29P - Prognostic value of systemic inflammatory index and platelet-to-lymphocyte ratio in muscle-invasive bladder cancer patients treated with neoadjuvant chemo-immunotherapy in the AURA trial

Background

Immune checkpoint inhibitors (ICI) will become the new standard therapy for early muscle-invasive bladder cancer (MIBC). Despite high response rates, a significant proportion of patients still dies from lethal relapse. Moreover, validated biomarkers to ICI are lacking. Here, we evaluated systemic inflammatory index (SII) and platelet-to-lymphocyte ratio (PLR) as prognostic biomarkers for MIBC patients in the AURA trial.

Methods

AURA is a prospective phase 2 trial (NCT03674424) evaluating neoadjuvant avelumab alone or in combination with different chemotherapy regimens according to cisplatin eligibility. Pre-treatment SII, deriving from the formula (neutrophils x platelets)/lymphocytes, and baseline PLR, absolute platelets to lymphocytes ratio, were categorized as low < median or high ≥ median. Associations of biomarkers with pathological responses, event-free survival (EFS) and overall survival (OS) were measured using Fisher’s exact test, Kaplan-Meier and Cox regression methods.

Results

Low SII showed a significant correlation (p=0.002) with pathological complete response (pCR), longer EFS (median: NR vs 26 months, HR = 0.42) and longer OS (median: NR vs 40 months, HR = 0.50) and a trend for downstaging (

Conclusions

Low pre-treatment SII, witnessing low level of systemic inflammation, was significantly associated with response to neoadjuvant chemo-immunotherapy as well as with longer survival, suggesting that SII could be used as a predictive biomarker for MIBC treatment tailoring, if further validated. In contrast, baseline low PLR was not correlated with better outcomes, suggesting that the platelet count alone is not strong enough to reflect the systemic inflammation.

Clinical trial identification

NCT03674424.

Legal entity responsible for the study

Institut Jules Bordet and FNRS.

Funding

Merck KGaA, Darmstadt, Germany.

Disclosure

J. Blanc: Financial Interests, Institutional, Advisory Role: Merck; Financial Interests, Institutional, Invited Speaker: BMS; Financial Interests, Personal, Other, Travel support: Ipsen, AstraZeneca, Merck. N. Martinez Chanza: Financial Interests, Institutional, Speaker, Consultant, Advisor: Merck. A. Carnot: Financial Interests, Personal, Advisory Board: MSD Oncology, Janssen Oncology; Financial Interests, Personal, Invited Speaker: Astellas Pharma. P. Barthelemy: Financial Interests, Personal, Advisory Board: BMS, MSD, Merck, Pfizer, Ipsen, Bayer, Janssen Cilag, Astellas, Novartis, Amgen, Gilead; Financial Interests, Personal, Invited Speaker: AstraZeneca. C. Sotiriou: Financial Interests, Institutional, Advisory Board: Astellas, Seattle Genetics, Amgen, Merck & Co; Financial Interests, Personal, Advisory Board: Cepheid; Financial Interests, Institutional, Other, Travel: Roche; Financial Interests, Personal, Other, Travel: Pfizer; Financial Interests, Institutional, Invited Speaker: Exact Sciences; Financial Interests, Personal, Invited Speaker: Prime Oncology; Financial Interests, Personal, Advisory Board, Stock options: Signatur Biosciences; Financial Interests, Personal, Stocks/Shares, Stock: Signatur Biosciences. All other authors have declared no conflicts of interest.