The Germelatox Decog-Trial German Melanoma Patients And Their Attitude Toward Toxicity During Adjuvant Interferon Treatment

TPS9113^ Background: Although trials of adjuvant interferon alfa-2b (IFN alpha-2b) in high-risk melanoma patients suggest improvement in disease-free survival (DFS), a metaanalysis could only show a marginal OS survival benefit (OS). Widespread use of adjuvant IFN alpha-2b has been decreased by its significant toxicity.In 2001 Kilbridge et al. (J Clin Oncol 2001) asked US-patients about the degree of improvement in 5-year DFS they would expect to tolerate IFN. At least half of the patients were willing to tolerate mild to moderate and severe IFNa-2b toxicity for 4% and 10% improvements of DFS. On average, patients rated quality of life (QoL) with melanoma recurrence much lower than even severe IFNa-2b toxicity.To date, no data exist on willingness of German melanoma patients to be treated with IFNa-2b. In Germany, melanoma patients are managed by specialized skin cancer units mainly located in certified skin cancer centers and core university hospitals. The willingness of dermatologists to use IFN depends strongly on their experience and capacity to manage IFN-related side effects.A comparison between a German cohort and the US-cohort of Kilbridge would allow new insights into country specific treatment differences. So far no direct comparison has been made between willingness of patients compared to their physicians. Methods: In this multicenter non-interventional trial (“GERMELATOX trial”) of the Dermatologic Cooperative Oncology Group we assessed preferences and utilities for health outcomes associated with adjuvant IFN among 200 melanoma patients not eligible for IFN due to the low-risk features of their melanoma and 100 dermatooncologists from 10 different melanoma units using the standard gamble technique supported by the willingness to pay mode. The trial described four typical IFN alpha-2b toxicity scenarios and the following three posttreatment outcomes: disease-free health and melanoma recurrence (with or without IFN alpha-2b) leading to cancer death. We also asked patients the improvement in 5-year disease-free survival they would require to tolerate IFN toxicities.The recruitment of the study will be completed in mid 2014.