Interleukin-2 with or without LAK cells in metastatic renal cell carcinoma: a report of a European multicentre study.

S Negrier, T Philip, G Stoter, S D Fossa, S Janssen, A Iacone, F S Cleton, O Eremin, L Israel, C Jasmin
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Abstract

Between October 1987 and November 1988, 95 European patients with metastatic renal cell carcinoma have been treated with recombinant interleukin-2 (rIL-2) (EuroCetus) at 18 X 10(6) IU/m2/day (equivalent to 3 X 10(6) Cetus Units/m2/day) according to the West schedule in two trials. 1. Forty-two patients received rIL-2 alone. Median time between initial diagnosis and metastases was three months. Eighty-one percent of the patients had at least two involved sites at inclusion and 86% underwent prior nephrectomy. Twenty-seven patients (64%) received two successive courses. Over 80% of the planned dose was administered in 69% and 44% of patients during courses 1 and 2, respectively. Fever, hypotension, weight gain, rise in creatinine level, hepatic disturbances, anaemia and thrombocytopenia were commonly observed but resolved promptly after completion of therapy. No toxic death was recorded. Two (6%) complete responses (CR), four (13%) partial responses (PR), four stable diseases (SD) and 22 progressive diseases (PD) were observed. The response rate is 6/32 (19%); the median progression-free survival time is not reached at 218+ days (92-394). 2. Fifty-three patients received rIL-2 with lymphokine-activated killer (LAK) cells. Median time from primary diagnosis to metastases was three months. Eighty-five percent of patients had at least two involved sites though 73% had previously undergone nephrectomy. Forty patients (75%) received two successive induction courses. Most patients, i.e. respectively, 77% and 60%, were given at least 80% of the planned dose during courses 1 and 2. Median numbers of LAK cells infused were 13.1 and 11.6 X 10(9) nucleated cells per course, respectively. Toxicity was not different from that described above; no toxic death occurred; five CR (10%), nine PR (18%), 11 SD and 26 PD were observed. The response rate is 14/51 (27%) and the median progression-free survival time is not reached at 7.2+ months (3-13.1). In conclusion, rIL-2, with or without LAK cells, is obviously active on metastatic renal cell carcinoma. The difference in response rate between the two trials is not statistically significant but has to be paralleled with the difference in dose received by the patients rather than with the addition of a cellular therapy. Toxicity was always manageable and reversible. The association of rIL-2 with other lymphokines should represent a major issue to improve the response rate and will be considered in further European studies.

白介素-2伴或不伴LAK细胞在转移性肾细胞癌中的作用:一项欧洲多中心研究报告
1987年10月至1988年11月,95名欧洲转移性肾细胞癌患者在两项试验中接受重组白细胞介素-2 (il -2) (EuroCetus)治疗,剂量为18 X 10(6) IU/m2/天(相当于3 X 10(6) Cetus单位/m2/天)。1. 42例患者单独接受il -2治疗。从最初诊断到转移的中位时间为3个月。81%的患者至少有两个受累部位,86%的患者曾接受过肾切除术。27例患者(64%)连续接受2个疗程。在疗程1和疗程2中,69%和44%的患者分别使用了超过80%的计划剂量。发烧、低血压、体重增加、肌酐水平升高、肝脏紊乱、贫血和血小板减少症是常见的症状,但在治疗完成后迅速消退。无中毒死亡记录。完全缓解(CR) 2例(6%),部分缓解(PR) 4例(13%),病情稳定(SD) 4例,进展性疾病(PD) 22例。应答率为6/32 (19%);中位无进展生存期未达到218+天(92-394)。2. 53例患者接受il -2淋巴因子活化杀伤细胞(LAK)治疗。从初诊到转移的中位时间为3个月。85%的患者至少有两个受累部位,但73%的患者曾接受过肾切除术。40例患者(75%)连续接受两次诱导疗程。大多数患者,分别为77%和60%,在疗程1和2期间给予至少80%的计划剂量。每疗程注射LAK细胞的中位数分别为13.1和11.6 × 10(9)个有核细胞。毒性与上面描述的没有什么不同;未发生中毒性死亡;CR 5例(10%),PR 9例(18%),SD 11例,PD 26例。缓解率为14/51(27%),中位无进展生存期未达到7.2+个月(3-13.1)。总之,无论是否有LAK细胞,rIL-2在转移性肾细胞癌中都有明显的活性。两项试验之间反应率的差异在统计学上并不显著,但必须与患者接受的剂量差异而不是细胞治疗的增加相平行。毒性总是可控和可逆的。il -2与其他淋巴因子的关联应该是提高反应率的主要问题,并将在进一步的欧洲研究中予以考虑。
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