Phase II trial of high-dose intermittent interleukin-2 in metastatic renal cell carcinoma: a Southwest Oncology Group study.
Phase II trial of high-dose intermittent interleukin-2 in metastatic renal cell carcinoma: a Southwest Oncology Group study.
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高剂量间歇性白细胞介素 2 治疗转移性肾细胞癌的 II 期试验：西南肿瘤学小组的一项研究。
DOI：
10.1093/jnci/82.2.143
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发表时间：
1990
期刊：
影响因子：
--
通讯作者：
Whitehead,RP
中科院分区：
文献类型：
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作者：
Bukowski,RM;Goodman,P;Crawford,ED;Sergi,JS;Redman,BG;Whitehead,RP
一项II期临床试验，间歇性高剂量重组白细胞介素-2（rIL-2）的开始，以评估缓解率，缓解持续时间，可测量的转移性肾细胞癌患者的毒性作用。rIL-2以10.0 × 106U/m2的剂量静脉推注，每周3次，在此之前口服吲哚美辛50 mg。允许因低血压和其他3级或4级毒性反应而降低rIL-2剂量。44例患者入组，41例合格。既往治疗包括肾切除术（23例），放射治疗（7例）和激素治疗（3例）。观察到的大多数毒性反应为中度，包括恶心、呕吐、厌食（85%）;低血压（85%）;发热、寒战（78%）;中枢神经系统变化（24%）;骨髓抑制（27%）;和肌酐升高（15%）。观察到4例4级毒性，包括恶心、呕吐伴脱水、低血压和心肌梗死。30例患者（73%）因毒性需要调整剂量。观察到5例反应（12%），其中包括1例完全反应和4例部分反应。缓解部位包括肺、肝和软组织;缓解持续时间范围为2至20+个月。这些结果表明，该rIL-2方案可以在门诊环境中施用，并且可以在患有转移性肾细胞癌的患者中产生肿瘤消退，包括持久的完全反应。[J Natl Cancer Inst 82：143 - 146，1990]
A phase II trial of intermittent highdose recombinant interleukin-2 (rIL-2) was initiated to evaluate the response rate, remission duration, and toxic effects in patients with measurable metastatic renal cell carcinoma. The rIL-2 was administered as a bolus intravenous infusion at a dose level of 10.0 × 106U/m2three times weekly, preceded by indomethacin (50 mg orally). Dose reductions of rIL-2 for hypotension and other grade 3 or 4 toxic effects were permitted. Forty-four patients were entered and 41 were eligible. Previous treatment included nephrectomy (23 patients), radiation therapy (seven), and hormone therapy (three). Most toxic effects observed were moderate and included nausea, vomiting, anorexia (85%); hypotension (85%); fever, chills (78%); central nervous system changes (24%); myelosuppression (27%); and creatinine elevation (15%). Four instances of grade 4 toxicity were observed and included nausea, vomiting with dehydration; hypotension; and myocardial infarction. Thirty patients (73%) required dose adjustments because of toxicity. Five responses (12%) were seen, which included one complete and four partial. Sites of response included lung, liver, and soft tissue; the duration of response ranged from 2 to 20+ months. These results demonstrate that this schedule of rIL-2 can be administered in an outpatient setting, and can produce tumor regression in patients with metastatic renal cell carcinoma, including durable complete responses. [J Natl Cancer Inst 82: 143–146, 1990]