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Table 4 Current and recent perioperative targeted therapy phase II trials for MIBC

From: Current and recent clinical trials for perioperative systemic therapy for muscle invasive bladder cancer: a systematic review

Institution

Regimen

Receptor target

Setting

Results/Status

Trial ID

University of North Carolina

Erlotinib

EGFR

Neoadjuvant

Completed. Well tolerated. 35% (7/20) histologic downstaging preoperatively [26].

 

University of North Carolina

Erlotinib

EGFR

Neoadjuvant + Adjuvant

Ongoing

NCT00380029

MDACC

Erlotinib

EGFR

Neoadjuvant

Ongoing

NCT00749892

Dendreon

DN24-02

HER2R

Adjuvant

Ongoing. Updated results: 75% of 226 patients had HER2 expression in primary tumor, 84% in lymph nodes. APC activation for all 30 patients who have received 3 infusions of drug [27].

NCT01353222

Medical University of South Carolina

Bevacizumab + GC and Bevacizumab + Paclitaxel#

VEGFR-A

Neoadjuvant + Adjuvant

Ongoing. Preliminary results: 42% (5/12) postoperative complication rate. 31% (4/13) downstaging preoperatively [28].

NCT00268450

MDACC

Bevacizumab + MVAC

VEGFR-A

Neoadjuvant

Ongoing

NCT00506155

FTRC

Sorafenib + GC

VEGFR + PDGFR*

Neoadjuvant

Unknown.

NCT01222676

US Oncology

Sunitinib + GC

VEGFR + PDGFR*

Neoadjuvant

Terminated early due to patient toxicity. Only 9 MIBC patients studied for neoadjuvant therapy [29].

 

MSKCC

Sunitinib + GC

VEGFR + PDGFR*

Neoadjuvant

Completed early due to limited study accrual. pT0 rate was low with combination [30].

NCT00847015

CCCC

Sunitinib

VEGFR + PDGFR*

Neoadjuvant

Completed, Results Unreported

NCT00526656

Hoosier Oncology Group

Dasatinib

BCR/Abl^

Neoadjuvant

Completed. Well tolerated. Follow-up pathology study: SFK expression downregulated in 77% (14/18) of patients [31, 32].

NCT00706641

University of Michigan

Sunitinib

VEGFR + PDGFR*

Adjuvant

Terminated due to poor accrual

NCT01042795

Hoosier Oncology Group

Sunitinib + GC

VEGFR + PDGFR*

Neoadjuvant

Terminated due to patient toxicities

NCT00859339

  1. MDACC = M.D. Anderson Cancer Center. FTRC = Fondazione C.N.R./Regione Toscana “G. Monasterio”, Pisa, Italy. MSKCC = Memorial Sloan-Kettering Cancer Center. CCCC = Case Comprehensive Cancer Center. GC = Gemcitabine and Cisplain. MVAC = Methotrexate, Vinblastine, Doxorubicin, Cisplatin. SFK = SRC Family Kinase. APC: Antigen Presenting Cell.
  2. *Sorafenib and Sunitinib target multiple receptor tyrosine kinases (RTKs) in addition to the aforementioned receptors.
  3. ^Dasatinib targets multiple tyrosine kinases.
  4. #This trial includes neoadjuvant bevacizumab with GC followed by surgery and adjuvant bevacizumab and paclitaxel.