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Patient reported outcomes and patient experiences of immune checkpoint modulators for advanced or recurrent melanoma: a mixed methods study

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Abstract

Purpose

Little is known about late and long-term patient-reported outcomes (PROs) of immune checkpoint modulators (ICMs) outside clinical trials. We conducted a cross-sectional, mixed-methods study to describe long-term PROs among advanced melanoma patients who began standard of care treatment with ICMs at least 1 year previously.

Methods

All participants completed the Functional Assessment of Cancer Therapy—Immune Checkpoint Modulator (FACT-ICM), assessing 46 immune-related side effects on a 5-point Likert scale, and a subset completed individual interviews. Descriptive statistics were computed for quantitative data and applied thematic analysis was used to examine qualitative data.

Results

Participants (N = 80) had a mean age of 67 years, and the majority were male (66%), non-Hispanic White (96%), and college graduates (61%). Single-agent nivolumab was the most common first (47%) and current/recent ICM (64%). On the FACT-ICM, 98% of participants reported at least one side effect, and 78% reported moderate or severe side effects. The most common moderate or severe side effects were aching joints (43%) and fatigue (38%). In interviews (n = 20), we identified five themes regarding patients’ longer-term experiences after ICMs: lasting fatigue or decline in functioning, minimal side effects, manageable thyroid and pituitary dysfunction, skin conditions can be difficult to manage, and treating the cancer is worth the side effects.

Conclusions

Nearly all patients reported side effects of ICMs at least 1 year after starting treatment. Our findings suggest that ICM side effect screening and management—especially for aching joints and fatigue—are indicated during long-term care of people living with advanced melanoma.

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Data availability

The datasets generated and analyzed during the current study are available from the corresponding author on reasonable request.

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Acknowledgements

We would like to express gratitude to the people who shared their personal experiences with melanoma and immunotherapy.

Funding

This work was supported by the National Cancer Institute (K99CA270294), the H. Lee Moffitt Cancer Center Office of Community Outreach, Engagement, and Equity, and the Participant Research, Interventions, and Measurements Core Facility at the H. Lee Moffitt Cancer Center & Research Institute, an NCI designated Comprehensive Cancer Center, grant number P30CA076292.

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Authors and Affiliations

  1. Moffitt Cancer Center, 12902 USF Magnolia Drive, Tampa, FL, 33612, USA

    Danielle B. Tometich, Carley Geiss, Melinda L. Maconi, Melody Chavez, Aasha I. Hoogland, Xiaoyin Li, Amarilis Nieves-Lopez, Yvelise Rodriguez, Crystal Bryant, Andrew S. Brohl, Zeynep Eroglu, Joseph Markowitz, Ahmad A. Tarhini, Patrick Hwu, Nikhil I. Khushalani & Heather S. L. Jim

  2. University of South Florida, 12901 Bruce B Downs Blvd, Tampa, FL, 33612, USA

    Danielle B. Tometich

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  1. Danielle B. Tometich
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Contributions

Conceptualization – D.B.T., H.S.L.J; Methodology – D.B.T, C.G., M.L.M, M.C., A.I.H, X.L., H.S.L.J; Software – D.B.T., C.G., M.L.M., M.C., H.J.F.; Validation – D.B.T., C.G., M.L.M., M.C., X.L.; Formal analysis – D.B.T., C.G., M.L.M., M.C., X.L.; Investigation –A.N.-L., Y.R., C.B.; Resources – D.B.T., A.S.B., Z.E., J.M, A.A.T., P.H, N.I.K., H.S.L.J; Data curation – D.B.T., C.G., M.L.M., M.C., X.L.; Writing—original draft preparation – D.B.T., H.S.L.J.; Writing—review and editing – all authors; Visualization, D.B.T., H.S.L.J.; Supervision –H.S.L.J; Project administration, D.B.T., A.N.-L., Y.R., C.B.; Funding acquisition, D.B.T., H.S.L.J. All authors have read and agreed to the published version of the manuscript.

Corresponding author

Correspondence to Danielle B. Tometich.

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Disclaimer

The views expressed in this article are the authors’ own and do not necessarily represent the official positions of the National Cancer Institute or Moffitt Cancer Center. The funders had no role in the design of the study, collection, analyses, or interpretation of data, writing of the manuscript, or in the decision to publish the results.

Ethical approval and human subjects

This study was performed in line with the principles of the Declaration of Helsinki and US Federal Policy for the Protection of Human Subjects. Approval was granted by the Advarra Institutional Review Board (January 19, 2021/Pro00049107).

Consent to participate

Informed consent was obtained from all individual participants included in the study. The authors affirm that human research participants provided informed consent for publication of their quotations.

Competing interests

ASB reports membership on the advisory boards of Dicephera and Bayer outside the submitted work.

JM reports funding from Merck and Morphogenesis Inc to Moffitt Cancer Center unrelated to this study.

AAT reports contracted research grants with institution from Bristol Myers Squib, Novartis, Scholar Rock, Genentech-Roche, Regeneron, Sanofi-Genzyme, Nektar, Clinigen, Merck, Acrotech, Pfizer, Checkmate, OncoSec; personal consultant/advisory board fees from Bristol Myers Squibb, Merck, Easai, Instil Bio, Clinigen, Regeneron, Sanofi-Genzyme, Partner Therapeutics, Genentech/Roche, BioNTech, Concert AI, AstraZeneca, Pfizer outside the submitted work.

NIK reports consulting fees from BMS, Merck, Jounce, Novartis, Regeneron, Genzyme, Iovance, Castle Biosciences, Nektar, Replimmune, and Instil Bio; research funding (to institute) from BMS, Merck, Celgene, Novartis, GSK, HUYA, Regeneron, Replimmune, Modulation Therapeutics; participation on a data safety monitoring board with Incyte, AstraZeneca; participation in a study steering committee with BMS, Nektar, Regerenon, Replimmune; and ownership of common stock in Bellicum, Amarin, and Asensus Surgical.

HSLJ reports consulting fees from SBR Bioscience and grant funding from Kite Pharma outside the submitted work.

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Tometich, D.B., Geiss, C., Maconi, M.L. et al. Patient reported outcomes and patient experiences of immune checkpoint modulators for advanced or recurrent melanoma: a mixed methods study. Support Care Cancer 32, 330 (2024). https://doi.org/10.1007/s00520-024-08538-8

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