Current Clinical Trials

Stage III penile cancer is defined by the following TNM classifications:

• T1, N2, M0
• T2, N2, M0
• T3, N0, M0
• T3, N1, M0
• T3, N2, M0

Inguinal adenopathy in patients with penile cancer is common but may be the result of infection rather than neoplasm. If palpable enlarged lymph nodes exist 3 or more weeks after removal of the infected primary lesion and completion of a course of antibiotic therapy, bilateral inguinal lymph node dissection should be performed.

In cases of proven regional inguinal lymph node metastasis without evidence of distant spread, bilateral ilioinguinal dissection is the treatment of choice.[1-4] Since many patients with positive lymph nodes are not cured, clinical trials may be appropriate.

Standard treatment options:

1. Clinically evident regional lymph node metastasis without evidence of distant spread is an indication for bilateral ilioinguinal lymph node dissection after penile amputation.[5]
2. Radiation therapy may be considered as an alternative to lymph node dissection in patients who are not surgical candidates.
3. Postoperative radiation therapy may decrease incidence of inguinal recurrences.

Treatment options under clinical evaluation:

• Clinical trials using radiosensitizers or cytotoxic drugs are appropriate. A combination of vincristine, bleomycin, and methotrexate has been effective as both neoadjuvant and adjuvant therapy.[6] Cisplatin (100 mg/m²) as neoadjuvant therapy plus continuous-infusion 5-fluorouracil has also been shown to be effective.[5] Single-agent cisplatin (50 mg/m²) was tested in a large trial and was found to be ineffective.[7]

Because of the high incidence of microscopic node metastases, adjunctive inguinal dissection of clinically uninvolved (negative) lymph nodes in conjunction with amputation is often used for patients with poorly differentiated tumors. Lymphadenectomy can carry substantial morbidity, such as infection, skin necrosis, wound breakdown, chronic edema, and even a low, but finite, mortality rate. The impact of prophylactic lymphadenectomy on survival is not known. [2,3,8,9]

To reduce the morbidity associated with prophylactic lymphadenectomy, dynamic sentinel node biopsy is being used in patients with stage T2 and stage T3 clinically node-negative penile cancer. One retrospective single-institution study of 22 patients reported a false-negative rate of 11%.[10]

Check for U.S. clinical trials from NCI's PDQ Cancer Clinical Trials Registry that are now accepting patients with stage III penile cancer. The list of clinical trials can be further narrowed by location, drug, intervention, and other criteria.

General information about clinical trials is also available from the NCI Web site.

References

1. Harty JI, Catalona WJ: Carcinoma of the penis. In: Javadpour N, ed.: Principles and Management of Urologic Cancer. 2nd ed. Baltimore, Md: Williams and Wilkins, 1983, pp 581-597. 
   
   
2. Theodorescu D, Russo P, Zhang ZF, et al.: Outcomes of initial surveillance of invasive squamous cell carcinoma of the penis and negative nodes. J Urol 155 (5): 1626-31, 1996.  [PUBMED Abstract]
   
   
3. Lindegaard JC, Nielsen OS, Lundbeck FA, et al.: A retrospective analysis of 82 cases of cancer of the penis. Br J Urol 77 (6): 883-90, 1996.  [PUBMED Abstract]
   
   
4. Lynch DF, Pettaway CA: Tumors of the penis. In: Walsh PC, Retik AB, Vaughan ED, et al., eds.: Campbell's Urology. 8th ed. Philadelphia: Saunders, 2002, pp 2945-2947. 
   
   
5. Fisher HA, Barada JH, Horton J, et al.: Neoadjuvant therapy with cisplatin and 5-fluorouracil for stage III squamous cell carcinoma of the penis. [Abstract] J Urol 143(4 Suppl): A-653, 352A, 1990. 
   
   
6. Pizzocaro G, Piva L: Adjuvant and neoadjuvant vincristine, bleomycin, and methotrexate for inguinal metastases from squamous cell carcinoma of the penis. Acta Oncol 27 (6b): 823-4, 1988.  [PUBMED Abstract]
   
   
7. Gagliano RG, Blumenstein BA, Crawford ED, et al.: cis-Diamminedichloroplatinum in the treatment of advanced epidermoid carcinoma of the penis: a Southwest Oncology Group Study. J Urol 141 (1): 66-7, 1989.  [PUBMED Abstract]
   
   
8. Ornellas AA, Seixas AL, Marota A, et al.: Surgical treatment of invasive squamous cell carcinoma of the penis: retrospective analysis of 350 cases. J Urol 151 (5): 1244-9, 1994.  [PUBMED Abstract]
   
   
9. Young MJ, Reda DJ, Waters WB: Penile carcinoma: a twenty-five-year experience. Urology 38 (6): 529-32, 1991.  [PUBMED Abstract]
   
   
10. Perdonà S, Autorino R, De Sio M, et al.: Dynamic sentinel node biopsy in clinically node-negative penile cancer versus radical inguinal lymphadenectomy: a comparative study. Urology 66 (6): 1282-6, 2005.  [PUBMED Abstract]
    
    

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