Chronic Liver Disease and Radiation-induced Second Primary Liver Malignancy

Suez Canal University

Status: Completed

Conditions: Chronic Liver Disease (CLD); Liver Fibrosis; Cancer

Treatments: Other: No intervention; Radiation: radiotherapy

Study type: Observational

Funder types: Other

Identifiers

NCT06868394

H2730

Details and patient eligibility

About

Cancer survivors are at a high risk to develop second primary malignancy (SPM) which constitutes a serious threat for them. Radiotherapy is the cornerstone for the management of many cancers as a locoregional treatment modality. Due to the low liver tolerance, cirrhotic patients are at a high risk of developing radiation-induced liver toxicities despite the modern safe radiation delivery techniques. Radiation damages cells through direct energy deposition and reactive free radical generation. Recent studies demonstrated a potential risk of SPMs following radiotherapy with further investigations for strategies to decrease radiation-induced SPMs. However, it is insufficiently addressed if developing liver SPMs is a serious adverse event following radiotherapy for cirrhotic patients. The aim of this study was to quantitatively assess the risk of gastrointestinal (GI) and liver SPMs following radiotherapy in patients with chronic liver disease.

Full description

The SEER.stat software version 8.4.3 was used to obtain and analyze the data of patients with chronic liver disease diagnosed from 2010 to 2021. Using Ishak fibrosis score: F0-4 no to moderate fibrosis and F5-6 advanced or severe cirrhosis. patients were subgrouped according to the history of receiving radiotherapy for prior cancer treatment in two groups and excluded patients with unknown radiotherapy administration history. An MP-SIR session was used to calculate the Standardized Incidence Ratio (SIR) as Observed/Expected (O/E) with 95% confidence interval (CI). Significance was achieved at 0.05.

Enrollment: 20,846 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Cancer patients were classified according to fibrosis severity using the Ishak fibrosis score: F0-F4 (no to moderate fibrosis) and F5-F6 (advanced or severe cirrhosis) from 2010 to 2021.

Exclusion criteria

• Patients with unknown radiotherapy history or unknown fibrosis score or missing age data

Trial design

20,846 participants in 2 patient groups

Patients with no to moderated liver fibrosis (ISHAK 0-4)

Description:

They were subgrouped according to previous history of radiotherapy exposure into two groups. Both groups were followed up for 10 years to assess the risk of second primary malignancies. The investigators retrospectively analyzed the data.

Treatment:

Radiation: radiotherapy

Other: No intervention

Patients with advanced or severe liver fibrosis (ISHAK 5-6)

Description:

They were subgrouped according to previous history of radiotherapy exposure into two groups. Both groups were followed up for 10 years to assess the risk of second primary malignancies. The investigators retrospectively analyzed the data.

Treatment:

Radiation: radiotherapy

Other: No intervention