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Accepted for/Published in: JMIR Formative Research

Date Submitted: Jan 20, 2020
Date Accepted: Sep 22, 2020

The final, peer-reviewed published version of this preprint can be found here:

Follow-Up of Cancer Patients Receiving Anti-PD-(L)1 Therapy Using an Electronic Patient-Reported Outcomes Tool (KISS): Prospective Feasibility Cohort Study

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

PMID: 33112242

PMCID: 7657724

Follow-up of Cancer Patients Receiving Anti-PD-(L)1 Therapy by Electronic Patient Reported Outcomes-tool (KISS): a pilot feasibility study

  • Sanna Iivanainen; 
  • Tuomo Alanko; 
  • Pia Vihinen; 
  • Teemu Konkola; 
  • Jussi Ekstrom; 
  • Henri Virtanen; 
  • Jussi Koivunen

ABSTRACT

Background:

Immune checkpoint inhibitors (ICIs) have become standard of care in 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 QoL 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:

Prospective one-arm multi-institutional study recruited adult cancer patients whose advanced cancer was treated with PD-(L)1 agents in outpatient settings. 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 NCI-CTCAE, and an urgency algorithm sending alerts to care team. Patient experience survey was conducted monthly.

Results:

37 patients (lung cancer, n=15; melanoma, n=9; genito-urinary cancer, n=9; head and neck cancer, n=4) filled altogether 889 symptom questionnaires. Patients showed good adherence to ePRO follow-up. The most common gr1-2 symptoms were fatigue (39%) and cough (21%) whereas the most common gr3-4 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, and progressive disease and chest pain.

Conclusions:

According to 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. Clinical Trial: Clinical Trials Register, (NCT3928938)


 Citation

Please cite as:

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

PMID: 33112242

PMCID: 7657724

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