Annals of Oncology Advance Access originally published online on January 23, 2009
Annals of Oncology 2009 20(6):1074-1079; doi:10.1093/annonc/mdn749
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urogenital tumors |
A phase II trial of cisplatin (C), gemcitabine (G) and gefitinib for advanced urothelial tract carcinoma: results of Cancer and Leukemia Group B (CALGB) 90102
1 Division of Hematology–Oncology, University of Vermont, Burlington
2 Department of Biostatistics and Bioinformatics, Duke University Medical Center
3 CALGB Statistical Center, Duke University Medical Center, Durham
4 Memorial Sloan-Kettering Cancer Center, New York
5 University of California at San Francisco, San Francisco, USA
* Correspondence to: Dr G. K. Philips, Division of Hematology–Oncology, University of Vermont, Given Building E214, 89 Beaumont Avenue, Burlington, VT 05405, USA. Tel: +1-802-656-5487; Fax: +1-802-656-5493; E-mail: george.philips{at}vtmednet.org
Background: This phase II trial (Cancer and Leukemia Group B 90102) sought to determine the efficacy of cisplatin, standard infusion of gemcitabine and gefitinib in patients with advanced urothelial carcinoma.
Patients and methods: Eligible patients had previously untreated measurable disease, Eastern Cooperative Oncology Group (ECOG) performance status of zero to two and creatinine clearance >50 ml/min. Treatment consisted of cisplatin 70 mg/m2 day 1 and gemcitabine 1000 mg/m2 on days 1 and 8 given every 3 weeks concurrent with gefitinib 500 mg/day orally for six cycles. Maintenance gefitinib 500 mg/day was continued for responding or stable disease.
Results: Fifty-four of 58 patients were assessable. Twelve patients (22%) had node-only disease, and 25 (46%) had an ECOG performance status of zero. There were 23 objective responses for an overall response rate of 42.6% [95% confidence interval (CI) 29.2% to 56.8%]. The median survival time was 15.1 months (95% CI 11.1–21.7 months) and the median time to progression was 7.4 months (95% CI 5.6–9.2 months).
Conclusions: The combination of cisplatin, gemcitabine and gefitinib is well tolerated and active in advanced transitional cell carcinoma. The addition of gefitinib does not appear to improve response rate or survival in comparison to historical controls of cisplatin and gemcitabine alone.
Key words: gefitinib, chemotherapy, EGFR, transitional cell carcinoma, urothelial
Received for publication June 5, 2008. Revision received November 11, 2008. Accepted for publication November 19, 2008.