Abstract
Blood eosinophils as prognostic biomarkers for advanced urothelial carcinoma in patients treated with avelumab: First results of the MALVA study (Meet-URO 25).
Author
person
Elisabetta Gambale
Clinical Oncology Unit, Careggi University Hospital, Florence, Italy
info_outline
Elisabetta Gambale, Marco Maruzzo, Carlo Messina, Irene De Gennaro Aquino, Ismaela Anna Vascotto, Virginia Rossi, Davide Bimbatti, Nicolò Cavasin, Marco Messina, Alessia Mennitto, Sara Elena Rebuzzi, Chiara Mercinelli, Martina Fanelli, Mariella Sorarù, Federico Scolari, Marinella Micol Mela, Laura Doni, Serena Pillozzi, Lorenzo Antonuzzo
Full text
Authors
person
Elisabetta Gambale
Clinical Oncology Unit, Careggi University Hospital, Florence, Italy
info_outline
Elisabetta Gambale, Marco Maruzzo, Carlo Messina, Irene De Gennaro Aquino, Ismaela Anna Vascotto, Virginia Rossi, Davide Bimbatti, Nicolò Cavasin, Marco Messina, Alessia Mennitto, Sara Elena Rebuzzi, Chiara Mercinelli, Martina Fanelli, Mariella Sorarù, Federico Scolari, Marinella Micol Mela, Laura Doni, Serena Pillozzi, Lorenzo Antonuzzo
Organizations
Clinical Oncology Unit, Careggi University Hospital, Florence, Italy, Istituto Oncologico Veneto, IOV-RCCS, Padova, Italy, Ospedale A.R.N.A.S Civico, Palermo, Italy, Istituto Oncologico Veneto IOV-IRCCS, Padova, Italy, Medical Oncology Unit, A.R.N.A.S. Civico, Palermo, Italy, Division of Oncology, University Hospital Maggiore della Carità, Novara, Italy, Department of Internal Medicine and Medical Specialties (Di.M.I.), University of Genova, Genova; Medical Oncology Unit, Ospedale San Paolo, Savona, Italy, Medical Oncology Unit 2, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy, Department of Oncology, University Hospital of Udine, Udine, Italy, U.O. Oncologia, Ospedale di Camposampiero (PD), Camposampiero (PD), Italy, Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy, Clinical Oncology Unit, Careggi University Hospital, Florence, Italy. Department of Experimental and Clinical Medicine, University of Florence, Italy, Florence, Italy
Abstract Disclosures
Research Funding
No funding received
None.
Background:
Platinum-based chemotherapies (CTs) represent the standard first-line treatment of advanced urothelial carcinoma (aUC). However, the development of resistance and toxicities to these regimens is responsible for poor progression-free survival (PFS) and overall survival (OS). Maintenance treatment with the programmed death-ligand 1 (PD-L1) inhibitor avelumab after initial response to CT improved significantly OS. Despite the survival advantage, only a limited percentage of patients (pts) benefits from immunotherapy. Therefore, prognostic/predictive factors for immunotherapy are needed. Studies carried out on small cohorts of pts with melanoma, renal cell cancer or lung carcinoma proved that eosinophil count or variations could be used as prognostic factors during immunotherapy. Thus, the aim of the present study is to evaluate eosinophil levels as potential biomarker for outcome among aUC pts enrolled in the MALVA (Maintenance with AVeLumAb in advanced urothelial neoplasms in response to first-line CT: an observational retrospective and prospective study) ongoing study (Meet-URO 25).
Methods:
The MALVA study is an ongoing real-life multicentric retro-/prospective observational study on aUC pts receiving avelumab maintenance after response to platinum-based first-line CT. The co-primary endpoints are OS and PFS. We present here data of the first 100 enrolled aUC pts who received avelumab as maintenance therapy after response to platinum-based CT between January 2021 and January 2023. Absolute Eosinophil Counts (AEC) were registered at baseline (week 0) and at time of the first tumor assessment (week 12). This study aims to evaluate whether the AEC could be a predictive biomarker of efficacy in pts with aUC treated with avelumab.
Results:
One-hundred pts (median age, 72 years), 71.4% of whom were men, were enrolled (data cut off, January 2, 2023). Median follow-up time was 8.5 months. Median duration of avelumab treatment was 5.9 months. Median PFS for the entire population was 8.7 months (95% CI; 5.7 months-not reached). Predefined subgroup analyses showed PFS and OS improvement (5.1 months vs NR, p = 0.0031; 12.9 months vs NR, p = 0.056 respectively) in pts with
high
AEC at week 0 vs
low
AEC pts. Additionally, a pilot analysis was conducted for 34 pts, for whom PFS and OS were stratified by AEC at first tumor assessment (week 12). PFS was longer (6.4 months vs NR, p = 0.045) for pts with
high
AEC vs
low
AEC pts.
Conclusions:
In order to optimize treatment efficacy in aUC, reliable biomarkers are required. In this study, we provide data from a homogeneous cohort investigating the relevance of eosinophils in aUC pts receiving avelumab, suggesting that AEC could be an easily accessible and reproducible prognostic biomarker that warrants further studies.
31 organizations
2 drugs
2 targets
Organization
Clinical Oncology Unit, Faculty of Medicine, University of Malaya, Kuala Lumpur, MalaysiaOrganization
Careggi University HospitalOrganization
Florence, ItalyOrganization
Ospedale A.R.N.A.S CivicoOrganization
Palermo, ItalyOrganization
Istituto Oncologico Veneto IOV-IRCCSOrganization
Padova, ItalyOrganization
A.R.N.A.S. CivicoOrganization
University Hospital Maggiore della CaritàOrganization
Novara, ItalyOrganization
University of Genova, Genova, ItalyOrganization
Genovate BiotechnologyOrganization
Ospedale San PaoloOrganization
Savona, ItalyOrganization
Medical Oncology Unit 2Organization
Azienda Ospedaliero-Universitaria PisanaOrganization
Pisa, ItalyOrganization
Department of Oncology and Haematology, Division of Oncology, University Hospital of Modena, Modena, ItalyOrganization
University Hospital of UdineOrganization
Udine, ItalyOrganization
Ospedale di Camposampiero (PD)Organization
Camposampiero (PD)Organization
University of Florence, AOUCOrganization
ItalyOrganization
Florence Nightingale HospitalDrug
avelumabTarget
PD-L1 (CD274)Target
DNA