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

TY - JOUR

T1 - 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

AU - Kaehler, Katharina C

AU - Blome, Christine

AU - Forschner, Andrea

AU - Gutzmer, Ralf

AU - Haalck, Thomas

AU - Heinzerling, Lucie

AU - Kornek, Thomas

AU - Livingstone, Elisabeth

AU - Loquai, Carmen

AU - Maul, Lara Valeska

AU - Lang, Berenice M

AU - Schadendorf, Dirk

AU - Stade, Barbara

AU - Terheyden, Patrick

AU - Utikal, Jochen

AU - Wagner, Tobias

AU - Hauschild, Axel

AU - Garbe, Claus

AU - Augustin, Matthias

PY - 2016/11

Y1 - 2016/11

N2 - 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.

AB - 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.

KW - Antineoplastic Agents

KW - Chemotherapy, Adjuvant

KW - Dose-Response Relationship, Drug

KW - Drug-Related Side Effects and Adverse Reactions

KW - Female

KW - Germany

KW - Humans

KW - Interferon-alpha

KW - Male

KW - Melanoma

KW - Middle Aged

KW - Neoplasm Recurrence, Local

KW - Outcome and Process Assessment (Health Care)

KW - Patient Preference

KW - Pharmacovigilance

KW - Quality of Life

KW - Recombinant Proteins

KW - Severity of Illness Index

KW - Journal Article

KW - Observational Study

U2 - 10.1097/MD.0000000000005375

DO - 10.1097/MD.0000000000005375

M3 - SCORING: Journal article

C2 - 27861370

VL - 95

SP - e5375

JO - MEDICINE

JF - MEDICINE

SN - 0025-7974

IS - 46

ER -