Tumor Microenvironment in Patients With Localized Osteosarcoma Treated With Mifamurtide: a Translational Study

Istituto Ortopedico Rizzoli80 enrolled

Overview

International, multicenter retrospecitve biological study

International, multicenter retrospecitve biological study that will analyze the tumor micro environment in biological archival samples of patients, who were treated with chemotherapy +/- mifamurtide according the protocols for primary localized osteosarcoma (ISG-OS2 and GEIS-33)

Study Type

OBSERVATIONAL

Enrollment

Conditions

Localized Osteosarcoma

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients with primary localized osteosarcoma who received chemotherapy +/- mifamurtide according to ISG-OS2/GEIS-33 trials, 2. Paraffin-embedded tissue tumor (FFPE) blocks from archive available to perform the biological analysis 3. Written informed consent prior to any study-specific analysis and/or data collection Exclusion Criteria: 1\) Patients with diagnosis different from osteosarcoma \-

Locations (1)

SSD Chemioterapia dei tumori dell'apparato locomotore

Bologna, Italy

Outcomes

Primary Outcomes

Characterize the immunephenotype in patients with localized osteosarcoma treated with chemotherapy +/- mifamurtide for primary osteosarcoma

A gene expression profile analysis will be performed through NanoString, using the PanCancer Immune Profiling Panel, which includes 770 genes related to the tumor microenvironment. This analysis will be carried out on the NanoString platform, present at the Hemolympopathology Division of the European Institute of Oncology

Time frame: at baseline (Day0)

Correlate the rate of immune cells, and the level of the PDL-1 checkpoint with event-free survival and overall-survival

For survival analysis the following factors will be correlated with Overall Suvival and Event Free Survival age (pediatric \< 18 years vs adult ≥ 18 years), gender, LDH and phosphatase alkaline (PA) levels at baseline (normal vs high), pathologic response (good: chemotherapy-induced tumor necrosis ≥ 90%; poor: chemotherapy-induced tumor necrosis \< 90%, \[10\]), tumoral miroenvironment components, PD-1 expression on IC, and PD-L1 both on TC and IC., genetic signatures.

Time frame: at baseline (Day0)

Data from ClinicalTrials.gov

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