Medizinische Universität Graz Austria/Österreich - Forschungsportal - Medical University of Graz
Gewählte Publikation:
Kainbacher, N.
Adjuvant Melanoma therapy with Nivolumab, Pembrolizumab, or Dabrafenib plus Trametinib – a real life study
Humanmedizin; [ Diplomarbeit ] Medizinische Universität Graz; 2022. pp. 79
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- Autor*innen der Med Uni Graz:
- Betreuer*innen:
- Rainer Barbara
- Richtig Erika
- Altmetrics:
- Abstract:
- Introduction With the use of immunotherapy and targeted therapy, a breakthrough in oncological medicine was achieved in the last few years. This study should now bring first results of efficacy and safety in real-life practice. Methods For this study, we retrospectively enrolled 51 stage III or IV melanoma patients after R0-resection, who received adjuvant treatment with PD-1-antibodies nivolumab or pembrolizumab or a combination of BRAF/MEK-inhibitors dabrafenib and trametinib. Primary endpoint was recurrence-free survival (RFS), secondary endpoints included overall survival (OS) and subgroup and safety analyses. Results Survival analysis revealed a one-year RFS of 70 % in the D+T, 59 % in the NIV, and 50 % in the PEM treated group. After two years, subjects showed a RFS of 44 % in the D+T, 43 % in the NIV, and 50 % in the PEM treated group. If we combine the two PD-1-antibodies, 58 % of patients were relapse free after one year, and 43 % after two years. OS was very similar in PD-1 (82 %) and BRAF/MEK treated patients (78 %). In the PD-1 treated group, factors that significantly improved RFS were age under 65 (HR for relapse 0.43 vs. 1.96; p=0.045; 95 % CI), only one positive lymph node (HR for relapse 0.5 vs. 1.5; p=0.02; 95 % CI), and a time to start of therapy that is less than three months (HR for relapse 0.4 vs. 2.2; p=0.028; 95 % CI). Immune-related adverse events due to immunotherapy did not indicate a reduced recurrence risk in our study. In the BRAF/MEK group, no factor leading to an improvement in RFS could be observed. Serious adverse events were similar in the PD-1 (25.8 %) and BRAF/MEK treated group (25 %) and no new toxicity signs were identified. Conclusion Immunotherapy and targeted therapy agents continue to be very effective treatments for advanced melanoma. Nevertheless, there are multiple difficulties, since a number of patients do not respond to the treatment or experience severe adverse events. Therefore, early recurrence of advanced melanoma remains a challenge in medicine even to this date and intensive research is still needed for therapy improvement.