Chemotherapy for Metastatic Disease

The data on the use of single-agent chemotherapy are limited due to the studies involving small numbers and mixed populations whereby chemotherapy has been administered in different settings and stages of the disease. Small studies have demonstrated modest efficacy of bleomycin, methotrexate, cisplatin, and 5-FU, either as single agents or as combination therapy, as illustrated in Table 12.1.

The use of bleomycin was first reported in 1969 whereby twice weekly intravenous/intramuscular bleomycin produced an objective response in six out of eight patients.3 However, the use of bleomycin has been limited due to the associated pulmonary toxicity.

The Memorial Sloan Kettering Cancer Center (MSKCC) reported the outcomes of single-agent cisplatin at both low (1.6-2.0 mg/kg) and high doses (3 mg/kg or 120 mg/m2). The overall response rate in this study was 33%. A later Southwest Oncology Group (SWOG) study of 26 patients treated with cisplatin 50 mg/m2 showed partial response in four patients.4

Multiagent therapies seem to be more active than single-agent therapy but induce considerable toxicity. Again no randomized controlled trials are currently available. In one of the early studies, Hussein et al. reported their experience using a combination of cisplatin and 5-FU in six patients (five with SCC penis and one with SCC urethra). There was one complete response (in the patient with urethral SCC) and five partial responses in this group.2 Of the five patients with penile SCC, one underwent inguinal lymphadenectomy followed by adjuvant radiotherapy but died 18 months later due to a local recurrence. The remaining patients underwent local radiotherapy with a median overall survival of 15 months.

The most commonly used regimen is the combination of cisplatin, bleomycin, and methotrexate as studied by the Southwest Oncology Group (SWOG). Although this regimen induced response rates of 32%, the toxicity was high (five toxic deaths in 40 patients).2 Side effects included infection, gastrointestinal and pulmonary tox-icity, as well as renal impairment. The reported toxic character of this regimen is in accordance with more recent literature, including the experience at our own institution (see below).6,7 Cisplatin in combination with 5-FU seems to be as active as the SWOG regimen with less toxicity.8

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