Μελέτη κόστους-αποτελεσματικότητας του Atezolizumab στον τριπλά αρνητικό καρκίνο του μαστού
Cost-effectiveness of Atezolizumab in triple negative breast cancer

View/Open
Keywords
Τριπλά αρνητικός καρκίνος του μαστού ; Ανάλυση κόστους-αποτελεσματικότητας ; ICER ; AtezolizumabAbstract
Breast cancer is the second leading cause of cancer-related death among women worldwide. There are various subtypes of the disease, which influence both the treatment approach and the prognosis. Among these subtypes, Triple-Negative Breast Cancer (TNBC) is one of the most aggressive forms, characterized by treatment difficulty, a high rate of metastasis, and poor prognosis. TNBC accounts for 10-15% of all breast cancer cases.
The IMpassion 130 clinical trial investigates the clinical efficacy of atezolizumab in combination with the taxane nab-paclitaxel, compared to nab-paclitaxel monotherapy, in both the intention-to-treat population (ITT) and in the group of patients with PD-L1 positive expression in their tumors.
The study results in the ITT population showed that patients who received atezolizumab in combination with nab-paclitaxel had a longer median progression-free survival compared to those who received a placebo in combination with nab-paclitaxel (median, 7.2 months vs 5.5 months). As for overall survival, it was found to be 21 months for patients who received atezolizumab with nab-paclitaxel and 18.7 months for those who received the placebo with nab-paclitaxel.
Although the results in the general population were not as encouraging, there was a significant difference in both median progression-free survival as well as the overall survival in the subgroup of patients with PD-L1 positive tumors. Specifically, the median progression-free survival was 7.5 months with atezolizumab in combination with nab-paclitaxel, compared to 5.3 months with the placebo and nab-paclitaxel. The corresponding median overall survival was 25.4 months for the atezolizumab + nab-paclitaxel group and 17.9 months for the placebo + nab-paclitaxel group.
The purpose of this analysis is to assess the effectiveness and cost of atezolizumab in combination with nab-paclitaxel, compared to monotherapy with taxanes (nab-paclitaxel) in the treatment of unresectable locally advanced or metastatic TNBC.
For the analysis, a Markov model with three health states was constructed: a) progression-free survival (PFS), b) progressive disease (PD), and c) death. The model involved monthly cycles and attempted to extrapollate the results over a 120-month period, corresponding to the estimated life expectancy of the patients. Survival data were derived from the IMpassion 130 clinical trial. The result of the analysis was expressed in an ICER index, and a sensitivity analysis was conducted to investigate its variability under different parameters.
Results: The therapeutic intervention of atezolizumab in combination with nab-paclitaxel, compared to placebo with nab-paclitaxel, for patients with unresectable locally advanced or metastatic TNBC improved both life expectancy (LYs) and quality-adjusted life years (QALYs) for both the ITT population and the PD-L1-positive population, although it increased the cost per patient in both intervention groups. The ICER for the ITT population was estimated at 47.102,60 € per QALY gained and 33.971,32 €/ LY. For the PD-L1-positive population, the ICER was estimated at 30.876,19 € per QALY gained and 21.840,22€ per LY gained. The sensitivity analysis results showed that the ICER in both intervention groups is not sensitive to the discount rate, but is sensitive to the cost of the drug atezolizumab.
Conclusions: According to the study results, treatment with atezolizumab in combination with nab-paclitaxel is a cost-effective intervention for both the general population and the PD-L1-positive population.