Understanding quality of life issues in patients with advanced melanoma: Phase 1 and 2 in the development of the EORTC advanced melanoma module.

Aims: We aimed to develop a European Organization for Research and Treatment of Cancer (EORTC) Quality of Life (QoL) module tailored for patients with advanced (resectable or unresectable stage III/IV) melanoma receiving immune checkpoint inhibitors or targeted therapy.
Methods: Following the EORTC QoL Group module development guidelines, we conducted phases 1 and 2 of the development process. In phase 1, we generated a list of health-related (HR)QoL issues through a systematic literature review and semi-structured interviews with healthcare professionals (HCPs) and patients with advanced melanoma. In phase 2, these issues were converted into questionnaire items to create the preliminary module.
Results: Phase 1: we retrieved 8006 articles for the literature review, of which 35 were deemed relevant, resulting in 84 HRQoL issues being extracted to create the initial issue list. Semi-structured interviews with 18 HCPs and 28 patients with advanced melanoma resulted in 28 issues being added to the initial issue list. Following EORTC module development criteria, 26 issues were removed, and two issues were added after review by patient advocates. Phase 2: To ensure uniformity and avoid duplication, 16 issues were consolidated into eight items. Additionally, an independent expert contributed one new item, resulting in a preliminary module comprising 80 HRQoL items.
Conclusion: We identified a range of HRQoL issues (dry skin, xerostomia, and arthralgia) relevant to patients with stage III/IV melanoma. Future module development phases will refine the questionnaire. Once completed, this module will enable standardized assessment of HRQoL in patients with (locally) advanced melanoma.
Competing Interests: Declaration of Competing Interest The authors disclose the following potential conflicts of interest: HE: Member of advisory board for Amgen, Pierre Fabre Nordic, BMS, Merck, and Novartis. Research grants received from SkyLine Dx. LN: received institutional research grants from Merck and Syndax Pharmaceuticals; speaker honoraria from BMS, Johnson&Johnson, MSD, and Novartis; has served on advisory boards for BMS, MSD, Novartis, Pierre Fabre, Sanofi Genzyme, and Zealth; and is a shareholder in SATMEG Ventures AB. ROB: received institutional research grants from BMS, Endomagnetics Ltd (Endomag), and SkyLineDx; speaker honorarium from Roche, Pfizer, and Pierre-Fabre; has served on advisory boards for Amgen, BMS, MSD, BD/BARD, Novartis, Roche, and Sanofi Genzyme; and is a shareholder in SATMEG Ventures. AR: Received consultancy fees from Bristol Myers Squibb, Janssen Pharmaceuticals, and Merck Sharp & Dohme. RS: Received honoraria for advisory board participation from MSD, Novartis and Qbiotics and speaking honoraria from BMS. AvA: Advisory Board / Consultancy Honoraria received from Amgen, Bristol-Myers Squibb, Novartis, MSD-Merck, Merck-Pfizer, Pierre Fabre, Provectus, Sanofi, Sirius Medical, 4SC, Neracare. Research Grants received from Amgen, Merck-Pfizer. All other authors (ME, MvL, JLK, IB, SE, LF, MvH, MJ, JL, ALB, OM, SS, LI, JT, HS, NV, LvdP) declare no competing interests.
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