Perioperative chemotherapy with ifosfamide and doxorubicin for high-grade soft tissue sarcomas in the extremities (JCOG0304)
Perioperative chemotherapy with ifosfamide and doxorubicin for high-grade soft tissue sarcomas in the extremities (JCOG0304)
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DOI：
10.1093/jjco/hyv042
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发表时间：
2015-06-01
影响因子：
2.4
通讯作者：
Iwamoto, Yukihide
中科院分区：
文献类型：
--
作者：
Tanaka, Kazuhiro;Mizusawa, Junki;Iwamoto, Yukihide
软组织肉瘤围手术期化疗的疗效存在争议，只有少数关于四肢软组织肉瘤术前化疗的前瞻性研究报道。因此，我们对四肢软组织肉瘤患者进行了围手术期化疗的II期研究，III期四肢非圆细胞软组织肉瘤患者符合条件。术前给予阿霉素60 mg/m2+异环磷酰胺10 g/m2化疗3个疗程。在肿瘤切除后，再进行2个疗程的相同方案治疗，共入组72例患者，70例患者合格。患者的中位年龄为49岁。主要病理类型为滑膜肉瘤20例，未分化多形性肉瘤17例。74%的合格病例完成了方案治疗。2年和5年无进展生存率分别为75.7%（95% CI，63.9-84.1%）和63.8%（95% CI，51.3-73.9%）。5年总生存率为82.6%（95%CI，71.3-89.7%）。无治疗相关死亡。大部分患者出现3 ~ 4级血液学毒性反应（白细胞减少和中性粒细胞减少），虽然该方案的毒性反应明显，但术前化疗后加用阿霉素和大剂量异环磷酰胺化疗是可行的。该试验对四肢高级别软组织肉瘤患者的结果是有利的，该方案有望进一步研究。本试验在UMIN临床试验注册中心（）注册为C 000000096。
The efficacy of perioperative chemotherapy for soft tissue sarcomas is controversial and only a few prospective studies of pre-operative chemotherapy for soft tissue sarcomas in the extremities have been reported. We therefore carried out Phase II study of perioperative chemotherapy for patients with soft tissue sarcomas in the extremities.Patients with Stage III non-round cell soft tissue sarcomas in the extremities were eligible. The patients were treated with pre-operative chemotherapy consisting doxorubicin 60 mg/m(2) and ifosfamide 10 g/m(2) for three courses. After the tumor resection, two additional courses of the same regimen were carried out.A total of 72 patients were enrolled and 70 patients were eligible. The median age of the patients was 49 years. The major pathological subtypes were synovial sarcoma in 20 and undifferentiated pleomorphic sarcoma in 17 patients. The protocol treatments were completed in 74% of the eligible cases. The 2 and 5-year progression-free survival rates were 75.7% (95% CI, 63.9-84.1%) and 63.8% (95% CI, 51.3-73.9%), respectively. The 5-year overall survival was 82.6% (95% CI, 71.3-89.7%). There was no treatment-related death. Grade 3 or 4 hematological toxicities (leukopenia and neutropenia) were observed in most of the patients.Although the toxicities of the regimen were significant, pre-operative chemotherapy followed by post-operative chemotherapy using doxorubicin and high-dose ifosfamide was feasible. The outcome of the trial for the patients with high-grade soft tissue sarcomas in the extremities was favorable, and this regimen is promising for further investigation. This trial was registered at the UMIN Clinical Trials Registry () as C000000096.