Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2016 Mar:89:83-9.
doi: 10.1016/j.urology.2015.12.007. Epub 2015 Dec 23.

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

Arlene O Siefker-Radtke  1 , Matthew T Campbell  1 , Mark F Munsell  2 , Deborah R Harris  1 , Robert L Carolla  3 , Lance C Pagliaro  4
Affiliations
Clinical Trial

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

Arlene O Siefker-Radtke et al. Urology. 2016 Mar.

Abstract

Objective: 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.

Methods: 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.

Results: 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.

Conclusion: 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.

PubMed Disclaimer

Figures

Figure 1
Figure 1
Kaplan-Meier estimate of OS.
Figure 2
Figure 2
Kaplan-Meier estimate of OS for patients with stable disease or better, grouped by response; complete response (black), partial response (blue) and stable disease (red).
See this image and copyright information in PMC

References

    1. Dash A, Galsky MD, Vickers AJ, et al. Impact of renal impairment on eligibility for adjuvant cisplatin-based chemotherapy in patients with urothelial carcinoma of the bladder. Cancer. 2006;107:506–513. - PubMed
    1. Dogliotti L, Carteni G, Siena S, et al. Gemcitabine plus cisplatin versus gemcitabine plus carboplatin as first-line chemotherapy in advanced transitional cell carcinoma of the urothelium: results of a randomized phase 2 trial. Eur Urol. 2006;52:134–141. - PubMed
    1. Dreicer R, Manola J, Roth BJ, et al. Phase III trial of methotrexate, vinblastine, doxorubicin, and cisplatin versus carboplatin and paclitaxel in patients with advanced carcinoma of the urothelium. Cancer. 2004;100:1639–1645. - PubMed
    1. Vaughn D, Manola J, Dreicer R, et al. Phase II study of paclitaxel plus carboplatin in patients with advanced carcinoma of the urothelium and renal dysfunction (E2 896): a trial of the Eastern Cooperative Oncology Group. Cancer. 2002;95:1022–1027. - PubMed
    1. Redman B, Smith DC, Flaherty L, et al. Phase II trial of paclitaxel and carboplatin in the treatment of advanced urothelial carcinoma. J Clin Oncol. 1998;16:1844–1848. - PubMed

Publication types

MeSH terms

LinkOut - more resources