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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.

Publication ,  Journal Article
Philips, GK; Halabi, S; Sanford, BL; Bajorin, D; Small, EJ; Cancer and Leukemia Group B,
Published in: Ann Oncol
June 2009

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(2) day 1 and gemcitabine 1000 mg/m(2) 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.

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Published In

Ann Oncol

DOI

EISSN

1569-8041

Publication Date

June 2009

Volume

20

Issue

6

Start / End Page

1074 / 1079

Location

England

Related Subject Headings

  • Urologic Neoplasms
  • Quinazolines
  • Oncology & Carcinogenesis
  • Middle Aged
  • Male
  • Humans
  • Gemcitabine
  • Gefitinib
  • Female
  • Deoxycytidine
 

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Philips, G. K., Halabi, S., Sanford, B. L., Bajorin, D., Small, E. J., & Cancer and Leukemia Group B, . (2009). 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. Ann Oncol, 20(6), 1074–1079. https://doi.org/10.1093/annonc/mdn749
Philips, G. K., S. Halabi, B. L. Sanford, D. Bajorin, E. J. Small, and E. J. Cancer and Leukemia Group B. “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.Ann Oncol 20, no. 6 (June 2009): 1074–79. https://doi.org/10.1093/annonc/mdn749.
Philips GK, Halabi S, Sanford BL, Bajorin D, Small EJ, Cancer and Leukemia Group B. 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. Ann Oncol. 2009 Jun;20(6):1074–9.
Philips, G. K., et al. “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.Ann Oncol, vol. 20, no. 6, June 2009, pp. 1074–79. Pubmed, doi:10.1093/annonc/mdn749.
Philips GK, Halabi S, Sanford BL, Bajorin D, Small EJ, Cancer and Leukemia Group B. 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. Ann Oncol. 2009 Jun;20(6):1074–1079.
Journal cover image

Published In

Ann Oncol

DOI

EISSN

1569-8041

Publication Date

June 2009

Volume

20

Issue

6

Start / End Page

1074 / 1079

Location

England

Related Subject Headings

  • Urologic Neoplasms
  • Quinazolines
  • Oncology & Carcinogenesis
  • Middle Aged
  • Male
  • Humans
  • Gemcitabine
  • Gefitinib
  • Female
  • Deoxycytidine