Background:Invasive carcinoma of the male urethra is an aggressive tumor with dismal survival. Patients with this diagnosis are faced with disfiguring surgery and overall poor outcome. We present a series of patients treated with the modified Nigro chemo-radiation protocol as a primary therapeutic modality.
Methods: Between January 1991 and September 2004, 14 patients with invasive carcinoma of the urethra were managed with a modified Nigro chemo-radiation protocol. Thirteen patients had squamous cell carcinoma and one had adenocarcinoma of the urethra. The pendulous urethra was the origin in 5 patients and in 9 patients the bulbo-membranous urethra was the primary site of cancer. Presenting symptoms in patients included a history of urethral strictures in 8, painful mass in 1, penile ulceration in 2, lower urinary tract symptoms (dysuria) and pain in 3. Initial evaluation included retrograde urethrogram, cystourethroscopy with urethral biopsy and CT scan of the chest and abdomen. Clinical stage was T2N0 in 1, T2N2 in 1, T3N0 in 6, T3N1 in 1, T3N2 in 1, and T4N0 in 4. The initial treatment was by suprapubic cystotomy urinary diversion. The modified chemo-radiation regimen consisted of 45 Gy in 25 fractions over 35-45 days. Radiation was administered to the primary site and to bilateral groin areas. Concurrently, mitomycin (10mg/m2) was given on day one, continuous infusion of 5FU (1000mg/m2/24 hrs) was also administered starting on day one and continued for 4 days. The chemotherapy cycle was repeated 28 days later, usually starting on the last 4 days of the radiation cycle. Local recurrence was evaluated by performing serial physical examinations and cystourethroscopy with repeat biopsy. Radiological examination included CT scan of the abdomen and pelvis.
Results:No evidence of local recurrence was noted in 12 patients, consistent with a disease specific survival rate of 85.7%. One patient died of metastatic disease. Two patients had local recurrence. Of these, one death occurred at 15 months. This patient had a pendulous lesion. He underwent surgical excision and adjuvant chemotherapy. The other local non-responder, underwent radical surgical resection and reconstruction and is currently NED at 7 years. Urethral stricture resulted in 8 survivors with urethral reconstruction performed in 4 patients.
Conclusions: The modified Nigro chemo-radiation protocol is an alternative primary treatment modality for invasive urethral carcinoma with genital preservation and increased survival rates.

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