Impact of IDH Mutation and Adjuvant Chemo(radio)therapy on Survival Outcome in Grade II/III Astrocytoma

This study looked at a type of brain tumor called astrocytoma and how specific genetic changes like IDH mutations affect patients outcomes. Recent studies found that people with IDH-mutated astrocytomas tend to live longer and have better survival rates compared to those without these mutations. One reason for this is that IDH-mutated tumors usually grow more slowly and are less aggressive. These findings suggest that testing for IDH mutations could help doctors make more personalized treatment plans for patients, which may lead to better results. However, larger studies are needed to confirm these observations. the investigators used the Surveillance, Epidemiology and End Results (SEER) database to obtain the data of 811 patients with grade II/III astrocytoma. The data are publicly available and no consent or ethical approval is needed for this study. The clinicopathological data of patients, including the age, gender, race, IDH status (mutant/wild), astrocytoma type (diffuse/anaplastic), surgery (tumor destruction, Local excision, partial, radical, total gross resection, Surgery), radiation (Beam radiation, Radioactive implants including brachytherapy, Radioisotopes, Combination of beam with implants or isotopes, Radiation, method or source not specified), chemotherapy, vital status, and survival months, were extracted. Patients were sub-grouped according to the IDH type into IDH mutant-type and wild-type. with further stratification according to the treatment modality into three groups: adjuvant chemotherapy, adjuvant radiotherapy, and combined adjuvant chemoradiotherapy. The Observed survival and cause-specific survival were calculated using SEER*stat software version 8.4.3 and SPSS version 25 was used for survival analysis. Significance was achieved at 0.05.

Study Overview

• Status: Completed
• Conditions: Astrocytoma; Astrocytic Tumors; Astrocytoma of Brain
• Intervention / Treatment: Other: IDH mutant-type; Other: IDH wild-type

• Study Type: Observational
• Enrollment (Actual): 811

Contacts and Locations

Study Locations

• Egypt
  • Ismailia, Egypt
    • Suez Canal University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with grade II/III astrocytoma with malignant behavior. The investigators sub-grouped the data according to the IDH mutation type into two groups: IDH wild-type and IDH-mutant type with further stratification according to the treatment modalities the patients received: adjuvant chemotherapy, adjuvant radiotherapy and adjuvant chemoradiotherapy; following any surgical intervention (tumor destruction, Local excision, partial, radical, total gross resection, Surgery)

Description

Inclusion Criteria:

• Patients were selected only if they had astrocytoma with malignant behavior
• Grade II-III astrocytoma
• First primary tumor with sequence 0 or 1
• Had surgical intervention (tumor destruction, Local excision, partial, radical, total gross resection, Surgery)

Exclusion Criteria:

• unknown survival time
• patients with unknown age
• death certificate only and autopsy only cases

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients having astrocytoma with IDH mutant-type	Other: IDH mutant-type; The first arm had IDH mutant-type, then stratified according to the treatment modality they received: adjuvant chemotherapy, adjuvant radiotherapy, adjuvant chemoradiotherapy.
Patients having astrocytoma with IDH wild-type	Other: IDH wild-type; The second arm had IDH mutant-type, then stratified according to the treatment modality they received: adjuvant chemotherapy, adjuvant radiotherapy, adjuvant chemoradiotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The 2-year relative survival and 2-year observed survival of grade II/III astrocytoma with IDH mutation	from Jan, 2018 till Dec, 2020

Secondary Outcome Measures

Outcome Measure	Time Frame
The 2-year relative survival of different treatment with modalities chemo(radio)therapy among both groups: IDH wild type and IDH mutant type astrocytoma	Jan, 2018 till Dec, 2020

Collaborators and Investigators

• Sponsor: asmaa salama ibrahim
• Investigators: Principal Investigator: Asmaa Ellaithy, MD, Suez Canal University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): December 30, 2020
• Study Completion (Actual): December 30, 2021

Study Registration Dates

• First Submitted: September 28, 2024
• First Submitted That Met QC Criteria: September 28, 2024
• First Posted (Actual): October 1, 2024

Study Record Updates

• Last Update Posted (Actual): October 29, 2024
• Last Update Submitted That Met QC Criteria: October 25, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: chemotherapy; survival; Astrocytoma; Wild IDH
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Astrocytoma
• Other Study ID Numbers: A1997

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The data is publicly available through SEER database

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No