Development of a Functional Assessment of Chronic Illness Therapy item library and primary symptom list for the assessment of patient-reported adverse events associated with immune checkpoint modulators

Webster, Kimberly; O'connor, Mary L.; Hansen, Aaron Richard; Kircher, Sheetal Mehta; Jim, Heather; Dicker, Adam P.; Janda, Monika; Ala‐Leppilampi, Kari; Bingham, Clifton O.; Feliciano, Josephine; Henry, Norah Lynn; McLouth, Laurie E.; Cella, David

doi:10.20517/2394-4722.2019.38

Cited by 6 publications

(9 citation statements)

References 57 publications

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“…Variables assessed included age, race, ethnicity, marital status, and education (see Appendix A ). Severity of symptomatic toxicities during treatment with ICIs (e.g., fatigue, muscle pain, rash) was assessed using a 5-point Likert scale with 0 = not at all and 4 = very much [ 31 ]. Symptomatic toxicities were identified based on a review of the literature as well as qualitative interviews with 14 patients, 7 caregivers, and 9 providers.…”

Section: Methodsmentioning

confidence: 99%

Use of a Cancer Registry to Evaluate Patient-Reported Outcomes of Immune Checkpoint Inhibitors

Jim

Eisel

Hoogland

et al. 2020

Cancers

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Immune checkpoint inhibitors (ICIs) are increasingly used for advanced lung cancer, but few studies have reported on patient-reported outcomes (PROs) outside the context of a clinical trial. The goal of the current study was to assess PROs in participants of a lung cancer registry who had been treated with an ICI. Patients participating in the GO2 Foundation’s Lung Cancer Registry who reported receiving atezolizumab, durvalumab, nivolumab, or pembrolizumab were invited to participate in a survey about their experiences during treatment. Quality of life was evaluated using the Functional Assessment of Cancer Therapy–General (FACT-G). Common symptomatic adverse events were evaluated using an item bank generated for ICIs. Internationally, 226 patients (mean age 61, 75% female) participated. Patients reported worse quality of life at the time of assessment than U.S. population and cancer normative samples. The most common moderate to severe adverse events during ICI treatment were fatigue (41%), aching joints (27%), and aching muscles (20%). Due to toxicity, 25% reported a treatment delay, 11% an emergency room visit, and 9% a hospitalization. This study is among the first to our knowledge to report on PROs of ICIs outside the context of a clinical trial. Results suggest higher rates of adverse events than previously reported in clinical trials.

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Section: Methodsmentioning

confidence: 99%

Use of a Cancer Registry to Evaluate Patient-Reported Outcomes of Immune Checkpoint Inhibitors

Jim

Eisel

Hoogland

et al. 2020

Cancers

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“…PROs may be general assessments of QOL or HRQOL, as in the European Quality of Life Five Dimensions, 167 European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 items (QLQ-C30), 168 and the Functional Assessment of Cancer Therapy (FACT) 169 or they may be specific to a disease state, as in the Lung Cancer Symptom Scale, 170 the EORTC Quality of life Questionnaire Lung Cancer 13 items (QLQ-LC13), 168 and the FACT-Lung. 171 172 Tools have also been developed to more specifically assess PROs in patients receiving immunotherapy, including the Functional Assessment of Chronic Illness Therapy Immunotherapy item library 173 and the FACT-Immune Checkpoint Modulator. 174 …”

Section: Patient Support and Qolmentioning

confidence: 99%

Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immunotherapy for the treatment of lung cancer and mesothelioma

Govindan

Aggarwal

Antonia

et al. 2022

J Immunother Cancer

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Immunotherapy has transformed lung cancer care in recent years. In addition to providing durable responses and prolonged survival outcomes for a subset of patients with heavily pretreated non-small cell lung cancer (NSCLC), immune checkpoint inhibitors (ICIs)— either as monotherapy or in combination with other ICIs or chemotherapy—have demonstrated benefits in first-line therapy for advanced disease, the neoadjuvant and adjuvant settings, as well as in additional thoracic malignancies such as small-cell lung cancer (SCLC) and mesothelioma. Challenging questions remain, however, on topics including therapy selection, appropriate biomarker-based identification of patients who may derive benefit, the use of immunotherapy in special populations such as people with autoimmune disorders, and toxicity management. Patient and caregiver education and support for quality of life (QOL) is also important to attain maximal benefit with immunotherapy. To provide guidance to the oncology community on these and other important concerns, the Society for Immunotherapy of Cancer (SITC) convened a multidisciplinary panel of experts to develop a clinical practice guideline (CPG). This CPG represents an update to SITC’s 2018 publication on immunotherapy for the treatment of NSCLC, and is expanded to include recommendations on SCLC and mesothelioma. The Expert Panel drew on the published literature as well as their clinical experience to develop recommendations for healthcare professionals on these important aspects of immunotherapeutic treatment for lung cancer and mesothelioma, including diagnostic testing, treatment planning, immune-related adverse events, and patient QOL considerations. The evidence- and consensus-based recommendations in this CPG are intended to give guidance to cancer care providers using immunotherapy to treat patients with lung cancer or mesothelioma.

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“…Symptoms were then mapped onto existing items in the FACIT measurement system to form the immunotherapy library, which comprised 239 items covering 142 unique symptoms across 75 conditions. Clinical experts reviewed iterations of the symptom summaries to produce a subset known as the Primary Symptom List, which includes symptoms considered the most relevant to ICM treatment 51 …”

Section: Development Of New Pro Items and Optimizing Hrqol Instruments For Immunotherapymentioning

confidence: 99%

“…For this to occur, more comprehensive capturing of irAEs is required, and the effects of irAEs have on HRQOL must be evaluated. Efforts to develop these tools are underway and will be an important step forward in the understanding and accurate reporting of irAEs 2,50,51 . However, as multiple classes of IO treatments have entered clinical testing in recent years, including cancer vaccines, adoptive cell transfer, and CAR‐T cells in addition to the ICMs–each with their own unique mechanism of action and toxicity profile–PRO tools will need to be developed and validated for each of these classes of therapy.…”

Section: Development Of New Pro Items and Optimizing Hrqol Instruments For Immunotherapymentioning

confidence: 99%

Health‐related quality‐of‐life assessment of patients with solid tumors on immuno‐oncology therapies

Voon

Cella

Hansen

2021

Cancer

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Immuno‐oncology therapies have been approved for various solid tumors; however, the high cost of these treatments and their potential toxicities require a thorough assessment of their risks and benefits. Collection of data directly from patients through patient‐reported outcome instruments can improve the precision and reliability of adverse event detection, assess tolerability of adverse events, and provide an evaluation of health‐related quality of life (HRQOL) changes from immuno‐oncology therapies. There is robust development in HRQOL tools specifically for patients treated with immuno‐oncology agents. This review examines the history and basic concepts of HRQOL and patient‐reported outcome assessments commonly used in oncological trials, highlighting the strengths and weaknesses of current approaches when applied to immunotherapies, as well as some of the current efforts to develop tools for this field and opportunities for future research. Lay Summary Immuno‐oncology (IO) therapies are costly and carry potential toxicities known as immune‐related adverse events. Evaluation of health‐related quality of life (HRQOL) can impact the risk‐benefit assessment of IO therapies. Integration of HRQOL end points and patient‐reported outcome data for IO therapies are urgently needed. Ongoing robust development of patient‐reported outcome tools specific to IO therapies are currently underway and will permit the evaluation of HRQOL for IO agents. Improvement in precision and reliability of HRQOL evaluation will enhance the ultimate true value of these expensive and effective drugs.

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Development of a Functional Assessment of Chronic Illness Therapy item library and primary symptom list for the assessment of patient-reported adverse events associated with immune checkpoint modulators

Cited by 6 publications

References 57 publications

Use of a Cancer Registry to Evaluate Patient-Reported Outcomes of Immune Checkpoint Inhibitors

Use of a Cancer Registry to Evaluate Patient-Reported Outcomes of Immune Checkpoint Inhibitors

Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immunotherapy for the treatment of lung cancer and mesothelioma

Health‐related quality‐of‐life assessment of patients with solid tumors on immuno‐oncology therapies

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