Development of the functional assessment of cancer therapy-immune checkpoint modulator (FACT-ICM): A scale to measure quality of life in cancer patients treated with ICMs

Hansen, Aaron Richard; Ala‐Leppilampi, Kari; McKillop, Chris; Siu, Lillian L.; Bédard, Philippe L.; Razak, Albiruni R. Abdul; Spreafico, Anna; Sridhar, Srikala S.; Leighl, Natasha B.; Butler, Margaret; Hogg, David; Sacher, Adrian G.; Oza, A.M.; Nisenbaum, Rosane; Webster, Kimberly; Cella, David; Parsons, Janet

doi:10.1093/annonc/mdz253.101

Cited by 4 publications

(15 citation statements)

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“…Currently, there is no widely adopted, validated instrument that has been tailored for this patient population, although a tool to measure HRQOL has been developed in patients receiving ICMs 50 . This crucial unmet need was exemplified by the phase 3 randomized trial, Checkmate 141, which compared nivolumab against investigator's choice chemotherapy in platinum refractory recurrent metastatic head and neck squamous cell carcinoma 36 .…”

Section: Use Of Pro and Hrqol Tools In Io Clinical Trialsmentioning

confidence: 99%

“…To develop and validate an IO‐specific HRQOL instrument, a traditional HRQOL development methodology has been used in the FACT‐ ICM study 50 . The development methodology of FACT‐ICM replicated the successful formulation of FACT‐AntiA, which has been validated for use in patients taking antiangiogenesis agents.…”

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

confidence: 99%

“…The final list was the first HRQOL‐focused toxicity subscale for patients treated with ICMs. It was developed in accordance with US Food and Drug Administration (FDA) guidelines, which prioritize patient input in developing PRO tools 50 . The toxicity subscale is to be combined with the FACT‐G to form the FACT‐ICM tool to measure HRQOL in patients treated with ICMs.…”

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%

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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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Section: Use Of Pro and Hrqol Tools In Io Clinical Trialsmentioning

confidence: 99%

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

confidence: 99%

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

confidence: 99%

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

confidence: 99%

See 2 more Smart Citations

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

Voon

Cella

Hansen

2021

Cancer

View full text Add to dashboard Cite

show abstract

“…To date, general HRQOL tools such as EORTC QLQC30 and the FACT‐General (FACT‐G) are used in clinical trials of IO agents to measure HRQOL. The first tool developed specifically to measure HRQOL in patients treated with IO agents is the FACT‐ICM 162 . This instrument was developed in accordance with the FDA guidelines and is undergoing validity testing in longitudinal clinical trials.…”

Section: Novel Ici Approaches To Precision Oncologymentioning

confidence: 99%

Novel strategies in immune checkpoint inhibitor drug development: How far are we from the paradigm shift?

Watson

Doi

Hansen

et al. 2020

Brit J Clinical Pharma

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The development of immune checkpoint inhibitors (ICI) represents a major milestone in immune‐oncology. Over the years these agents have demonstrated efficacy in an increasing array of malignancies. Despite this success however, significant challenges remain. Novel approaches to both drug development and trial design are required to incorporate the unique pharmacokinetic and pharmacodynamic properties of ICIs. Further, it has also been established that the benefit of ICIs is limited to only a subset of patients. The molecular interactions between native immune cells and tumorigenesis and progression represent an active area of biomarker research, and elucidating the mechanisms of response and resistance is crucial to develop rational trial designs for the next wave of immune‐oncology (IO) clinical trials, particularly in patients with primary and/or acquired resistance. Efforts are now being made to integrate both biological and clinical information using novel multi‐omic approaches which are now being developed to further elucidate the molecular signatures associated with IO treatment response and resistance and enable rational drug development and trial design processes. As such, precision IO and the ability to deliver patient‐specific choices for ICI monotherapies or combination therapies has become an increasingly tangible goal. We herein describe the current landscape in ICI drug development and discuss the challenges and future directions in this exciting and evolving era in immune‐oncology.

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Cancer patients’ experiences with immune checkpoint modulators: A qualitative study

Ala‐Leppilampi

Baker

McKillop³

et al. 2020

Cancer Medicine

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Background: Minimal qualitative data exist on the experiences of cancer patients treated with immune checkpoint inhibitors or costimulatory antibodies.Understanding the day to day experiences of patients being treated with immune checkpoint modulators, and how these relate to their health-related quality of life, can inform future research and lead to better clinical decision-making and care. We report here the first in depth qualitative study to consider patients' diverse and complex experiences with immune checkpoint modulators, with a focus on side effects and how these impact daily life. Methods: This single-center qualitative study was based on focus groups and semistructured interviews. Patients who were being treated or who had been treated with immune checkpoint modulators within the last year for a range of cancer diagnoses were recruited. Interpretive description informed our inductive, iterative approach to analysis. Results: Eight themes were identified, characterizing the complexity of these patients' lived experiences: major categories of side effects experienced and how they impacted patient well-being; the heterogeneous nature of side effects experienced; living with uncertainty; reframing the meaning and severity of SEs; focus on survival, hope, and being positive; acceptance and adaptation; feeling supported; and faith in medical innovation. Throughout their accounts, participants highlighted the profound impact that immune checkpoint modulators had on their daily lives. Conclusion: This is the first in-depth qualitative study into patient accounts of their experiences of treatment with immune checkpoint modulators, related side effects, and how it impacted their daily lives. This research is an integral initial step in developing an instrument that will assess treatment-related side effects in patients treated with this form of therapy. |ALA-LEPPILAMPI Et AL. K E Y W O R D Scostimulatory antibodies, Health-related quality of life, immune checkpoint inhibitors, immunotherapy, patient experiences

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Development of the functional assessment of cancer therapy-immune checkpoint modulator (FACT-ICM): A scale to measure quality of life in cancer patients treated with ICMs

Cited by 4 publications

References 0 publications

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

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

Novel strategies in immune checkpoint inhibitor drug development: How far are we from the paradigm shift?

Cancer patients’ experiences with immune checkpoint modulators: A qualitative study

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