Clinical trial NCT04614818: A Multi-center, Retrospective Analysis of Clinical Character, Outcome and Prognosis of Lymphoepithelioma-like Carcinoma
Official title: A Multi-center, Retrospective Analysis of Clinical Character, Outcome and Prognosis of Lymphoepithelioma-like Carcinoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lymphoepithelioma-Like Carcinoma
Lymphoepithelioma-Like Carcinoma of Thymus
Lung Cancer
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2020-11-04
Enrollment: 700
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with confirmed diagnosis of lymphoepithelioma-like carcinoma of any primary site, including lung, salivary glands, thymus, tonsil, liver, stomach, esophagus, ovary, cervix et al.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Progression-free survival
timeFrame: 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.
Secondary outcomes:
measure: Overall survival
timeFrame: From date of diagnosis until the date of death from any cause, whichever came first, assessed up to 24 months.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun yat-sen University Cancer Center
state: Guangdong
Study officials:
References:
citation: Wu Q, Wang W, Zhou P, Fu Y, Zhang Y, Shao YW, Jiang L. Primary pulmonary lymphoepithelioma-like carcinoma is characterized by high PD-L1 expression, but low tumor mutation burden. Pathol Res Pract. 2020 Aug;216(8):153043. doi: 10.1016/j.prp.2020.153043. Epub 2020 Jun 2.
citation: Fang W, Hong S, Chen N, He X, Zhan J, Qin T, Zhou T, Hu Z, Ma Y, Zhao Y, Tian Y, Yang Y, Xue C, Tang Y, Huang Y, Zhao H, Zhang L. PD-L1 is remarkably over-expressed in EBV-associated pulmonary lymphoepithelioma-like carcinoma and related to poor disease-free survival. Oncotarget. 2015 Oct 20;6(32):33019-32. doi: 10.18632/oncotarget.5028.
citation: He J, Shen J, Pan H, Huang J, Liang W, He J. Pulmonary lymphoepithelioma-like carcinoma: a Surveillance, Epidemiology, and End Results database analysis. J Thorac Dis. 2015 Dec;7(12):2330-8. doi: 10.3978/j.issn.2072-1439.2015.12.62.
citation: Abouelfad DM, Yassen NN, Amin HAA, Shabana ME. Lymphoepithelioma-Like Carcinoma of the Breast Mimicking Granulomatous Mastitis- Case Report and Review of the Literature. Asian Pac J Cancer Prev. 2017 Jul 27;18(7):1737-1741. doi: 10.22034/APJCP.2017.18.7.1737.
citation: Chen M, Chen Y, Fang X, Wang Z, Pu X, Liang C, Guo H, Li Q, Pan F, Hong H, Huang H, Li J, Lin T. Clinical features and treatment outcome of lymphoepithelioma-like carcinoma from multiple primary sites: a population-based, multicentre, real-world study. BMC Pulm Med. 2022 Sep 22;22(1):360. doi: 10.1186/s12890-022-02097-6.