10-year follow-up results of perioperative chemotherapy with doxorubicin (DXR) and ifosfamide (IFM) for high-grade soft tissue sarcomas (STS) in the extremities: Japan Clinical Oncology Group study JCOG0304.

Abstract

e22533 Background: STS are rare malignant tumors and relatively resistant against chemotherapy. We have previously reported 3-year follow-up on the efficacy results of perioperative chemotherapy with DXR and IFM for STS in the extremities (JCOG0304) in ASCO 2011 (abstract ID:#10078). In the present report, we analyzed 10-year follow-up results of JCOG0304. Methods: Patients with operable, FNCLCC grade 2/3 STS (T2bN0M0, AJCC 6th edition) in the extremities were treated with 3 courses of preoperative and 2 courses of postoperative chemotherapy consisted of DXR 60 mg/m2plus IFM 10 g/m2in 3-week interval. Primary endpoint was progression-free survival (PFS). Prognostic factors were evaluated by log-rank test. Results: A total of 72 patients were enrolled between March 2004 and September 2008, and 70 patients were eligible. Median follow-up period was 10.0 years for all eligible cases. The local recurrence and distant metastasis were observed in 5 and 19 patients, respectively. Ten-year progression-free survival (PFS) was 65.7% (95% CI, 53.4%-75.5%) with no PFS event within last 5-year of follow-up. Ten-year overall survival (OS) was 78.1% (95% CI, 66.3%-86.2%). Subgroup analysis demonstrated no significant difference in PFS and OS regarding age, sex, histological grade, and histology. Secondary malignancy occurred in 6 patients. Conclusions: Only a few long-term results of clinical trials of perioperative chemotherapy for STS have been reported. Our results demonstrated that the 10-year outcome of JCOG0304 for the patients with operable, high-grade STS in the extremities was stable and remained favorable. Clinical trial information: C000000096.