A randomized trial of cytoreductive surgery followed by chemotherapy versus chemotherapy alone in bulky stage testicular cancer with poor prognostic features.

Thirty-nine patients with Stage III nonseminomatous testicular cancer were treated in a prospective randomized trial comparing cytoreductive surgery followed by a cis-platinum containing combination chemotherapy regimen versus chemotherapy alone. All patients had one or more of the following poor prognostic signs: palpable retroperitoneal disease, liver involvement, invasion or obstruction of the inferior vena cava, or lung metastases larger than 2 cm in diameter. Cytoreductive surgery was technically feasible in this group of patients as assessed radiographically (70-90% reduction in tumor mass) and by the decline in serum levels of alpha-fetoprotein and human chorionic gonadotropin in 75% of the patients following surgery. However, there was no statistically significant improvement in overall response rate (75% versus 84%), complete response rate (50 versus 37%) or in survival between the patients treated with surgery prior to chemotherapy or with chemotherapy as the initial treatment. It is unlikely (P less than 0.028) that any true beneficial effect of surgery was missed due to the relatively small number of patients in each treatment arm. The authors of this study conclude that cytoreductive surgery prior to chemotherapy in patients with poor prognosis Stage III testicular carcinoma is not routinely indicated. Since the overall complete response rate to chemotherapy in these 39 patients with bulky Stage III disease was only 43%, alternate approaches, other than cytoreductive surgery, are necessary to improve the prognosis for this group of patients.

RCT Entities:   Population Interventions Outcomes