ePROs in the follow-up of cancer patients treated with immune checkpoint inhibitors: a retrospective study

Iivanainen, Sanna; Alanko, Tuomo; Peltola, Katriina; Konkola, Teemu; Ekström, Jussi; Virtanen, Henri; Koivunen, Jussi

doi:10.1007/s00432-018-02835-6

Cited by 43 publications

(40 citation statements)

References 48 publications

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“…While time to deterioration was defined as the time from randomization until confirmed clinically meaningful deterioration (i.e., a ≥10-point score change from baseline) [2], in our study, a grade 3 or worse symptom automated a trigger for alerts. In most questionnaires and PRO settings, missing data remain a concern, but backup data collection strategies can bring self-report compliance rates up to about 85% in unselected routine care patients with advanced cancers [4, 9].…”

Section: Resultsmentioning

confidence: 99%

Consilium Smartphone App for Real-World Electronically Captured Patient-Reported Outcome Monitoring in Cancer Patients Undergoing anti-PD-L1-Directed Treatment

Trojan

Huber²,

Brauchbar³

et al. 2020

Case Rep Oncol

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Digital patient monitoring gains importance for quality of clinical cancer care. Our case report provides insight into usability and acceptance of a smartphone app for monitoring of electronically captured patient-reported outcomes in patients undergoing immunotherapy. During 3 months, 6 patients with advanced or metastatic PD-L1-positive cancer of the lung, prostate, and bladder who underwent checkpoint immunotherapy were using the Consilium app for standardized and structured electronic reporting of symptoms and therapy side effects. We evaluated the number and quality of symptom entries as well as usability and safety of shared reporting between the patient and the treating physician. Duration of anti-PD-L1-directed immunotherapy in the 6 patients ranged from 4 to 10 months and comprised a total of 21 anti-PD-L1-directed immunotherapy cycles. Patients reported between 4 and 16 different symptoms, of which the most frequent (57%) were dry cough, fatigue, shortness of breath, fever, and appetite loss. Overall, 1,279 symptom entries were counted, corresponding to 2.4 symptom entries per patient per day. Symptom severity grading ranged from 0.1 (very slight symptoms) to 7.8 (severe symptoms), which triggered prespecified alerts in 4 of the 6 patients. No unplanned visits were noted, and no safety issues occurred. Satisfaction with the app usability was high, as was the beneficial effect on consultation. Usability and reviewed data entries indicate high shared reporting efforts of patients and treating physicians and overall satisfaction with electronically reported patient outcomes.

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Section: Resultsmentioning

confidence: 99%

Consilium Smartphone App for Real-World Electronically Captured Patient-Reported Outcome Monitoring in Cancer Patients Undergoing anti-PD-L1-Directed Treatment

Trojan

Huber²,

Brauchbar³

et al. 2020

Case Rep Oncol

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“…Nevertheless, there are notable omissions in the current literature. First, there are few published studies of PROs in patients treated with ICIs outside the context of a clinical trial [ 15 , 16 , 17 , 18 , 19 ]. This real-world evidence is important because patients treated on a clinical trial tend to be younger, healthier, and have higher socioeconomic status than those treated in the community setting [ 20 , 21 ].…”

Section: Introductionmentioning

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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“…The approach used herein is consistent with the guidance of the US Food and Drug Administration regarding the development of PROs, which emphasizes meaningful patient input from the outset, rather than after‐the‐fact endorsement . An electronic PRO immuno‐oncology module recently was developed consisting of 19 irAEs, which were selected based on information from clinical trial reports and drug labels, with no evaluation of their impact on HRQOL. Furthermore, this PRO immuno‐oncology module did not adhere to US Food and Drug Administration guidelines that recommend meaningful patient input for the development of any PRO measure.…”

Section: Discussionmentioning

confidence: 99%

Development of the Functional Assessment of Cancer Therapy–Immune Checkpoint Modulator (FACT‐ICM): A toxicity subscale to measure quality of life in patients with cancer who are treated with ICMs

Hansen

Ala‐Leppilampi

McKillop³

et al. 2020

Cancer

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Background Patients with cancer who are treated with immune checkpoint modulators (ICMs) have their health‐related quality of life (HRQOL) measured using general patient‐reported outcome (PRO) tools. To the authors' knowledge, no instrument has been developed to date specifically for patients treated with ICMs. The objective of the current study was to develop a toxicity subscale PRO instrument for patients treated with ICMs to assess HRQOL. Methods Input was collected from a systematic review as well as patients and physicians experienced with ICM treatment. Descriptive thematic analysis was used to evaluate the qualitative data obtained from patient focus groups and interviews, which informed an initial list of items that described ICM side effects and their impact on HRQOL. These inputs informed item generation and/or reduction to develop a toxicity subscale. Results Focus groups and individual interviews with 37 ICM‐treated patients generated an initial list of 176 items. After a first round of item reduction that produced a shortened list of 76 items, 16 physicians who care for patients who are treated with ICMs were surveyed with a list of 49 patient‐reported side effects and 11 physicians participated in follow‐up interviews. A second round of item reduction was informed by the physician responses to produce a list of 25 items. Conclusions To the authors' knowledge, this 25‐item list is the first HRQOL‐focused toxicity subscale for patients treated with ICMs and was developed in accordance with US Food and Drug Administration guidelines, which prioritize patient input in developing PRO tools. The subscale will be combined with the Functional Assessment of Cancer Therapy–General (FACT‐G) to form the FACT‐ICM. Prior to recommending the formal use of this PRO instrument, the authors will evaluate its validity and reliability in longitudinal studies involving substantially more patients.

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ePROs in the follow-up of cancer patients treated with immune checkpoint inhibitors: a retrospective study

Cited by 43 publications

References 48 publications

Consilium Smartphone App for Real-World Electronically Captured Patient-Reported Outcome Monitoring in Cancer Patients Undergoing anti-PD-L1-Directed Treatment

Consilium Smartphone App for Real-World Electronically Captured Patient-Reported Outcome Monitoring in Cancer Patients Undergoing anti-PD-L1-Directed Treatment

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

Development of the Functional Assessment of Cancer Therapy–Immune Checkpoint Modulator (FACT‐ICM): A toxicity subscale to measure quality of life in patients with cancer who are treated with ICMs

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