A phase II study of irinotecan in patients with advanced renal cell carcinoma

Abstract

Background: Patients with disseminated renal cell carcinoma (RCC) have a poor outcome, and the disease is considered highly resistant to chemotherapy. Irinotecan is an active drug in the treatment of a number of neoplastic diseases and is not concerned with the multidrug-resistance phenotype of tumor cells, a common mechanism of drug inactivation and resistance in patients with RCC. Therefore, the authors tested the antitumor activity of irinotecan in patients with RCC.

Methods: Patients with disseminated RCC received irinotecan (350 mg/m(2)) every 3 weeks. The primary objective of the study was to determine the overall response rate. Two groups of patients were defined: previously treated patients (Group A) and nonpretreated patients (Group B).

Results: Forty-two eligible patients were recruited: Twenty-six patients (Group A) had received previous chemotherapy or immunotherapy, and 16 patients had received no previous systemic therapy (Group B). The median number of cycles received per patient was 3 cycles (range, 1-6 cycles). A dose reduction was required in only 8% of cycles. Two patients, one in each group, had minor responses. Eleven patients (42%) in Group A and 1 patient (12%) in Group B had disease stabilization. Overall, therapy was tolerated well. Grade 4 neutropenic fever occurred in 17% of patients. The 1-year overall survival rate was 61% (95% confidence interval, 42-80%) in Group A and 19% (95% confidence interval, 0-49%) in Group B.

Conclusions: Irinotecan was tolerated well and had limited activity in patients with disseminated RCC at the dose and schedule used in the current study. A high percentage of disease stabilization was observed in cytokine-pretreated patients.