Clinical Research Details

Descriptive Information
Outcomes of Lebanese Patients with Advanced Malignancies Treated with Immunotherapy

Hazem Assi



Mohamad Srour
Extension: 7902
Conditions and Keywords
metastatic cancer patients,treated with immunotherapy
Nivolumab,Pembrolizumab,Advanced Malignancies
Study Design
N/A: Not Applicable
N/A: Not Applicable
N/A: Not Applicable
N/A: Not Applicable
Eligibility and IRB
Min: 18

Besides the traditional approaches of surgery, chemotherapy and radiotherapy, many recent clinical trials using novel immunotherapic strategies has established a very important role of these strategies for the treatment of advanced cancer patients. Several Immunotherapic approaches were developed for the treatment of advanced malignancies, including cancer vaccines, cytokines and oncolytic virus therapies, but the most important and effective are the immune check-point inhibitors used for the treatment of advanced and metastatic cancers. Despite the advances in metastatic cancers (including melanoma, Non-small cell lung cancer NSCLC, kidney cancer, bladder cancer and others) treatment strategies, these malignancies show relative resistance to cytotoxic chemotherapy. In addition, advanced cancers acquire intrinsic mechanisms driving resistance to the main targeted therapy [2, 3]. Thereby, major breakthroughs in the treatment of these malignancies have remained an area of unmet need until the discovery of immune checkpoint inhibitors.

The currently available immune-checkpoint inhibitors target either the cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4), the programmed death-1 receptor (PD-1), or the programmed death ligand-1 (PD-L1).  PD-1 is expressed on activated T cells. Its ligands PD-L1 and PD-L2, which are expressed by tumor cells, induce an immune suppressive response when engaged to PD-1.

PD-1 inhibitors are highly selective immunotherapic humanized monoclonal antibodies directly blocking the interaction between PD-1 and its ligand PDL-1.  Several studies have reported that PD-1 inhibitors showed effective and durable tumor regression and enhanced survival rates among metastatic malignancies patients.

Despite these promising results that were assessed among western patients, there were no studies of immunotherapy in advanced malignancies that included Arabic ethnic population and no data exist about the patterns of PD-1 inhibitors usage or the response rate among Arabic population. Several key questions need to be answered concerning the efficacy and safety as well as indications and patterns of usage of these novel drugs in the Middle East. As well, the accessibility of PD-1 inhibitors Immunotherapy in Lebanon is limited to personal access or compassionate use.

Therefore, we aimed at collecting data on the outcomes of advanced cancer Lebanese patients that were subjected to PD-1 inhibitors Immunotherapy. In the setting, all adult (≥18 years old) metastatic cancer patients, treated with PD-1 inhibitors at the American University of Beirut Medical Center are included. After obtaining IRB approval, our research team will review the patient’s baseline demographics, clinical and survival data, with the cooperation and supervision of the primary care oncologist in charge.

We hope to generate an overall perception on PD-1 inhibitors Immunotherapy treatment patterns and the response of Lebanese patients to this treatment, in an attempt to generalize it to Arabic population. As a future work, we are planning to extend the follow-up on PD-1 inhibitors Immunotherapy responding patients in a prospective way.

This is a retrospective study involving all metastatic cancer patients (Melanoma, Lung, HL,etc.., treated with immunotherapy PD-1 inhibitors ( Nivolumab and Pembrolizumab) at the American University of Beirut Medical Center, from January 1st 2014 to January 12th 2016.

After obtaining IRB approval, every involved oncologist will provide the number of treated patients and their identification data. Following that, our research team will have access to the patient’s data records, with the cooperation and supervision of the primary care oncologist in charge throughout the process of data collection. 

Baseline demographics, clinical data and last visit date /status will be collected from medical records and clinic charts. Descriptive analysis including frequencies of demographics, overall survival time, response rate and adverse effects will be calculated. The follow up period will be extended from the date of diagnosis till the last contact date of the patient.

All adult patients (≥18 years old) with an advanced malignancy, treated with Immunotherapy PD-1 inhibitors, are included

Patients below the age of 18 are excluded, and those not fitting the inclusion criteria.