Inoges Susana, Lopez-Diaz de Cerio Ascension, Zabalegui Natalia, Soria Elena, Villanueva Helena, Panizo Carlos, Rodriguez-Caballero Arancha, Suarez Lilia, Pastor Fernando, Rodriguez-Calvillo Mercedes, Orfao Alberto, Bendandi Maurizio
Laboratory of Immunotherapy, Oncology Division, Center for Applied Medical Research, University of Navarra, Pamplona, Spain.
Leuk Lymphoma. 2009 Jan;50(1):47-53. doi: 10.1080/10428190802601122.
During the last 2 decades, idiotypic vaccination has provided proof of principle of biological efficacy, clinical efficacy and clinical benefit in small follicular lymphoma trials. However, with the exception of anecdotal reports, most patients have received no more than 10 doses of their customised idiotype (Id) vaccine. Therefore, it is not known whether prolonged usage of idiotypic vaccination is safe. Since 2002, 18 previously treated patients with follicular lymphoma have received extended idiotypic vaccination at our institution outside clinical trials. Vaccination was provided as a compassionate alternative to no further treatment, and was meant to be stopped only upon complete consumption of the available patient- and tumor-specific vaccine [Id-keyhole limpet hemocyanin + granulocyte-macrophage colony-stimulating factor (Id-KLH + GM-CSF)], or in case of disease relapse or any serious non-local toxicity. So far, 18 patients have received an average of 18 doses of Id vaccine (median: 17; mean: 18; range: 10-31). Eleven patients are still actively receiving idiotypic vaccination: some of them are now over more than 6 years. Toxicity has been systematically negligible and mostly local. No patient has abandoned the vaccination program because of toxicity. Prolonged idiotypic vaccination with the soluble protein Id-KLH + GM-CSF formulation is safe and well tolerated.
在过去20年中，在小滤泡性淋巴瘤试验中，独特型疫苗接种已提供了生物学疗效、临床疗效和临床益处的原理证明。然而，除了一些轶事报道外，大多数患者接受的定制独特型（Id）疫苗剂量不超过10剂。因此，尚不清楚长期使用独特型疫苗接种是否安全。自2002年以来，18例先前接受过治疗的滤泡性淋巴瘤患者在我们机构接受了超出临床试验范围的延长独特型疫苗接种。疫苗接种是作为一种无进一步治疗的人道替代方案提供的，并且仅在可用的患者特异性和肿瘤特异性疫苗[Id-钥孔戚血蓝蛋白+粒细胞-巨噬细胞集落刺激因子（Id-KLH+GM-CSF）]完全用完时，或在疾病复发或出现任何严重的非局部毒性时才停止。到目前为止，18例患者平均接受了18剂Id疫苗（中位数：17；平均数：18；范围：10-31）。11例患者仍在积极接受独特型疫苗接种：其中一些患者现在已经接种超过6年。毒性一直可以忽略不计，且大多为局部毒性。没有患者因毒性而放弃疫苗接种计划。使用可溶性蛋白Id-KLH+GM-CSF制剂进行长期独特型疫苗接种是安全的，且耐受性良好。
