A Multi-center, Retrospective Analysis of Clinical Character, Outcome and Prognosis of Lymphoepithelioma-like Carcinoma

• Conditions: Lung Cancer; Lymphoepithelioma-Like Carcinoma; Lymphoepithelioma-Like Carcinoma of Thymus
• Interventions: Other: Non-intervention research

• Registration Number: NCT04614818
• Lead Sponsor: Sun Yat-sen University

Brief Summary

The investigators retrospective collect the clinical data of patients diagnosed with lymphoepithelioma-like carcinoma, including primary site, gender, age, smoking history, tumor stage, time of initial treatment, EBV-DNA copy number, first-line treatment and survival status.

Detailed Description

Lymphoepithelioma-like carcinoma (LELC) is a rare EBV-related tumor. Its histology is similar to that of nasopharyngeal carcinoma. In 2004, the WHO classified LELC into one subtype of large cell carcinoma, and the 2015 WHO classified it as other and unclassified cancers. LELC can originate in many organs, including parotid glands, throat, lungs, digestive tract, genitourinary system, etc. Driver gene mutations are rarely seen, and most of them are PD-L1 positive. In terms of treatment, there is no standard first-line treatment for lymphoepithelioma-like cancer. Patients with early-stage lymphoepithelioma-like cancer can receive surgery or radiotherapy, while palliative radiotherapy or chemotherapy is the main treatment for patients in advanced stage. The survival time is about 107 months, the 5-year OS is 59.5%, which is better than the prognosis of lung squamous cell carcinoma in the same period. A retrospective study of Sun yat-sen University Cancer Hospital included 127 patients with advanced lung LELC who received first-line chemotherapy between 2007 and 2018. Gemcitabine and platinum based chemotherapy and paclitaxel and platinum based regimens are significantly better than pemetrexed and platinum, but most of the current studies on lymphoepithelioma-like cancer focus on LELC that originates in the lung. But for other sites, such as parotid glands, liver, digestive tract, are mostly based on case reports, and there are few retrospective studies with large samples to explore their clinical features and treatment outcome. Therefore, investigators designed this retrospective clinical study to analyze the clinical characteristics, treatment, survival, and prognostic risk factors of patients with lymphoepithelioma-like carcinoma in order to summary the clinical character and guide treatment.

Study Timeline

• Study Start: 2008-01-01
• Study First Submitted: 2020-10-26
• Status Verified: 2020-11
• Study First Submitted QC: 2020-11-03
• Last Update Submitted: 2020-11-03
• Study First Posted: 2020-11-04
• Last Update Posted: 2020-11-04
• Primary Completion: 2020-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 700

Inclusion Criteria

• 1. Lymphoepithelioma-like carcinoma confirmed by histopathology;
• 2. The primary lesion does not involve the nasopharynx;
• 3. Complete data for patient's character, laboratory and imaging test, treatment and follow-up are available.

Exclusion Criteria

• 1. Concomitant with other tumor components at the time of diagnosis;
• 2. Have a history of any other malignant tumors;
• 3. Lack of complete data

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
lymphoepithelioma-like carcinoma of cervix	Non-intervention research	The primary site of lymphoepithelioma-like carcinoma locates in the cervix.
lymphoepithelioma-like carcinoma of tonsil	Non-intervention research	The primary site of lymphoepithelioma-like carcinoma locates in the tonsil.
lymphoepithelioma-like carcinoma of stomach	Non-intervention research	The primary site of lymphoepithelioma-like carcinoma locates in the stomach.
pulmonary lymphoepithelioma-like carcinoma	Non-intervention research	The primary site of lymphoepithelioma-like carcinoma locates in the lungs.
lymphoepithelioma-like carcinoma of thymus	Non-intervention research	The primary site of lymphoepithelioma-like carcinoma locates in the thymus.
lymphoepithelioma-like carcinoma of salivary glands	Non-intervention research	The primary site of lymphoepithelioma-like carcinoma locates in the parotid gland or submandibular gland.
lymphoepithelioma-like carcinoma of esophagus	Non-intervention research	The primary site of lymphoepithelioma-like carcinoma locates in the esophagus.
lymphoepithelioma-like carcinoma of liver	Non-intervention research	The primary site of lymphoepithelioma-like carcinoma locates in the liver.
lymphoepithelioma-like carcinoma of ovaries	Non-intervention research	The primary site of lymphoepithelioma-like carcinoma locates in the ovaries.

Primary Outcome Measures

Name	Time	Method
Progression-free survival	From date of diagnosis until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months.	The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse.

Secondary Outcome Measures

Name	Time	Method
Overall survival	From date of diagnosis until the date of death from any cause, whichever came first, assessed up to 24 months.	The length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive.

Trial Locations

Locations (1)

Sun yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China