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Front-line Treatment with Gemcitabine, Paclitaxel, and Doxorubicin for Patients With Unresectable or Metastatic Urothelial Cancer and Poor Renal Function: Final Results from a Phase II Study.
- Source :
-
Urology . Mar2016, Vol. 89 Issue 1, p83-89. 7p. - Publication Year :
- 2016
-
Abstract
- <bold>Objective: </bold>To estimate the response rate of gemcitabine, paclitaxel, and doxorubicin in patients with advanced urothelial carcinoma, we conducted a phase II clinical trial. Patients with renal insufficiency cannot receive standard cisplatin-based chemotherapy for urothelial carcinoma, and carboplatin-based regimens have proved unsatisfactory. Secondary end points for this study included overall survival, safety of the regimen, and safety of same-day pegfilgrastim dosing.<bold>Methods: </bold>A two-stage design was chosen with target response rate of 40%. Key inclusion criteria were metastatic or unresectable urothelial carcinoma, no prior chemotherapy, glomerular filtration rate <60 mL/min, and no dialysis. Gemcitabine (900 mg/m(2)), paclitaxel (135 mg/m(2)), and doxorubicin (40 mg/m(2)) were administered on day 1 of each 14-day cycle. Pegfilgrastim was given with every cycle on either day 1 or optionally day 2.<bold>Results: </bold>Forty patients were enrolled and 39 were treated. Median age was 72 years (range 51-89). There were 7 complete and 15 partial responses, for a response rate of 56.4% (95% confidence interval, 39.6-72.2). Most cycles (82.8%) were given with same-day pegfilgrastim. Notable grade 3 and 4 nonhematologic toxicities were fatigue and mucositis (10.3% each). There were 4 episodes of neutropenic fever (4 of 198 cycles [2%]; 4 of 39 patients [10.3%]) and no treatment-related deaths. Median overall survival was 14.4 months.<bold>Conclusion: </bold>The combination of gemcitabine, paclitaxel, and doxorubicin is effective first-line chemotherapy for patients with advanced urothelial carcinoma and renal insufficiency. Neutropenic prophylaxis was acceptable whether pegfilgrastim was given immediately or 24 hours after chemotherapy. [ABSTRACT FROM AUTHOR]
- Subjects :
- *PACLITAXEL
*DOXORUBICIN
*TRANSITIONAL cell carcinoma
*CANCER chemotherapy
*DRUG administration
*THERAPEUTICS
*ANTINEOPLASTIC agents
*RECOMBINANT proteins
*GRANULOCYTE-colony stimulating factor
*COMBINATION drug therapy
*CLINICAL trials
*COMPARATIVE studies
*KIDNEYS
*RESEARCH methodology
*MEDICAL cooperation
*KIDNEY failure
*RESEARCH
*RESEARCH funding
*URINARY organs
*EVALUATION research
*DEOXYCYTIDINE
*DISEASE complications
*TUMORS
Subjects
Details
- Language :
- English
- ISSN :
- 00904295
- Volume :
- 89
- Issue :
- 1
- Database :
- Academic Search Index
- Journal :
- Urology
- Publication Type :
- Academic Journal
- Accession number :
- 113724357
- Full Text :
- https://doi.org/10.1016/j.urology.2015.12.007