Dose escalation and feasibility study of amrubicin combined with cisplatin in previously untreated patients with advanced non-small cell lung cancer

American Journal of Clinical Oncology: Cancer Clinical Trials

Volumn 36, Issue 2, 2013, Pages 105-109

  Yoshimura, Naruo ^a   Kimura, Tatsuo ^a   Mitsuoka, Shigeki ^a   Kyoh, Shigenori ^a   Tochino, Yoshihiro ^a   Asai, Kazuhisa ^a   Ichimaru, Yukikazu ^a   Hirata, Kazuto ^a   Kudoh, Shinzoh ^a  

^a OSAKA CITY UNIVERSITY GRADUATE SCHOOL OF MEDICINE   (Japan)

Author keywords

amrubicin; chemotherapy; cisplatin; non small cell lung cancer

Indexed keywords

ALANINE AMINOTRANSFERASE; AMRUBICIN; ASPARTATE AMINOTRANSFERASE; BILIRUBIN; CARBOPLATIN; CISPLATIN; CREATININE; DOCETAXEL; GEFITINIB; PACLITAXEL; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR;

ADULT; ADVANCED CANCER; AGED; ANOREXIA; ARTICLE; CANCER COMBINATION CHEMOTHERAPY; CANCER PATIENT; CANCER STAGING; CANCER SURVIVAL; CHEMOTHERAPY INDUCED ANEMIA; CHEMOTHERAPY INDUCED EMESIS; CHEMOTHERAPY INDUCED NAUSEA AND VOMITING; CLINICAL ARTICLE; CLINICAL TRIAL; CONSTIPATION; DIARRHEA; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG FATALITY; DRUG FEVER; DRUG RESPONSE; FATIGUE; FEASIBILITY STUDY; FEBRILE NEUTROPENIA; FEMALE; HUMAN; LARGE CELL CARCINOMA; LEUKOPENIA; LUNG ADENOCARCINOMA; LUNG NON SMALL CELL CANCER; MALE; MULTIPLE CYCLE TREATMENT; NEUROPATHY; NEUTROPENIA; OVERALL SURVIVAL; PROGRESSION FREE SURVIVAL; RECOMMENDED DRUG DOSE; SIDE EFFECT; SQUAMOUS CELL CARCINOMA; SURVIVAL RATE; SURVIVAL TIME; THROMBOCYTOPENIA;

AGED; ANTHRACYCLINES; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CARCINOMA, NON-SMALL-CELL LUNG; CISPLATIN; DOSE-RESPONSE RELATIONSHIP, DRUG; FEASIBILITY STUDIES; FEMALE; HUMANS; LUNG NEOPLASMS; MALE; MIDDLE AGED; SURVIVAL RATE; TREATMENT OUTCOME;

EID: 84876144461     PISSN: 02773732     EISSN: 1537453X     Source Type: Journal    
DOI: 10.1097/COC.0b013e31823fe617     Document Type: Article

References (20)

1. Parkin DM. Global cancer statistics in the year 2000. Lancet Oncol. 2001;2:533-543.
2. Schiller JH, Harrington D, Belani CP, et al. Comparison of four chemotherapy regimens for advanced non-small-cell lung cancer. N Engl J Med. 2002;346:92-98.
3. Kelly K, Crowley J, Bunn PA, et al. Randomized phase III trial of paclitaxel plus carboplatin versus vinorelbine plus cisplatin in the treatment of patients with advanced non-small-cell lung cancer: a Southwest Oncology Group trial. J Clin Oncol. 2001;19:3210-3218.
4. Scagliotti GV, De Marinis F, Rinaldi M, et al. Phase III randomized trial comparing three platinum-based doublets in advanced non-small-cell lung cancer. J Clin Oncol. 2002;20:4285-4291.
5. Smit EF, van Meerbeeck JP, Lianes P, et al. Three-arm randomized study of two cisplatin-based regimens and paclitaxel plus gemcitabine in advanced non-small-cell lung cancer: a phase III trial of the European Organization for Research and Treatment of Cancer Lung Cancer Group-EORTC 08975. J Clin Oncol. 2003;21:3909-3917.
6. Ohe Y, Ohashi Y, Kubota T, et al. Randomized phase III study of cisplatin plus irinotecan versus carboplatin plus paclitaxel, cisplatin plus gemcitabine, and cisplatin plus vinorelbine for advanced non-small-cell lung cancer: four-arm cooperative study in Japan. Ann Oncol. 2007;18:317-323.
7. Scagliotti GV, Parikh P, von Pawel J, et al. Phase III study comparing cisplatin plus gemcitabine with cisplatin plus peme-trexed in chemotherapy-naive patients with advanced-stage non-small-cell lung cancer. J Clin Oncol. 2008;26:3543-3551.
8. Ishizumi K, Ohashi N, Tanno N. Stereospecific total synthesis of 9-aminoanthracyclines: (+)-9-amino-9-deoxydaunomycin and related compounds. J Org Chem. 1987;52:4477-4485.
9. Hanada M, Mizuno S, Fukushima A, et al. A new antitumor agent amrubicin induces cell growth inhibition by stabilizing topoisomer-ase II-DNA complex. Jpn J Cancer Res. 1998;89:1229-1238.
10. Yamaoka T, Hanada M, Ichii S, et al. Cytotoxicity of amrubicin, a novel 9-aminoanthracycline, and its active metabolite amrubicinol on human tumor cells. Jpn J Cancer Res. 1998;89:1067-1073.
11. Hanada M, Noguchi T, Yamaoka T. Amrubicin induces apoptosis in human tumor cells mediated by the activation of caspase-3/7 preceding a loss of mitochondrial membrane potential. Cancer Sci. 2009;97:1396-1403.
12. Morisada S, Yanagi Y, Noguchi T, et al. Antitumor activities of a novel 9-aminoanthracycline (SM-5887) against mouse experimental tumors and human tumor xenografts. Jpn J Cancer Res. 1989; 80:69-76.
13. Noda T, Watanabe T, Kohda A, et al. Chronic effects of a novel synthetic anthracycline derivative (SM-5887) on normal heart and doxorubicin-induced cardiomyopathy in beagle dogs. Invest New Drugs. 1998;16:121-128.
14. Takeda K, Takifuji N, Negoro S, et al. Phase II study of amrubicin, 9-amino-anthracycline, in patients with advanced non-small-cell cancer: a West Japan Thoracic Oncology Group (WJTOG) study. Invest New Drugs. 2007;25:377-383.
15. Yamauchi S, Kudoh S, Kimura T, et al. Additive effects of amrubicin with cisplatin on human lung cancer cell lines. Osaka City Med J. 2002;48:69-76.
16. Hanada H, Noguchi T, Yamaoka T. Amrubicin a novel 9-aminoanthracycline, enhances the antitumor activity of chemo-therapeutic agents against human cancer cell in vitro and in vivo. Cancer Sci. 2007;98:447-454.
17. Therasse P, Arbuck SG, Eisenhauer EA, et al. New guidelines to evaluate the response to treatment in solid tumors. J Natl Cancer Inst. 2000;92:205-216.
18. Kaplan EL, Meier P. Nonparametric estimation from incomplete observations. J Am Stat Assoc. 1958;53:457-481.
19. Ohe Y, Negoro S, Matsui K, et al. Phase I-II study of amrubicin and cisplatin in previously untreated patients with extensive-stage small-cell lung cancer. Ann Oncol. 2005;16:430-436.
20. Ikeda J, Maruyama R, Okamoto T, et al. Phase I study of amrubicin hydrochloride and cisplatin in patients previously treated for advanced non-small cell lung cancer. Jpn J Clin Oncol. 2006;36:12-16.