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卡铂和紫杉醇用于乳头状肾细胞癌的II期试验。

Phase II trial of carboplatin and paclitaxel in papillary renal cell carcinoma.

作者信息

Bylow Kathryn A, Atkins Michael B, Posadas Edwin M, Stadler Walter M, McDermott David F

机构信息

Department of Medicine, Section of Hematology/Oncology, University of Chicago, IL, USA.

出版信息

Clin Genitourin Cancer. 2009 Jan;7(1):39-42. doi: 10.3816/CGC.2009.n.007.

DOI:10.3816/CGC.2009.n.007
PMID:19213667
Abstract

BACKGROUND

Cytotoxic chemotherapy has not been well investigated in non-clear-cell renal cell carcinoma (RCC). A phase II study was thus conducted to assess the efficacy of carboplatin and paclitaxel in such patients.

PATIENTS AND METHODS

Patients were treated with carboplatin (area under the curve of 6) and paclitaxel 225 mg/m2 every 21 days and assessed for measurable disease response every 2 cycles. An initial 20 patients were planned to be enrolled to rule out a null hypothesized 15% response rate.

RESULTS

Seventeen patients were enrolled, of which 16 patients had papillary and 1 had collecting duct histology. The patient with collecting duct histology had a complete response, but no responses were observed in patients with papillary histology and the trial was thus terminated early. Toxicities were as expected for the carboplatin and paclitaxel regimen.

CONCLUSION

Carboplatin and paclitaxel is not an active regimen in patients with metastatic papillary RCC. Future studies should explore the role of this or similar regimens in collecting duct carcinoma.

摘要

背景

细胞毒性化疗在非透明细胞肾细胞癌(RCC)中的研究尚不充分。因此开展了一项II期研究,以评估卡铂和紫杉醇对此类患者的疗效。

患者与方法

患者接受卡铂(曲线下面积为6)和紫杉醇225mg/m²治疗,每21天一次,每2个周期评估可测量的疾病反应。最初计划纳入20例患者,以排除假设的15%缓解率为零的情况。

结果

共纳入17例患者,其中16例为乳头状组织学类型,1例为集合管组织学类型。集合管组织学类型的患者获得完全缓解,但乳头状组织学类型的患者未观察到缓解,因此试验提前终止。卡铂和紫杉醇方案的毒性符合预期。

结论

卡铂和紫杉醇对转移性乳头状RCC患者不是有效的治疗方案。未来的研究应探索该方案或类似方案在集合管癌中的作用。

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