Ravaud A, Négrier S, Cany L, Merrouche Y, Le Guillou M, Blay J Y, Clavel M, Gaston R, Oskam R, Philip T
Department of Medical Oncology, Foundation Bergonié, Comprehensive Cancer Centre, Bordeaux, France.
Br J Cancer. 1994 Jun;69(6):1111-4. doi: 10.1038/bjc.1994.218.
A double-institution phase II study was performed in patients with metastatic renal cell carcinoma treated subcutaneously (s.c.) with interleukin 2 (IL-2) and alpha-interferon (INF-alpha). Thirty-eight patients were treated over a course of 7 weeks. Initially (day 1 + 2) patients received s.c. IL-2 at 18 x 10(6) IU m-2. During the following 6 weeks, patients received s.c. IL-2 at 3.6 x 10(6) IU m-2 for 5 days per week and s.c. INF-alpha at 5 x 10(6) for 3 days per week. Thirty-eight patients were evaluated for response. An objective response was seen in seven patients (18.4 +/- 12.3%), with one complete response and six partial responses. Median duration of response was 6.7 months. Toxicity could be evaluated in 38 patients and was limited. Mild to moderate toxicity included fever (97%), fatigue or malaise (76%), nausea or vomiting (50%), anorexia (32%), hypotension (26%), neurological disturbances (26%) and hypercreatininaemia (39%). In addition, four grade IV haematological toxicities were noted. No cardiac side-effects were seen. IL-2 and INF-alpha given by this schedule can be safely administered in an outpatient setting. The objective response rate was similar to our previous treatments with high-dose IL-2 given as a continuous infusion.
一项双机构的II期研究在接受皮下注射白细胞介素2（IL-2）和α-干扰素（INF-α）治疗的转移性肾细胞癌患者中进行。38名患者接受了为期7周的治疗。最初（第1天+第2天），患者接受皮下注射IL-2，剂量为18×10⁶IU/m²。在接下来的6周内，患者每周5天接受皮下注射IL-2，剂量为3.6×10⁶IU/m²，每周3天接受皮下注射INF-α，剂量为5×10⁶。对38名患者进行了疗效评估。7名患者出现客观缓解（18.4±12.3%），其中1例完全缓解，6例部分缓解。缓解的中位持续时间为6.7个月。38名患者的毒性可进行评估，且毒性有限。轻度至中度毒性包括发热（97%）、疲劳或不适（76%）、恶心或呕吐（50%）、厌食（32%）、低血压（26%）、神经功能障碍（26%）和血肌酐升高（39%）。此外，记录到4例IV级血液学毒性。未观察到心脏副作用。按此方案给予的IL-2和INF-α可在门诊环境中安全给药。客观缓解率与我们之前持续输注高剂量IL-2的治疗相似。
