Research
Print page Print page
Switch language
Rigshospitalet - a part of Copenhagen University Hospital
Published

The use of patient-reported outcomes to detect adverse events in metastatic melanoma patients receiving immunotherapy: a randomized controlled pilot trial

Research output: Contribution to journalJournal articleResearchpeer-review

  1. The long-term course of fatigue following breast cancer diagnosis

    Research output: Contribution to journalJournal articleResearchpeer-review

  2. Patient-reported outcomes item selection for bladder cancer patients in chemo- or immunotherapy

    Research output: Contribution to journalJournal articleResearchpeer-review

  3. Selection of patient reported outcomes questions reflecting symptoms for patients with metastatic melanoma receiving immunotherapy

    Research output: Contribution to journalJournal articleResearchpeer-review

  1. Effect of Empagliflozin on Hemodynamics in Patients With Heart Failure and Reduced Ejection Fraction

    Research output: Contribution to journalJournal articleResearchpeer-review

  2. Optimal Systemic Treatment of Advanced Bladder Cancer-A Moving Target

    Research output: Contribution to journalJournal articleResearchpeer-review

  3. Sexual Health and Dysfunction in Patients With Rheumatoid Arthritis: A Cross-sectional Single-Center Study

    Research output: Contribution to journalJournal articleResearchpeer-review

View graph of relations

BACKGROUND: A randomized controlled pilot trial was conducted to assess if melanoma patients treated with immunotherapy had the number of grade 3 or 4 adverse events during treatment reduced by 50% using a tailored electronic patient-reported outcomes tool in addition to standard toxicity monitoring compared to standard monitoring alone. Secondary endpoints were: if more AEs were reported in the intervention group, if there was a difference between the two groups in the number of telephone consultations, extra out-patient visits, number of days in the hospital, days in steroid treatment and the time patients experienced grade 2 or higher toxicity.

PATIENTS AND METHODS: Melanoma patients receiving immunotherapy at the Department of Oncology, Odense University Hospital, Denmark participated. Standard care included assessment of AEs by a clinician before each treatment cycle using the Common Terminology Criteria for Adverse Events. In addition, patients randomized to the intervention reported their AEs weekly by an electronic PRO-tool based on the PRO-CTCAE platform.

RESULTS: One hundred forty-six melanoma patients were randomized. In this study, we did not detect a difference between the two groups in the number of grade 3 or 4 AEs (P = 0.983), in the overall number of AEs (P = 0.560) or in the time the patients in the two groups experienced grade 2 or higher toxicity (0.516). The number of phone contacts was significantly higher in the intervention group (P = 0.009) and there was a tendency towards patients in the intervention group having more extra visits (P = 0.156).

CONCLUSION: It has been examined if the number of severe AEs for melanoma patients receiving immunotherapy could be reduced by involving the patients in the reporting of symptoms. The results do not justify the expansion of the pilot study into a regular phase III study with this particular set-up. However, a significant difference in the number of phone contacts was found as patients in the intervention group called more frequently, indicating that their attention to AEs was increased. Even though the use of an electronic PRO tool could not reduce the number of severe AEs in this melanoma population, a positive impact on other endpoints such as QoL, communication, or treatment-planning, cannot be excluded.

TRIAL REGISTRATION: Clinicaltrials.gov NCT03073031 Registered 8 March 2017, Retrospectively registered.

Original languageEnglish
JournalJournal of Patient-Reported Outcomes
Volume4
Issue number1
Pages (from-to)88
ISSN2509-8020
DOIs
Publication statusPublished - 30 Oct 2020

ID: 61366450