Molecular profiling of metastatic bladder cancer early-phase clinical trial participants predicts patient outcomes

Omar Alhalabi, Andrew W. Hahn, Pavlos Msaouel, Alexander Y. Andreev-Drakhlin, Funda Meric-Bernstam, Aung Naing, Sarina Piha-Paul, Janku Filip, Shubham Pant, Timothy A. Yap, David S. Hong, Siqing Fu, Daniel Karp, Erick Campbell, Hung Le, Matthew T. Campbell, Amishi Y. Shah, Nizar M. Tannir, Arlene O. Siefker-Radtke, Jianjun GaoJason Roszik, Vivek Subbiah

Research output: Contribution to journalArticlepeer-review

1 Scopus citations


Prognosis for patients with metastatic bladder carcinoma (mBC) remains limited and in need of novel therapies. We retrospectively analyzed medical records of 43 patients with platinum-refractory metastatic bladder cancer (mBC) who participated in one or more phase I trials of various investigational therapies. Patients' tumors or circulating tumor DNA were analyzed by next-generation sequencing. The median progression-free survival was 4.2 months, the median overall survival was 9.6 months, and the overall response rate was 17.5%. TP53, ERBB2, PI3KCA, FGFR3, and ARID1A alterations were detected in 66%, 29%, 27%, 24%, and 22% of all patients, respectively. Alterations in FGFR3 were almost mutually exclusive of TP53. More than half (64%) of patients with an FGFR alt received an FGFR inhibitor, 67% of which achieved disease control. Among patients with urothelial carcinoma histology, those harboring a TP53 alteration had a shorter median progression-free survival (PFS) compared with those whose tumors carry wild-type TP53. The reverse relationship was observed in patients harboring an FGFR alteration.

Original languageEnglish (US)
Pages (from-to)395-402
Number of pages8
JournalMolecular Cancer Research
Issue number3
StatePublished - Mar 1 2021

ASJC Scopus subject areas

  • Molecular Biology
  • Oncology
  • Cancer Research


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