Validity Verification of Indices Utilizing TGF-b1, NF-kB, PET/CT, and MRS Predicting Response to Neoadjuvant Chemotherapy in Osteosarcoma Patients
We will conduct a prospective trial to verify the validity of indices utilizing TGF-b1,
NF-kB, PET/CT, and MRS for predicting response to neoadjuvant chemotherapy in osteosarcoma
patients. We assume that changes in plasma TGF-b1 levels, PET/CT and magnetic resonance
spectroscopy (MRS) findings during the period of neoadjuvant chemotherapy as well as the
initial nuclear NF-kB expression status of tumor biopsy specimen either alone or in
combination may predict a chemotherapeutic response determined by histopathologic necrosis
fractions of tumors removed. To test this, we will obtain TGF-b1 levels, PET/CT and MRS
findings at diagnosis and at follow-up (after first and second/third chemotherapy cycle).
Tumor will then be removed. Chemotherapy regimen comprised of various combination of
cisplatin, adriamycin, and high-dose methotrexate, ifosfamide, and etoposide. Indices
derived from TGF-b1, PET/CT, MRS predicting greater than 90% necrosis fractions will be
sought utilizing statistical methods.
Observational Model: Case-Only, Time Perspective: Prospective
histopathologic necrosis fractions of surgically removed tumor specimen
12-17 weeks after starting chemotherapy
Byung-Kiu Park, M.D., Ph.D.
Pediatric Oncology Branch, National Cancer Center, Korea
South Korea: Korea Food and Drug Administration (KFDA)