Huland E, Heinzer H, Huland H
Department of Urology, University Hospital Hamburg-Eppendorf, Germany.
Folia Biol (Praha). 2000;46(6):241-50.
The aim of the current study was to compare the objective response and survival rates of patients with mRCC treated with IL-2 administered either systemically (SYST, subcutaneously) or via inhalation (INH), using relatively large sample sizes to afford a more meaningful comparison. We used univariate and multivariate analyses to retrospectively evaluate the data from two different databases generated from 277 patients treated with IL-2 during the 1993-1997 period, one developed at the University Hospital Hamburg-Eppendorf, and the other at Chiron-Amsterdam. Patients treated with INH IL-2 tended to have a poorer ECOG performance status than patients receiving SYST IL-2. Of 75 patients receiving INH IL-2, eight (10.7%) achieved an objective response; of 202 patients administered SYST IL-2, 45 (22.2%) achieved an objective response. The median survival time was 13.8 months for patients receiving INH IL-2 and 13.1 months for patients treated with SYST IL-2. One- and two-year survival rates were also comparable for the two treatment modalities (one-year: INH, 55%; SYST, 56%; two-year: INH, 28%; SYST, 26%). There was no significant difference in the likelihood of survival for patients receiving INH IL-2 versus SYST IL-2 (risk ratio = 0.82, P = 0.27). Patients administered INH IL-2 experienced considerably less toxicity and complications than patients administered SYST IL-2. We conclude that INH IL-2 treatment is at least as effective as SYST IL-2 treatment in promoting the survival of patients with mRCC. Given that INH IL-2 treatment of patients with a poorer ECOG performance status elicited a survival rate comparable to that seen with SYST IL-2 treatment of patients with a superior performance status, the potential exists for INH IL-2 treatment to be even more effective for patients having a better performance status. Additionally, INH IL-2 treatment is considerably less toxic and associated with fewer complications than SYST IL-2 treatment, thus providing a therapeutic option for otherwise untreatable patients, offering patients a relatively good quality of life, and requiring fewer co-medications. Nonetheless, selection of an IL-2 treatment modality should be based on several patient-related considerations. Moreover, these two IL-2 treatment modalities need not be mutually exclusive.
本研究的目的是比较全身（SYST，皮下注射）或吸入（INH）给予白细胞介素-2（IL-2）治疗的转移性肾细胞癌（mRCC）患者的客观缓解率和生存率，采用相对大的样本量以进行更有意义的比较。我们使用单因素和多因素分析回顾性评估了1993年至1997年期间接受IL-2治疗的277例患者产生的两个不同数据库的数据，一个数据库来自汉堡-埃彭多夫大学医院，另一个来自基龙-阿姆斯特丹公司。接受INH IL-2治疗的患者的东部肿瘤协作组（ECOG）体能状态往往比接受SYST IL-2治疗的患者差。在75例接受INH IL-2治疗的患者中，8例（10.7%）获得客观缓解；在202例接受SYST IL-2治疗的患者中，45例（22.2%）获得客观缓解。接受INH IL-2治疗的患者的中位生存时间为13.8个月，接受SYST IL-2治疗的患者为13.1个月。两种治疗方式的1年和2年生存率也相当（1年：INH，55%；SYST，56%；2年：INH，28%；SYST，26%）。接受INH IL-2治疗与接受SYST IL-2治疗的患者的生存可能性没有显著差异（风险比=0.82，P=0.27）。接受INH IL-2治疗的患者比接受SYST IL-2治疗的患者经历的毒性和并发症要少得多。我们得出结论，INH IL-2治疗在促进mRCC患者生存方面至少与SYST IL-2治疗一样有效。鉴于对ECOG体能状态较差的患者进行INH IL-2治疗所产生的生存率与对体能状态较好的患者进行SYST IL-2治疗所观察到的生存率相当，INH IL-2治疗对体能状态更好的患者可能更有效。此外，INH IL-2治疗的毒性明显较小，并发症也比SYST IL-2治疗少，从而为否则无法治疗的患者提供了一种治疗选择，为患者提供了相对较好的生活质量，且所需的辅助药物较少。尽管如此，IL-2治疗方式的选择应基于几个与患者相关的考虑因素。此外，这两种IL-2治疗方式并非相互排斥。
