Escudier B, Farace F, Théodore C, Angevin E, Court B, Couanet D, Dietrich P Y, Culine S, Pallardy M, Hercend T
Unité d'immunothérapie, institut Gustave-Roussy, Villejuif, France.
Bull Cancer. 1995 Apr;82(4):296-302.
Treatment of metastatic renal cell carcinoma with interleukin 2 (IL2) remains controversial despite the authorization from the French government for IL2 with the West schedule in this disease. We report herein the study of the Institute Gustave-Roussy of 73 patients, who received from 1989 to 1991 a new schedule of high dose IL2. Seventy three patients received high dose IL2 according to the following schedule: IL2 by continuous infusion at 24.10(6) IU/m2/d, on 2 consecutive days per week, during 5 weeks. This treatment was associated in the first 33 patients with gamma interferon at a dose of 5.10(6) IU/m2/d subcutaneously the days of IL2 infusion, during the 5 weeks of therapy. Immunotherapy was further continued in responding patients, either as an association of IL2 and LANAK (lymphokine-activated natural killer) cells, or as IL2 alone. Finally, when possible, surgery was performed on residual masses. Twenty five percent of objective responses (PR + CR) have been observed. Moreover, 12.3% CR has been obtained after the overall therapy. The global mean survival is 15 months, with a mean survival of 8, 18 and 24+ months depending on the status of the disease (progressive, stable or responding) after initial treatment with IL2. Tolerance of this schedule was good with an actual received dose of 90% of the planned doses, and patients could leave the hospital within 2 hours after the end of IL2 in 87% of the cycles. No toxic death was observed. Among the parameters observed for correlation with the clinical response, only performance status and level of sTNF-alpha R were significantly associated with the response.
尽管法国政府已批准按照西方方案使用白细胞介素 2（IL2）治疗转移性肾细胞癌，但该疗法仍存在争议。我们在此报告古斯塔夫 - 鲁西研究所对73例患者的研究，这些患者在1989年至1991年接受了新的高剂量IL2方案治疗。73例患者按照以下方案接受高剂量IL2治疗：以24×10⁶IU/m²/d的剂量持续输注IL2，每周连续2天，共5周。在最初的33例患者中，在5周的治疗期间，于IL2输注日皮下注射剂量为5×10⁶IU/m²/d的γ干扰素。对有反应的患者进一步继续免疫治疗，采用IL2与淋巴因子激活的自然杀伤（LANAK）细胞联合使用，或单独使用IL2。最后，尽可能对残留肿块进行手术。观察到25%的客观缓解（PR + CR）。此外，在整个治疗后获得了12.3%的完全缓解（CR）。总体平均生存期为15个月，根据IL2初始治疗后疾病的状态（进展、稳定或有反应），平均生存期分别为8、18和24 + 个月。该方案耐受性良好，实际接受剂量为计划剂量的90%，87%的疗程中患者在IL2输注结束后2小时内即可出院。未观察到毒性死亡。在观察到的与临床反应相关的参数中，只有体能状态和可溶性肿瘤坏死因子α受体（sTNF-alpha R）水平与反应显著相关。
