COMBI-EU: Real-World Evidence on Adverse Event Management and Time on Therapy with Adjuvant Dabrafenib Plus Trametinib in Patients with BRAF V600-Mutant Melanoma.
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Weichenthal Michael, Debus Dirk, Zimmer Lisa, Wasielewski Imke von, Meier Friedegund, Tüting Thomas, Heppt Markus V, Hassel Jessica C, Ziller Fabian, Mohr Peter, Dücker Pia, Sindrilaru Anca, Dippel Edgar, Heinzerling Lucie, Bender Marc, Aoun Manar, Walecki Magdalena, Herbst Rudolf, Angela Yenny, Stadler Rudolf, Haferkampf Sebastian, Klemke Claus-Detlev, Kaune Kjell Matthias, Wohlrab Johannes, Leiter Ulrike, Rached Nessr Abu, Utikal Jochen, Schley Gaston, Ulrich Jens, Schultz Erwin, Gebhardt Christoffer, Terheyden Patrick, Gutzmer Ralf, Schadendorf Dirk
Аннотация
METHODS: Adults with complete surgical resection of stage III BRAF V600-mutant cutaneous melanoma were included. The primary endpoint was median time on treatment (TOT). Adverse event (AE) management was classified as either a high or low level of management. The rating of AE management based on a self-developed algorithm and rules from COMBI-APlus was used to analyze the impact of AE management on TOT. App-based documentation of medication intake and patient-reported outcomes (CANKADO PRO-React; version 6.0, 06.03.2019) was offered.
RESULTS: For 225 patients, the median TOT was 11.8 months (95% confidence interval [CI]: 11.7, 12.0). Treatment was completed by 138 patients (61.3%); 37 (16.4%) discontinued due to treatment-related AEs (TRAEs). TRAEs (≥1) were experienced by 181 patients (80.4%); the most common was pyrexia (38.2%). High-level AE management showed a trend toward improved treatment adherence (high versus low level: hazard ratio [HR]: 0.74; 95% CI: 0.49, 1.14); this improvement was significant with pyrexia management (HR: 0.52; 95% CI: 0.29, 0.93). Seventy-nine (35%) and 33 patients (15%) intended to use and eventually used the app, respectively. A similar proportion of patients remained on treatment for 12 months irrespective of app usage (use, 39.4% vs. non-use, 36.5%).
CONCLUSIONS: High-level TRAE management showed a trend toward improved treatment adherence, which was statistically significant for pyrexia. Optional use of an app did not influence treatment adherence.