Journal Article

Ten-year follow-up results of perioperative chemotherapy with doxorubicin and ifosfamide for high-grade soft-tissue sarcoma of the extremities: Japan Clinical Oncology Group study JCOG0304

Kawai, Akira, Iwamoto, Yukihide, Yoshida, Yukihiro, Ae, Keisuke, Nagano, Akihito, Hiruma, Toru, Naka, Norifumi, Mizusawa, Junki, Hatano, Hiroshi, Katagiri, Hirohisa, Watanuki, Munenori, Emori, Makoto, Nakayama, Robert, Okamoto, Takeshi, Yonemoto, Tsukasa, Yoshikawa, Hideki, Asanuma, Kunihiro, Morii, Takeshi, Ozaki, Toshifumi, Tanaka, Kazuhiro, Tsuchiya, Hiroyuki, Abe, Satoshi, Matsumoto, Yoshihiro, Yokoyama, Ryohei, Hiraga, Hiroaki, Fukuda, Haruhiko

2019

Overview

Background 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. Methods 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 2 of DXR plus 10 g/m 2 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. Results 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. Conclusions 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. Trial registration This trial was registered at the UMIN Clinical Trials Registry as C000000096 on August 30, 2005.

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: 10-year follow-up / Adult / Anthracyclines / Antineoplastic Combined Chemotherapy Protocols - administration & dosage / Antineoplastic Combined Chemotherapy Protocols - therapeutic use / Biomedical and Life Sciences / Biomedicine / Cancer / cancer imaging / Cancer metastasis / Cancer Research / Chemotherapy / Chemotherapy, Adjuvant / Clinical trials / Clinical Trials as Topic / Doxorubicin / Doxorubicin - administration & dosage / Doxorubicin - therapeutic use / Doxorubicin and ifosfamide / Drug Administration Schedule / Drug therapy / Enrollments / Extremities - pathology / Extremity / Female / Follow-Up Studies / Health Promotion and Disease Prevention / Humans / Ifosfamide / Ifosfamide - administration & dosage / Ifosfamide - therapeutic use / interventional therapeutics / Japan / Male / Malignancy / Management / Medical prognosis / Medicine/Public Health / Metastases / Odds Ratio / Oncology / Patients / Perioperative care / Perioperative chemotherapy / Perioperative Period / Radiation therapy / Research Article / Review boards / Risk factors / Sarcoma / Sarcoma - drug therapy / Sarcoma - mortality / Sarcoma - pathology / Sarcoma - surgery / Soft Tissue Neoplasms - drug therapy / Soft Tissue Neoplasms - mortality / Soft Tissue Neoplasms - pathology / Soft Tissue Neoplasms - surgery / Soft tissue sarcoma / Statistical analysis / Surgical Oncology / Survival / Survival Rate / Tissues / Treatment Outcome / Tumors