A phase II study of cisplatin, ifosfamide and epirubicin combination chemotherapy in adults with nonmetastatic and extremity osteosarcomas
A phase II study of cisplatin, ifosfamide and epirubicin combination chemotherapy in adults with nonmetastatic and extremity osteosarcomas
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DOI：
10.1159/000113017
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发表时间：
2007-01-01
期刊：
影响因子：
3.5
通讯作者：
Onat, Haluk
中科院分区：
文献类型：
--
作者：
Basaran, Mert;Bavbek, E. Sevil;Onat, Haluk
背景：骨肉瘤是一种罕见的恶性肿瘤，辅助化疗对骨肉瘤患者有好处。虽然顺铂、蒽环类和异环磷酰胺是治疗骨肉瘤最常用的药物，但仍在继续寻找具有更高疗效和最小毒性的最佳组合。我们计划评价表阿霉素联合顺铂和异环磷酰胺治疗局限性原发性骨肉瘤的疗效。方法：年龄大于15岁的四肢非转移性骨肉瘤患者纳入研究。术前化疗方案包括：第1天给予表阿霉素90 mg/m2，顺铂100 mg/m2，第2-4天给予异环磷酰胺2.0 g/m2/d，同时给予同等剂量的美司钠，每21天重复一次。给予6个周期的该联合方案（术前3个周期和术后3个周期）。结果：45例局限性骨肉瘤患者进入本II期试验。中位随访时间为64个月。32例患者（84%）接受了指定的6个周期的化疗。新辅助化疗的完全和良好组织学反应分别为26%和37%。5年无病生存率和总生存率分别为41.9%（95%CI 33.6-50.2）和48.2%（95%CI 39.6-56.8）。最突出的4级毒性是中性粒细胞减少，发生在32%的患者中。肺部是最常见的复发部位（32%）。结论：顺铂、异环磷酰胺和表阿霉素联合治疗是一种有效的、合理耐受的方案，在非转移性四肢骨肉瘤患者中没有3级或4级心脏毒性，值得在前瞻性III期试验中进一步研究。版权所有（C）2008 S. Karger AG，巴塞尔。
Background: Osteosarcoma is a rare malignancy, and patients with this disease benefit from adjuvant chemotherapy. While cisplatin, anthracyclines and ifosfamide are the most commonly used agents in the treatment of osteosarcoma, a search for the best combination with higher efficacy and minimal toxicity continues. We planned to evaluate the efficacy of epirubicin combined with cisplatin and ifosfamide in patients with localized primary osteosarcoma. Methods: Patients with nonmetastatic extremity osteosarcoma who were older than 15 years were included in the study. The preoperative chemotherapy regimen consisted of epirubicin 90 mg/m(2), cisplatin 100 mg/m(2) on day 1 and ifosfamide 2.0 g/m(2)/day with an equivalent dose of mesna on days 2-4, repeated every 21 days. Six cycles of this combination regimen were administered ( 3 cycles prior to surgery and 3 cycles postoperatively). Results: Forty-five patients with localized osteosarcoma entered this phase II trial. Median follow-up was 64 months. Thirty-two patients (84%) received the assigned 6 cycles of chemotherapy. Complete and good histological response to neoadjuvant chemotherapy was 26 and 37%, respectively. The 5-year disease-free and overall survival rates were 41.9% (95% CI 33.6-50.2) and 48.2% (95% CI 39.6-56.8). The most prominent grade 4 toxicity was neutropenia occurring in 32% of patients. The lungs were the most frequent site of relapse (32%). Conclusions: The combination of cisplatin, ifosfamide and epirubicin is an active, reasonably well-tolerated regimen without grade 3 or 4 cardiac toxicity in patients with nonmetastatic extremity osteosarcoma and deserves further investigation in the context of prospective phase III trials. Copyright (C) 2008 S. Karger AG, Basel.