Abstract
BackgroundSoft-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.MethodsPatients 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/m2 of DXR plus 10 g/m2 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.ResultsA 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.ConclusionsOnly 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.Trial registrationThis trial was registered at the UMIN Clinical Trials Registry as C000000096 on August 30, 2005.
Highlights
Soft-tissue sarcomas (STS) are rare malignant tumors those are resistant to chemotherapy
We have previously reported the perioperative chemotherapy with DXR and IFM was well tolerable and promising in the short-term results of JCOG0304, including the efficacy, safety, and correlation of outcomes with prognostic factors and radiological response [5,6,7]
Three courses of preoperative chemotherapy were completed in 66 patients and all 5 courses of the protocol treatment were completed in 53 patients
Summary
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). We analyzed the 10-year follow-up results of JCOG0304. Soft-tissue sarcomas (STS) are rare types of malignant tumors those account for less than 1% of all malignancies [1]. According to the Soft Tissue Tumor Registry conducted by the Japanese Orthopaedic Association, 1529 patients with STS were registered in 2015 in Japan [2]. We conducted a multicenter phase 2 trial (JCOG0304) of perioperative chemotherapy with doxorubicin (DXR) and ifosfamide (IFM) for treating high-risk STS of the extremities [4]. We analyzed the 10year follow-up results and report the final results of JCOG0304
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