title: Preferences of German melanoma patients for interferon (IFN) α-2b toxicities (the DeCOG "GERMELATOX survey") versus melanoma recurrence to quantify patients' relative values for adjuvant therapy.
abstract: Currently interferon alfa-2b (IFNα-2b) is an approved adjuvant drug for high-risk melanoma patients that leads to an improvement in disease-free survival (DFS). However, it is unclear whether it also impacts overall survival. Widespread use of adjuvant high-dose IFNα has been tempered by its significant toxicity and its limited efficacy. Current therapeutic strategies like immune checkpoint blockade or targeted therapy may also be useful in the adjuvant setting. Therefore, it is important to weigh the trade-offs between possible side effects and therapeutic benefit.We assessed patient utilities for health states associated with IFN therapy. Utilities are measures of preference for a specific health state on a scale of 0 (death) to 1 (perfect health).Utilities were determined for health states associated with adjuvant IFN among 130 German low-risk melanoma patients using the standard gamble technique. Four IFNα-2b toxicity scenarios and the following 3 posttreatment outcomes were assessed: disease-free health and melanoma recurrence (with or without previous use of IFNα-2b) resulting in cancer death. Patients were asked to trade-off the improvement in 5-year DFS and the IFN-related side effects.Utilities for melanoma recurrence (mean 0.60) were significantly lower than for all IFNα-2b toxicity scenarios (mean 0.81-0.90). Patients were willing to tolerate mild-to-moderate and severe toxicity for a 50% and 75% chance of 5-year DFS, respectively. Both utilities and threshold benefits were mostly independent from patient characteristics like gender, income, and social situation. Significant impact was only observed by age and previous personal experience with cancer.On average, German patients were willing to trade even severe IFNα-2b toxicity for reducing the rate of melanoma recurrence. This result points out the importance of a relapse-free survival for melanoma patients. The utilities measured in our study can be applied to decision-making processes in clinical trials of new adjuvant drugs.
authors.affiliation: Department of Dermatology, University Hospital Schleswig-Holstein (UKSH), Campus Kiel, Kiel Institute for Health Services Research in Dermatology and Nursing (IVDP), University Medical Center Hamburg, Hamburg Department of Dermatology, Eberhard-Karls University of Tuebingen, Tuebingen Skin Cancer Center Hannover, Hannover University of Hamburg, Hamburg Department of Dermatology, University Hospital Erlangen, Erlangen TABEA Clinic, Hamburg Department of Dermatology, University Hospital Essen, Essen Department of Dermatology, University of Mainz, Mainz MSD Sharp & Dohme GmbH, Munich Department of Dermatology, University Hospital (UKSH), Campus Lübeck, Luebeck Skin Cancer Unit, German Cancer Research Center (DKFZ) Department of Dermatology, Venereology and Allergology, University Medical Center Mannheim, Ruprecht-Karl University of Heidelberg, Heidelberg, Germany.
authors.forename: Katharina C
authors.initials: KC
authors.lastname: Kaehler
authors.forename: Christine
authors.initials: C
authors.lastname: Blome
authors.forename: Andrea
authors.initials: A
authors.lastname: Forschner
authors.forename: Ralf
authors.initials: R
authors.lastname: Gutzmer
authors.forename: Thomas
authors.initials: T
authors.lastname: Haalck
authors.forename: Lucie
authors.initials: L
authors.lastname: Heinzerling
authors.forename: Thomas
authors.initials: T
authors.lastname: Kornek
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Livingstone
authors.forename: Carmen
authors.initials: C
authors.lastname: Loquai
authors.forename: Lara Valeska
authors.initials: LV
authors.lastname: Maul
authors.forename: Berenice M
authors.initials: BM
authors.lastname: Lang
authors.forename: Dirk
authors.initials: D
authors.lastname: Schadendorf
authors.forename: Barbara
authors.initials: B
authors.lastname: Stade
authors.forename: Patrick
authors.initials: P
authors.lastname: Terheyden
authors.forename: Jochen
authors.initials: J
authors.lastname: Utikal
authors.forename: Tobias
authors.initials: T
authors.lastname: Wagner
authors.forename: Axel
authors.initials: A
authors.lastname: Hauschild
authors.forename: Claus
authors.initials: C
authors.lastname: Garbe
authors.forename: Matthias
authors.initials: M
authors.lastname: Augustin
mesh_terms: D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects; D017024:Chemotherapy, Adjuvant / Q000379:methods / Q000523:psychology; D004305:Dose-Response Relationship, Drug; D064420:Drug-Related Side Effects and Adverse Reactions / Q000209:etiology / Q000503:physiopathology / Q000523:psychology; D005260:Female; D005858:Germany / Q000453:epidemiology; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage / Q000009:adverse effects; D008297:Male; D008545:Melanoma / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000523:psychology; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000517:prevention & control*; D010043:Outcome and Process Assessment, Health Care; D057240:Patient Preference / Q000523:psychology / Q000706:statistics & numerical data; D060735:Pharmacovigilance; D011788:Quality of Life; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects; D012720:Severity of Illness Index
chemical_list: D000970:Antineoplastic Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins