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Results of the Southwest Oncology Group phase II evaluation (study S0031) of ZD1839 for advanced transitional cell carcinoma of the urothelium
Author(s) -
Petrylak Daniel P.,
Tangen Catherine M.,
Van Veldhuizen Peter J.,
Goodwin J. Wendall,
Twardowski Przemyslaw W.,
Atkins James N.,
Kakhil Shaker R.,
Lange Marianne K.,
Mansukhani Mahesh,
Crawford E. David
Publication year - 2010
Publication title -
bju international
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.773
H-Index - 148
eISSN - 1464-410X
pISSN - 1464-4096
DOI - 10.1111/j.1464-410x.2009.08799.x
Subject(s) - medicine , transitional cell carcinoma , urothelium , gefitinib , urology , regimen , oncology , metastatic urothelial carcinoma , progressive disease , carcinoma , chemotherapy , urinary bladder , epidermal growth factor receptor , surgery , bladder cancer , urothelial carcinoma , cancer
Study Type – Prognosis (inception cohort)
Level of Evidence 1b OBJECTIVE To evaluate the epidermal growth factor receptor (EGFR)‐targeted agent ZD1839 in patients who failed one previous chemotherapeutic regimen for metastatic transitional cell carcinoma (TCC), and to correlate patterns of response with the expression of EGFR. PATIENTS AND METHODS Thirty‐one patients with metastatic TCC of the urothelial tract were treated with ZD1839 500 mg oral daily. Patients were required to have a pretreatment biopsy to assess EGF expression. RESULTS The median progression‐free survival was 2 months, with only two patients (6.5%) surviving past 6 months with no disease progression. Thirty patients were evaluable for toxicity; there was grade 4 cerebrovascular ischaemia and an increase in creatinine level. All patients were evaluable for response, with one confirmed partial response (3%; 95% confidence interval, CI, 0–17%) in a patient with pulmonary metastases. All patients have died, and the estimated median (95% CI) survival is 3 (2–7) months. CONCLUSIONS ZD1839 is ineffective as a second‐line agent for urothelial carcinoma.