کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
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3943375 | 1254103 | 2008 | 4 صفحه PDF | دانلود رایگان |
![عکس صفحه اول مقاله: Phase I trial of the proteasome inhibitor bortezomib in combination with carboplatin in patients with platinum- and taxane-resistant ovarian cancer Phase I trial of the proteasome inhibitor bortezomib in combination with carboplatin in patients with platinum- and taxane-resistant ovarian cancer](/preview/png/3943375.png)
Objective.This phase I trial evaluated the dose-limiting toxicities (DLTs) and maximum tolerated dose (MTD) of the proteasome inhibitor bortezomib when combined with carboplatin in ovarian cancer patients with recurrent and platinum- and taxane-resistant disease.Methods.Patients with platinum- and taxane-resistant recurrent ovarian cancer, measurable disease, and a performance status of 0 to 2 were eligible. Bortezomib (0.8, 1.0, 1.3, or 1.5 mg/m2) was administered on days 1, 4, 8, and 11 by intravenous push with carboplatin (area under curve = 5) on day 1; therapy was repeated every 28 days.Results.Twenty-one women (median age, 63 years; range, 43 to 83 years) were treated with carboplatin and bortezomib at 0.8 mg/m2 (n = 6), 1.0 mg/m2 (n = 3), 1.3 mg/m2 (n = 6), or 1.5 mg/m2 (n = 6). At these levels, there were 1, 0, 1, and 3 DLTs, respectively, attributable to bortezomib; all were grade 3. The DLTs were fatigue (n = 3); nausea, vomiting, and dehydration (n = 1); and anorexia, dehydration, and syncope (n = 1). Common grade 2 toxicities included fatigue (n = 12), nausea (n = 10), and anorexia, anemia, and dyspnea (n = 7 each). The 18 patients evaluable for response all had stable disease (SD; n = 8) or progressive disease (n = 10). The median duration of SD was 4 months (range, 3 to 7 months). At the MTD of 1.3 mg/m2, 3 of 6 patients had SD.Conclusions.The recommended dose of bortezomib in combination with carboplatin is 1.3 mg/m2. Treatment was reasonably well tolerated at the MTD.
Journal: Gynecologic Oncology - Volume 108, Issue 1, January 2008, Pages 68–71