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Webster et al. J Cancer Metastasis Treat 2020;6:8 I http://dx.doi.org/10.20517/2394-4722.2019.38 Page 11 of 14

Figure 4. Current FACIT immunotherapy assessment options. FACIT: functional assessment of chronic therapy

and colleagues offer users a fixed-form assessment, developed in accordance with FDA PRO guidelines,
with items that are included in the overall item library [17,58] . A second initiative by Jim and colleagues aims
to develop a FACT measure with items reflective of common patient-reported toxicities in lung cancer
[59]
patients receiving immunotherapy . They have analyzed PRO and other data from the Addario Lung
Cancer Foundation international patient registry to describe patient-reported toxicities and quality of life
outside the context of a clinical trial in lung cancer patients treated with immune checkpoint inhibitors.
Figure 4 depicts current FACIT immunotherapy adverse event assessment options.

In conclusion, using literature review, expert consensus, and previously developed items from the FACIT
Measurement System, we developed an item library that collectively targets full-spectrum PRO assessment
of ICM-related adverse events. Library item selection for tailored forms allows for targeted, concise,
clinically relevant measurement of symptoms and concerns to monitor when assessing the value of ICM
treatment for patients with cancer. Collection of PRO data in the emerging field of immuno-oncology
will make it possible to more accurately assess the added adverse event burden associated with new
combination regimens and support longitudinal studies to evaluate the long-term effects of both single-
agent and combination therapies. At the point of care, PRO data can support shared decision-making
between clinicians and patients, and facilitate early detection of, and communication among, the wide
range of specialists required to provide comprehensive care for immunotherapy-related adverse events.
Direct patient report of immunotherapy-related adverse events may help to identify early symptoms before
clinical signs are manifest to the clinician. For example, patients report joint pain and stiffness prior to
clinical recognition of myalgia/arthralgia. Earlier detection and recognition of these adverse effects may
enable early symptom management and/or treatment modifications that contribute to better quality of life
over time.

DECLARATIONS
Acknowledgments
We gratefully acknowledge Dr. Patricia Ganz and Dr. Janet Parsons for their contributions to this project.

Authors’ contributions
Contributed to the design, analysis and interpretation of the results: Webster KA, O’Connor ML, Cella D
Contributed to the item review procedures and the writing and editing of the manuscript: Webster KA,