一线化疗方案联合血管生成抑制剂治疗四肢成骨肉瘤随机、对照、多中心研究的初步报告

 目的 评价一线化疗方案联合重组人血管内皮抑制素治疗四肢骨肉瘤的疗效及安全性,为寻找骨肉瘤化疗新的药物和评价化疗方案提供依据。方法 采用随机、对照和多中心的研究方法,将63例确诊为骨肉瘤的患者随机分为试验组(32例)和对照组(31例),剔除和脱落9例,有效病例54例(试验组29例、对照组25例)。试验组采用阿霉素、顺铂、氨甲喋呤、异环磷酰胺联合重组人血管内皮抑制素方案,对照组使用阿霉素、顺铂、氨甲喋呤、异环磷酰胺方案。采用中位无进展生存时间、临床受益率、无进展生存率、保肢率、生存率等指标来评价两组疗效。通过比较两组不良事件发生率来评价重组人血管内皮抑制剂的安全性。结果 试验组中位无进展生存时间18.9个月,对照组为13.1个月,两者差异无统计学意义。试验组临床受益率89.7%、无进展生存率37.9%、生存率65.5%、保肢率89.7%,对照组分别为88.0%、36%、68%和96.0%,上述四项指标两组间差异均无统计学意义。结论　在目前随访期内采用重组人血管内皮抑制剂治疗在控制肿瘤进展和患者生存方面与对照组比较尚未见明显差异。使用重组人血管内皮抑制剂未发现相关的毒性反应,也未有因其而增加基础化疗毒性反应的报告。

The preliminary report of a randomized controlled multicenter study of first-line chemotherapy regimen combined with angiogenesis inhibitor for osteosarcoma of the extremities

Objective To evaluate effect and safety of first-line chemotherapy regimen combined with rh-endostatin for osteosarcoma of the extremities. Methods Sixty three patients with osteosarcoma were randomly divided into experiment group and control group. There were 32 patients in experiment group, and 31 patients in control group. Nine patients 9 were rejected because they did not meet the standard. Finally, 54 patients were enrolled in this study, including 29 patients in experiment group, and 25 patients in control group. In the experiment group, the patients were treated with rh-endostatin combined with MTX, IFO, DDP, and ADM, while patients in control group were treated with MTX, IFO, DDP, and ADM. Several indexes including median progression-free survival time, clinical benefit rate, progression-free survival rate, limb salvage rate, and survival rate were used to assess clinical effect. The safety of rh-endostatin was evaluated by comparing incidence of adverse events in the two groups. Results The median progression-free survival time of experiment group and control group was 18.9 months and 13.1 months, respectively; there was no significant difference. In the experiment group, the clinical benefit rate, progression-free survival rate, survival rate and limb salvage rate were 89.7%, 37.9%, 65.5%, and 89.7%, respectively; while in the control group, the clinical benefit rate, progression-free survival rate, survival rate, and limb salvage rate were 88.0%, 36.0%, 68.0%, and 96.0%, respectively. There was no significant difference in 4 indexes mentioned above between two groups. Conclusion After being combined with first-line chemotherapy regimen, rh-endostatin doesn't show significant advantage in controlling tumour progression and improving survival rate. No more toxicity and new side effects are found after using rh-endostatin.