Published in Cancer Detection and Prevention 1998; 22(Supplement 1).
Adjuvant autolymphocyte therapy in T 1-3a,b,c or T 4N+M0 renal cell cancer1 New York, NY 2 Orange, CA 3 Boston, MA 4 Atlanta, GA 5Los Angeles, CA 6 Tacoma, WA 7 Chicago, Il 8 San Francisco, CA 9 Nashville, TN 10 San Diego, CA.
AIM: A randomized, controlled trial to determine the safety and efficacy of post nephrectomy adjuvant, autolymphocyte therapy (ALT) in delaying or preventing tumor recurrence was completed. METHODS: ALT involves the ex vivo activation of peripheral blood derived autologous T cells (CD4+/CD8+) by OKT3. 45 patients with T 1-3a,b,c or T 4N+M0 disease were randomized to monthly outpatient ALT (2-3 X 109) plus 2400mg oral cimetidine for 6 months followed by quarterly treatments, or observation. Efficacy was determined by time to progression and assessment of well being. Patient survival was a secondary endpoint. RESULTS: The median time to progression for ALT was 24.4 months vs. 7.9 months for no treatment. The risk ratio for time to progression was 0.55 in favor of ALT with a 95% CI from 0.27 to 1.13. Median survival for the ALT arm was 55.6 months compared to 32.6 months for the no treatment arm. Stage T3 patients treated with ALT had a median time to tumor recurrence of 33 months vs. 6 months for the observation arm (p=0.0155 log-rank test). For patients with N1 disease, median time to recurrence was 30 months for ALT patients vs. 7 months for the observation arm (p=0.0265). No deaths occurred from treatment. Toxicity was limited to grade 1, 2, and 3 reversible events. CONCLUSIONS: T 1-3a,b,c or T 4N+M0 renal cell cancer patients are at high risk to develop metastatic disease. Adjuvant outpatient ALT delayed the median time to tumor progression and was associated with minimal toxicity.
Paper presented at the International Symposium on the Impact of Biotechnology on Prediction, Prevention and Treatment of Cancer; Nice, France; October 24 - 27, 1998; in the section on Immunotherapy.