Abstract 767P
Background
The SAUL study showed atezolizumab is a tolerable and effective second- and beyond line treatment for the advanced urinary tract carcinoma in the real-world setting. However, only a small percentage of patients experienced disease response and survival benefit. Moreover, there is still an unmet need of well-established biomarkers to identify patients most likely to benefit from immunotherapy.
Methods
In the Italian SAUL study cohort, baseline NLR and SII (NLR x Platelets) were post-hoc analysed according to progression-free survival (PFS), overall survival (OS) and disease control rate (DCR). Cut-offs of both biomarkers were identified using ROC curves (pre-planned).
Results
267 patients were treated with atezolizumab. NLR <3.65 and SII <884 were associated with longer PFS, OS and higher DCR. According to AUC criteria, SII performed slightly better than NLR (AUC=0.71 vs. 0.66, respectively) to identify patients who experienced longer survival and higher disease control. Multivariate analyses adjusted for sex, age, PS, creatinine clearance, liver and lymph-nodes metastases, also suggested an association of both biomarkers with survival and response outcomes independently to other covariates (Table). Table: 767P
| Bio-marker | Value | % patients | PFS | OS | DCR | |||
| Median (95% CI), months | Adjusted HR* (95% CI) | Median (95% CI), months | Adjusted HR* (95% CI) | % | Adjusted OR* (95% CI) | |||
| NLR | <3.65 | 46% | 3.8 (2.3-5.9) | 1.00 (Ref) | 14.7 (9.9-NR) | 1.00 (Ref) | 53.0% | 1.00 (Ref) |
| >3.65 | 54% | 2.1 (2.0-2.2) | 1.43 (1.06-1.93) | 6.0 (3.9-9.4) | 1.61 (1.10-2.35) | 28.3% | 0.39 (0.22-0.68) | |
| SII | <884 | 44% | 4.2 (2.9-6.2) | 1.00 (Ref) | 14.7 (10.6-NR) | 1.00 (Ref) | 57.5% | 1.00 (Ref) |
| >884 | 56% | 2.1 (1.9-2.1) | 1.79 (1.32-2.43) | 6.0 (3.7-8.6) | 1.99 (1.35-2.94) | 25.3% | 0.25 (0.14-0.45) |
* HRs and ORs from, respectively, multivariate Cox and logistic regression models.
Conclusions
The analysis on the Italian cohort of the SAUL study showed that lower NLR and, especially, lower SII may identify patients with advanced urinary tract carcinoma who most benefit from atezolizumab in terms of survival and disease control.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Roche Spa.
Funding
Roche Spa.
Disclosure
S.E. Rebuzzi: Research grant/Funding (self): Roche. C.N. Sternberg: Advisory/Consultancy: Roche; Advisory/Consultancy: Pfizer; Advisory/Consultancy: MSD; Advisory/Consultancy: Merck; Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: Astellas; Advisory/Consultancy: Sanofi Genzyme ; Advisory/Consultancy: Incyte; Advisory/Consultancy: Medscape; Advisory/Consultancy: Urotoday. G.L. Banna: Honoraria (self): Janssen CIlag; Honoraria (self): Boeringher Ingelheim; Honoraria (self): roche; Non-remunerated activity/ies: BMS; Non-remunerated activity/ies: AstraZeneca Medimmune; Non-remunerated activity/ies: Pierre Fabre; Non-remunerated activity/ies: Ipsen. P. Ermacora: Research grant/Funding (institution): Roche. L. Marandino: Research grant/Funding (institution): roche. S. Panni: Advisory/Consultancy: BMS; Advisory/Consultancy: Roche; Research grant/Funding (institution): Roche. F. Massari: Research grant/Funding (institution): Roche. A. Hamzaj: Research grant/Funding (institution): Roche. L. Milesi: Research grant/Funding (institution): Roche. M. Scartozzi: Honoraria (self): Merck Serono; Honoraria (self): MSD; Honoraria (self): Amgen; Honoraria (self): Sanofi; Honoraria (self): Merck; Research grant/Funding (institution): Roche. C. Astolfi: Full/Part-time employment: Roche spa. G. Fornarini: Advisory/Consultancy: Pfizer; Advisory/Consultancy: MSD; Advisory/Consultancy: Merck; Advisory/Consultancy: Astellas; Advisory/Consultancy: Roche Genentech; Advisory/Consultancy: Janssen. All other authors have declared no conflicts of interest.