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E-Poster Display

766P - Prognostic effect of systemic immune-inflammation index (SII) in 987 patients with advanced/metastatic urinary tract carcinoma (mUTC) treated with atezolizumab in the real-world global SAUL study

Date

17 Sep 2020

Session

E-Poster Display

Topics

Immunotherapy

Tumour Site

Urothelial Cancer

Presenters

Michal Mego

Citation

Annals of Oncology (2020) 31 (suppl_4): S550-S550. 10.1016/annonc/annonc274

Authors

M. Mego1, R.A. Huddart2, J. Voortman3, M. Ong4, C. Gedye5, H. Gurney6, A.P. Fay7, A. Bamias8, B. Mellado Gonzalez9, Y. Loriot10, A.S. Merseburger11, D. Castellano Gauna12, S. de Ducla13, J. Pavlova13, S. Fear14, C.N. Sternberg15

Author affiliations

  • 1 Medical Oncology, National Cancer Institute (Národny Onkologicky Ustav), 83310 - Bratislava/SK
  • 2 Radiotherapy And Imaging Dept, Royal Marsden NHS Trust, SM2 5NG - Sutton/GB
  • 3 Department Of Medical Oncology, Cancer Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, 1081 HV - Amsterdam/NL
  • 4 Medical Oncology, The Ottawa Hospital Cancer Center, Ottawa/CA
  • 5 Medical Oncology, Calvary Mater Newcastle, 2298 - Waratah/AU
  • 6 Department Of Medical Oncology, Macquarie University Hospital, 2109 - Sydney/AU
  • 7 Medical Oncology Department, Oncoclínicas Group, PUCRS School of Medicine, 05321-900 - Porto Alegre/BR
  • 8 Department Of Oncology, Alexandra Hospital, National and Kapodistrian University of Athens, 11528 - Athens/GR
  • 9 Oncology Service, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Hospital Clínic i Provincial, Barcelona/ES
  • 10 Department Of Cancer Medicine And Inserm U981, Université Paris-Sud, Université Paris-Saclay, Gustave Roussy, 94805 - Villejuif/FR
  • 11 Department Of Urology, Campus Lübeck, University Hospital Schleswig-Holstein, 23538 - Lübeck/DE
  • 12 Medical Oncology Service, Hospital Universitario 12 de Octubre, Madrid/ES
  • 13 Product Development Medical Affairs, F Hoffmann-La Roche Ltd, 4070 - Basel/CH
  • 14 Pharma Development Biostatistics Oncology, F Hoffmann-La Roche Ltd, Basel/CH
  • 15 Medical Oncology, San Camillo and Forlanini Hospitals, Rome, Italy; and Englander Institute of Precision Medicine, Weill Cornell Medicine, 10021 - New York/US

Resources

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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.

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