Abstract 766P
Background
SII has shown prognostic value in several tumour types. Low SII was associated with better outcomes in patients receiving immune checkpoint inhibitor therapy for lung cancer, but evidence in mUTC or atezolizumab-treated patients is lacking. We explored the prognostic role of SII in 997 atezolizumab-treated patients with mUTC in the single-arm SAUL study (NCT02928406).
Methods
Patients with mUTC, including populations typically excluded from clinical trials, received atezolizumab 1200 mg IV q3w until loss of clinical benefit or unacceptable toxicity. The primary endpoint was safety. SII was defined as platelet count x neutrophil/lymphocyte ratio. Outcomes were analysed using median and quartile cut-offs for SII. Specificity and sensitivity of SII were assessed via a receiver operating characteristic (ROC) curve.
Results
Median SII was 909; ROC suggested an optimal cut-off of 910. Patients with low (≤909) SII had better ECOG performance status than patients with high (>909) SII but there were no major imbalances between subgroups for age, prior treatment lines, smoking history, sex or PD-L1 status. Clinical outcomes were better in patients with low vs high SII (median overall survival [OS] 13.8 vs 4.8 mo, 1-year OS rate 54% vs 28%, objective response rate [ORR] 17% vs 10%). SII analysis by quartile showed a consistent pattern (Table). Patients with low vs high SII had longer median treatment duration (4.2 vs 1.5 mo), more grade 1/2 treatment-related adverse events (AEs; 47% vs 34%) but a similar incidence of grade ≥3 AEs (13% vs 12%). 12%). Table: 766P
| Endpoint | SIIa | |||
| ≤Q1 (n=248) | >Q1–≤Q2 (n=245) | >Q2–≤Q3 (n=248) | >Q3 (n=246) | |
| OS | ||||
| Median, mo (95% CI) | NE (NE–NE) | 11.9 (9.5–NE) | 7.8 (6.3–10.3) | 3.3 (2.9–3.9) |
| 6-mo, % (95% CI) | 79 (74–84) | 71 (65–76) | 58 (51–64) | 32 (26–38) |
| 1-year, % (95% CI) | 59 (52–65) | 49 (42–56) | 39 (32–46) | 16 (11–21) |
| Median progression-free survival, mo (95% CI) | 4.2 (3.9–5.9) | 2.5 (2.2–4.0) | 2.1 (2.1–2.3) | 2.0 (1.9–2.1) |
| ORR, n (%) [95% CI] | 48 (19) [15–25] | 34 (14) [10–19] | 37 (15) [11–20] | 14 (6) [3–9] |
| Complete response, n (%) [95% CI] | 12 (5) [3–8] | 9 (4) [2–7] | 7 (3) [1–6] | 1 (<1) [0–2] |
| Disease control rate, n (%) [95% CI] | 139 (56) [50–62] | 113 (46) [40–53] | 85 (34) [28–41] | 57 (23) [18–29] |
CI = confidence interval; NE = not estimable; Q = quartile. aQ1 = 559; Q2 = 909; Q3 = 1650.
Conclusions
Compared with high SII, low SII patients had better clinical outcomes and longer treatment duration, likely contributing to slightly increased low-grade AEs. The prognostic role of SII seen in atezolizumab-treated patients with mUTC is consistent with other tumour types.
Clinical trial identification
NCT02928406.
Editorial acknowledgement
Jennifer Kelly (Medi-Kelsey Ltd), funded by F Hoffmann-La Roche.
Legal entity responsible for the study
F Hoffmann-La Roche.
Funding
F Hoffmann-La Roche.
Disclosure
R.A. Huddart: Honoraria (self), Research grant/Funding (institution): MSD; Honoraria (self), Research grant/Funding (institution), Non-remunerated activity/ies: Roche; Honoraria (self): Bayer; Honoraria (self), Non-remunerated activity/ies: Nektar; Honoraria (self), Non-remunerated activity/ies: Janssen; Honoraria (self): Bristol Myers Squibb; Honoraria (self): NICE; Officer/Board of Directors: Cancer Centre London. J. Voortman: Honoraria (institution): F Hoffmann-La Roche; Honoraria (institution): MSD Oncology; Research grant/Funding (institution): Sanofi; Research grant/Funding (institution): Pfizer; Research grant/Funding (institution): Merck; Research grant/Funding (institution): Teva; Research grant/Funding (institution): Astellas; Research grant/Funding (institution): Ipsen. M. Ong: Honoraria (self), Advisory/Consultancy, Research grant/Funding (self): AstraZeneca; Honoraria (self), Advisory/Consultancy: Bristol-Myers Squibb; Honoraria (self), Advisory/Consultancy: Merck; Honoraria (self), Travel/Accommodation/Expenses: Roche; Honoraria (self), Advisory/Consultancy: Janssen; Honoraria (self), Advisory/Consultancy: Bayer. H. Gurney: Honoraria (self), Advisory/Consultancy: Roche; Honoraria (self), Advisory/Consultancy: Astellas; Honoraria (self), Advisory/Consultancy: Janssen; Honoraria (self), Advisory/Consultancy: AstraZeneca; Honoraria (self), Advisory/Consultancy: BMS; Honoraria (self), Advisory/Consultancy: MSD; Honoraria (self), Advisory/Consultancy: Pfizer; Honoraria (self), Advisory/Consultancy: Sanofi; Honoraria (self), Advisory/Consultancy: Ipsen. A.P. Fay: Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: BMS; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Roche; Honoraria (self), Advisory/Consultancy: Novartis; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Janssen; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Astellas; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Merck; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: AstraZeneca; Advisory/Consultancy, Travel/Accommodation/Expenses: Ipsen. A. Bamias: Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Roche; Honoraria (self), Advisory/Consultancy: MSD; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): BMS. B. Mellado Gonzalez: Advisory/Consultancy, Speaker Bureau/Expert testimony: Roche; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self), Travel/Accommodation/Expenses: Janssen; Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Bayer; Advisory/Consultancy, Speaker Bureau/Expert testimony: Astellas; Advisory/Consultancy, Research grant/Funding (self), Travel/Accommodation/Expenses: Pfizer; Advisory/Consultancy, Speaker Bureau/Expert testimony: Sanofi; Speaker Bureau/Expert testimony: Merck-MSD; Speaker Bureau/Expert testimony: BMS. Y. Loriot: Honoraria (self), Research grant/Funding (institution): Roche; Honoraria (self), Research grant/Funding (institution): Astellas; Honoraria (self), Research grant/Funding (institution): Janssen; Honoraria (self), Research grant/Funding (institution): Seattle Genetics; Honoraria (self), Research grant/Funding (institution): AstraZeneca; Honoraria (self), Research grant/Funding (institution): BMS; Honoraria (self), Research grant/Funding (institution): MSD; Honoraria (self), Research grant/Funding (institution): Pfizer; Honoraria (self), Research grant/Funding (institution): Sanofi; Honoraria (self): Ipsen; Research grant/Funding (institution): Clovis; Research grant/Funding (institution): Incyte. A.S. Merseburger: Honoraria (self): Amgen; Honoraria (self): Merck Sharp & Dohme; Honoraria (self): Clovis; Honoraria (self): Bristol-Myers Squibb; Honoraria (self): Astellas; Honoraria (self): Pfizer; Honoraria (self): Sanofi; Honoraria (self): Roche; Honoraria (self): AstraZeneca. D. Castellano Gauna: Advisory/Consultancy, Research grant/Funding (self): Janssen Oncology; Advisory/Consultancy: Roche/Genentech; Advisory/Consultancy: Astellas Pharma; Advisory/Consultancy: AstraZeneca; Advisory/Consultancy, Travel/Accommodation/Expenses: Pfizer; Advisory/Consultancy: Novartis; Advisory/Consultancy: Ipsen; Advisory/Consultancy, Travel/Accommodation/Expenses: Bristol-Myers Squibb; Advisory/Consultancy: MSD Oncology; Advisory/Consultancy: Bayer; Advisory/Consultancy: Lilly; Advisory/Consultancy: Sanofi; Advisory/Consultancy: Pierre Fabre; Advisory/Consultancy: Boehringer Ingelheim; Travel/Accommodation/Expenses: Roche; Travel/Accommodation/Expenses: AstraZeneca Spain. S. de Ducla: Shareholder/Stockholder/Stock options, Full/Part-time employment: Roche. J. Pavlova: Shareholder/Stockholder/Stock options, Full/Part-time employment: Roche. S. Fear: Full/Part-time employment: Roche (for Hayes Schweiz AG). C.N. Sternberg: Advisory/Consultancy: Pfizer; Advisory/Consultancy: MSD; Advisory/Consultancy: Merck; Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: Astellas Pharma; Advisory/Consultancy: Sanofi-Genzyme; Advisory/Consultancy: Roche/Genentech; Advisory/Consultancy: Incyte; Advisory/Consultancy: Medscape; Advisory/Consultancy: UroToday. All other authors have declared no conflicts of interest.