University of Oulu

Iivanainen S, Alanko T, Vihinen P, Konkola T, Ekstrom J, Virtanen H, Koivunen J. Follow-Up of Cancer Patients Receiving Anti-PD-(L)1 Therapy Using an Electronic Patient-Reported Outcomes Tool (KISS): Prospective Feasibility Cohort Study, JMIR Form Res 2020;4(10):e17898, doi: 10.2196/17898

Follow-up of cancer patients receiving anti-PD-(L)1 therapy using an electronic patient-reported outcomes tool (KISS) : prospective feasibility cohort study

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Author: Iivanainen, Sanna1; Alanko, Tuomo2; Vihinen, Pia3;
Organizations: 1Department of Oncology and Radiotherapy, Oulu University Hospital, Oulu, Finland
2Docrates Cancer Center, Helsinki, Finland
3Development Unit, Hospital District of South-West Finland, Turku, Finland
4Kaiku Health Oy, Helsinki, Finland
Format: article
Version: published version
Access: open
Online Access: PDF Full Text (PDF, 0.9 MB)
Persistent link: http://urn.fi/urn:nbn:fi-fe202102104380
Language: English
Published: JMIR Publications, 2020
Publish Date: 2021-02-10
Description:

Abstract

Background: Immune checkpoint inhibitors (ICIs) have become a standard of care for various tumor types. Their unique spectrum of side effects demands continuous and long-lasting assessment of symptoms. Electronic patient-reported outcome (ePRO) follow-up has been shown to improve survival and quality of life of cancer patients treated with chemotherapy.

Objective: This study aimed to investigate whether ePRO follow-up of cancer patients treated with ICIs is feasible. The study analyzed (1) the variety of patient reported symptoms, (2) etiology of alerts, (3) symptom correlations, and (4) patient compliance.

Methods: In this prospective, one-arm, multi-institutional study, we recruited adult cancer patients whose advanced cancer was treated with anti-programmed cell death protein 1 (PD)- ligand (L)1 agents in outpatient settings. The ePRO tool consisted of a weekly questionnaire evaluating the presence of typical side effects, with an algorithm assessing the severity of the symptom according to National Cancer Institute Common Terminology Criteria for Adverse Events and an urgency algorithm sending alerts to the care team. A patient experience survey was conducted monthly. The patients were followed up to 6 months or until disease progression.

Results: A total of 889 symptom questionnaires was completed by 37 patients (lung cancer, n=15; melanoma, n=9; genitourinary cancer, n=9; head and neck cancer, n=4). Patients showed good adherence to ePRO follow-up. The most common grade 1 symptoms were fatigue (28%) and itching (13%), grade 2 symptoms were loss of appetite (12%) and nausea (12%), and grade 3-4 symptoms were cough (6%) and loss of appetite (4%). The most common reasons for alerts were loss of appetite and shortness of breath. In the treatment benefit analysis, positive correlations were seen between clinical benefit and itching as well as progressive disease and chest pain.

Conclusions: According to the results, ePRO follow-up of cancer patients receiving ICIs is feasible. ePROs capture a wide range of symptoms. Some symptoms correlate to treatment benefit, suggesting that individual prediction models could be generated.

Trial Registration: Clinical Trials Register, NCT3928938; https://clinicaltrials.gov/ct2/show/NCT03928938

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Series: Journal of medical internet research
ISSN: 1439-4456
ISSN-E: 1438-8871
ISSN-L: 1439-4456
Volume: 22
Issue: 10
Article number: e17898
DOI: 10.2196/17898
OADOI: https://oadoi.org/10.2196/17898
Type of Publication: A1 Journal article – refereed
Field of Science: 3122 Cancers
Subjects:
Funding: The study was funded by Oulu University and Finnish Cancer Society. Kaiku Health employees were involved in the data acquisition and analysis.
Copyright information: © Sanna Iivanainen, Tuomo Alanko, Pia Vihinen, Teemu Konkola, Jussi Ekstrom, Henri Virtanen, Jussi Koivunen. Originally published in JMIR Formative Research (http://formative.jmir.org), 28.10.2020. This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Formative Research, is properly cited. The complete bibliographic information, a link to the original publication on http://formative.jmir.org, as well as this copyright and license information must be included.
  https://creativecommons.org/licenses/by/4.0/