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Clinical Trial
. 2018 Aug 10;16(1):162.
doi: 10.1186/s12957-018-1462-y.

Prospective Comparison of Various Radiological Response Criteria and Pathological Response to Preoperative Chemotherapy and Survival in Operable High-Grade Soft Tissue Sarcomas in the Japan Clinical Oncology Group Study JCOG0304

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Free PMC article
Clinical Trial

Prospective Comparison of Various Radiological Response Criteria and Pathological Response to Preoperative Chemotherapy and Survival in Operable High-Grade Soft Tissue Sarcomas in the Japan Clinical Oncology Group Study JCOG0304

Kazuhiro Tanaka et al. World J Surg Oncol. .
Free PMC article

Abstract

Background: Soft tissue sarcomas (STS) are rare malignant tumors. The efficacy of preoperative chemotherapy for STS is evaluated using various tumor size-based radiological response criteria. However, it is still unclear which set of criteria would show the best association with pathological response and survival of the patients with STS.

Methods: We compared radiological responses to preoperative chemotherapy for operable STS by the Response Evaluation Criteria in Solid Tumors (RECIST), modified RECIST, World Health Organization criteria, Japanese Orthopaedic Association criteria, and modified Choi criteria and analyzed the association with pathological response and survival using the data from the Japan Clinical Oncology Group (JCOG) study JCOG0304, a phase II clinical trial evaluating the efficacy of perioperative chemotherapy for STS in the extremities.

Results: Seventy eligible patients in JCOG0304 were analyzed. The results demonstrated that none of the size-based radiological response criteria showed significant association with pathological response to preoperative chemotherapy for STS. The difference between overall survival of the patients assessed as partial response and stable disease/progressive disease by RECIST was not significant (hazard ratio 1.37, p = 0.63), and calculated C-index was 0.50. All other response criteria also could not exhibit significant association between radiological responses and survival.

Conclusion: In the present study, none of the radiological response criteria analyzed demonstrated association of response to preoperative chemotherapy with pathological response or survival of the patients with operable STS. Further prospective investigation is required to develop criteria to evaluate not only tumor shrinkage but biological effects of preoperative chemotherapy for the patients with localized STS.

Trial registration: UMIN Clinical Trials Registry C000000096. Registered 30 August, 2005 (retrospectively registered).

Keywords: Pathological response; Preoperative chemotherapy; Radiological response criteria; Soft tissue sarcoma; Survival.

Conflict of interest statement

All procedures performed in this study involving human participants were in accordance with the ethical standards of the institutional committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. This ancillary study plan was included in the JCOG0304 protocol and it was approved by the Clinical Trial Review Committee of JCOG, and also approved by the Institutional Review Boards of each of the 27 participating institutes. All patients gave written informed consent before entry to JCOG0304.

All patients gave written informed consent before entry to JCOG0304.

The authors declare that they have no competing interests.

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Patients flow diagram of JCOG0304
Fig. 2
Fig. 2
Kaplan-Meier estimates of overall survival (a) and progression free survival (b) of the patients with STS assessed as PR or SD/PD by RECIST

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