A Phase II Study of Weekly Docetaxel as Second-Line Chemotherapy in Patients With Metastatic Urothelial Carcinoma
- Abstract
- The present multicenter phase II study evaluated the efficacy and safety of weekly docetaxel as second-line chemotherapy for metastatic urothelial carcinoma. Weekly docetaxel was well tolerated but demonstrated modest activity, with a response rate of 6%, a median progression-free survival (PFS) of 1.4 months, and a median overall survival (OS) of 8.3 months. The dichotomy between PFS and OS was likely associated with subsequent platinum-based chemotherapy received by 58% of the patients. BACKGROUND: Docetaxel is commonly used for second-line therapy for metastatic urothelial carcinoma (UC). However, myelosuppression is a substantial concern when the traditional 3-week docetaxel cycle is used. The present multicenter phase II study evaluated the efficacy and safety of weekly docetaxel as second-line chemotherapy for metastatic UC. PATIENTS AND METHODS: Patients with progression after previous platinum-based chemotherapy for advanced or metastatic disease were treated with docetaxel 30 mg/m(2) on days 1 and 8 every 21 days. The primary endpoint was the response rate. RESULTS: The study enrolled 31 patients. Their median age was 64 years (range, 40-79 years). An Eastern Cooperative Oncology Group performance status of 1, liver metastasis, and a hemoglobin level < 10 g/dL were observed in 100%, 32%, and 23% of patients, respectively. Previous platinum-based chemotherapy had been administered for metastatic disease in 29 patients (94%). Although fatigue (13%) and anorexia (6%) were the most frequently observed grade 3 to 4 toxicities, the safety profiles were generally mild and manageable. Two patients (6%) achieved an objective response, which was maintained for 3.0 to 7.8 months. Eight patients experienced disease stabilization (disease control rate, 32%). The median progression-free survival (PFS) and overall survival (OS) were 1.4 months (95% confidence interval [CI], 1.3-1.6) and 8.3 months (95% CI, 5.9-10.6), respectively. A relatively long OS was associated with further salvage platinum-based chemotherapy (n = 18, 58%) showing an encouraging activity (response rate, 44%; median PFS, 4.0 months). CONCLUSION: Second-line chemotherapy with weekly docetaxel was well tolerated but demonstrated modest activity in patients with metastatic UC. A platinum-based combination as second-line treatment might be considered for selected patients.
- All Author(s)
- Y. S. Kim
; S. I. Lee
; S. H. Park
; S. Park
; I. G. Hwang
; S. C. Lee
; J. M. Sun
; J. Lee
; H. Y. Lim
- Issued Date
- 2016
- Type
- Article
- Keyword
- Bladder cancer; Chemotherapy; Docetaxel; Phase II; Second-line; Urothelial carcinoma
- Publisher
- Cancer Information Group
- ISSN
- 1558-7673
- Citation Title
- Clinical Genitourinary Cancer
- Citation Volume
- 14
- Citation Number
- 1
- Citation Start Page
- 76
- Citation End Page
- 81
- Language(ISO)
- eng
- DOI
- 10.1016/j.clgc.2015.09.008
- URI
- http://schca-ir.schmc.ac.kr/handle/2022.oak/1792
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