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 cancer

I Sawczuk1, S Armentrout 2, R Babayan 3, S Graham, Jr 4, S Holden 5, J Klarnet 6, T Kuzel 7 , S Leong 8, J A. Smith, Jr. 9, and C White <

1 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.

KEY WORDS: renal cancer, autolymphocyte, adjuvant therapy, adjuvant therapy, .

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.