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Introduction/Background We describe the demographics and outcomes of patients with gynae-oncology malignancies treated on early phase trials (EPT) at the University College London Hospital (UCLH) phase 1 unit over an 8-year period. Methodology Medical records were retrospectively analysed. Results 96 women with gynae-oncology cancer (22 cervical, 19 endometrial, 50 ovarian, 5 vaginal/vulval) and an average age of 58 years (range 28 to 88 years) treated between 14/05/2015 and 12/10/2023 were identified. 63 were Caucasian, 7 Asian, 3 Black, 23 other/unknown and 92% spoke English as a first language. 59% of patents were referred from outside the Trust. There was a range of investigational medicinal product (IMP) types, including immunotherapy (33%) combination chemotherapy and small molecule inhibitor (19%), small molecule inhibitor monotherapy (15%), combination immunotherapy and targeted therapy (10%), cancer vaccine (3%) Participants received a median of 2 lines of treatment before receiving EPT treatment (range 0 – 9). Following discontinuation on EPT, patients received a median of 0.87 further lines of therapy (range 0 -5). Median length of time between initial diagnosis and commencing EPT treatment was 32.1 months (range 4 – 196 months). Median Eastern Cooperative Oncology Group Performance status at time of referral was 1 (range 0–1). At data cut off, 21 patients remain alive, of whom 6 continue to receive active EPT therapy. The median length of time on EPT was 3.6 months (range 0.5 - 26.9 months). Reasons for withdrawing from EPT included radiological disease progression (65%), toxicity (21%), clinical disease progression (7%), unknown/other (4%), completed trial (3%). The average survival time following discontinuation of treatment was 10.8 months (0.5 - 39 months). Conclusion The EPT unit at UCLH has a strong background in treating patients with varied gynae-oncology malignancies across a range of IMP types. Future collection of quality-of-life data will also be important to further evaluate clinical benefit. Disclosures The authors have no disclosures to make.
Mukherjee et al. (Fri,) studied this question.