羟基喜树碱联合顺铂治疗晚期恶性肿瘤的初步临床研究

Preliminary study of lyophilized 10-Hydroxycamptothecin (Tuoxi) combine with cisplatin in advanced or recurrent malignancies

目的:观察羟基喜树碱(hydroxycamptothecin,HCPT)联合顺铂(DDP)治疗晚期食管癌和鼻咽癌的疗效及毒副反应。方法:50例晚期食管癌和鼻咽癌患者应用HCPT4.68～7.04mg/(m2·d)[中位剂量为5.6mg/(m2·d)],静脉滴入,连续3d,DDP58.5～100mg/m2(中位剂量为70mg/m2),静脉滴入,d1,21d为1个周期,至少治疗2个周期,全组化疗共161个周期。结果:46例可评价患者中有效率为45.7%(21/46),CR2例,PR19例,SD18例,PD7例;食管癌有效率为42.9%(12/28),鼻咽癌有效率50.0%(9/18)。主要毒副反应为骨髓抑制,恶心呕吐及腹泻;一过性肝、肾功能轻度损伤。Ⅲ/Ⅳ度白细胞下降,恶心呕吐、血小板下降及腹泻发生率分别为29.2%(47/161)、21.7%(35/161)、13.0%(21/161)和2.5%(4/161)。结论:HCPT联合DDP治疗食管癌和鼻咽癌疗效好,毒副反应可以耐受。

OBJECTIVE： To investigate the efficacy, toxicity of hydroxycamptothecin （HCPT, Tuoxi） combine with cisplatin in the treatment of advanced and recurrent solid tumors. METHODS： Fifty patients with the median age of 53 years were enrolled into this clinical trial. Among them, 34 patients were chemonaive and 16 were recurrent from chemotherapy, 30 patients with esophageal cancer, 20 patients with nasopharyngeal carcinoma. HCPT was give at the dosage of 4.68- 7.04 mg/（m^2 · d） Emedian dosage 5.6 mg/（m^2· d）] for 3 consecutive days. cisplatin was give at the dosage of 58. 8- 100 mg/m^2 （median dosage 70 mg/m^2 ） on d1. The treatment cycle was repeated every 3 weeks. RESULTS： Forty-six patients were valuable for effectiveness, The objective response rate for the whole group was 45.7%（21/46）. The partial remission （PR） rates were 42.9% （12/28） for esophageal cancer and 50.0% （9/18） for advanced nasopharyngeal carcinoma, respectively. Myelosuppression was the dose-limiting toxicity and other adverse reactions included nausea/vomiting, diarrhea, and transient hepatic and renal function disorder. The incidence of grade 11/IV adverse events were 29.2%（47/161）, 21.7% （35/161）, 13.0%（21/161）, 2.5%（4/161） for leucopoenia, nausea/vomiting, thrombocytopenia, and diarrhea, respectively. No pulmonary and cardiac toxicity were found. CONCLUSION; Tuoxi and cisplatin represents a well-tolerated active palliative regimen for patients with recurrent /metastasis esophageal cancer and nasopharyngeal cancer.