洛铂联合阿霉素、异环磷酰胺化疗方案新辅助治疗骨肉瘤的剂量探索

临床肿瘤学杂志

洛铂联合阿霉素、异环磷酰胺化疗方案新辅助治疗骨肉瘤的剂量探索

陈国景¹，王臻¹，叶新红²，吴智钢¹，朱皓东¹，石磊¹，付军¹

1 西安第四军医大学西京医院骨肿瘤科 2 海南长安国际制药有限公司

收稿日期:2013-10-30 修回日期:2014-01-15 出版日期:2014-04-30 发布日期:2014-04-30
通讯作者: 王臻

Dose escalation trial of lobaplatin combined with adriamycin and ifosfamide for neoadjuvant chemotherapy in osteosarcoma

HEN Guojing， WANG Zhen，YE Xinhong， WU Zhigang， ZHU Haodong， SHI Lei， FU Jun.

Department of Orthopedics， Xijing Hospital， Fourth Military Medical University

Received:2013-10-30 Revised:2014-01-15 Online:2014-04-30 Published:2014-04-30
Contact: WANG Zhen

摘要/Abstract

摘要： 目的探讨洛铂（LBP）联合阿霉素（ADM）、异环磷酰胺（IFO）化疗方案新辅助治疗骨肉瘤的最大耐受量（MTD），并观察其毒副反应。方法 LBP设定3个剂量水平，分别为45mg／m²、50mg／m²、55mg／m²，ADM和IFO剂量固定（ADM 60mg／m²、IFO 12g／m²），观察到出现剂量限制性毒性（DLT）即终止试验，或至55mg／m²未出现DLT，试验亦终止。结果共有6例患者完成了爬坡试验，当试验进行到第1个剂量组时，出现2例DLT，试验终止。从而确定联合化疗方案的MTD为LBP 45mg／m²、ADM 60mg／m²和IFO 12g／m²。主要不良反应为骨髓抑制，血小板减少的发生率为66.6％（4/6），3级发生率为33.3％（2/6）；白细胞减少的发生率为83.3％（5/6），未发生4级白细胞减少；中性粒细胞减少的发生率为83.3％（5/6），4级发生率为33.3％（2/6）。所有患者经对症治疗后均好转，未影响继续治疗。结论 LBP联合ADM、IFO化疗方案新辅助治疗骨肉瘤的MTD为LBP 45mg／m²、ADM 60mg／m²和IFO12g／m²，毒副反应可耐受，建议以此为依据开展进一步临床研究。

Abstract: Objective To investigate the maximum-tolerated dose（MTD） and observe the side effects of lobaplatin（LBP） combined with adriamycin（ADM） and ifosfamide （IFO） for neoadjuvant chemotherapy in osteosarcoma.
MethodsThe doses of ADM and IFO were fixed（ADM 60mg／m²，IFO 12g／m²），and three dose levels of LBP were setted， namely 45mg／m²， 50mg／m²， 55mg／m². The dose of LBP would increase gradually until doselimiting toxicity（DLT） or 55mg／m². Results Six cases were enrolled， and 2 DLT cases were observed when the test to the first dose group. So the MTD was LBP 45mg／m2， ADM 60mg／m²， IFO 12g／m². The main toxicities were reversible bone marrow suppression. The incidence rate of thrombocytopenia was 66.6％（4／6） and grade 3 was 33.3％（2／6）. The incidence rate of leukocytopenia was 83.3％（5／6） and no grade 3-4 toxicity was observed 0 （0／6）. The incidence of neutropenia was 83.3％（5／6） and grade 4 was 33.3％（2／6）. All patients were recovered by symptomatic treatment. Conclusion The MTD of LBP combined with ADM and IFO as neoadjuvant chemotherapy in treating osteosarcoma is LBP 45mg／m2， ADM 60mg／m²， IFO 12g／m². The therapy is well tolerated and recommended as a basis for further clinical studies.

陈国景¹，王臻¹，叶新红²，吴智钢¹，朱皓东¹，石磊¹，付军¹. 洛铂联合阿霉素、异环磷酰胺化疗方案新辅助治疗骨肉瘤的剂量探索[J]. 临床肿瘤学杂志, 2014, 19(4): 354-.

HEN Guojing， WANG Zhen，YE Xinhong， WU Zhigang， ZHU Haodong， SHI Lei， FU Jun. . Dose escalation trial of lobaplatin combined with adriamycin and ifosfamide for neoadjuvant chemotherapy in osteosarcoma[J]. Chinese Clinical Oncology, 2014, 19(4): 354-.

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