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  string(149) "Association between hyperphosphatemia and overall survival among patients with advanced urothelial cancer treated with erdafitinib in clinical trials"
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  string(854) "Hyperphosphatemia is a recognized “on-target” adverse event of erdafitinib, a pan-FGFR tyrosine kinase inhibitor with FDA approval to treat locally advanced and metastatic urothelial carcinoma with FGFR3 or 2 mutations. Mechanistic studies have suggested that erdafitinib’s affinity for tumoral FGFR is correlated to its ability to produce hyperphosphatemia; however, it remains unexplored whether erdafitinib-related hyperphosphatemia correlates to oncologic outcomes. This study aims to determine whether the incidence of hyperphosphatemia was associated with improved overall survival and other oncologic end points in phase II/III clinical trials of erdafitinib for the treatment of UC. Data from this study may inform the clinical practice of erdafitinib, and whether hyperphosphatemia should be recognized as a biomarker of clinical activity."
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    ["last_name"]=>
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    string(38) "University of Rochester Medical Center"
    ["email"]=>
    string(33) "Jathin_bandari@urmc.rochester.edu"
    ["state_or_province"]=>
    string(2) "NY"
    ["country"]=>
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      string(6) "Malshy"
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    ["label"]=>
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  ["property_scientific_abstract"]=>
  string(1619) "Background: Hyperphosphatemia is a recognized on-target adverse event of erdafitinib, a pan-FGFR tyrosine kinase inhibitor with FDA approval to treat advanced urothelial carcinoma (UC) with FGFR3/2 mutations. We hypothesize that hyperphosphatemia is a biomarker for drug activity and is associated with improved overall survival (OS) and other oncologic end points in phase II/III clinical trials. 

Objectives: To evaluate the association between serum phosphate levels and oncologic outcomes (OS, progression-free survival (PFS), and objective response rate (ORR)) among patients with advanced urothelial cancer and FGFR3/2 alterations treated with erdafitinib in phase II–III trials.

Study Design: This will be a pooled meta-analysis of the two phase II/III clinical trials captured by the YODA collaborative on erdafitinib. 

Participants: Patients with advanced UC receiving erdafitinib.

Primary and Secondary Outcome Measures: Primary outcome will be OS; secondary outcomes will be PFS and ORR.

Statistical Analysis: We will perform Kaplan Meier survival analysis and Cox proportional hazards modelling to determine the effect of hyperphosphatemia, categorized by Common Terminology Criteria for Adverse Events (CTCAE) categories, or serum phosphate will have on oncologic outcomes.

Significance: Hyperphosphatemia has not yet been demonstrated to be an biomarker of FGFR inhibitor efficacy in phase II/III clinical trials. Determining whether the association is present will help guide the current clinical care of advanced UC patients receiving FGFR inhibitors.

"
  ["project_brief_bg"]=>
  string(2913) "Fibroblast growth factor receptor (FGFR) are a family of receptor tyrosine kinases which regulate cell proliferation, differentiation, and migration.1 Mutations in FGFR3 are present in 15% of high risk urothelial cell (UC) tumors, and within that subset of UC tumors, gain of function mutations have been implicated in driving tumorigenesis.2 Erdafitinib is a pan-FGFR tyrosine kinase inhibitor (TKI) studied in two clinical trials among patients with advanced UC who have progressed past checkpoint inhibitor (CPI) immunotherapy, and has been demonstrated to improve overall survival (OS), progression free survival (PFS), and objective response (OR), when compared to chemotherapy.3-5 Among patients who were CPI therapy naïve, erdafitinib had efficacy among advanced UC patients with FGFR3 mutations compared to pembrolizumab.6 Hyperphosphatemia is a recognized “on-target” adverse event of FGFR inhibition; specifically, inhibition of FGFR23 within the renal proximal tubule cells results in activation of 1-hydroxylase (CYP27B1) and induction of hypervitaminosis D, and inhibition of urinary phosphate excretion through inhibition of sodium-phosphate co-transporters NPT2a/c.7 As a result, serum phosphate has been utilized as a biomarker for optimal dosing of erdafitinib in certain clinical trials.3,8 

In contrast, dovitinib, a TKI with broad activity against FGFR, VEGFR, PDGFR, CSF-1 R, and others,9 was studied in a phase II open-label clinical trial among patients with advanced UC who had either wildtype FGFR3 or mutated FGFR3, failed to demonstrate efficacy, even among patients with FGFR3 mutations.10 The investigators noted that hyperphosphatemia was not observed in the trial, implying that failure to induce hyperphosphatemia indicates a failure to reach the threshold for clinical activity. Infigratinib, a pan-FGFR TKI demonstrated efficacy among patients with advanced UC in a single arm study; hyperphosphatemia was observed in 46% of the study population.11 Therefore, there is ample pre-clinical/clinical data implying that serum phosphate levels are a biomarker of drug activity, however the post-hoc analyses to demonstrate that hyperphosphatemia correlates to improved drug efficacy has remained unexplored. The purpose of this study is to pool data from the THOR phase III4,6 and BLC2001 phase II5 clinical trial of erdafitinib to explore the relationship between hyperphosphatemia and oncologic outcomes. Specifically, we will perform meta-analyses between the presence of hyperphosphatemia or examine serum phosphate as a continuous variable and determine whether it is associated with improved OS, PFS, and OR. Establishing the relationship between serum phosphate and clinical outcomes among patients undergoing FGFR inhibition will help inform clinical care and strengthen similar associations previously published with the addition of Phase III work.8

"
  ["project_specific_aims"]=>
  string(788) "Among patients with advanced urothelial cancer and with tumors expressing FGFR3/2 mutations receiving erdafitinib as part of phase II-III clinical trials captured in the YODA collaborative, our objectives are to: 

1.	To determine association between hyperphosphatemia or serum phosphate expressed as a continuous variable with oncologic outcomes as reported by the clinical trial, e.g. overall survival (OS), progression free survival (PFS) and objective response (OR). 

2.	To capture data regarding patient discontinuation of the study drug due to hyperphosphatemia and understand its relation to oncologic outcomes. 

3.	To explore relationship between chronic kidney disease (CKD), serum phosphate, and oncologic outcomes among patients taking erdafitinib. 

"
  ["project_study_design"]=>
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    ["value"]=>
    string(7) "meta_an"
    ["label"]=>
    string(52) "Meta-analysis (analysis of multiple trials together)"
  }
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      ["label"]=>
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    }
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      ["label"]=>
      string(36) "Participant-level data meta-analysis"
    }
    [2]=>
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      ["value"]=>
      string(37) "participant_level_data_only_from_yoda"
      ["label"]=>
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    }
    [3]=>
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      ["value"]=>
      string(28) "research_on_comparison_group"
      ["label"]=>
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    }
    [4]=>
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      ["label"]=>
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    }
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  ["project_research_methods"]=>
  string(572) "We will include all phase II-III clinical trials captured in the YODA collaborative which involve patients with advanced UC who received erdafitinib. Inclusion criteria are: member of the arm receiving erdafitinib, having at least one follow-up assessment to report oncologic outcome, and having clinical data regarding serum phosphate levels measured during the study period. Patients in the chemotherapy or immunotherapy arms will be excluded. Patients who were lost to follow up will be excluded, or failed to have their serum phosphate levels monitored at least once. "
  ["project_main_outcome_measure"]=>
  string(152) "Primary outcome will be OS as defined by the clinical trial protocol; secondary outcomes will be PFS and ORR as defined by the clinical trial protocol. "
  ["project_main_predictor_indep"]=>
  string(789) "Serum phosphate as measured by the study. We will analyze it as: 

- A continuous variable 

- We will dichotomize it using the Common Terminology Criteria for Adverse Events (CTCAE) grades for hyperphosphatemia, using CTCAE grade 0 vs 1-2 and ≥3:12 

- CTCAE grade 0: no hyperphosphatemia 

- CTCAE grade 1: laboratory finding and intervention not indicated 

- CTCAE grade 2: noninvasive intervention indicated 

- CTCAE grade 3: severe or medically significant but not immediately, hospitalization or prolongation of existing hospitalization indicated 

- CTCAE grade 4: life-threatening consequences, urgent intervention indicated, e.g. dialysis. 

- Dichotomize hyperphosphatemia using a threshold of 4.5 mg/dL, and 7 mg/dL.13

"
  ["project_other_variables_interest"]=>
  string(553) "- Presence of chronic kidney disease (CKD)

- Serum creatinine measured at time of phosphate measurement 

- Serum alkaline phosphatase 

- Serum calcium 

- Presence of osseous metastatic disease 

- Gender

- Age 

- Baseline comorbidities 

- Baseline performance status score, i.e. ECOG 0 vs 1 vs 2 

- Overall survival 

- Progression free survival 

- Objective response rate 

- Usage of phosphate binders 

- Discontinuation of study due to hyperphosphatemia 

"
  ["project_stat_analysis_plan"]=>
  string(1457) "Descriptive statistics will be used to summarize baseline characteristics of the included patients. Specifically, continuous variables will be presented using medians and interquartile ranges (IQR). Differences between groups will be assessed using Student’s t-tests or Wilcoxon rank-sum tests, based on the distribution of the data. Categorical variables will be summarized using frequencies and percentages, and comparisons will be made using chi-square tests or Fisher’s exact tests as appropriate.



For time-to-event outcomes such as OS, PFS and ORR, we will perform Kaplan-Meier survival analyses between patients with either hyperphosphatemia or euphosphatemia. Differences in survival distributions will be assessed using log-rank tests. Additionally, we will perform survival analyses using Cox proportional hazards (PH) models to estimate the HR of death or progression, and compare patients with hyperphosphatemia based on CTCAE grades 0 vs 1-2 vs ≥3; or  4.5 mg/dL, and when expressed as a continuous variable. Finally, multivariable Cox models will adjust for potential confounders including age, sex, baseline comorbidities, ECOG performance status, and presence of chronic kidney disease. The proportional hazards assumption will be assessed using Schoenfeld residuals. All analyses will be performed using Stata version 19.0, with a two-sided alpha level of 0.05 used to determine statistical significance.



"
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      ["label"]=>
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  ["project_timeline"]=>
  string(232) "August 2025 Project Submission 

October 2025 Data Cleaning

November 2025 Data Analysis

December 2025 Manuscript Drafting, Submission to Oncology Meetings 

February 2026 Submission for Publication 

"
  ["project_dissemination_plan"]=>
  string(382) "Our results will be presented at local, national, and international cancer meetings. The results of this project will be published in a high impact oncology journal. Potential journals/conferences include: European Urology Oncology, JCO Oncology Advances, American Urological Association (AUA) Meeting, American Society of Clinical Oncology – Genitourinary Symposium (ASCO-GU).   "
  ["project_bibliography"]=>
  string(3406) "
 

Iyer G, Milowsky MI. Fibroblast growth factor receptor-3 in urothelial tumorigenesis. Urologic Oncology: Seminars and Original Investigations. 2013/04/01/ 2013;31(3):303-311. doi:https://doi.org/10.1016/j.urolonc.2011.12.001
Bernard-Pierrot I, Brams A, Dunois-Lardé C, et al. Oncogenic properties of the mutated forms of fibroblast growth factor receptor 3b. Carcinogenesis. Apr 2006;27(4):740-7. doi:10.1093/carcin/bgi290
Siefker-Radtke AO, Necchi A, Park SH, et al. Efficacy and safety of erdafitinib in patients with locally advanced or metastatic urothelial carcinoma: long-term follow-up of a phase 2 study. Lancet Oncol. Feb 2022;23(2):248-258. doi:10.1016/s1470-2045(21)00660-4
Loriot Y, Matsubara N, Park SH, et al. Erdafitinib or Chemotherapy in Advanced or Metastatic Urothelial Carcinoma. N Engl J Med. Nov 23 2023;389(21):1961-1971. doi:10.1056/NEJMoa2308849
Loriot Y, Necchi A, Park SH, et al. Erdafitinib in Locally Advanced or Metastatic Urothelial Carcinoma. N Engl J Med. Jul 25 2019;381(4):338-348. doi:10.1056/NEJMoa1817323
Siefker-Radtke AO, Matsubara N, Park SH, et al. Erdafitinib versus pembrolizumab in pretreated patients with advanced or metastatic urothelial cancer with select FGFR alterations: cohort 2 of the randomized phase III THOR trial. Ann Oncol. Jan 2024;35(1):107-117. doi:10.1016/j.annonc.2023.10.003
Gutiérrez OM. Fibroblast growth factor 23, Klotho, and disordered mineral metabolism in chronic kidney disease: unraveling the intricate tapestry of events and implications for therapy. J Ren Nutr. May 2013;23(3):250-4. doi:10.1053/j.jrn.2013.01.024
Dosne AG, Valade E, Stuyckens K, et al. Erdafitinib’s effect on serum phosphate justifies its pharmacodynamically guided dosing in patients with cancer. CPT Pharmacometrics Syst Pharmacol. May 2022;11(5):569-580. doi:10.1002/psp4.12727
Mazzola CR, Siddiqui KM, Billia M, Chin J. Dovitinib: rationale, preclinical and early clinical data in urothelial carcinoma of the bladder. Expert Opin Investig Drugs. Nov 2014;23(11):1553-62. doi:10.1517/13543784.2014.966900
Milowsky MI, Dittrich C, Durán I, et al. Phase 2 trial of dovitinib in patients with progressive FGFR3-mutated or FGFR3 wild-type advanced urothelial carcinoma. European Journal of Cancer. 2014/12/01/ 2014;50(18):3145-3152. doi:https://doi.org/10.1016/j.ejca.2014.10.013
Pal SK, Rosenberg JE, Hoffman-Censits JH, et al. Efficacy of BGJ398, a Fibroblast Growth Factor Receptor 1-3 Inhibitor, in Patients with Previously Treated Advanced Urothelial Carcinoma with FGFR3 Alterations. Cancer Discov. Jul 2018;8(7):812-821. doi:10.1158/2159-8290.Cd-18-0229
Meric-Bernstam F, Hollebecque A, Furuse J, et al. Safety Profile and Adverse Event Management for Futibatinib, An Irreversible FGFR1-4 Inhibitor: Pooled Safety Analysis of 469 Patients. Clin Cancer Res. Apr 15 2024;30(8):1466-1477. doi:10.1158/1078-0432.Ccr-23-2646
Christov M, Jüppner H. Phosphate homeostasis disorders. Best Pract Res Clin Endocrinol Metab. Oct 2018;32(5):685-706. doi:10.1016/j.beem.2018.06.004

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