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(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.
Subject(s)
Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Carcinoma, Transitional Cell/drug therapy , Urologic Neoplasms/drug therapy , Aged , Carcinoma, Transitional Cell/pathology , Cisplatin/administration & dosage , Deoxycytidine/administration & dosage , Deoxycytidine/analogs & derivatives , Female , Gefitinib , Humans , Male , Middle Aged , Quinazolines/administration & dosage , Urologic Neoplasms/pathology , GemcitabineABSTRACT
We conducted a ten-year review of our patients of adult acute lymphoblastic leukemia. Most patients received vincristine and prednisone for induction. Twenty-four patients additionally received doxorubicin. Serious pretreatment morbidity included intracerebral haemorrhage (8 patients), septicaemia (22 patients), pneumonia (8 patients) and CNS leukemia (3 patients). Our complete remission (CR) rate was 41%, predicted median duration of remission was 20.8 months and predicted median duration of overall survival was 10.4 months. Significantly higher CR rates were observed for lower age, female sex and lesser degrees of haemorrhage and infection. High initial WBC count was the only adverse prognostic factor for remission duration. Survival was significantly inferior for nonresponders, age greater than 20 years, and severe haemorrhage and infection. Remission attainment remains the chief obstacle to enhancing overall survival in adult acute lymphoblastic leukemia. However responders often experience years of good quality life.
