TY - JOUR
T1 - Phase II trial of pazopanib in patients with metastatic or unresectable chemoresistant sarcomas
T2 - A Japanese Musculoskeletal Oncology Group study
AU - Urakawa, Hiroshi
AU - Kawai, Akira
AU - Goto, Takahiro
AU - Hiraga, Hiroaki
AU - Ozaki, Toshifumi
AU - Tsuchiya, Hiroyuki
AU - Nakayama, Robert
AU - Naka, Norifumi
AU - Matsumoto, Yoshihiro
AU - Kobayashi, Eisuke
AU - Okuma, Tomotake
AU - Kunisada, Toshiyuki
AU - Ando, Masahiko
AU - Ueda, Takafumi
AU - Nishida, Yoshihiro
N1 - Funding Information:
This work was supported by Novartis Pharmaceuticals Corporation. This study was designed as an investigator-initiated trial and the study sponsor was not involved in study design, provision of drugs, data collection/analysis, writing of the report, or in the decision to submit the article for publication. We thank the patients who participated in our study, members of JMOG participating institutions, Data and Safety Monitoring Committee (Dr H. Sugiura, Dr A. Nagano, and Dr Y. Shido), the Center for Advanced Medicine and Clinical Research in Nagoya University Hospital (Dr Y. Kuwatsuka, Ms F. Sugiura, and Ms M. Ito), and employees of Novartis Pharmaceuticals Corporation (Mr T. Yonezu, Ms M. Endo, Mr R. Kano, and Ms M. Machida) for their contributions to this study.
Funding Information:
This work was supported by Novartis Pharmaceuticals Corporation. This study was designed as an investigator‐initiated trial and the study sponsor was not involved in study design, provision of drugs, data collection/analysis, writing of the report, or in the decision to submit the article for publication. We thank the patients who participated in our study, members of JMOG participating institutions, Data and Safety Monitoring Committee (Dr H. Sugiura, Dr A. Nagano, and Dr Y. Shido), the Center for Advanced Medicine and Clinical Research in Nagoya University Hospital (Dr Y. Kuwatsuka, Ms F. Sugiura, and Ms M. Ito), and employees of Novartis Pharmaceuticals Corporation (Mr T. Yonezu, Ms M. Endo, Mr R. Kano, and Ms M. Machida) for their contributions to this study.
Publisher Copyright:
© 2020 The Authors. Cancer Science published by John Wiley & Sons Australia, Ltd on behalf of Japanese Cancer Association.
PY - 2020/9/1
Y1 - 2020/9/1
N2 - Alveolar soft part sarcoma (ASPS), epithelioid sarcoma (ES), and clear cell sarcoma (CCS) are known to be chemoresistant tumors. The aim of this study was to investigate the effect of pazopanib on these chemoresistant tumors. This study is designed as a single-arm, multicenter, investigator-initiated phase II trial. Patient enrollment was undertaken between July 2016 and August 2018 at 10 hospitals participating in the Japanese Musculoskeletal Oncology Group. The primary end-point is the CBR (CBR, including complete or partial response and stable disease) at 12 weeks after treatment with pazopanib according to RECIST. Eight patients were enrolled within the period. The histological subtypes were 5 ASPS, 2 ES, and 1 CCS. The median follow-up period was 22.2 (range, 4.9-24.9) months. All patients initially received pazopanib 800 mg once daily. The CBRs were 87.5% (7 of 8) and 75.0% (6 of 8) according to RECIST and Choi criteria at 12 weeks after pazopanib treatment, respectively. The CBRs at 12 weeks according to RECIST were 80.0%, 100.0%, and 100.0% in ASPS, ES, and CCS, respectively. Partial response was observed in 1 ASPS according to RECIST and 3 ASPS and 1 ES according to Choi criteria at 12 weeks after pazopanib treatment. This study documented antitumor activity of pazopanib, especially in ASPS. These results support the frontline use of pazopanib for ASPS. Prospective data collection is desired using both RECIST and Choi criteria for these rare chemoresistant tumors.
AB - Alveolar soft part sarcoma (ASPS), epithelioid sarcoma (ES), and clear cell sarcoma (CCS) are known to be chemoresistant tumors. The aim of this study was to investigate the effect of pazopanib on these chemoresistant tumors. This study is designed as a single-arm, multicenter, investigator-initiated phase II trial. Patient enrollment was undertaken between July 2016 and August 2018 at 10 hospitals participating in the Japanese Musculoskeletal Oncology Group. The primary end-point is the CBR (CBR, including complete or partial response and stable disease) at 12 weeks after treatment with pazopanib according to RECIST. Eight patients were enrolled within the period. The histological subtypes were 5 ASPS, 2 ES, and 1 CCS. The median follow-up period was 22.2 (range, 4.9-24.9) months. All patients initially received pazopanib 800 mg once daily. The CBRs were 87.5% (7 of 8) and 75.0% (6 of 8) according to RECIST and Choi criteria at 12 weeks after pazopanib treatment, respectively. The CBRs at 12 weeks according to RECIST were 80.0%, 100.0%, and 100.0% in ASPS, ES, and CCS, respectively. Partial response was observed in 1 ASPS according to RECIST and 3 ASPS and 1 ES according to Choi criteria at 12 weeks after pazopanib treatment. This study documented antitumor activity of pazopanib, especially in ASPS. These results support the frontline use of pazopanib for ASPS. Prospective data collection is desired using both RECIST and Choi criteria for these rare chemoresistant tumors.
KW - alveolar soft part sarcoma
KW - chemoresistant tumor
KW - clear cell sarcoma
KW - epithelioid sarcoma
KW - pazopanib
UR - http://www.scopus.com/inward/record.url?scp=85087767423&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85087767423&partnerID=8YFLogxK
U2 - 10.1111/cas.14542
DO - 10.1111/cas.14542
M3 - Article
C2 - 32579783
AN - SCOPUS:85087767423
SN - 1347-9032
VL - 111
SP - 3303
EP - 3312
JO - Cancer Science
JF - Cancer Science
IS - 9
ER -
