Artikel
Temozolomide in the management of progressive metastatic renal cell cancer (RCC) following immunotherapy
Suche in Medline nach
Autoren
Veröffentlicht: | 20. März 2006 |
---|
Gliederung
Text
Objectives: Temozolomide (TMZ) is an oral alkylating agent that produces methyl adducts at the 0.6 position of guanine. TMZ has shown in vitro activity against renal cell cancer cell lines. We report the phase-II results of a prospective study evaluating the efficacy of TMZ in the management of patients with metastatic renal cell cancer who progressed after immunochemotherapy.
Patients & Methods: From January 2001 to September 2004, 45 patients (11 females, 34 males) were enrolled in the study. Mean age at time of study entry was 66.2 (46 to 79) years, 40 (89%) patients had undergone radical nephrectomy, 14 (31%) had undergone resection of solitary visceral and/or lymph node metastases. All patients had received at least 2 cycles (mean 2.7) immunochemotherapy according to the Hannover protocol before systemic progression developed. Treatment consisted of 6 cycles of TMZ at 200mg/m2 on days 1-5 of a 4-weeks regime. Restaging with computed tomography was performed after 3 and 6 cycles.
Results: After a mean follow-up 25 (2 – 45) months, 8 (18%) patients demonstrated a partial response, 19 (42%) exhibited a stable disease resulting in a total response rate of 60%. 18 (40%) developed progressive disease during therapy. The mean time to progression in responding patients was 7.2 months, mean survival time is 11.9 months. Side effects were moderate with WHO grade II nausea and emesis in 24%, fatigue in 25% and headache in 20% of the patients; no WHO grade III/IV side effects were observed.
Conclusion: These early results are encouraging and demonstrate that TMZ appears to be a valuable therapeutic alternative in immunorefractory metastatic renal cell cancer with minimal side effects and a total response rate of 60%. Further studies are initiated to explore the clinical utility of TMZ in the management of recurrent metastatic RCC as compared to the results of signal transduction inhibitors.