-cell lung cancer. J Clin Oncol 2006;24:5441-7.
3. 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 2006;24:5448-53.
4. Murakami H, Yamamoto N, Shibata T, et al. A single-arm confirmatory study of amrubicin therapy in patients with refractory small-cell lung cancer: Japan Clinical Oncology Group Study (JCOG0901). Lung Cancer 2014;84:67-72.
5. von Pawel J, Jotte R, Spigel DR, et al. Randomized Phase III trial of amrubicin versus topotecan as second-line treatment for patients with small-cell lung cancer. J Clin Oncol 2014;32:4012-9.
6. von Pawel J, Schiller JH, Shepherd FA, et al. Topotecan versus cyclophosphamide, doxorubicin, and vincristine for the treatment of recurrent smallcell lung cancer. J Clin Oncol 1999;17:658-67.
7. 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 2007;25:2086-92.
8. Goto K, Sekine I, Nishiwaki Y, et al. Multi-institutional phase II trial of irinotecan, cisplatin, and etoposide for sensitive relapsed small-cell lung cancer. Br J Cancer 2004;91:659-65.
9. Takigawa N, Ohnoshi T, Ueoka H, Kiura K, Kimura I. Comparison of antitumor activity of new anthracycline analogues, ME2303, KRN8602, and SM5887 using human lung cancer cell lines. Acta Med Okayama 1992;46:249-56.
10. Noguchi T, Ichii S, Morisada S, Yamaoka T, Yanagi Y. Tumor-selective distribution of an active metabolite of the 9-aminoanthracycline amrubicin. Jpn J Cancer Res 1998;89:1061-6
11. Sugiura T, Ariyoshi Y, Negoro S, et al. Phase I/II study of amrubicin, a novel 9-aminoanthracycline, in patients with advanced non-small-cell lung cancer. Invest New Drugs 2005;23:331-7.
12. Inoue A, Sugawara S, Yamazaki K, et al. 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. J Clin Oncol 2008;26:5401-6.
13. Therasse P, Arbuck SG, Eisenhauer EA, et al. 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 2000;92:205-16.
14. Simon R. Optimal two-stage designs for phase II clinical trials. Control Clin Trials 1989;10:1-10.
15. Jotte R, Conkling P, Reynolds C, et al. Randomized phase II trial of single-agent amrubicin or topotecan as second-line treatment in patients with small-cell lung cancer sensitive to first-line platinum-based chemotherapy. J Clin Oncol 2011;29:287-93.
16. Goto K, Ohe Y, Seto T, et al. A randomized phase III study of cisplatin (CDDP), etoposide (ETOP) and irinotecan versus topotecan as second-line chemotherapy in patients with sensitive relapsed small-cell lung cancer (SCLC): Japan Clinical Oncology Group study JCOG0605. ASCO Meeting Abstracts 2014;32(15 suppl):7504.
17. Giaccone G, Ferrati P, Donadio M, Testore F, Calciati A. Reinduction chemotherapy in small cell lung cancer. Eur J Cancer Clin Oncol 1987;23:1697-9.
18. Postmus PE, Berendsen HH, van Zandwijk N, Splinter TA, Burghouts JT, BakkerW. Retreatment with the induction regimen in small cell lung cancer relapsing after an initial response to short term chemotherapy. Eur J Cancer Clin Oncol 1987;23:1409-11.