Phase II study of recombinant human tumor necrosis factor in colorectal carcinoma.

M Schaadt, M Pfreundschuh, G Lorscheidt, K M Peters, T Steinmetz, V Diehl
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Abstract

Fifteen patients with colorectal carcinoma received a 30-min intravenous infusion of recombinant human tumor necrosis factor (rHuTNF) to investigate the value of rHuTNF in the treatment of colorectal carcinoma. Patients received 5 x 10(5) U/m2 (217 micrograms/m2) on day 1, and in the absence of serious side effects 10 x 10(5) U/m2 (435 micrograms/m2) on day 3 and 15 x 10(5) U/m2 (652 micrograms/m2) on day 5. The cycle was repeated on day 28. Full dose escalation was possible in all patients. There was a minor response in one patient (disappearance of retroperitoneal lymph nodes). All other patients showed progressive disease. At the dose and schedule used, rHuTNF had minimal therapeutic activity in colorectal carcinoma.

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重组人肿瘤坏死因子在结直肠癌中的II期研究。
15例结直肠癌患者静脉滴注重组人肿瘤坏死因子(rHuTNF) 30 min,探讨重组人肿瘤坏死因子在结直肠癌治疗中的价值。患者第1天给予5 × 10(5) U/m2(217微克/m2),在无严重副作用的情况下,第3天给予10 × 10(5) U/m2(435微克/m2),第5天给予15 × 10(5) U/m2(652微克/m2)。第28天重复上述循环。在所有患者中,完全剂量递增是可能的。1例患者有轻微反应(腹膜后淋巴结消失)。其余均为进行性疾病。在使用的剂量和方案下,大黄坏死因子对结直肠癌的治疗作用最小。
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