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目的评价甲氨蝶呤+异环磷酰胺+阿霉素(MMIT方案)与顺铂+异环磷酰胺+阿霉素(DIA方案)新辅助化疗治疗骨肉瘤的临床疗效及安全性。方法将51例ⅡB期骨肉瘤患者分为试验组24例和对照组27例。试验组第1,2周予以甲氨蝶呤10 g·m-2,静脉持续滴注4~6 h,持续应用14 d+四氢叶酸15 mg·m-2,q6 h,持续应用3 d,第3周予以异环磷酰胺2 g·m-2,静脉滴注,持续应用5 d+阿霉素30 mg·m-2,静脉滴注,持续应用3 d;对照组第1周予以顺铂120 mg·m-2,持续静脉滴注4~6 h,持续应用7 d,第2周予以异环磷酰胺2 g·m-2,静脉滴注,持续应用5 d+阿霉素30 mg·m-2,静脉滴注,持续应用3 d。2组患者1个周期均为4周,术前进行2个周期的化疗,术后继续化疗4~6个周期。比较2组患者术后中位疾病进展时间及化疗相关不良反应发生率。结果治疗后,试验组的中位疾病无进展时间为31.2个月略高于对照组26.8个月(P>0.05)。2组患者化疗相关的血液学毒性、胃肠道反应和其他不良反应发生率比较差异无统计学意义(P>0.05)。结论 MMIT与DIA方案新辅助化疗治疗骨肉瘤患者的临床疗效和安全性相当。
Objective To evaluate the clinical efficacy and safety of neoadjuvant chemotherapy with methotrexate + ifosfamide + doxorubicin (MMIT) and cisplatin + ifosfamide (DIA) in the treatment of osteosarcoma. Methods 51 cases of stage Ⅱ B osteosarcoma patients were divided into experimental group 24 cases and control group 27 cases. Methotrexate 10 g · m-2 was administered in the first and second week in the experimental group, and the vein was continuously instilled for 4 ~ 6 h with continuous application of 14 mg / day of tetrahydrofolic acid (15 mg · m-2, q6 h) for 3 days. 3 weeks ifosfamide 2 g · m-2, intravenous infusion, continuous application of 5 d + doxorubicin 30 mg · m-2, continuous application of 3 d; the first week of the control group to cisplatin 120 mg · m-2, continuous intravenous infusion of 4 ~ 6 h, continuous application of 7 d, the first 2 weeks ifosfamide 2 g · m-2, intravenous infusion, continuous application of 5 d + doxorubicin 30 mg · m-2, intravenous infusion, continuous application of 3 d. Two groups of patients with a cycle of 4 weeks, preoperative chemotherapy for 2 cycles, chemotherapy continued after 4 to 6 cycles. The duration of postoperative median disease progression and the incidence of chemotherapy-related adverse events were compared between the two groups. Results After treatment, median progression-free time was 31.2 months in the experimental group slightly higher than that in the control group (26.8 months) (P> 0.05). Chemotherapy-related hematologic toxicity, gastrointestinal reactions and other adverse reactions in the two groups showed no significant difference (P> 0.05). Conclusion MMIT and DIA neoadjuvant chemotherapy in the treatment of osteosarcoma in patients with clinical efficacy and safety.