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Use of PRO-CTCAE May Help Identify Underreported Adverse Effects in Phase 1 Clinical Trials


Adopting patient-reported outcomes version
of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) may help
better identify adverse events (AEs) that otherwise go underreported, study findings
presented at the ESMO Congress 2019 in Barcelona, Spain, have shown. The use of
PRO-CTCAE by patients in phase 1 trials revealed that clinician reports of AEs
had poor to fair agreement with PRO-CTCAE results.

Although analyses are ongoing, the investigators
report that AEs in phase I trial participants may be underreported and suggest
an improved tool is needed. A single-center, prospective study was conducted to
investigate how well PRO-CTCAE holds up against AEs captured by clinicians compared
with patient reported outcome tools among phase I clinical trial participants.

For this investigation, patients
eligible for phase I trials were evaluated using tablet-based PRO-CTCAE with an
80-item library. The patients were also evaluated via clinician-reported CTCAE
grading of adverse effects at baseline, mid cycle 1, and mid cycle 2.

A total of 292 patients were approached
between May 2017 and January 2019.  From
that group, 265 patients (91%) consented and 243 (92%) were evaluable. The
group was 51% female, the median age was 61 (range, 18 to 82), and 79% were
ECOG 1. The most frequent tumor types were gastrointestinal (31.7%), head and
neck (13.2%), and breast (10.7%); 66% were treated with immune therapy, 21%
with immune and/or targeted therapy, 35% with monotherapy, and 61% with combination

PRO-CTCAE completion rate was 98.7%. Fatigue
(75%), pain (68%), and anxiety (54%) were the most common patient-reported AEs.
Those findings were significantly different from the physician reported AEs
(fatigue [41%], pain [39%], and insomnia [18%]).

The study showed the overall
patient-clinician agreement was poor for fatigue. Similar findings were
observed for anxiety and pain. Clinician-reported insomnia was found to be fair.
The highest patient-clinician agreement was observed for dyspnea at baseline,
and edema and rash at mid cycle 2. Clinician reporting failed to pick up
palpitations, hiccups, and vaginal dryness. The clinicians also had poor
overall agreement when it came to cognitive symptoms, urinary issues, and mood


Veitch ZW,
Shepshelovich D, Gallagher C, et al. Implementation of PRO-CTCAE in phase I
clinical trials identifies under reporting of adverse events. Presented at:
ESMO Congress 2019; September 27-October 1, 2019; Barcelona, Spain.  Abstract 1755PD.

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