Background/Aim:
Patients (pts) are referred to Melanoma Institute Australia (MIA) from a variety of areas, including regional/rural clinics from 1 to 2,580 km away. We sought to explore whether recruitment to systemic therapy clinical trials is influenced by patient location, particularly in an era of intense clinical trial activity with early phase trials requiring frequent visits and with unpredictable toxicities.
Methods:
All pts enrolled on systemic therapy clinical trials at MIA from 2014 to 2017 were included. Disease stage, clinical trial treatment type and trial phase were examined based upon distance of residence from MIA using Google Maps. Long-distance (LD) was defined as ≥100km from MIA, <100km defined as local.
Results:
Between 1/2014 and 4/2017, 271 pts were enrolled on systemic therapy clinical trials; 19 clinical trials were opened to recruitment; including 2 neo-adjuvant, 3 adjuvant, 14 metastatic (2 for pts with brain metastases). 85 (31%) pts on clinical trials were from LD including 11 who lived outside NSW and 2 from overseas. The proportion of LD pts on trials were similar on phase 1/2 (30%) and phase 3/4 (32%) trials, (neo)-adjuvant (42%) adjuvant (26%) trials and metastatic (31%) trials. Notably, 32% of pts on ipilimumab-based trials were from LD, and 27% of pts on systemic therapy trials for active brain metastases were from LD. Further analyses examining proportions of all patients enrolled on trials and additional factors that may influence trial recruitment, such as trial availability, trial eligibility, trial commitments and standard therapy options will be presented.
Conclusions:
MIA has recruited melanoma pts on systemic drug trials who live a LD from the unit. These trials included early phase trials, metastatic trials, and trials with significant toxicities. Distance does not appear to be a barrier to recruitment.