In:
Neuro-Oncology, Oxford University Press (OUP), Vol. 21, No. Supplement_6 ( 2019-11-11), p. vi239-vi240
Kurzfassung:
OptimalTTF-1(open-label phase-1) combines Tumor Treating Fields(TTFields) treatment with targeted skull-remodeling surgery(SR-surgery) aiming to enhance the electric field strength in the tumor(NCT02893137). SR-surgery aims to reduce the electrical impedance of the skull. Pre-clinical modeling indicates that SR-surgery increases the electric field strength. The final analysis examined toxicity and efficacy of TTFields combined with SR-surgery and best-choice-chemotherapy in first glioblastoma recurrence(rGBM). METHODS 18 patients were screened and 15 (4F/11M) enrolled between Dec2016 and Mar2019. The primary endpoint was frequency of serious adverse events (CTCAEv4.0) and secondary endpoints were overall survival (OS) and progression-free survival (PFS). Eligible patients were ≥18-years, had focal supratentorial rGBM, KPS≥70, and a minimum calculated increase in TTFields strength of ≥25% after SR-surgery. At the time-of-analysis patients were censored for time-to-event endpoints. RESULTS Baseline data(median (range)) demonstrated a patient age of 57(39;67), skull defect area=10.6 cm2(7;37), increase in the TTFields strength by 43%(25;59). All tumors were IDH-wt and 4 had MGMT-promoter methylation. In total, 4 patients were excluded from the study prior to TTFields initiation (consent withdrawal, radionecrosis/non-recurrence, postoperative infection and neurodeficit), 11 patients (2F/9M) underwent treatment. Treatment compliance was 90%(48;98), mean treatment duration and follow-up was 6.8 months(2.3;20.4) and 10 months respectively. Grade 1–2 AEs included, headache 60% CI95%=[32;84], fatigue 53%, CI95%=[27;79] , skin rash 47%, CI95%=[21;73], and nausea 40%, CI95%=[16;68] . No grade 3 SAEs were related to the intervention (6 seizures, 1 headache, 1 fatigue, 1 TIA, 1 post-op infection, 1 diarrhea and 1 DVT). Efficacy outcomes were PFS6=64%, CI95%=[35;85], PFS=8.8 months, CI95%=[6.2;13.2] , OS=15.0 months, CI95%=[9.6;16.2], and OS12=64%, CI95%=[35;85] . CONCLUSION Targeted SR-surgery combined with TTFields is safe and does not induce additional toxicity. Furthermore, it potentially increases overall survival in rGBM. A phase 2 clinical trial is currently being planned.
Materialart:
Online-Ressource
ISSN:
1522-8517
,
1523-5866
DOI:
10.1093/neuonc/noz175.1002
Sprache:
Englisch
Verlag:
Oxford University Press (OUP)
Publikationsdatum:
2019
ZDB Id:
2094060-9
