Phase II study of MTX-HSA in combination with Cisplatin as first line treatment in patients with advanced or metastatic transitional cell carcinoma

被引：64

作者：

Bolling, C.

Graefe, T.

Luebbing, C.

Jankevicius, F.

Uktveris, S.

Cesas, A.

Meyer-Moldenhauer, W. -H.

Starkmann, H.

Weigel, M.

Burk, K.

Hanauske, A. -R.

机构：

[1] Allgemein Krankenhaus St Georg, Med Abt, D-20099 Hamburg, Germany

[2] Lithuanian Oncol Ctr, Vilnius, Lithuania

[3] City Hosp, Klaipeda, Lithuania

[4] Fujisawa Deutsch GmbH, Munich, Germany

[5] ClinDesci, Munich, Germany

来源：

INVESTIGATIONAL NEW DRUGS | 2006年 / 24卷 / 06期

关键词：

MTX; MTX-HSA; cisplatin; albumin; bladder cancer; urothelial cancer; phase II; pharmacokinetic;

D O I：

10.1007/s10637-006-8221-6

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Purpose: To assess the efficacy, tolerability and safety of MTX-HSA (methotrexate (MTX) covalently linked to human serum albumin (HSA)) combined with cisplatin as first line therapy for advanced bladder cancer. Methods: Patients (pat) were treated with a loading dose of 110 mg/m(2) of MTX-HSA followed by a weekly dose of 40 mg/m(2) starting on day 8. Cisplatin was given on day 2 of each 28 day cycle at a dose of 75 mg/m(2). Results: Tumor response evaluation was possible in 7 patients. Complete response (CR) and partial response (PR) was observed in 1 patient each (overall response rate: 29%). Key toxicities included CTC Grade (G) 3/4 stomatitis in 6 patients, vomiting G3 in 1 patient, fatigue G3 in 1 patient and thrombocytopenia G3 in 3 patients. Conclusion: The combination of MTX-HSA with cisplatin is feasible and shows antitumor activity against urothelial carcinomas combined with an acceptable toxicity profile.

引用

页码：521 / 527

页数：7

共 34 条

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