Abstract
Introduction
Studies of bevacizumab and pembrolizumab in the treatment of malignant pleural mesothelioma
suggest anticancer efficacy; clinical trial populations are not reflective of real-world
patients. We aimed to determine the proportion of real-world patients who would be
eligible for trials, identify patients who participated in clinical trials, and examine
treatment and outcome data.
Patients and Methods
Consecutive patients with unresectable malignant pleural mesothelioma seen at our
center from January 2012 to July 2018 were assessed with regards to their eligibility
for Mesothelioma Avastin Cisplatin Study (MAPS) and KEYNOTE-028 clinical trials. Prognostic
information, treatment use, and overall survival (OS) data were also collected.
Results
A total of 133 patients were included: 50% and 37%, respectively, did not meet trial
eligibility for MAPS or KEYNOTE-028, most commonly owing to age ≥75 (23%), Eastern
Cooperative Oncology Group performance status of ≥2 (21%), concomitant medication
(21%), or comorbidity (12%). MAPS eligibility did not correlate with use of bevacizumab
(P = .30) or improved OS (P = .87). Eligibility for KEYNOTE-028 correlated with pembrolizumab use (P < .001), but not improved OS (P = .21). Patients who received an investigational anticancer therapy on any clinical
trial had improved OS: 32.4 (95% CI, 23.9-40.9) months versus 20.5 (95% CI, 15.8-25.3)
months (P = .01).
Conclusion
Only ≤63% of our patients were eligible for these trials, highlighting the differences
between real-world patients and the highly select trial population. Our patients who
participated in clinical trials had superior OS, further emphasizing the selection
bias in the trial population.
Graphical abstract
Graphical Abstract
Keywords
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Article info
Publication history
Published online: March 06, 2020
Accepted:
January 20,
2020
Received in revised form:
December 30,
2019
Received:
September 23,
2019
Identification
Copyright
© 2020 Elsevier Inc. All rights reserved.
