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 Journal Article
| Authors: | Philips, G. K.; Halabi, S.; Sanford, B. L.; Bajorin, D.; Small, E. J. |
| Article Title: | 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 |
| Abstract: | 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/m<sup>2</sup> day 1 and gemcitabine 1000 mg/m<sup>2</sup> 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. © The Author 2009. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. |
| Keywords: | adult; cancer survival; treatment response; aged; middle aged; major clinical study; clinical trial; drug tolerability; fatigue; neutropenia; cisplatin; advanced cancer; cancer combination chemotherapy; diarrhea; drug dose reduction; drug efficacy; drug safety; gastrointestinal hemorrhage; monotherapy; side effect; treatment duration; gemcitabine; chemotherapy; edema; drug eruption; infection; multiple cycle treatment; phase 2 clinical trial; sensory neuropathy; anemia; blood toxicity; mucosa inflammation; stomatitis; thrombocytopenia; vomiting; antineoplastic combined chemotherapy protocols; dehydration; maintenance therapy; creatinine; creatinine blood level; urogenital tract cancer; hematuria; dyspnea; febrile neutropenia; hypomagnesemia; hypokalemia; hyponatremia; hypotension; survival time; urologic neoplasms; multicenter study; thromboembolism; gefitinib; egfr; carcinoma, transitional cell; bladder carcinoma; kidney pelvis carcinoma; ureter carcinoma; melena; deoxycytidine; quinazolines; transitional cell carcinoma; hearing loss; creatinine clearance; hypocalcemia; electrocorticography; urothelial; maintenance drug dose; motor neuropathy; urethra carcinoma |
| Journal Title: | Annals of Oncology |
| Volume: | 20 |
| Issue: | 6 |
| ISSN: | 0923-7534 |
| Publisher: | Oxford University Press |
| Date Published: | 2009-01-01 |
| Start Page: | 1074 |
| End Page: | 1079 |
| Language: | English |
| DOI: | 10.1093/annonc/mdn749 |
| PUBMED: | 19168670 |
| PROVIDER: | scopus |
| PMCID: | PMC2685451 |
| DOI/URL: | |
| Notes: | --- - "Cited By (since 1996): 5" - "Export Date: 30 November 2010" - "CODEN: ANONE" - "Source: Scopus" |
