Rapid Fire Best of the Best Poster Oral Clinical Oncology Society of Australia Annual Scientific Meeting 2022

Articulating the gap between the real-world and clinical trial populations – a retrospective analysis of a first-line metastatic colorectal cohort (mCRC) and standard Phase 3 eligibility criteria (EC) (#114)

Jun Hee Hong 1 2 , Udit Nindra 1 2 , Stephanie Lim 2 3 4 , Ray Asghari 5 , Aflah Roohullah 1 2 4 , Megan Ford 3 , Stephen A. Della-Fiorentina 2 , Annette Tognela 2 4 , Weng Ng 1 , Abhijit Pal 1 , Wei Chua 1 3 4 6
  1. Liverpool Cancer Therapy Centre, Liverpool Hospital, Liverpool, NSW, Australia
  2. Macarthur Cancer Therapy Centre, Campbelltown Hospital, Campbelltown, NSW, Australia
  3. Ingham Institute for Applied Medical Research, Liverpool, NSW, Australia
  4. Western Sydney University, Sydney, NSW, Australia
  5. Bankstown Hosptial, Bankstown, NSW, Australia
  6. University of New South Wales, Sydney, NSW, Australia

Aims: Determine the prevalence of mCRC patients eligible for first-line clinical trials in South Western Sydney Local Health District (SWSLHD) according to standard EC and assess the impact of broadening EC. Restrictive EC lead to highly selective patient enrolment, limiting trial opportunities for current patients and compromising the generalisability of previous results in the real-world setting.

Methods: A retrospective analysis using electronic medical records in patients with newly diagnosed mCRC in SWSLHD between November 2019 and October 2021 was used to assess the prevalence of potentially eligible patients for first-line clinical trials using standard phase 3 EC and repeated with broadened EC.

Results: We identified 138 patients (median age 65; 61.6% male; 48.6% CALD; 21.0% CALD-Preferred Language Not English). 78.3% of patients were offered first-line systemic therapy. 65.7% of patients who received first-line systemic therapy were eligible for clinical trials based on standard EC. None of these patients were offered a clinical trial. Broadening EC to include patients with ECOG PS ≥ 2 and creatinine clearance 45mL/min increased this to 71.3% and 83.3% respectively. This increased to 95.3% when EC was broadened to include patients with stable cardiac-comorbidities, prior or stable active malignancy, hepatic dysfunction secondary to metastasis, and treated brain metastases.

Conclusions:35% of patients who received first-line systemic therapy for mCRC in this real-world cohort would not have been included in the pivotal Phase 3 clinical trials demonstrating the efficacy of these regimens. This has implications when discussing potential benefits and risks with patients in the real-world setting who did not fit trial EC.  Patient eligibility for trials increased from 65.7% to 95.3% when EC was broadened. In our cohort, no patient was referred to clinical trials which are reflective of broader challenges to clinical trial recruitment within SWSLHD apart from restrictive EC.