治癒切除腎細胞癌症例に対するインターフェロン療法の臨床的検討

Abstract

腎細胞癌の治癒的切除術施行例44例を対象にrIFNα-2b投与に関する臨床的検討を行った.1) 44例のstage分類(Robson)は1が29例, 2が15例であった.2)適格例42例中, 再発が認められた症例は5例であり, うち2例が死亡している.再発から死亡までの期間は2ヵ月と6ヵ月であった.3)適格例の42例中, 死亡例は3例であり, 累積生存率は1年生存率97.6%, 2年生存率89.7%であった.4) IFN初期治療終了後のIFNαおよびIFNγ産生能は前者においてすべて低下(4/4)し, 後者においては3例が上昇(3/4), 1例が正常値を示した.5) 2-5AS活性は評価できた4症例において, いずれもrIFNα-2b投与により上昇が認められた.6)副作用を認めたものは24例であり, 発熱が22例と最も多く, その他に白血球数減少, 肝機能障害などを認めたが, 多くは投与継続が可能であり副作用による中止例は5例であった.7)抗rIFNα-2b抗体について22例で継続的に測定したが, いずれも測定限界値未満であった

A clinical trial using interferon alpha 2b (IFN alpha-2b) for prophylactic therapy was done on 44 patients who had received nephrectomy for renal cell carcinoma. Principally, the daily intramuscular injection of 3 of 6 million units of IFN alpha-2b was done for 4 consecutive weeks after 2 weeks postoperatively and thereafter followed by injection once every 2 weeks. The clinical evaluation was done for the recurrence rate, the survival rate, the IFN alpha and IFN gamma producing ability, the activity of 2', 5' oligoadenylate synthetase (2-5AS) and the side effect. Out of 44 cases entered, 42 were completely evaluable and recurrence was observed in 5 (11.9%) of the 42 cases. The recurrence rate was 5.5% and 16.4%, at the first and second year, respectively. Three (7.1%) of the 42 patients died. The survival rate was 97.6% at the first year, 89.7% at the second year for the followup study. The IFN alpha producing capacity was low in all of the 4 evaluable cases. The IFN gamma producing capacity was high in 3 cases and normal in 1 case. 2-5AS, the enzyme produced by IFN, was activated by IFN alpha-2b administration in all of the 4 evaluable cases. Side effects were observed in 24 (54.5%) of the 44 cases. The main side effect was fever. Leucopenia, general fatigue, appetite loss, temporary elevation of liver transaminase were also observed. However, there were only 5 cases (11.4%) in which administration of IFN alpha-2b had to be discontinued.