TY - JOUR
T1 - Ten-year follow-up results of perioperative chemotherapy with doxorubicin and ifosfamide for high-grade soft-tissue sarcoma of the extremities
T2 - Japan Clinical Oncology Group study JCOG0304
AU - Tanaka, Kazuhiro
AU - Mizusawa, Junki
AU - Naka, Norifumi
AU - Kawai, Akira
AU - Katagiri, Hirohisa
AU - Hiruma, Toru
AU - Matsumoto, Yoshihiro
AU - Tsuchiya, Hiroyuki
AU - Nakayama, Robert
AU - Hatano, Hiroshi
AU - Emori, Makoto
AU - Watanuki, Munenori
AU - Yoshida, Yukihiro
AU - Okamoto, Takeshi
AU - Abe, Satoshi
AU - Asanuma, Kunihiro
AU - Yokoyama, Ryohei
AU - Hiraga, Hiroaki
AU - Yonemoto, Tsukasa
AU - Morii, Takeshi
AU - Ae, Keisuke
AU - Nagano, Akihito
AU - Yoshikawa, Hideki
AU - Fukuda, Haruhiko
AU - Ozaki, Toshifumi
AU - Iwamoto, Yukihide
N1 - Funding Information:
This work was supported in part by the National Cancer Center Research and Development Fund [grant number 29-A-3] and AMED [grant number JP18ck0106336] for the collection, analysis, and interpretation of data and for preparing the manuscript.
Publisher Copyright:
© 2019 The Author(s).
PY - 2019/9/6
Y1 - 2019/9/6
N2 - 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.
AB - 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.
KW - 10-year follow-up
KW - Doxorubicin and ifosfamide
KW - Extremity
KW - Perioperative chemotherapy
KW - Soft tissue sarcoma
KW - Survival
UR - http://www.scopus.com/inward/record.url?scp=85071896887&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85071896887&partnerID=8YFLogxK
U2 - 10.1186/s12885-019-6114-2
DO - 10.1186/s12885-019-6114-2
M3 - Article
C2 - 31492159
AN - SCOPUS:85071896887
SN - 1471-2407
VL - 19
JO - BMC Cancer
JF - BMC Cancer
IS - 1
M1 - 890
ER -
