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E-Poster Display

758P - Assessment of prognostic and predictive value of FGFR alterations (FGFRa) in a real-world cohort of patients (pts) with high-risk pT1 non-muscle-invasive bladder cancer (NMIBC)

Date

17 Sep 2020

Session

E-Poster Display

Topics

Tumour Site

Urothelial Cancer

Presenters

Johannes Breyer

Citation

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

Authors

J. Breyer1, M. Monga2, R. Mayr3, W. Otto3, M. Burger3, M. Eckstein4, R. Stöhr4, P. Erben5, C. Bolenz6, S. Eidt7, R. Sundaram2, M. Baig2, A. Galluzzi8, R. Wirtz9, A. Hartmann4, A. Santiago-Walker2

Author affiliations

  • 1 Department Of Urology, Caritas St. Josef Medical Center, University of Regensburg, 93053 - Regensburg/DE
  • 2 Janssen, Research & Development, 19477 - Spring House/US
  • 3 Department Of Urology, Caritas St. Josef Medical Center, University of Regensburg, Regensburg/DE
  • 4 Institute Of Pathology, University Hospital Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen/DE
  • 5 Department Of Urology, University Medical Centre Mannheim, Medical Faculty Mannheim, University of Heidelberg, 69120 - Mannheim/DE
  • 6 Department Of Urology, University of Ulm, Ulm/DE
  • 7 Institute Of Pathology, St Elisabeth Hospital Köln-Hohenlind, 50935 - Cologne/DE
  • 8 Iqvia, Montreal, Canada, Janssen Research & Development, Spring House/US
  • 9 Stratifyer Molecular Pathology Gmbh, Institute of Pathology, St Elisabeth Hospital Köln-Hohenlind, 50935 - Cologne/DE

Resources

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Abstract 758P

Background

Limited data are available on the prognostic and predictive value of FGFRa in pts with high-risk NMIBC. We assessed the role of FGFRa in a real-world cohort comprising solely pts with stage pT1 high-risk NMIBC and the effect of bacillus Calmette-Guérin (BCG) therapy.

Methods

We assessed a pooled dataset of matched clinical and genomic data for pts with stage pT1 NMIBC treated (1992-2015) by the Bladder Cancer Research Initiative for Drug Targets in Germany (BRIDGE) consortium. FGFRa status was defined by prespecified panel of FGFR2/3 mutations and fusions via QIAGEN therascreen® FGFR test. FGFR1-4 mRNA expression was assessed by single-step RT-qPCR. Recurrence-free survival (RFS), progression-free survival (PFS), and disease-specific survival (DSS) were estimated by Kaplan-Meier analysis. Hazard ratio (HR) was calculated by multivariate Cox proportional hazards model.

Results

Of 263 analyzed pts, 43% had FGFRa (39% mutations, 6% fusions, not mutually exclusive), 27% had concomitant carcinoma in situ (CIS), and 42% received BCG. Spearman correlation showed significant inverse associations between FGFR3a mRNA levels and WHO 1973 grade (ρ -0.3220, p < 0.0001) and CIS (ρ -0.2101, p < 0.0006). FGFR3 mRNA levels positively correlated with FGFR3a (ρ 0.6115, p < 0.0001). Presence of FGFRa was not associated with RFS, PFS, or DSS overall or when stratified by BCG-treated or BCG-naïve pts (Table). Stage pT1 pts with or without FGFRa had similar survival outcomes in response to BCG. Table: 758P

Pts with FGFRa vs pts without FGFRa RFS HR (95% CI) p Value PFS HR (95% CI) p Value DSS HR (95% CI) p Value
Overall cohort 0.93 (0.60-1.43) 0.60 (0.31-1.16) 0.59 (0.29-1.23)
0.724 0.121 0.154
Pts with BCG treatment 0.66 (0.32-1.36) 0.32 (0.09-1.15) 0.39 (0.08-1.87)
0.251 0.066 0.221
Pts without treatment 0.83 (0.44-1.57) 0.68 (0.28-1.62) 0.68 (0.28-1.64)
0.558 0.374 0.387

Conclusions

FGFRa were frequent in high-risk pts. In stage pT1 NMIBC, distinct from previous reports, prognosis for pts with FGFRa was not different from those without FGFRa. Pts with FGFRa who had recurrence/relapse post-BCG treatment have high unmet need. The role of FGFR directed therapy is being investigated in a randomized study (NCT03390504).

Clinical trial identification

Editorial acknowledgement

Sally Hassan PhD, CMPP, of Parexel International provided editorial assistance for this abstract.

Legal entity responsible for the study

Janssen Research & Development, LLC.

Funding

Janssen Research & Development, LLC.

Disclosure

J. Breyer: Research grant/Funding (institution), Travel/Accommodation/Expenses: Janssen; Research grant/Funding (institution): Cepheid; Honoraria (self): Ipsen; Honoraria (self), Travel/Accommodation/Expenses: Pfizer; Honoraria (institution): Bristol Myers Squibb, AstraZeneca, Merck; Honoraria (self): Roche. M. Monga: Full/Part-time employment: Janssen. R. Mayr: Travel/Accommodation/Expenses: Ipsen. M. Burger: Honoraria (self), Speaker Bureau/Expert testimony: Bristol Myers Squibb; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Janssen. M. Eckstein: Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: AstraZeneca; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses, Full/Part-time employment: Diaceutics; Honoraria (self), Speaker Bureau/Expert testimony: Roche; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Janssen-Cilag; Honoraria (self), Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: MSD; Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Astellas; Advisory/Consultancy, Travel/Accommodation/Expenses: GenomicHealth. R. Stöhr: Full/Part-time employment: Universitiy Hospital Erlangen, Germany Institute of Pathology. P. Erben: Research grant/Funding (self): Janssen. C. Bolenz: Honoraria (self), Research grant/Funding (institution): Janssen; Honoraria (self), Travel/Accommodation/Expenses: AstraZeneca; Honoraria (self), Travel/Accommodation/Expenses: Takeda; Research grant/Funding (institution): ERBE. S. Eidt: Leadership role, Shareholder/Stockholder/Stock options: Stratifyer, Molecula Pathology. R. Sundaram: Full/Part-time employment: Janssen; Shareholder/Stockholder/Stock options: Johnson & Johnson. M. Baig: Full/Part-time employment: Janssen; Shareholder/Stockholder/Stock options: Johnson & Johnson. A. Galluzzi: Full/Part-time employment: Janssen; Shareholder/Stockholder/Stock options: Johnson & Johnson. R. Wirtz: Leadership role, Travel/Accommodation/Expenses, Shareholder/Stockholder/Stock options, Licensing/Royalties, Officer/Board of Directors: Stratifyer; Advisory/Consultancy, Research grant/Funding (institution): Janssen, Johnson & Johnson; Advisory/Consultancy, Research grant/Funding (institution), Licensing/Royalties: BioNTech; Advisory/Consultancy, Travel/Accommodation/Expenses: Medicover; Research grant/Funding (self), Licensing/Royalties: Qiagen; Advisory/Consultancy, Research grant/Funding (institution): Intellexon. A. Hartmann: Honoraria (self), Advisory/Consultancy, Research grant/Funding (self), Research grant/Funding (institution): Janssen; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: AstraZeneca; Honoraria (self), Advisory/Consultancy: MSD; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: BMS; Honoraria (self), Honoraria (institution), Speaker Bureau/Expert testimony, Research grant/Funding (self): Roche; Honoraria (self), Advisory/Consultancy: Ipsen; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Cepheid. A. Santiago-Walker: Shareholder/Stockholder/Stock options, Full/Part-time employment: Janssen. All other authors have declared no conflicts of interest.

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