Jones M, Philip T, Palmer P, von der Maase H, Vinke J, Elson P, Franks C R, Selby P
Department of Clinical Medicine, University of Leeds, St James's University Hospital.
Cancer Biother. 1993 Winter;8(4):275-88. doi: 10.1089/cbr.1993.8.275.
The purpose of this analysis was to compare the survival of patients with advanced renal carcinoma treated with intravenous recombinant interleukin-2 to the survival of matched patients taken from the large and well characterised database of the Eastern Cooperative Oncology Group (ECOG). Recombinant interleukin-2 (rIL-2) given by continuous intravenous infusion was used to treat 387 patients with advanced adenocarcinoma of the kidney in five multi-centre studies and 327 of these patients fulfilled the study eligibility criteria and were evaluable for response, toxicity and survival. The survival of patients treated with rIL-2 was compared in a multi-variate survival analysis taking account of all identified prognostic factors to 390 control patients receiving chemotherapy derived from the database. Thirteen patients treated with rIL-2 achieved a complete remission of their disease and 32 a partial remission giving an overall response rate of 14%. Remissions were durable with a median duration of 357 days for partial remissions and a median duration in excess of 926 days for complete remissions. Most patients experienced fever or mild to moderate hypotension and other toxicities are described. However, only 11 patients required admission to intensive care and in only five cases was this judged to be due to treatment toxicity. There were three deaths judged to be probably due to treatment toxicity. rIL-2 treatment was associated with significantly prolonged survival compared to the ECOG control patients. Patients with good prognostic features appeared to have a greater survival benefit from rIL-2 than those with poor prognostic features. This analysis provides the first evidence that rIL-2 prolongs survival in patients with advanced renal cancer but cannot provide proof which should be sought in randomised prospective trials drawing on the hypotheses generated herein.
本分析的目的是比较接受静脉注射重组白细胞介素-2治疗的晚期肾癌患者的生存率与从东部肿瘤协作组（ECOG）大型且特征明确的数据库中选取的匹配患者的生存率。在五项多中心研究中，采用持续静脉输注重组白细胞介素-2（rIL-2）治疗387例晚期肾腺癌患者，其中327例患者符合研究纳入标准，可对其反应、毒性和生存率进行评估。在多因素生存分析中，将考虑所有已确定的预后因素的接受rIL-2治疗的患者的生存率与从数据库中选取的390例接受化疗的对照患者进行比较。13例接受rIL-2治疗的患者疾病完全缓解，32例部分缓解，总缓解率为14%。缓解持续时间较长，部分缓解的中位持续时间为357天，完全缓解的中位持续时间超过926天。大多数患者出现发热或轻度至中度低血压，并描述了其他毒性反应。然而，只有11例患者需要入住重症监护病房，其中只有5例被判定是由于治疗毒性所致。有3例死亡可能被判定是由于治疗毒性。与ECOG对照患者相比，rIL-2治疗可显著延长生存期。具有良好预后特征的患者似乎比具有不良预后特征的患者从rIL-2治疗中获得更大的生存益处。本分析首次证明rIL-2可延长晚期肾癌患者的生存期，但无法提供证据，而这应在基于本文提出的假设进行的随机前瞻性试验中寻找。
