Phase 1 clinical trials are vitally important in the development of novel cancer treatments. This study examined the clinical characteristics and outcomes of patients enrolled on phase 1 clinical trials at Liverpool Cancer Therapy Centre.
We collected data retrospectively from the medical records of patients enrolled on phase 1 clinical trials from 2012 to 2016 at Liverpool Hospital. Data collected included patient demographics, cancer type, sites of metastatic disease, previous lines of treatment, further lines of treatment after trial, duration on trial, toxicity, overall survival, reason for ceasing treatment, deaths on trial and deaths within 30 days.
There were 40 patients treated over the period studied. The median age was 62 years and all were ECOG 0-1 . Most had colorectal cancer (40%) followed by cervical cancer (10%). The most common sites for metastatic disease were lung (60%) and nodes (60%). The most common toxicities encountered were fatigue (66%), nausea (33%) and anorexia (23%). The majority of toxicity was grade 1 (70%) with all toxicities being grade 1-3. At the time of data collection, 75% were dead, 12.5% alive and 12.5% unknown. The median duration on trial was 52 days. The median overall survival from trial enrollment was 6 months (and from initial diagnosis 50 months). The most common reason for ceasing treatment was progressive disease (78%); toxicity (25%) and ECOG decline (25%). One patient died whilst enrolled on a trial and 4 patients (13%) died within 30 days of ceasing a trial.
Our data suggest that phase 1 trials are a therapeutic option for oncology patients with limited options. Toxicity was manageable and predominately Grade 1, with no toxic deaths observed. Patient selection is important for clinical trials and a minority of our patients progressed rapidly during, or soon after, participating in a trial.