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Pharmacokinetic Re-evaluation and Phase I Study of High Dose Epirubicin in Advanced Non-small Cell Lung Cancer |
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| Authors: | Nishio, Makoto Ohata, Masahiro Kobayashi, Hisashi Suruda, Tadatoshi Uetani, Kousaku Funasako, Masato Nishio, Kazuto Sasaki, Yasutsuna Saijo, Nagahiro |
| Affiliation: | 1 Department of Internal Medicine, Wakayama Medical College, Kihoku Hospital Katsuragi, Wakayama 2 Pharmacology Division, National Cancer Center Research Institute Tokyo 3 Division of Hematology/Oncology, National Cancer Center Hospital East Kashiwa 4 Department of Medical Oncology, National Cancer Center Hospital Tokyo |
| Abstract: | We performed a phase I trial to evaluate the toxicity and themaximum tolerated dose of high dose epirubicin on a three-consecutive-dayschedule on Japanese patients with advanced non-small cell lungcancer. Fourteen patients were entered in the study. At leastthree patients were assigned to each different dose level. Epirubicinwas given intravenously daily for three day by bolus injection.The dose was started at 60 mg/m2/course and escalated by 30mg/m2/course. Granulocytopenia was found to be the dose limitingtoxicity with a maximum tolerated dose of 150 mg/m2/course.Thrombocytopenia and non-hematological toxicities were mildand well tolerated. The maximum tolerated dose was lower thanthat in Europe and Canada. Partial responses were observed intwo out of five patients on 150 mg/m2/course. The recommendedphase II dose for high dose epirubicin was demonstrated to be120 mg/m2/course. A further dose-escalating study of epirubicinin conjunction with the administration of granulocyte colonystimulating factor is scheduled for the determination of itsantitumor activity in non-small cell lung cancer. |
| Keywords: | Epirubicin Phase I study Pharmacokinetics Pharmacodynamics |
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