TY - JOUR
T1 - Standardization of evaluation method and prognostic significance of histological response to preoperative chemotherapy in high-grade non-round cell soft tissue sarcomas
AU - Oda, Yoshinao
AU - Tanaka, Kazuhiro
AU - Hirose, Takanori
AU - Hasegawa, Tadashi
AU - Hiruta, Nobuyuki
AU - Hisaoka, Masanori
AU - Yoshimoto, Masato
AU - Otsuka, Hiroshi
AU - Bekki, Hirofumi
AU - Ishii, Takeaki
AU - Endo, Makoto
AU - Kunisada, Toshiyuki
AU - Hiruma, Toru
AU - Tsuchiya, Hiroyuki
AU - Katagiri, Hirohisa
AU - Matsumoto, Yoshihiro
AU - Kawai, Akira
AU - Nakayama, Robert
AU - Kawashima, Hiroyuki
AU - Takenaka, Satoshi
AU - Emori, Makoto
AU - Watanuki, Munenori
AU - Yoshida, Yukihiro
AU - Okamoto, Takeshi
AU - Mizusawa, Junki
AU - Fukuda, Haruhiko
AU - Ozaki, Toshifumi
AU - Iwamoto, Yukihide
AU - Nojima, Takayuki
N1 - Funding Information:
We would like to thank all members of the JCOG Bone and Soft Tissue Tumor Study Group. Participating Institutions of JCOG0304-A1 were as follows (from north to south): Sapporo Medical University, Hokkaido Cancer Center, Tohoku University, Chiba Cancer Center, National Cancer Center Hospital, Nihon University, Kyorin University, Keio University, Teikyo University, Kanagawa Cancer Center, Niigata Cancer Center Hospital, Kanazawa University, Gifu University, Shizuoka Cancer Center, Mie University, Kyoto University, Osaka International Cancer Center, Okayama University, Kyushu University, National Kyushu Cancer Center. We would like to thank Editage (www.editage.com) for English language editing.
Funding Information:
This work was supported in part by the National Cancer Center Research and Development Fund [grant number 29-A-3 and 2020-J-3], JSPS KAKENHI [grant number JP19H03444] and AMED [grant number JP17ck0106336 and JP20ck0106614] for the collection, analysis, and interpretation of data and for preparing the manuscript.
Publisher Copyright:
© 2022, The Author(s).
PY - 2022/12
Y1 - 2022/12
N2 - Background: Preoperative chemotherapy is widely applied to high-grade localized soft tissue sarcomas (STSs); however, the prognostic significance of histological response to chemotherapy remains controversial. This study aimed to standardize evaluation method of histological response to chemotherapy with high agreement score among pathologists, and to establish a cut-off value closely related to prognosis. Methods: Using data and specimens from the patients who had registered in the Japan Clinical Oncology Group study, JCOG0304, a phase II trial evaluating the efficacy of perioperative chemotherapy with doxorubicin (DOX) and ifosfamide (IFO), we evaluated histological response to preoperative chemotherapy at the central review board. Results: A total of 64 patients were eligible for this study. The percentage of viable tumor area ranged from 0.1% to 97.0%, with median value of 35.7%. Regarding concordance proportion between pathologists, the weighted kappa coefficient (κ) score in all patients was 0.71, indicating that the established evaluation method achieved substantial agreement score. When the cut-off value of the percentage of the residual tumor area was set as 25%, the p-value for the difference in overall survival showed the minimum value. Hazard ratio of the non-responder with percentage of the residual tumor < 25%, to the responder was 4.029 (95% confidence interval 0.893–18.188, p = 0.070). Conclusion: The standardized evaluation method of pathological response to preoperative chemotherapy showed a substantial agreement in the weighted κ score. The evaluation method established here was useful for estimating of the prognosis in STS patients who were administered perioperative chemotherapy with DOX and IFO. Trial registration: UMIN Clinical Trials Registry C000000096. Registered 30 August, 2005 (retrospectively registered).
AB - Background: Preoperative chemotherapy is widely applied to high-grade localized soft tissue sarcomas (STSs); however, the prognostic significance of histological response to chemotherapy remains controversial. This study aimed to standardize evaluation method of histological response to chemotherapy with high agreement score among pathologists, and to establish a cut-off value closely related to prognosis. Methods: Using data and specimens from the patients who had registered in the Japan Clinical Oncology Group study, JCOG0304, a phase II trial evaluating the efficacy of perioperative chemotherapy with doxorubicin (DOX) and ifosfamide (IFO), we evaluated histological response to preoperative chemotherapy at the central review board. Results: A total of 64 patients were eligible for this study. The percentage of viable tumor area ranged from 0.1% to 97.0%, with median value of 35.7%. Regarding concordance proportion between pathologists, the weighted kappa coefficient (κ) score in all patients was 0.71, indicating that the established evaluation method achieved substantial agreement score. When the cut-off value of the percentage of the residual tumor area was set as 25%, the p-value for the difference in overall survival showed the minimum value. Hazard ratio of the non-responder with percentage of the residual tumor < 25%, to the responder was 4.029 (95% confidence interval 0.893–18.188, p = 0.070). Conclusion: The standardized evaluation method of pathological response to preoperative chemotherapy showed a substantial agreement in the weighted κ score. The evaluation method established here was useful for estimating of the prognosis in STS patients who were administered perioperative chemotherapy with DOX and IFO. Trial registration: UMIN Clinical Trials Registry C000000096. Registered 30 August, 2005 (retrospectively registered).
KW - Chemotherapy
KW - Clinical trial
KW - Doxorubicin
KW - Histological response
KW - Ifosfamide
KW - Neoadjuvant
KW - Prognosis
KW - Soft tissue sarcoma
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U2 - 10.1186/s12885-022-09195-y
DO - 10.1186/s12885-022-09195-y
M3 - Article
C2 - 35062915
AN - SCOPUS:85123504949
SN - 1471-2407
VL - 22
JO - BMC Cancer
JF - BMC Cancer
IS - 1
M1 - 94
ER -
