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


Authors: Kris, M. G.; Gralla, R. J.; Kelsen, D. P.; Casper, E. S.; Burke, M. T.; Fiore, J. J.; Cibas, I. R.; Heelan, R. T.
Article Title: Phase II trial of oral 4-demethoxydaunorubicin in patients with non-small cell lung cancer
Abstract: 4-Demethoxydaunorubicin (4-DMDR) is an orally active analog of daunorubicin that in preclincial 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 ≤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.
Keywords: cancer chemotherapy; clinical article; clinical trial; diarrhea; drug efficacy; skin toxicity; phase 2 clinical trial; leukopenia; thrombocytopenia; vomiting; gastrointestinal toxicity; lung carcinoma; idarubicin; drug therapy; toxicity; heart left ventricle ejection fraction; adverse drug reaction; therapy; oral drug administration; hair loss; intoxication; respiratory system; human; priority journal; blood and hemopoietic system
Journal Title: American Journal of Clinical Oncology
Volume: 8
Issue: 5
ISSN: 0277-3732
Publisher: Lippincott Williams & Wilkins  
Date Published: 1985-10-01
Start Page: 377
End Page: 379
Language: English
DOI: 10.1097/00000421-198510000-00007
PROVIDER: scopus
PUBMED: 3864366
DOI/URL:
Notes: Article -- Export Date: 26 October 2021 -- Source: Scopus
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MSK Authors
  1. David P Kelsen
    537 Kelsen
  2. Mark Kris
    869 Kris
  3. Robert T Heelan
    140 Heelan
  4. Ephraim S Casper
    108 Casper
  5. Richard J. Gralla
    69 Gralla