Feasibility of trials in ovarian cancer by line of therapy and platinum sensitivity.
Shaboodien R., Diamantis N., Blagden S., Gabra H., Agarwal R.
BACKGROUND: To rapidly evaluate the significant numbers of novel therapies entering clinical development requires maximization of clinical trial capacity. To enable this, we evaluated the profile of patients with epithelial ovarian cancer (EOC) in clinical practice, compared with those targeted in clinical trials. METHODS: Patients with EOC treated between March-September 2009 (cohort A, n = 115 patients) and January-July 2012 (cohort B, n = 109 patients), in the North West London Cancer Network with a catchment of 1.2 million, were identified. Patient characteristics were compared with phase II/III EOC studies identified using clinicaltrials.gov (85 trials; 54,603 patients). RESULTS: In cohort A, comparing the proportion of patients in clinical practice with those in trials, 40% versus 55% (P = 0.0006) were chemotherapy-naive, 20% versus 9% (P < 0.0001) had platinum-resistant disease (platinum-free interval, <6 months), 16.2% versus 39% (P < 0.0001) were receiving second line, and 43.8% versus 5% (P < 0.0001) third-line chemotherapy or greater, respectively. Ninety-eight percent of treated patients had a performance status of 2 or less. These results were validated in cohort B, U.K. National Cancer Research Network and U.S. Gynecologic Oncology Group trial databases. CONCLUSIONS: These results provide the data to enable EOC trial portfolios to be balanced to clinical practice and suggest an increase in emphasis on trials for patients with platinum-resistant disease and third-line chemotherapy or greater, to address an area of clinical need and maximize recruitment.