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Ifosfamide plus paclitaxel in advanced non-small-cell lung cancer: A phase I study |
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| Authors: | Hoffman, P. C. Masters, G. A. Drinkard, L. C. Krauss, S. A. Samuels, B. L. Golomb, H. M. Vokes, E. E. |
| Affiliation: | 1Department of Medicine and Cancer Research Center, The University of Chicago Park Ridge, IL, U.S.A. 2Department of Medicine and Cancer Research Center, Louis A. Weiss Memorial Hospital, Chicago, IL Park Ridge, IL, U.S.A. 3Department of Medicine and Cancer Research Center, Lutheran General Hospital Park Ridge, IL, U.S.A. |
| Abstract: | BACKGROUND:: ifosfamide and paclitaxel are active drugs in the managementof non-small-cell lung cancer. We have performed a phase I studyusing a fixed dose of ifosfamide with escalating doses of paclitaxel,with G-CSF support, in an effort to determine the maximum tolerateddose (MTD) of paclitaxel in this combination, and to describethe dose-limiting toxicities of the combination at the recommendedphase II dose of paclitaxel. We also studied the feasibilityof delivering the paclitaxel as a one-hour infusion at the recommended phase II dose. PATIENTS AND METHODS:: Thirty-one patients were treated, 25 with stage IV disease,and 6 with stage IIIB disease. Ifosfamide was administered ata dose of 1.6 g/m2 i.v. bolus daily x 3 days, with mesna uroprotection.Paclitaxel was administered as a 24-hour infusion at dose levelsof 135, 170, 200, 250, and 300 mg/m2 six patients were treatedwith a one-hour infusion, at a dose of 250 mg/m2 G-CSF, 5 µ/kg,was administered subcutaneously on days 4 through 10, or untilthe absolute neutrophil count exceeded 4000/µl. Cycleswere repeated every 21 days. RESULTS:: The dose-limiting toxicity was granulocytopenia, which increasedwith increasing dose levels of paclitaxel. The MTD was 300 mg/m2of paclitaxel, and the recommended phase II dose 250 mg/m2 administeredas a 24-hour infusion. Other toxicities were generally mild,with only 5 patients demonstrating grade 3 neurotoxicity and5 with grade 3 thrombocytopenia. Partial responses were seenin seven patients (23%), all in the 18 patients who receiveddose levels of 250 mg/m2 or higher. CONCLUSIONS:: Ifosfamide plus paclitaxel is an active treatment regimen inadvanced non-small-cell lung cancer, and compares favorablywith the results of cisplatin-based chemotherapy. A phase IIstudy is in progress by the Cancer and Leukemia Group B, inan effort to better characterize the tolerance of the regimen,as well as its effect on tumor response and survival. non-small-cell lung cancer, chemotherapy, ifosfamide/paclitaxel |
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