A randomized phase II study with two schedules of the novel indoloquinone EO9 in non-small-cell lung cancer: a study of the EORTC Early Clinical Studies Group (ECSG)
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Pavlidis, N.
Hanauske, A. R.
Gamucci, T.
Smyth, J.
Lehnert, M.
te Velde, A.
Lan, J.
Verweij, J.
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peer-reviewed
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Ann Oncol
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In a multicentre randomized trial of the EORTC-ECSG, we have treated 38 chemotherapy naive patients with advanced non-small-cell lung cancer (NSCLC) with EO9, a novel bio-reductive alkylating indoloquinone. The drug was given at two different dose schedules by a single bolus i.v. injection: arm A 12 mg/m2 weekly and arm B 22 mg/m2 every three weeks. All together 185 courses were administered (145 in arm A and 40 in arm B). The major toxicity was reversible proteinuria more frequently occurring in the three-weekly schedule (arm A 34.5% vs. arm B 62.5%). Creatinine elevation, fluid retention and pericardial or pleural effusion were also recorded in a limited number of patients. Other common toxicities more frequent in the three-weekly administration were asthenia (21% vs. 35% of cycles), nausea (15% vs. 27.5% of cycles) and vomiting (5% vs. 17.5% of cycles). Toxicities were mainly of grade I and II. No responses have been observed. Five patients (26%) on arm A and eight (53%) on arm B experienced stable disease. These doses and schedules of EO9 do not yield activity in NSCLC.
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Adult, Aged, Aged, 80 and over, *Antineoplastic Agents/adverse effects/therapeutic use, *Aziridines/adverse effects/therapeutic use, Carcinoma, Non-Small-Cell Lung/*drug therapy/pathology, Dose-Response Relationship, Drug, Drug Administration Schedule, Female, Humans, *Indolequinones, *Indoles/adverse effects/therapeutic use, Injections, Intravenous, Lung Neoplasms/*drug therapy/pathology, Male, Middle Aged, Survival Rate, Treatment Outcome
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http://www.ncbi.nlm.nih.gov/pubmed/8839911
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en
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Πανεπιστήμιο Ιωαννίνων. Σχολή Επιστημών Υγείας. Τμήμα Ιατρικής