Abstract
The data from two prospective randomised phase III trials that were initiated by the West Midlands Ovarian Cancer Study Group (WMOCSG) in 1981 and 1986, recruiting 167 and 195 patients respectively, have been pooled and the survival patterns of the 362 patients treated for advanced epithelial ovarian cancer within clinical trials in the West Midlands over the 10 year period (1981-91) have been explored. All patients had histologically proven epithelial ovarian cancer and all had residual disease after primary surgery, with the majority having stage III/IV disease. The primary treatment for all patients was debulking surgery followed by platinum-based chemotherapy. Eligible patients were further randomised to undergo a second debulking operation. The main end point, survival, was assessed using Kaplan-Meier curves and the log-rank test. A Cox proportional hazards model identified performance status (P = 0.002), residual disease (P = 0.005) and albumin level (P = 0.04) as independent prognostic factors. A multivariate model to predict survival curves for patients with the best and worst prognoses was developed with predicted 5 year survival of 30% and 3% for those in the best and worst prognostic groups respectively. The identification of clinical interventions to improve outcome is an urgent matter since the prognosis for patients with advanced ovarian cancer remains poor.
Highlights
The long-term follow-up, survival patterns and prognostic factors for this group of 362 patients treated for epithelial ovarian cancer in the West Midlands over the 10 year period 1981-91 are presented. These results suggest that the development of an index to identify good and poor prognostic groups may be possible and could help in targeting optimal therapy for patients with this disease
Patients who were unlikely to benefit from second surgery were randomised between the standard chemotherapy (CP) consisting of eight courses of cisplatin 75 mg m2 and cyclophosphamide 750 mg m2 and an alternative non-cross-resistant chemotherapy consisting of three cycles of cisplatin 75 mg m-2, doxorubicin 50 mg m-2 and bleomycin 15 mg m-2 followed by five courses of cyclophosphamide starting at 1 g m-2, increasing by 0.5 g m-2 each course to a maximum of 3 g m-2 (PAB Esc-Cyclo)
Women entering the two trials were not balanced as regards histological type, grade, residual disease after primary surgery and performance status
Summary
In the first study 167 patients were given five courses of cisplatin at 100 mg m-2 following primary laparotomy. They were randomised, stratifying by residual disease after primary surgery (2 cm), to one of three consolidation treatment arms: (1) second-look laparotomy (SLL) plus radiotherapy; (2) SLL plus 12 courses of chlorambucil; or (3) 12 courses of chlorambucil only. The second study investigated intervention debulking surgery (IDS) in patients who had significant amounts of residual disease following primary surgery and subsequently responded to chemotherapy. All patients who entered the study after that date received cisplatin and cyclophosphamide The results from both trials were reported in 1988 and 1994 respectively (Luesley et al, 1988; Redman et al, 1994)
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