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Poster display - Cocktail

1276 - Effect of Reasons for Screen Failure (RFSF) on Standard of Care in Cancer Patients Screened for Clinical Trials


24 Nov 2018


Poster display - Cocktail


Clinical Research

Tumour Site


Crescens Tiu


Annals of Oncology (2018) 29 (suppl_9): ix170-ix172. 10.1093/annonc/mdy433


C. Tiu, Z. Loh, C. Gan, J. Hakanson, H. Gan, T. John, E. Hawkes

Author affiliations

  • Olivia Newton-john Cancer Research Institute, Austin Health, 3084 - Heidelberg/AU


Abstract 1276


Researchers are questioning the rationale for current rigidity of eligibility criteria in cancer clinical trials. In ineligible patients, the effect of RFSF on subsequent standard treatment (SST) is unclear. We review RFSF in a tertiary centre and their impact on SST.


From Feb 2011-Mar 2018, patients were identified from a tertiary hospital cancer trials screening log. Data collected included RFSF, SST details, & change in RFSF. Patients were excluded if RFSF was biomarker-related, absence of measurable target lesion, inadequate tissue sample, incorrect prior treatment or stage, or patient choice.


216 patients were eligible. Median age was 62 years (range 18-87), 82% had ECOG PS 0-1. 42% had ≥1 comorbidity. Most common cancers were lung (28%), melanoma, colon and pancreatic (all 11%). RFSF were rapid disease progression (PD, 16%); PS 2-4 (12%); abnormal liver function (aLFT, 12%), of which 19 had liver metastases; brain metastases (11%); active comorbidity (11%); renal injury (RI, 17, 8%); suspected metastases (15, 7%) and concurrent cancer (11, 5%). Other reasons (19%) included abnormal blood test, heart disease, contraindicated drugs and leptomeningeal disease. 132/216 (61%) had SST. 8/132 (6%) had a dose reduction of SST, most commonly due to renal impairment (n = 3) or active comorbidities (n = 2). RFSF stabilised/improved in 87/132 (66%) on SST. Of note, all those with aLFTs in the absence of liver metastases improved, however only 26% of aLFTs with documented liver metastases improved, and only 19% of poor PS patients improved. Response to SST occurred in 44/132 (33%). 31/216 (14%) died ≤2 months post screening, mostly from PD (12/35, 34%), PS (8/26, 31%) and aLFT with liver metastases (9/19, 47%).


Most RFSF do not impact SST in cancer patients, especially abnormal organ function with no direct organ involvement. Rapid PD does not affect outcomes. Those with RFSF of poor PS and aLFTs due to liver metastases are less suitable for SST and rarely respond. Careful broadening of trial eligibility is warranted.

Editorial acknowledgement

Clinical trial identification

Legal entity responsible for the study

Austin Health.


Has not received any funding.


All authors have declared no conflicts of interest.

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