Abstract Introduction TTFields in combination with TMZ showed significant survival benefit for newly diagnosed glioblastoma patients in the EF-14 trial, compared to TMZ standard therapy; independent of MGMT-promotor methylation-status, age and performance status. Recently, the CeTeG trial (NOA-09) demonstrated improved efficacy of lomustine (CCNU)/TMZ compared to TMZ standard therapy in newly diagnosed MGMT-promotor methylated GBM patients. Given that TTFields demonstrated a strong safety profile as well as a high potential being combined with other modalities and the very promising results for GBM patients with methylated MGMT-promotor in the CeTeG trial, there is a strong rationale in combining these modalities. This is the first report on patients, treated with a combination of both treatment regimens, TTFields and CCNU/TMZ. Methods Patients with newly diagnosed GBM and MGMT-promoter methylation were treated after surgery and radiochemotherapy with a combination of TTFields plus CCNU/TMZ at our institutions. Patients with complete resection (N=4), partial resection (N=3) as well as biopsy (N=1) were included in the analysis. We assessed safety and feasibility of this combined therapy. Results Currently, eight patients (medians: age 49, [39–69]; KPS 90, [70–100]) have been treated and analyzed: GBM IDH mutant (N=2), IDH wild-type (N=6). To-date, CTCAE grade 3 hematotoxicities were observed in two patients, but were not considered to be related to the addition of TTFields to CCNU/TMZ. No further non-hematologic toxicity was observed. In one patient a grade 3 event (herpes zoster) emerged. Regarding medical device site reactions, low-grade skin irritations were detected in four patients (50%), corresponding to the safety analysis from the EF-14 trial with low-grade skin irritations in 52% of the patients. Conclusion These data provide first indications that the combination of TTFields and CCNU/TMZ is probably safe and feasible. Additional follow-up and a higher sample size are needed for further toxicity analysis and efficacy assessment of this combination.
P01.012 Tumor Treating Fields (TTFields) in combination with lomustine (CCNU) and temozolomide (TMZ) in patients with newly diagnosed glioblastoma (GBM)
[Category] 대상포진,
[Article Type] Poster Presentations
[Source] PMC
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