Phase II trial of radical surgery for locally advanced pelvic neoplasia

Background: Reported operative mortality and survival rates following total pelvic exenteration (TPE) for recurrent pelvic neoplasia are now as good a s those for many primary treatments. The currently accepted primary treatme nts for these tumours are, however, still either radiotherapy alone or radi otherapy and chemotherapy. The primary aim of this study was to evaluate th e safety and tolerability of TPE and secondarily to ascertain survival afte r TPE. Methods: This was a phase II study of 50 patients with locally advanced pel vic tumours who underwent TPE. Results: Thirty-two patients (64 per cent) underwent TPE for recurrent carc inoma of the cervix, seven (14 per cent) for rectal cancer, three (6 per ce nt) for vulval carcinoma, three (6 per cent) for vaginal carcinoma, two (4 per cent) for prostate cancer and three (6 per cent) for other tumours. The 30-day mortality rate was 8 per cent with an in-hospital mortality rate of 16 per cent. The crude morbidity rate was 62 per cent, with 23 patients (4 6 per cent) having grade III or IV toxicity. A complete response was achiev ed in 63 per cent and a partial response in 37 per cent of patients. The ov erall median survival time was 86 weeks; it was 111 weeks in patients in wh om a complete response was achieved. Conclusion: The survival and operative mortality rates that are now attaina ble with TPE are comparable to those achieved with chemoradiotherapy in adv anced pelvic neoplasia. TPE should no longer be reserved for salvage therap y and should perhaps be compared with chemoradiotherapy as first-line treat ment in a phase III randomized trial in patients with these tumours.