Treatment of patients with metastatic renal carcinoma with a combination of subcutaneous interleukin-2 and interferon alfa with or without fluorouracil. Groupe Français d'Immunothérapie, Fédération Nationale des Centres de Lutte Contre le Cancer.
Treatment of patients with metastatic renal carcinoma with a combination of subcutaneous interleukin-2 and interferon alfa with or without fluorouracil. Groupe Français d'Immunothérapie, Fédération Nationale des Centres de Lutte Contre le Cancer.
复制标题
法国国家免疫治疗中心联合皮下注射白细胞介素 2 和干扰素 α 联合或不联合氟尿嘧啶治疗转移性肾癌患者。
DOI：
10.1200/jco.2000.18.24.4009
复制
发表时间：
2000
期刊：
影响因子：
--
通讯作者：
Frédéric Gomez
中科院分区：
文献类型：
--
作者：
S. Négrier;Armelle Caty;Thierry Lesimple;J. Douillard;B. Escudier;Jean;Patrice Viens;Frédéric Gomez
目的
皮下注射重组白细胞介素-2（rIL-2）和重组干扰素α-2a（rIFN α-2a）已广泛用于转移性肾癌的治疗。来自非对照II期试验的大多数结果显示反应率不一致。最近，提出了添加氟尿嘧啶（FU）以提高这些方案的疗效。
患者和方法
研究了rIL-2和rIFN α-2a与或不与FU皮下组合的作用。患者被随机分配在第1、3、5和7周接受rIL-2和rIFN α-2a联合治疗，或在第1和5周接受相同的联合治疗并持续输注FU。这项多中心随机试验的主要终点是无进展生存期、缓解率和毒性。总生存期是次要终点。肿瘤缓解由独立委员会审查。在意向治疗的基础上进行结果分析。
结果
131例患者入组。两组之间的毒性无差异，未观察到中毒性死亡。在A组中观察到1例部分缓解，在B组中观察到5例部分缓解。两组间的无进展生存率无差异，A组和B组的1年无进展生存率分别为12%和15%。在任何终点均未检测到统计学显著差异。
结论
rIL-2和rIFN α-2a联合或不联合FU的皮下给药对转移性肾癌患者没有益处。这两种方案都不能推荐作为标准治疗。皮下细胞因子疗法的结果似乎令人失望。
PURPOSE
Subcutaneous recombinant interleukin-2 (rIL-2) and recombinant interferon alfa-2a (rIFNalpha-2a) have been used extensively in the treatment of metastatic renal cancer. Most results, coming from noncontrolled phase II trials, showed inconsistent rates of response. More recently, the addition of fluorouracil (FU) was proposed to improve the efficacy of these regimens.
PATIENTS AND METHODS
The role of a subcutaneous combination of rIL-2 and rIFNalpha-2a with or without FU was investigated. Patients were randomly assigned to receive a combination of rIL-2 and rIFNalpha-2a at weeks 1, 3, 5, and 7 or the same combination together with a continuous infusion of FU at weeks 1 and 5. The major end points of this multicenter, randomized trial were progression-free survival, response rate, and toxicity. Overall survival was a secondary end point. Tumor responses were reviewed by an independent committee. Analysis of the results was performed on an intention-to-treat basis.
RESULTS
One hundred thirty-one patients were enrolled. There was no difference in toxicity between the arms, and no toxic death was observed. One partial response was observed in arm A and five in arm B. Progression-free survival did not differ between the arms, and rates at 1 year were 12% and 15% in arms A and B, respectively. No statistically significant differences were detected in any end point.
CONCLUSION
The subcutaneous combination of rIL-2 and rIFNalpha-2a with or without FU does not benefit patients with metastatic renal carcinoma. Neither of these regimens can be recommended as standard treatment. The results of the subcutaneous cytokine regimen seem disappointing.
影响因子：
45.3
作者：
ATKINS, MB;SPARANO, J;SZNOL, M
通讯作者：
SZNOL, M
基于白细胞介素 2 的转移性肾细胞癌治疗：细胞因子工作组的经验，1989-1997 年。
DOI：
--
发表时间：
1997
期刊：
The cancer journal from Scientific American.
影响因子：
--
作者：
Dutcher,JP;Atkins,M;Fisher,R;Weiss,G;Margolin,K;Aronson,F;Sosman,J;Lotze,M;Gordon,M;Logan,T;Mier,J
通讯作者：
Mier,J