Center for Global Research Data

Evaluation of the performance of the modified Glasgow prognostic score in urothelial carcinoma, non-small cell lung cancer and renal cell carcinoma

Lead Investigator: Jörg Ellinger, University Hospital Bonn
Title of Proposal Research: Evaluation of the performance of the modified Glasgow prognostic score in urothelial carcinoma, non-small cell lung cancer and renal cell carcinoma
Vivli Data Request: 7797
Funding Source: None
Potential Conflicts of Interest: None

Summary of the Proposed Research:

Urothelial carcinoma or bladder cancer (UC) is a common disease that affects about 80000 people and kills 17000 in the US each year. Non-small cell lung cancer (NSCLC) is one of the most common cancers with more than 236000 new cases diagnosed each year in the US and more than 130000 deaths. Renal cell carcinoma (RCC) or kidney cancer (renal = kidney) is also one of the most common malignancies worldwide, affecting about 80000 people and killing about 14000 people in the US each year.

These cancers are preferably removed by surgery, however, if the tumor has spread in the body (metastatic disease), patients need a systemic treatment.

In the last years, immune-checkpoint inhibition (ICI) has evolved as a promising treatment approach. It works by enabling the patient´s immune system to attack and kill the tumor. This is achieved by blocking signals on the tumor cells that prevent the immune system from attacking the cells, these signals are called immune checkpoints. However, not every patient profits from ICI. Thus, it is important to identify patients who are candidates for this kind of treatment.

The modified Glasgow prognostic score (mGPS) is a score based on two different laboratory parameters (albumin and C reactive protein) that can be measured in any routine blood draw. It has been shown to be able to yield information on prognosis of patients with different cancers, such as UC, NSCLC and RCC. However, it has not been validated in a prospective study on ICI-treated patients with UC and NSCLC (meaning the data was collected in a standardized, structured manner). In the proposed study the mGPS will be validated in a prospective trial including patients with metastatic bladder cancer (IMvigor211) and lung cancer (NCT02008227).

As part of a currently ongoing research project (Vivli ID: 00007164), we demonstrated that the mGPS outperforms the international metastatic RCC database consortium (IMDC) score, the current clinical standard for risk stratification for patients with metastatic kidney cancer prior start of oncological treatment. In the past, immunotherapy was only used for patients with metastatic kidney cancer. To date, there is growing evidence for the advantages of adjuvant therapy in non-metastatic high-risk kidney cancer (i.e. after surgical removal of the tumor to prevent recurrence). There is currently no way to identify patients that will profit from this treatment. This study aims to validate the mGPS in patients receiving adjuvant therapy for high-risk kidney cancer (S-TRAC and ASSURE).

This study will help to more precisely predict an individual patient´s risk and thereby add an important tool for clinicians to inform the choice of treatment.

Requested Studies:

A Phase III, Open-Label, Multicenter, Randomized Study to Investigate the Efficacy and Safety of Atezolizumab (Anti-PD-L1 Antibody) Compared With Chemotherapy in Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer After Failure With Platinum-Containing Chemotherapy
Data Contributor: Roche
Study ID: NCT02302807
Sponsor ID: GO29294

A Phase III, Open-Label, Multicenter, Randomized Study to Investigate the Efficacy and Safety of Atezolizumab (Anti-PD-L1 Antibody) Compared With Docetaxel in Patients With Non-Small Cell Lung Cancer After Failure With Platinum Containing Chemotherapy
Data Contributor: Roche
Study ID: NCT02008227
Sponsor ID: GO28915

Sunitinib Treatment Of Renal Adjuvant Cancer (S-trac): A Randomized Double-blind Phase 3 Study Of Adjuvant Sunitinib Vs. Placebo In Subjects At High Risk Of Recurrent Rcc
Data Contributor: Pfizer Inc.
Study ID: NCT00375674
Sponsor ID: A6181109

ASSURE: Adjuvant Sorafenib or Sunitinib for Unfavorable Renal Carcinoma
Data Contributor: Project Data Sphere
Study ID: NCT00326898
Sponsor ID: NCI-2009-00534