Phase II trial of oral 4-demethoxydaunorubicin in patients with non-small cell lung cancer. 1985

M G Kris, and R J Gralla, and D P Kelsen, and E S Casper, and M T Burke, and J J Fiore, and I R Cibas, and R T Heelan

4-Demethoxydaunorubicin (4-DMDR) is an orally active analog of daunorubicin that in preclinical testing has demonstrated greater antitumor activity and less cardiotoxicity than its parent compound. Thirty-two patients with metastatic non-small cell lung cancer received 4-DMDR at a dose of 40-50 mg/m2 orally every 21 days. Thirteen patients had received no prior chemotherapy. Among the 30 adequately treated patients, one major response lasting 5.2 months was observed. Leukopenia 10-14 days after treatment was the most commonly observed toxicity. With an overall observed major response rate of 3.3% in 30 patients, the predicted true response rate is less than or equal to 16% (p = 0.05). At the dose and schedule studied in this group of patients with non-small cell lung cancer, 4-DMDR had only marginal activity.

UI MeSH Term Description Entries
D007970 Leukopenia A decrease in the number of LEUKOCYTES in a blood sample below the normal range (LEUKOCYTE COUNT less than 4000). Leukocytopenia,Leukocytopenias,Leukopenias
D008175 Lung Neoplasms Tumors or cancer of the LUNG. Cancer of Lung,Lung Cancer,Pulmonary Cancer,Pulmonary Neoplasms,Cancer of the Lung,Neoplasms, Lung,Neoplasms, Pulmonary,Cancer, Lung,Cancer, Pulmonary,Cancers, Lung,Cancers, Pulmonary,Lung Cancers,Lung Neoplasm,Neoplasm, Lung,Neoplasm, Pulmonary,Pulmonary Cancers,Pulmonary Neoplasm
D008297 Male Males
D008875 Middle Aged An adult aged 45 - 64 years. Middle Age
D003630 Daunorubicin A very toxic anthracycline aminoglycoside antineoplastic isolated from Streptomyces peucetius and others, used in treatment of LEUKEMIA and other NEOPLASMS. Daunomycin,Rubidomycin,Rubomycin,Cerubidine,Dauno-Rubidomycine,Daunoblastin,Daunoblastine,Daunorubicin Hydrochloride,NSC-82151,Dauno Rubidomycine,Hydrochloride, Daunorubicin,NSC 82151,NSC82151
D004341 Drug Evaluation Any process by which toxicity, metabolism, absorption, elimination, preferred route of administration, safe dosage range, etc., for a drug or group of drugs is determined through clinical assessment in humans or veterinary animals. Evaluation Studies, Drug,Drug Evaluation Studies,Drug Evaluation Study,Drug Evaluations,Evaluation Study, Drug,Evaluation, Drug,Evaluations, Drug,Studies, Drug Evaluation,Study, Drug Evaluation
D005260 Female Females
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000328 Adult A person having attained full growth or maturity. Adults are of 19 through 44 years of age. For a person between 19 and 24 years of age, YOUNG ADULT is available. Adults
D000368 Aged A person 65 years of age or older. For a person older than 79 years, AGED, 80 AND OVER is available. Elderly

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