Department of Orthopaedic Surgery, Faculty of Medicine, Oita University, Idaigaoka 1-1, Hasama, Yufu City, Oita, 879-5593, Japan.
JCOG Data Center, National Cancer Center Hospital, Tokyo, 104-0045, Japan.
BMC Cancer. 2019 Sep 6;19(1):890. doi: 10.1186/s12885-019-6114-2.
Soft-tissue sarcomas (STS) are rare malignant tumors those are resistant to chemotherapy. We have previously reported the 3-year follow-up result on the efficacy of perioperative chemotherapy with doxorubicin (DXR) and ifosfamide (IFM) for high-risk STS of the extremities (JCOG0304). In the present study, we analyzed the 10-year follow-up results of JCOG0304.
Patients with operable, high-risk STS (T2bN0M0, AJCC 6th edition) of the extremities were treated with 3 courses of preoperative and 2 courses of postoperative chemotherapy, which consisted of 60 mg/m of DXR plus 10 g/m of IFM over a 3-week interval. The primary study endpoint was progression-free survival (PFS) estimated by Kaplan-Meier methods. Prognostic factors were evaluated by univariable and multivariable Cox proportional hazards model.
A total of 72 patients were enrolled between March 2004 and September 2008, with 70 of these patients being eligible. The median follow-up period was 10.0 years for all eligible patients. Local recurrence and distant metastasis were observed in 5 and 19 patients, respectively. The 10-year PFS was 65.7% (95% CI: 53.4-75.5%) with no PFS events being detected during the last 5 years of follow-up. The 10-year overall survival was 78.1% (95% CI: 66.3-86.2%). Secondary malignancy was detected in 6 patients. The subgroup analysis demonstrated that there was significant difference in survival with regard to primary tumor size.
Only a few long-term results of clinical trials for perioperative chemotherapy treatment of STS have been reported. Our results demonstrate that the 10-year outcome of JCOG0304 for patients with operable, high-risk STS of the extremities was stable and remained favorable during the last 5 years of follow-up.
This trial was registered at the UMIN Clinical Trials Registry as C000000096 on August 30, 2005.
软组织肉瘤（STS）是一种罕见的恶性肿瘤，对化疗有抗性。我们之前报告了接受多柔比星（DXR）和异环磷酰胺（IFM）围手术期化疗的肢体高危 STS 的 3 年随访结果（JCOG0304）。在本研究中，我们分析了 JCOG0304 的 10 年随访结果。
我们对可手术的肢体高危 STS（T2bN0M0，AJCC 第 6 版）患者进行了 3 个疗程的术前和 2 个疗程的术后化疗，化疗方案为每 3 周给予 60mg/m 的 DXR 和 10g/m 的 IFM。主要研究终点为 Kaplan-Meier 方法估计的无进展生存期（PFS）。通过单变量和多变量 Cox 比例风险模型评估预后因素。
2004 年 3 月至 2008 年 9 月期间共纳入 72 例患者，其中 70 例符合条件。所有符合条件的患者中位随访时间为 10.0 年。5 例患者出现局部复发，19 例患者出现远处转移。10 年 PFS 为 65.7%（95%CI：53.4-75.5%），在最后 5 年随访中未检测到 PFS 事件。10 年总生存率为 78.1%（95%CI：66.3-86.2%）。6 例患者检测到继发性恶性肿瘤。亚组分析表明，生存与原发肿瘤大小有关。
只有少数 STS 围手术期化疗治疗的临床试验有长期结果报告。我们的结果表明，JCOG0304 对肢体可手术高危 STS 患者的 10 年结果在最后 5 年的随访中是稳定的，仍然是有利的。
该试验于 2005 年 8 月 30 日在 UMIN 临床试验注册中心注册，注册号为 C000000096。
