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
Kazuhiro Tanaka,
Junki Mizusawa,
Norifumi Naka,
Akira Kawai,
Hirohisa Katagiri,
Toru Hiruma,
Yoshihiro Matsumoto,
Hiroyuki Tsuchiya,
Robert Nakayama,
Hiroshi Hatano,
Makoto Emori,
Munenori Watanuki,
Yukihiro Yoshida,
Takeshi Okamoto,
Satoshi Abe,
Kunihiro Asanuma,
Ryohei Yokoyama,
Hiroaki Hiraga,
Tsukasa Yonemoto,
Takeshi Morii,
Keisuke Ae,
Akihito Nagano,
Hideki Yoshikawa,
Haruhiko Fukuda,
Toshifumi Ozaki,
Yukihide Iwamoto
Affiliations
Kazuhiro Tanaka
Department of Orthopaedic Surgery, Faculty of Medicine, Oita University
Junki Mizusawa
JCOG Data Center, National Cancer Center Hospital
Norifumi Naka
Musculoskeletal Oncology Service, Osaka International Cancer Institute
Akira Kawai
Department of Orthopaedic Surgery, National Cancer Center
Hirohisa Katagiri
Department of Orthopaedic Surgery, Shizuoka Cancer Center
Toru Hiruma
Department of Orthopaedic Surgery, Kanagawa Cancer Center
Yoshihiro Matsumoto
Department of Orthopaedic Surgery, Kyushu University
Hiroyuki Tsuchiya
Department of Orthopaedic Surgery, Kanazawa University
Robert Nakayama
Department of Orthopaedic Surgery, Keio University
Hiroshi Hatano
Department of Orthopaedic Surgery, Niigata Cancer Center Hospital
Makoto Emori
Department of Orthopaedic Surgery, Sapporo Medical University
Munenori Watanuki
Department of Orthopaedic Surgery, Tohoku University
Yukihiro Yoshida
Department of Orthopaedic Surgery, Nihon University
Takeshi Okamoto
Department of Orthopaedic Surgery, Kyoto University
Satoshi Abe
Department of Orthopaedic Surgery, Teikyo University
Kunihiro Asanuma
Department of Orthopaedic Surgery, Mie University
Ryohei Yokoyama
Department of Orthopaedic Surgery, National Kyushu Cancer Center
Hiroaki Hiraga
Department of Orthopaedic Surgery, Hokkaido Cancer Center
Tsukasa Yonemoto
Department of Orthopaedic Surgery, Chiba Cancer Center
Takeshi Morii
Department of Orthopaedic Surgery, Kyorin University
Keisuke Ae
Department of Orthopaedic Surgery, Cancer Institute Hospital
Akihito Nagano
Department of Orthopaedic Surgery, Gifu University
Hideki Yoshikawa
Department of Orthopaedic Surgery, Osaka University
Haruhiko Fukuda
JCOG Data Center, National Cancer Center Hospital
Toshifumi Ozaki
Department of Orthopaedic Surgery, Okayama University
Abstract 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/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. 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.