B58: Clinical trial participation; barriers detected in a specialist cancer centre
1The Royal Marsden NHS Foundation Trust, London and Surrey, UK
In the UK, less than 5% of patients with gynaecological cancers are treated within interventional clinical trials.
A retrospective study of patients with gynaecological cancers attending one tertiary referral centre over a six-month period was performed. Patients attending medical oncology clinics with whom a change in systemic treatment was discussed were included in this study. Data were collected from electronic patient records.
204 patients (213 treatment change discussions) discussed a change in systemic therapy, (median age 63; range 19-93; epithelial ovarian cancer, primary peritoneal or fallopian tube carcinoma 182/204, advanced endometrial carcinoma 13, cervical carcinoma 4, sex cord stromal tumours 4; germ cell tumours 1) Clinical trials were discussed at 114 of 213 treatment discussions (53.5%). Reasons for not discussing clinical trials included no suitable study available 39/99 (39%), inadequate performance status (22%), other ineligibility (5%) and patient preference for no further treatment (3%). No reason was documented in 22%.
From 114 clinical trial discussions, 58 patients consented to a clinical trial, with two consenting to two studies sequentially. Common reasons for not consenting to a study included patient choice (33%), ineligibility (30%) and no suitable study (24%). Nine patients either failed screening (8) or decided not to participate after consent (1), of whom one participated in a subsequent study. Of 50 patients who participated in a clinical trial, 90% had epithelial ovarian, primary peritoneal or fallopian tube carcinoma; 10% endometrial cancer and 0% cervical cancer, germ cell or sex cord stromal tumours.
Clinical trials should be discussed with more patients. The most common reason for not entering a trial is lack of a suitable study. Clinical trials in endometrial, cervical and rare gynaecological cancers are urgently needed.