Feasibility and activity of sorafenib and sunitinib in advanced penile cancer: a preliminary report

Urol Int. 2010;85(3):334-40. doi: 10.1159/000315432. Epub 2010 Oct 27.


Introduction: We describe our experience with sorafenib and sunitinib in the treatment of chemotherapy-refractory advanced penile squamous cell carcinoma (SCC).

Patients and methods: Between May 2008 and June 2009, 6 advanced penile cancer patients were treated with sorafenib or sunitinib in our center. All of them had previously received at least two chemotherapy regimens. Tumor responses were evaluated by radiologic assessment and serum SCC antigen change. Immunohistochemical staining of CD34 and Ki-67 was performed in 3 paired tumor tissues before and after treatment.

Results: In the 6 patients, 1 partial response and 4 stable diseases were observed. Three patients showed pain response and had an improvement in quality of life. After molecular-targeted therapies, reduction in microvessel density and Ki-67 labeling index was observed in paired specimens. Serum SCC antigen levels were decreased in 5 patients after 1 week of medication. The patient who achieved partial response had an SCC antigen reduction of nearly 95% after treatment with sunitinib. Serious adverse events were fatal infection and rupture of the femoral vessel, which were unlikely related to the medication.

Conclusions: The feasibility and activity of sorafenib and sunitinib in our series suggest that this approach may be a promising alternative in chemotherapy-refractory advanced penile SCC.

MeSH terms

  • Adult
  • Antigens, CD34 / biosynthesis
  • Antineoplastic Agents / therapeutic use*
  • Benzenesulfonates / therapeutic use*
  • Carcinoma, Squamous Cell / drug therapy*
  • Humans
  • Immunohistochemistry / methods
  • Indoles / therapeutic use*
  • Ki-67 Antigen / biosynthesis
  • Male
  • Middle Aged
  • Neoplasm Metastasis
  • Niacinamide / analogs & derivatives
  • Penile Neoplasms / drug therapy*
  • Penile Neoplasms / pathology
  • Phenylurea Compounds
  • Positron-Emission Tomography / methods
  • Pyridines / therapeutic use*
  • Pyrroles / therapeutic use*
  • Sorafenib
  • Sunitinib
  • Tomography, X-Ray Computed / methods
  • Treatment Outcome


  • Antigens, CD34
  • Antineoplastic Agents
  • Benzenesulfonates
  • Indoles
  • Ki-67 Antigen
  • Phenylurea Compounds
  • Pyridines
  • Pyrroles
  • Niacinamide
  • Sorafenib
  • Sunitinib