Clinical Evaluation of Neoadjuvant Chemotherapy for Primary Malignant Sarcomas That Originate in Bone

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

190 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-06-01

Study Completion Date

2018-10-30

Brief Summary

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For bone lesions treated with chemotherapy or targeted therapy, particularly for sarcomas that originate in bones, Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 is spurious because bone lesions are typically located in irregularly shaped bones, are difficult to measure accurately, and usually respond more slowly to treatment than soft tissue lesions. Positron Emission Tomography Response Criteria in Solid Tumors (PERCIST) allows for response to be measured in the absence of anatomic changes through assessment of metabolic activity. It does not, however, account for morphologic changes. This study evaluated whether clinical imaging findings of sarcomas after preoperative chemotherapy correlate with tumor responses by pathological evaluation using the rate of necrosis to develop reliable and quantitative clinical response criteria.

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Detailed Description

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We reviewed a total of 190 primary lesions by clinical imaging, including X-ray, computed tomography (CT), magnetic resonance imaging, and bone scan or PET/CT in patients who received neoadjuvant chemotherapy. All patients had curative surgery of those lesions at Peking University People's Hospital or Peking University Shougang Hospital. Pathological evaluation was completed by determination of the tumor necrosis rate following Huvos' description. We also performed statistical diversity analysis for different pathological groups and generated receiver operating characteristic curves (ROC) to define the thresholds to distinguish different pathological groups.

Conditions

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Clinical Response Histopathological Response Prognosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Huvos group I

Upon histopathological examination, the tumor response was assessed on the basis of the presence and extent of necrosis, which was assessed by a combination of gross and microscopic observations. Tumor necrosis was graded as per Picci et al. tumor histopathological response grading (Huvos classification), where grade I is 0% to 49%.