Aim:
To identify and summarise the demographic factors of patients referred to Scientia Clinical Research (SCR) Phase 1 oncology trials.
Background:
Phase 1 trials are first-in-human studies evaluation the safety, efficacy and pharmacokinetics of newly developed medications. SCR is a dedicated Phase 1 trial unit located in NSW, Australia.
Methods:
Descriptive statistics were used to summarise data from the clinical records of patients referred to the SCR Phase 1 unit, including:
Results:
In the 2022 calendar year, 168 patients were referred to SCR for an opinion about early phase clinical trials, from 51 referrers. Of those referred, 139 patients had a first consultation. Reasons for not proceeding with a consultation included; no formal referral provided for 15 patients, 9 patients declined a consultation, 3 patients died prior to consultation, 2 patients were uncontactable. The mean age at time of referral was 59 years, (standard deviation 12, median 61, range 12-83).
The most common primary diagnoses were upper gastrointestinal (29%), colorectal (23%) and gynaecological (23%) cancers. Others are represented in table/fig 1.
Figure 1. Cancer diagnosis of patients referred to phase 1 trials
Of the patients where referral location was available, the majority resided in metropolitan Sydney (47%). Regional NSW residents comprised 29% and interstate referrals 9%. Referrals by regional site is represented in figure 2 (table and ‘heat map’).
Figure 2. Local Health District (LHD) of origin (by postcode) for patients referred to phase 1 trials
The median time between referral and first consultation was 10 days, (interquartile range 13), [mean 14, SD13]. (Fig 3)
Figure 3. Time from referral and first conusltation
Five initial consultations were conducted with the assistance of an interpreter (3 Mandarin, 1 Cambodian, 1 AUSLAN).
Conclusion:
In 2022, SCR referrals demonstrated strong representation from regional NSW, while CALD patients from culturally and linguistically diverse backgrounds were under-represented. Patients with gastrointestinal malignancies constituted the bulk of referrals, reflecting a high unmet clinical need for therapeutic options in these patients.