摘要
目的:通过前瞻性多中心Ⅱ期临床试验,观察重组人白细胞介素-2(125Ser-rhIL-2)对晚期实体肿瘤及恶性胸腹腔积液患者的疗效及不良反应。方法:180例入组患者可评价疗效者174例,癌性胸腹腔积液和实体瘤患者分别为126例和48例,肾透明细胞癌和恶性黑色素瘤等实体瘤采用皮下注射(200～300万IU,每周3次,疗程4～6周),胸腔内注射(200～300万IU,每周1～2次,疗程2周),恶性胸腔积液采用腹腔内注射(300～400万IU,每周1～2次,疗程2周)。结果:恶性胸腹腔积液和晚期实体瘤的总有效率分别为59.5%和25.0%,治疗后大部分患者生存质量和免疫功能有一定提高。主要的不良反应为低热、寒颤、乏力、局部皮肤红肿及消化道反应。未发现低血压及毛细血管渗漏综合征。结论:125Ser-rhIL-2对恶性黑色素瘤、肾透明细胞癌及恶性胸腹腔积液有效,不良反应较轻。
Objective: A prospective multicentre phase Ⅱ clinical trial of 125Ser-rhIL-2 was conducted to evaluate the response rate and adverse reaction in patients with malignant pleural/ peritoneal effusion and advanced solid tumor. Methods: 125Ser-rhIL-2 was administered subcutaneously in patients with advanced renal cell carcinoma and malignant melanoma (2×10~6～3×10~6IU, three times one week, 4～6weeks) or intrapleurally in patients with malignant pleural effusion (2×10~6×3× 10~6IU,one or twice one week,2 weeks) and intraperitoneally in patients with malignant peritoneal effusion (3×10~6～4×10~6IU,once or twice one week,2 weeks). Results: Among 180 patients, 172 were evaluable. The response rate was 59. 5% in 126 cases with malignant effusion and ascites,and 25.0% in 48 cases with advanced renal cell carcinoma and malignant melanoma. Quality of life and immune function were improved in majority of the patients. The major adverse reaction were fever, chill, fatigue, erythroderma and gastrointestinal reaction. No hypotension and capillary leak syndrome were observed. Conclusion: 125Ser-rhIL-2 has anti-tumor activity in patients with advanced renal cell carcinoma and malignant melanoma, as well as malignant pleural/peritoneal effusion. Its adverse reaction was mild.
出处
《中国新药杂志》
CAS
CSCD
北大核心
2005年第3期338-341,共4页
Chinese Journal of New Drugs
