Are clinical trial eligibility criteria an accurate reflection of a real-world population of advanced non-small-cell lung cancer patients?

Khalid Al-Baimani, H. Jonker, T. Zhang, G. D. Goss, S. A. Laurie, G. Nicholas, P. Wheatley-Price

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

Background Advanced non-small-cell lung cancer (nsclc) represents a major health issue globally. Systemic treatment decisions are informed by clinical trials, which, over years, have improved the survival of patients with advanced nsclc. The applicability of clinical trial results to the broad lung cancer population is unclear because strict eligibility criteria in trials generally select for optimal patients. Methods We performed a retrospective chart review of all consecutive patients with advanced nsclc seen in outpatient consultation at our academic institution between September 2009 and September 2012, collecting data about patient demographics and cancer characteristics, treatment, and survival from hospital and pharmacy records. Two sets of arbitrary trial eligibility criteria were applied to the cohort. Scenario A stipulated Eastern Cooperative Oncology Group performance status (ecog ps) 0–1, no brain metastasis, creatinine less than 120 μmol/L, and no second malignancy. Less-strict scenario B stipulated ecog ps 0–2 and creatinine less than 120 μmol/L. We then used the two scenarios to analyze treatment and survival of patients by trial eligibility status. Results The 528 included patients had a median age of 67 years, with 55% being men and 58% having adenocarcinoma. Of those 528 patients, 291 received at least 1 line of palliative systemic therapy. Using the scenario A eligibility criteria, 73% were trial-ineligible. However, 46% of “ineligible” patients actually received therapy and experienced survival similar to that of the “eligible” treated patients (10.2 months vs. 11.6 months, p = 0.10). Using the scenario B criteria, only 35% were ineligible, but again, the survival of treated patients was similar in the ineligible and eligible groups (10.1 months vs. 10.9 months, p = 0.57). Conclusions Current trial eligibility criteria are often strict and limit the enrolment of patients in clinical trials. Our results suggest that, depending on the chosen drug, its toxicities and tolerability, eligibility criteria could be carefully reviewed and relaxed.

Original languageEnglish
Pages (from-to)e291-e297
JournalCurrent Oncology
Volume25
Issue number4
DOIs
Publication statusPublished - Aug 1 2018

Fingerprint

Non-Small Cell Lung Carcinoma
Clinical Trials
Population
Survival
Creatinine
Second Primary Neoplasms
Hospital Records
Therapeutics
Survival Analysis
Drug-Related Side Effects and Adverse Reactions
Palliative Care
Lung Neoplasms
Adenocarcinoma
Outpatients
Referral and Consultation
Demography
Neoplasm Metastasis
Health
Brain

Keywords

  • Clinical trial eligibility
  • Non-small-cell lung cancer
  • NSCLC

ASJC Scopus subject areas

  • Oncology

Cite this

Are clinical trial eligibility criteria an accurate reflection of a real-world population of advanced non-small-cell lung cancer patients? / Al-Baimani, Khalid; Jonker, H.; Zhang, T.; Goss, G. D.; Laurie, S. A.; Nicholas, G.; Wheatley-Price, P.

In: Current Oncology, Vol. 25, No. 4, 01.08.2018, p. e291-e297.

Research output: Contribution to journalArticle

Al-Baimani, Khalid ; Jonker, H. ; Zhang, T. ; Goss, G. D. ; Laurie, S. A. ; Nicholas, G. ; Wheatley-Price, P. / Are clinical trial eligibility criteria an accurate reflection of a real-world population of advanced non-small-cell lung cancer patients?. In: Current Oncology. 2018 ; Vol. 25, No. 4. pp. e291-e297.
@article{54ed330add65415c99638aa9e7a66910,
title = "Are clinical trial eligibility criteria an accurate reflection of a real-world population of advanced non-small-cell lung cancer patients?",
abstract = "Background Advanced non-small-cell lung cancer (nsclc) represents a major health issue globally. Systemic treatment decisions are informed by clinical trials, which, over years, have improved the survival of patients with advanced nsclc. The applicability of clinical trial results to the broad lung cancer population is unclear because strict eligibility criteria in trials generally select for optimal patients. Methods We performed a retrospective chart review of all consecutive patients with advanced nsclc seen in outpatient consultation at our academic institution between September 2009 and September 2012, collecting data about patient demographics and cancer characteristics, treatment, and survival from hospital and pharmacy records. Two sets of arbitrary trial eligibility criteria were applied to the cohort. Scenario A stipulated Eastern Cooperative Oncology Group performance status (ecog ps) 0–1, no brain metastasis, creatinine less than 120 μmol/L, and no second malignancy. Less-strict scenario B stipulated ecog ps 0–2 and creatinine less than 120 μmol/L. We then used the two scenarios to analyze treatment and survival of patients by trial eligibility status. Results The 528 included patients had a median age of 67 years, with 55{\%} being men and 58{\%} having adenocarcinoma. Of those 528 patients, 291 received at least 1 line of palliative systemic therapy. Using the scenario A eligibility criteria, 73{\%} were trial-ineligible. However, 46{\%} of “ineligible” patients actually received therapy and experienced survival similar to that of the “eligible” treated patients (10.2 months vs. 11.6 months, p = 0.10). Using the scenario B criteria, only 35{\%} were ineligible, but again, the survival of treated patients was similar in the ineligible and eligible groups (10.1 months vs. 10.9 months, p = 0.57). Conclusions Current trial eligibility criteria are often strict and limit the enrolment of patients in clinical trials. Our results suggest that, depending on the chosen drug, its toxicities and tolerability, eligibility criteria could be carefully reviewed and relaxed.",
keywords = "Clinical trial eligibility, Non-small-cell lung cancer, NSCLC",
author = "Khalid Al-Baimani and H. Jonker and T. Zhang and Goss, {G. D.} and Laurie, {S. A.} and G. Nicholas and P. Wheatley-Price",
year = "2018",
month = "8",
day = "1",
doi = "10.3747/co.25.3978",
language = "English",
volume = "25",
pages = "e291--e297",
journal = "Current Oncology",
issn = "1198-0052",
publisher = "Multimed Inc.",
number = "4",

}

TY - JOUR

T1 - Are clinical trial eligibility criteria an accurate reflection of a real-world population of advanced non-small-cell lung cancer patients?

AU - Al-Baimani, Khalid

AU - Jonker, H.

AU - Zhang, T.

AU - Goss, G. D.

AU - Laurie, S. A.

AU - Nicholas, G.

AU - Wheatley-Price, P.

PY - 2018/8/1

Y1 - 2018/8/1

N2 - Background Advanced non-small-cell lung cancer (nsclc) represents a major health issue globally. Systemic treatment decisions are informed by clinical trials, which, over years, have improved the survival of patients with advanced nsclc. The applicability of clinical trial results to the broad lung cancer population is unclear because strict eligibility criteria in trials generally select for optimal patients. Methods We performed a retrospective chart review of all consecutive patients with advanced nsclc seen in outpatient consultation at our academic institution between September 2009 and September 2012, collecting data about patient demographics and cancer characteristics, treatment, and survival from hospital and pharmacy records. Two sets of arbitrary trial eligibility criteria were applied to the cohort. Scenario A stipulated Eastern Cooperative Oncology Group performance status (ecog ps) 0–1, no brain metastasis, creatinine less than 120 μmol/L, and no second malignancy. Less-strict scenario B stipulated ecog ps 0–2 and creatinine less than 120 μmol/L. We then used the two scenarios to analyze treatment and survival of patients by trial eligibility status. Results The 528 included patients had a median age of 67 years, with 55% being men and 58% having adenocarcinoma. Of those 528 patients, 291 received at least 1 line of palliative systemic therapy. Using the scenario A eligibility criteria, 73% were trial-ineligible. However, 46% of “ineligible” patients actually received therapy and experienced survival similar to that of the “eligible” treated patients (10.2 months vs. 11.6 months, p = 0.10). Using the scenario B criteria, only 35% were ineligible, but again, the survival of treated patients was similar in the ineligible and eligible groups (10.1 months vs. 10.9 months, p = 0.57). Conclusions Current trial eligibility criteria are often strict and limit the enrolment of patients in clinical trials. Our results suggest that, depending on the chosen drug, its toxicities and tolerability, eligibility criteria could be carefully reviewed and relaxed.

AB - Background Advanced non-small-cell lung cancer (nsclc) represents a major health issue globally. Systemic treatment decisions are informed by clinical trials, which, over years, have improved the survival of patients with advanced nsclc. The applicability of clinical trial results to the broad lung cancer population is unclear because strict eligibility criteria in trials generally select for optimal patients. Methods We performed a retrospective chart review of all consecutive patients with advanced nsclc seen in outpatient consultation at our academic institution between September 2009 and September 2012, collecting data about patient demographics and cancer characteristics, treatment, and survival from hospital and pharmacy records. Two sets of arbitrary trial eligibility criteria were applied to the cohort. Scenario A stipulated Eastern Cooperative Oncology Group performance status (ecog ps) 0–1, no brain metastasis, creatinine less than 120 μmol/L, and no second malignancy. Less-strict scenario B stipulated ecog ps 0–2 and creatinine less than 120 μmol/L. We then used the two scenarios to analyze treatment and survival of patients by trial eligibility status. Results The 528 included patients had a median age of 67 years, with 55% being men and 58% having adenocarcinoma. Of those 528 patients, 291 received at least 1 line of palliative systemic therapy. Using the scenario A eligibility criteria, 73% were trial-ineligible. However, 46% of “ineligible” patients actually received therapy and experienced survival similar to that of the “eligible” treated patients (10.2 months vs. 11.6 months, p = 0.10). Using the scenario B criteria, only 35% were ineligible, but again, the survival of treated patients was similar in the ineligible and eligible groups (10.1 months vs. 10.9 months, p = 0.57). Conclusions Current trial eligibility criteria are often strict and limit the enrolment of patients in clinical trials. Our results suggest that, depending on the chosen drug, its toxicities and tolerability, eligibility criteria could be carefully reviewed and relaxed.

KW - Clinical trial eligibility

KW - Non-small-cell lung cancer

KW - NSCLC

UR - http://www.scopus.com/inward/record.url?scp=85055093785&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85055093785&partnerID=8YFLogxK

U2 - 10.3747/co.25.3978

DO - 10.3747/co.25.3978

M3 - Article

VL - 25

SP - e291-e297

JO - Current Oncology

JF - Current Oncology

SN - 1198-0052

IS - 4

ER -