Abstract 1126
Background
Prognostic factors for survival in metastatic urothelial carcinoma (mUC) have been established in patients (pts) treated with chemotherapy. However, their role has not been clearly defined in the era of immune-checkpoint inhibitors (ICIs). We have previously reported the Vall d’Hebron immuno-oncology prognostic index (VIO score) for refractory pts treated in phase I clinical trials with ICIs (Hierro C, et al ESMO 2018). In this retrospective study, we assessed VIO in pts with mUC treated with ICIs.
Methods
Pts with mUC enrolled from May 2015 to May 2018 in clinical trials at the Vall d’Hebron University Hospital were analysed. VIO score includes: albumin < 3.5 g/dl; LDH> upper limit of normal; neutrophil/[leukocytes minus neutrophils] ratio (dNLR) > 3; more than 2 sites of metastasis; and presence of liver metastasis. The following VIO clusters were defined: good prognosis (0-1), intermediate prognosis (2) and poor prognosis (³3 variables). Median overall survival (OS) was calculated using Kaplan-Meier method, long rank test was used for statistical comparison. All analyses were performed using SPSS v25; IBM Inc.
Results
Overall, 86 mUC pts received therapy with ICIs and 72 pts with complete annotation for VIO index were included in our analysis. Median age was 67.4 years, 62 (86.1%) pts were male, 66 pts (91.7%) had ECOG PS 0-1, 17 pts (23.6%) had liver metastasis and 8 pts (72%) had >2 sites of metastasis. Forty-eight pts (66.6%) were treated with ICIs as monotherapy and 24 pts (33.3%) in combination regimens. Follow-up was 13.2 moths (m) (95% CI; 10.5-15.9) and median OS was 11.3 m (95% CI; 7.1-15.4) in the evaluable population. Estimated mOS in good prognosis (62.5% of all pts), intermediate prognosis (23.6%) and poor prognosis (13.9%) were 19.3 m (95% CI; 5.1-33.6), 8.2 m (95% CI; 3.3-13.1) and 2.9 m (95% CI;0.1-7.7), respectively (p < 0.001). 3-m OS rates were 95.6%, 82.4% and 50% for good, intermediate and poor prognosis, respectively (p = 0.001).
Conclusions
VIO score is a powerful tool for predicting outcome in mUC pts treated with ICI and objectively estimating their life expectative at 3 m, which can help prioritize alternative therapies in clinical trials.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Vall d’Hebron Institute of Oncology, Vall d’ Hebron University Hospital, Universitat Autònoma de Barcelona, Barcelona, Spain.
Funding
Has not received any funding.
Disclosure
R. Morales Barrera: Honoraria (self), Honoraria (institution), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: MSD; Honoraria (self), Honoraria (institution), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Sanofi; Honoraria (self), Honoraria (institution), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: AstraZeneca; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony: Asofarma; Honoraria (self), Honoraria (institution), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Astellas; Honoraria (self), Honoraria (institution), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Johnson & Johnson; Honoraria (institution), Travel / Accommodation / Expenses: Bayer; Honoraria (institution), Travel / Accommodation / Expenses: Clovis Oncology; Honoraria (institution), Travel / Accommodation / Expenses: Lilly; Honoraria (self), Honoraria (institution), Advisory / Consultancy, Travel / Accommodation / Expenses: Roche/Genentech; Research grant / Funding (institution): AB Science; Research grant / Funding (institution): Aragon Pharmaceuticals; Research grant / Funding (institution): Arog Pharmaceuticals; Research grant / Funding (institution): INC; Research grant / Funding (institution): Aveo Pharmaceuticals INC; Research grant / Funding (institution): Blueprint Medicines Corporation; Research grant / Funding (institution): BN Immunotherapeutics INC; Research grant / Funding (institution): Boehringer Ingelheim España, S.A.; Research grant / Funding (institution): Cougar Biotechnology INC; Research grant / Funding (institution): Deciphera Pharmaceuticals LLC; Research grant / Funding (institution): Exelixis INC; Research grant / Funding (institution): Glaxosmithkline; Research grant / Funding (institution): Incyte Corporation; Research grant / Funding (institution): Karyopharm Therapeutics INC; Research grant / Funding (institution): Laboratoires Leurquin Mediolanum SAS; Research grant / Funding (institution): Medimmune; Research grant / Funding (institution): Millennium Pharmaceuticals; Research grant / Funding (institution): Nanobiotix SA; Research grant / Funding (institution): Novartis Farmacéutica, S.A; Research grant / Funding (institution): Pfizer, S.L.U; Research grant / Funding (institution): Puma Biotechnology; Research grant / Funding (institution): SFJ Pharma LTD; Research grant / Funding (institution): Teva Pharma S.L.U. M. Gonzalez: Travel / Accommodation / Expenses: Roche; Travel / Accommodation / Expenses: Astellas; Travel / Accommodation / Expenses: Bayer; Travel / Accommodation / Expenses: Novartis. C. Suárez: Research grant / Funding (institution): AB Science; Research grant / Funding (institution): Aragon Pharmaceuticals; Research grant / Funding (institution): Arog Pharmaceuticals; Advisory / Consultancy, Research grant / Funding (institution): Astellas Pharma; Speaker Bureau / Expert testimony, Research grant / Funding (institution): AstraZeneca AB; Research grant / Funding (institution): Aveo Pharmaceuticals INC; Research grant / Funding (institution): Bayer AG; Research grant / Funding (institution): Blueprint Medicines Corporation; Research grant / Funding (institution): BN Immunotherapeutics INC; Research grant / Funding (institution): Boehringer Ingelheim España, S.A.,; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution): Bristol-Myers Squibb International Corporation (BMS),; Research grant / Funding (institution): Clovis Oncology; Research grant / Funding (institution): Cougar Biotechnology INC; Research grant / Funding (institution): Deciphera Pharmaceuticals LLC; Research grant / Funding (institution): Exelixis INC; Research grant / Funding (institution), Travel / Accommodation / Expenses: Hoffmann-La Roche LTD; Research grant / Funding (institution): Genentech INC; Research grant / Funding (institution): Genentech INC; Research grant / Funding (institution): GlaxoSmithKline, SA; Research grant / Funding (institution): Incyte Corporation; Research grant / Funding (institution): Janssen-Cilag International NV; Research grant / Funding (institution): Karyopharm Therapeutics INC; Research grant / Funding (institution): Lilly, S.A; Research grant / Funding (institution): Millennium Pharmaceuticals, INC; Research grant / Funding (institution): Nanobiotix SA; Research grant / Funding (institution): Novartis Farmacéutica, S.A; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution), Travel / Accommodation / Expenses: Pfizer; Research grant / Funding (institution): Puma Biotechnology; Speaker Bureau / Expert testimony, Research grant / Funding (institution): Sanofi-Aventis, S.A; Research grant / Funding (institution): SFJ Pharma LTD. II; Research grant / Funding (institution): Teva Pharma S.L.U.; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (self), Travel / Accommodation / Expenses: Ipsen; Advisory / Consultancy: Eusa; Advisory / Consultancy: Novartis. C. Fernandez: Travel / Accommodation / Expenses: AstraZeneca. C. Hierro: Research grant / Funding (self): Bayer; Advisory / Consultancy, Travel / Accommodation / Expenses: Roche; Advisory / Consultancy, Travel / Accommodation / Expenses: Lilly; Advisory / Consultancy, Travel / Accommodation / Expenses: Ignyta. E. Serra: Travel / Accommodation / Expenses: Clovis Oncology; Travel / Accommodation / Expenses: Bayer. J. Mateo: Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: AstraZeneca; Advisory / Consultancy, Travel / Accommodation / Expenses: Janssen; Advisory / Consultancy: Roche; Advisory / Consultancy: Amgen; Speaker Bureau / Expert testimony: Sanofi. J. Martín Liberal: Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Novartis; Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: BMS; Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Pierre Fabre; Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Roche; Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Pfizer; Travel / Accommodation / Expenses: Ipsen. A. Quintana: Honoraria (self): Fundación Respira; Travel / Accommodation / Expenses: MSD. R. Dienstmann: Advisory / Consultancy, Speaker Bureau / Expert testimony: Roche; Speaker Bureau / Expert testimony: Symphogen; Speaker Bureau / Expert testimony: Ipsen; Speaker Bureau / Expert testimony: Amgen; Speaker Bureau / Expert testimony: MSD; Speaker Bureau / Expert testimony: Servier; Research grant / Funding (self): Merck. C. Serrano: Advisory / Consultancy, Research grant / Funding (institution): Deciphera; Research grant / Funding (institution), Travel / Accommodation / Expenses: Pfizer; Speaker Bureau / Expert testimony, Research grant / Funding (institution), Travel / Accommodation / Expenses: Bayer; Advisory / Consultancy: Blueprint; Travel / Accommodation / Expenses: PharmaMar; Travel / Accommodation / Expenses: Novartis; Travel / Accommodation / Expenses: Lilly. E. Garralda: Advisory / Consultancy, Research grant / Funding (institution): Roche/Genentech; Advisory / Consultancy: Ellipses Pharma; Advisory / Consultancy: Neomed Therapeutics; Advisory / Consultancy: Boeringer Ingelheim; Advisory / Consultancy: Janssen Global Services; Speaker Bureau / Expert testimony: BMS; Travel / Accommodation / Expenses: Merck; Research grant / Funding (institution), Travel / Accommodation / Expenses: Glycotope; Research grant / Funding (institution), Travel / Accommodation / Expenses: Menarini; Research grant / Funding (self), Research grant / Funding (institution): Novartis; Research grant / Funding (institution): Principia Biopharma; Research grant / Funding (institution): Lilly; Research grant / Funding (institution): Loxo Oncology; Research grant / Funding (institution): Symphogen; Research grant / Funding (institution): Merck; Honoraria (institution): Incyte; Research grant / Funding (institution): Pharma Mar; Research grant / Funding (institution): Kura Oncology; Research grant / Funding (institution): Macrogenics; Research grant / Funding (institution): Pierre Fabre; Research grant / Funding (institution): Cellestia; Research grant / Funding (institution): Blueprint; Research grant / Funding (institution): Beigene; Research grant / Funding (institution): Sierra; Research grant / Funding (institution): Genmab. J. Carles: Research grant / Funding (institution): AB Science; Research grant / Funding (institution): Aragon Pharmaceuticals; Research grant / Funding (institution): Arog Pharmaceuticals; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution): Astellas Pharma; Advisory / Consultancy, Research grant / Funding (institution): AstraZeneca AB; Research grant / Funding (institution): Aveo Pharmaceuticals INC; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution): Bayer AG; Research grant / Funding (institution): Blueprint Medicines Corporation; Research grant / Funding (institution): BN Immunotherapeutics INC; Research grant / Funding (institution): Boehringer Ingelheim España; Advisory / Consultancy, Research grant / Funding (institution): Bristol-Myers Squibb International Corporation (BMS),; Research grant / Funding (institution): Clovis Oncology, INC; Research grant / Funding (institution): Cougar Biotechnology INC; Research grant / Funding (institution): Deciphera Pharmaceuticals LLC; Research grant / Funding (institution): Exelixis INC; Research grant / Funding (institution): F. Hoffmann-La Roche LTD, Genentech INC,; Research grant / Funding (institution): GlaxoSmithKline; Research grant / Funding (institution): Incyte; Research grant / Funding (institution): Janssen-Cilag International NV; Research grant / Funding (institution): Karyopharm Therapeutics; Research grant / Funding (institution): Laboratoires Leurquin Mediolanum SAS; Research grant / Funding (institution): Lilly; Research grant / Funding (institution): Medimmune; Research grant / Funding (institution): Millennium Pharmaceuticals; Research grant / Funding (institution): Nanobiotix SA; Research grant / Funding (institution): Novartis Farmacéutica; Advisory / Consultancy, Research grant / Funding (institution): Pfizer; Research grant / Funding (institution): Puma Biotechnology; Research grant / Funding (institution): SFJ Pharma LTD. II; Research grant / Funding (institution): Teva Pharma S.L.U.; Advisory / Consultancy, Speaker Bureau / Expert testimony: Johnson & Johnson; Advisory / Consultancy, Research grant / Funding (institution): Sanofi-Aventis; Advisory / Consultancy, Research grant / Funding (institution): MSD Oncology; Advisory / Consultancy, Research grant / Funding (institution): Roche; Speaker Bureau / Expert testimony: Asofarma. All other authors have declared no conflicts of interest.
Resources from the same session
4543 - Long-term real-world (RW) outcomes in patients with advanced melanoma (MEL) treated with ipilimumab (IPI) and non-IPI therapies: IMAGE study
Presenter: Stéphane Dalle
Session: Poster Display session 3
Resources:
Abstract
4523 - Prognostic Factors for efficacy of Ipilimumab used after AntiPD1 and/or BRAF+MEK inhibitors in Melanoma Patients: an Italian Melanoma Intergroup study
Presenter: Riccardo Marconcini
Session: Poster Display session 3
Resources:
Abstract
3632 - Rechallenge with combination ipilimumab and anti-PD-1 (IPI+PD1) in metastatic melanoma after acquired resistance to IPI+PD1 immunotherapy
Presenter: Adriana Hepner
Session: Poster Display session 3
Resources:
Abstract
3732 - Clinicopathologic characteristics of immune colitis in melanoma patients treated with combination ipilimumab and anti-PD1 (IPI+PD1) and PD1 monotherapy.
Presenter: Kazi Nahar
Session: Poster Display session 3
Resources:
Abstract
5005 - Real-world outcomes of ipilimumab plus nivolumab for advanced melanoma in the Netherlands
Presenter: Michiel van Zeijl
Session: Poster Display session 3
Resources:
Abstract
5524 - Utilization of Real-World Data to Assess the Effectiveness of Immune Checkpoint Inhibitors (ICIs) in Elderly Patients with Metastatic Melanoma
Presenter: D Scott Ernst
Session: Poster Display session 3
Resources:
Abstract
5884 - Tumor mutational burden and response to PD-1 inhibitors: an analysis of 89 cases of metastatic melanoma.
Presenter: Léa Dousset
Session: Poster Display session 3
Resources:
Abstract
3120 - Increase in S100B and LDH as early outcome predictors for non-responsiveness to anti-PD-1 monotherapy in advanced melanoma.
Presenter: Elisa Rozeman
Session: Poster Display session 3
Resources:
Abstract
2157 - Immune status defined by molecular information layers predicts response to pembrolizumab treatment in advanced melanoma
Presenter: Guillermo Prado-Vázquez
Session: Poster Display session 3
Resources:
Abstract
2553 - Interim analysis of a phase Ib study of cobimetinib plus atezolizumab in patients with advanced BRAFV600 wild type melanoma progressing on prior anti-PD-L1 therapy
Presenter: Shahneen Sandhu
Session: Poster Display session 3
Resources:
Abstract