KEY TAKEAWAYS
- The SHIVA Phase 2 trial, registered under NCT01771458, aimed to investigate the distribution of TILs and PD-L1 expression in metastatic cancer patients, using CPS, TPS, and paired primary and metastatic samples, and correlate these variables with clinical outcomes.
- The method involved evaluating 550 pan-cancer patients with available FFPE samples from metastatic biopsies and 111 paired primary and metastatic samples for TILs.
- The study’s outcome suggested that TILs and PD-L1 expression could be useful biomarkers for predicting clinical outcomes in metastatic cancer patients. However, further research is needed to confirm these findings.
For a study, researchers aimed to investigate the distribution of tumor-infiltrating lymphocytes (TILs) and programmed cell death ligand 1 (PD-L1) expression using Combined Positive Score (CPS), Tumor Proportion Score (TPS), as well as TILs in metastatic samples from 550 pan-cancer patients of the SHIVA01 trial (NCT01771458), with 111 paired primary and metastatic samples.
A total of 550 metastatic specimens obtained from various anatomical sites were analyzed and categorized into seven groups: liver biopsies (n=179; 33%), visceral organ biopsies (n=92; 17%), lung biopsies (n=89; 16%), cutaneous biopsies (n=53; 10%), soft tissue biopsies (n=48; 9%), brain biopsies (n=1; 0.2%), lymph node biopsies (n=88; 16%). In 494 metastatic tumors and 77 patients with paired primary and metastatic cancers who had contributive immunohistochemistry, the expression of PD-L1 was measured using immunohistochemistry with the 22C3 antibody clone (Merck & Co.) and quantified using CPS and TPS scores.
The median percentage of TILs was 10% [range: 0%-70%] with no significant difference in TILs distribution according to histological subtype, primary system, or biopsy site. The median percentage of TILs in metastases was significantly lower than in their corresponding central lesions (20% [5%-60%] versus 10% [0%-40%], p<0.0001). PD-L1 expression was homogenous in all metastatic tumors independently of the primary system or biopsy site (median TPS = 2%; CPS = 0 n=218, CPS = 0 n=218, CPS≥1 n=265; p=0.056). The correlations of TILs and PD-L1 expression with clinical outcomes are still ongoing. A strong association between TPS count and histological subtypes (p=0.015) was not observed with CPS (p=0.23). Furthermore, there were no significant changes in CPS and TPS scores in paired primary/metastatic samples (p>0.3 for both).
The results suggested that metastatic sites have a lower density of TILs than paired primary lesions, regardless of the initial prior tumor site, histological type, or biopsy site and that PD-L1 expression is consistent between paired primary and metastatic samples.
Source: https://www.abstractsonline.com/pp8/#!/10517/presentation/11601
Clinical Trial: https://clinicaltrials.gov/ct2/show/NCT01771458/
Beaino, Z. E., Dupain, C., Marret, G., Paoletti, X., Fuhrmann, L., Martinat, C., Bièche, I., Tourneau, C. L., Kamal, M., & Salomon, A. V. (n.d.). 1724 / 21 – Pancancer evaluation of tumor-infiltrating lymphocytes (TILs) and PD-L1 in SHIVA-01 trial patients with different biopsy sites and histological types. https://www.abstractsonline.com/pp8/#!/10517/presentation/11601
