Abstract
BACKGROUND: The current prognostic models for patients with advanced urinary tract cancers were developed and validated in the chemotherapy setting. As immunotherapy has become the backbone of novel treatments, updated prognostic scores are needed. METHODS: A comprehensive analysis of inflammatory indexes from peripheral blood and clinical factors was planned on the entire real-world cohort of pretreated patients with advanced urinary tract carcinoma receiving atezolizumab in the prospective, single-arm, phase IIIb SAUL study. Univariable and multivariable analyses with overall survival as the primary endpoint, bootstrap internal validation, Schneeweiss scoring system and calibration test were performed to develop a novel immunotherapy prognostic score. RESULTS: Thirteen clinical variables from 1001 patients were analyzed. The following eight prognostic factors were included in a model: ECOG PS, liver and bone metastases, histology, pre-treatment steroids, systemic immune-inflammatory index (i.e., neutrophils-to-lymphocytes ratio times platelets count), hemoglobin and lactate dehydrogenase. The prognostic model was able to stratify patients into five risk groups with significantly different (P<0.001) median overall survival of NR, 18.0, 8.7, 4.6 and 2.4 months, respectively. The c-index for OS was higher than the Bellmunt Score one (0.702 vs. 0.672). CONCLUSIONS: A novel 5-class prognostic model contemporary to immunotherapy provides robust prognostic discrimination of patients with advanced urinary tract carcinoma homogeneously treated with immunotherapy through baseline affordable and reproducible clinical and laboratory factors. It could be quickly adopted in clinical practice to inform patients about prognosis with immunotherapy and assess the benefit of novel immunotherapy combinations in clinical trials.
| Original language | English |
|---|---|
| Journal | Minerva Urology and Nephrology |
| Volume | 75 |
| Issue number | 3 |
| Pages (from-to) | 308-318 |
| Number of pages | 11 |
| ISSN | 2724-6051 |
| DOIs | |
| Publication status | Published - 06.2023 |
Funding
The SAUL study was sponsored and funded by F. Hoffmann-La Roche. This subanalyses did not receive any additional funding. We thank the Meet-URO Italian Network For Research In Urologic-Oncology for supporting the analysis’s planning and results’ interpretation. Dr Rebuzzi and Dr Fornarini would like to thank the Italian Ministry of Health (Ricerca Corrente 2018-2021 grants) for financially supporting their research on identifying prognostic and predictive markers for patients with genitourinary tumours. Dr Rescigno’s work is funded by Prostate Cancer Foundation through a PCF YI award and by the FPRC 5 PER MILLE - Ministero della Salute 2017 - PTCRC SEE PROS - INTRA 2020 and “Italian Ministry of Health, Ricerca Corrente 2022”. All authors would like to thank F. Hoffmann-La Roche for the approval of this subanalysis project and sharing of the dataset of the original study, in particular Cinzia Astolfi for her technical support.
UN SDGs
This output contributes to the following UN Sustainable Development Goals (SDGs)
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SDG 3 Good Health and Well-being
Research Areas and Centers
- Research Area: Luebeck Integrated Oncology Network (LION)
- Centers: University Cancer Center Schleswig-Holstein (UCCSH)
DFG Research Classification Scheme
- 2.22-14 Hematology, Oncology
- 2.22-23 Reproductive Medicine, Urology
- 2.21-05 Immunology
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