Tiu, Crescens; Loh, Zoe; Gan, Chun Loo; Gan, Hui K; John, Thomas; Hawkes, Eliza A

doi:10.1159/000501211

Author(s)

Tiu, Crescens

Loh, Zoe

Gan, Chun Loo

Gan, Hui K

John, Thomas

Hawkes, Eliza A

Publication Date

2019

Abstract

The cancer research community increasingly question the rigidity of eligibility criteria in clinical trials. Common reasons for "screen failure" (RFSF) are well documented; however, their effect on subsequent standard therapy (SST) and outcomes is unclear. This retrospective study evaluated patients aged ≥18 years with solid malignancy who were listed as ineligible on a screening log between February 2011 and March 2018. Patients screen-failed for biomarker results or incorrect cancer stage/prior treatment profile were excluded. Data were collected from electronic hospital records, including demographics, cancer history, RFSF, subsequent therapy, and outcomes. Overall, 217 patients were eligible. The most common histologies were lung (28%), melanoma, colon, and pancreatic (all 11%); 90% were metastatic. The most common RFSF were rapid disease progression (PD; 16%), performance status (PS) ≥2 (12%), and abnormal liver function tests (aLFT; 12%). After screen failure, 129/217 (59%) had SST; 9 were dose-reduced. Treatment-naïve or phase III trial-ineligible patients were more likely to receive SST than those pre-treated or phase I trial-ineligible (72/104 vs. 52/113, p = 0.0006; 71/109 vs. 15/42, p = 0.00013), respectively. RFSF stabilised/improved in 104/217 (48%); the main RFSF was co-morbidity (19/104). The most common RFSF to deteriorate were rapid PD (27/72), PS ≥2 (20/72), and aLFT with liver metastases (LM; 13/72). RFSF related to organ function rarely deteriorate unless directly involved with underlying malignancy. Most RFSF do not prevent patients from having SST, nor increase dose reductions, especially in treatment-naïve/phase III trial-ineligible patients. Those with RFSF of poor PS, rapid PD, and aLFT from LM are less suitable for SST. Careful broadening of trial eligibility is warranted.

Citation

Oncology 2019; 97(5): 270-276

Jornal Title

Oncology

OrcId

0000-0002-9215-1441

0000-0002-0376-2559

Link

https://ahro.austin.org.au/austinjspui/handle/1/21510

Subject

Clinical trials

Eligibility criteria

Exclusion criteria

Screen failure

Title

Effect of Reasons for Screen Failure on Subsequent Treatment Outcomes in Cancer Patients Assessed for Clinical Trials.

Type of document

Journal Article

Austin Health

Effect of Reasons for Screen Failure on Subsequent Treatment Outcomes in Cancer Patients Assessed for Clinical Trials.

Files:

Author(s)	Tiu, Crescens Loh, Zoe Gan, Chun Loo Gan, Hui K John, Thomas Hawkes, Eliza A
Publication Date	2019
Abstract	The cancer research community increasingly question the rigidity of eligibility criteria in clinical trials. Common reasons for "screen failure" (RFSF) are well documented; however, their effect on subsequent standard therapy (SST) and outcomes is unclear. This retrospective study evaluated patients aged ≥18 years with solid malignancy who were listed as ineligible on a screening log between February 2011 and March 2018. Patients screen-failed for biomarker results or incorrect cancer stage/prior treatment profile were excluded. Data were collected from electronic hospital records, including demographics, cancer history, RFSF, subsequent therapy, and outcomes. Overall, 217 patients were eligible. The most common histologies were lung (28%), melanoma, colon, and pancreatic (all 11%); 90% were metastatic. The most common RFSF were rapid disease progression (PD; 16%), performance status (PS) ≥2 (12%), and abnormal liver function tests (aLFT; 12%). After screen failure, 129/217 (59%) had SST; 9 were dose-reduced. Treatment-naïve or phase III trial-ineligible patients were more likely to receive SST than those pre-treated or phase I trial-ineligible (72/104 vs. 52/113, p = 0.0006; 71/109 vs. 15/42, p = 0.00013), respectively. RFSF stabilised/improved in 104/217 (48%); the main RFSF was co-morbidity (19/104). The most common RFSF to deteriorate were rapid PD (27/72), PS ≥2 (20/72), and aLFT with liver metastases (LM; 13/72). RFSF related to organ function rarely deteriorate unless directly involved with underlying malignancy. Most RFSF do not prevent patients from having SST, nor increase dose reductions, especially in treatment-naïve/phase III trial-ineligible patients. Those with RFSF of poor PS, rapid PD, and aLFT from LM are less suitable for SST. Careful broadening of trial eligibility is warranted.
Citation	Oncology 2019; 97(5): 270-276
Jornal Title	Oncology
OrcId	0000-0002-9215-1441 0000-0002-0376-2559
Link	https://ahro.austin.org.au/austinjspui/handle/1/21510
Subject	Clinical trials Eligibility criteria Exclusion criteria Screen failure
Title	Effect of Reasons for Screen Failure on Subsequent Treatment Outcomes in Cancer Patients Assessed for Clinical Trials.
Type of document	Journal Article