PMID- 33215088
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20231112
IS  - 2632-2498 (Electronic)
IS  - 2632-2498 (Linking)
VI  - 2
IP  - 1
DP  - 2020 Jan-Dec
TI  - OptimalTTF-1: Enhancing tumor treating fields therapy with skull remodeling 
      surgery. A clinical phase I trial in adult recurrent glioblastoma.
PG  - vdaa121
LID - 10.1093/noajnl/vdaa121 [doi]
LID - vdaa121
AB  - BACKGROUND: Preclinical studies suggest that skull remodeling surgery 
      (SR-surgery) increases the dose of tumor treating fields (TTFields) in 
      glioblastoma (GBM) and prevents wasteful current shunting through the skin. 
      SR-surgery introduces minor skull defects to focus the cancer-inhibiting currents 
      toward the tumor and increase the treatment dose. This study aimed to test the 
      safety and feasibility of this concept in a phase I setting. METHODS: Fifteen 
      adult patients with the first recurrence of GBM were treated with personalized 
      SR-surgery, TTFields, and physician's choice oncological therapy. The primary 
      endpoint was toxicity and secondary endpoints included standard efficacy 
      outcomes. RESULTS: SR-surgery resulted in a mean skull defect area of 10.6 cm(2) 
      producing a median TTFields enhancement of 32% (range 25-59%). The median 
      TTFields treatment duration was 6.8 months and the median compliance rate 90%. 
      Patients received either bevacizumab, bevacizumab/irinotecan, or temozolomide 
      rechallenge. We observed 71 adverse events (AEs) of grades 1 (52%), 2 (35%), and 
      3 (13%). There were no grade 4 or 5 AEs or intervention-related serious AEs. Six 
      patients experienced minor TTFields-induced skin rash. The median 
      progression-free survival (PFS) was 4.6 months and the PFS rate at 6 months was 
      36%. The median overall survival (OS) was 15.5 months and the OS rate at 12 
      months was 55%. CONCLUSIONS: TTFields therapy combined with SR-surgery and 
      medical oncological treatment is safe and nontoxic and holds the potential to 
      improve the outcome for GBM patients through focal dose enhancement in the tumor.
CI  - (c) The Author(s) 2020. Published by Oxford University Press, the Society for 
      Neuro-Oncology and the European Association of Neuro-Oncology.
FAU - Korshoej, Anders Rosendal
AU  - Korshoej AR
AUID- ORCID: 0000-0003-4285-8171
AD  - Department of Neurosurgery, Aarhus University Hospital, Aarhus, Denmark.
AD  - Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.
FAU - Lukacova, Slavka
AU  - Lukacova S
AD  - Department of Oncology, Aarhus University Hospital, Aarhus, Denmark.
FAU - Lassen-Ramshad, Yasmin
AU  - Lassen-Ramshad Y
AD  - Danish Centre for Particle Therapy, Aarhus University Hospital, Aarhus, Denmark.
FAU - Rahbek, Christian
AU  - Rahbek C
AD  - Department of Neuroradiology, Aarhus University Hospital, Aarhus Denmark.
FAU - Severinsen, Kare Eg
AU  - Severinsen KE
AD  - Department of Neurology, Aarhus University Hospital, Aarhus, Denmark.
FAU - Guldberg, Trine Lignell
AU  - Guldberg TL
AD  - Department of Oncology, Aalborg University Hospital, Aalborg, Denmark.
FAU - Mikic, Nikola
AU  - Mikic N
AD  - Department of Neurosurgery, Aarhus University Hospital, Aarhus, Denmark.
AD  - Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.
FAU - Jensen, Mette Haldrup
AU  - Jensen MH
AD  - Department of Neurosurgery, Aarhus University Hospital, Aarhus, Denmark.
FAU - Cortnum, Soren Ole Stigaard
AU  - Cortnum SOS
AD  - Department of Neurosurgery, Aarhus University Hospital, Aarhus, Denmark.
FAU - von Oettingen, Gorm
AU  - von Oettingen G
AD  - Department of Neurosurgery, Aarhus University Hospital, Aarhus, Denmark.
FAU - Sorensen, Jens Christian Hedemann
AU  - Sorensen JCH
AD  - Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.
LA  - eng
PT  - Journal Article
DEP - 20200915
PL  - England
TA  - Neurooncol Adv
JT  - Neuro-oncology advances
JID - 101755003
PMC - PMC7660275
OTO - NOTNLM
OT  - craniectomy
OT  - glioblastoma
OT  - neuro-oncology
OT  - neurosurgery
OT  - tumor treating fields
EDAT- 2020/11/21 06:00
MHDA- 2020/11/21 06:01
PMCR- 2020/09/15
CRDT- 2020/11/20 05:50
PHST- 2020/11/20 05:50 [entrez]
PHST- 2020/11/21 06:00 [pubmed]
PHST- 2020/11/21 06:01 [medline]
PHST- 2020/09/15 00:00 [pmc-release]
AID - vdaa121 [pii]
AID - 10.1093/noajnl/vdaa121 [doi]
PST - epublish
SO  - Neurooncol Adv. 2020 Sep 15;2(1):vdaa121. doi: 10.1093/noajnl/vdaa121. 
      eCollection 2020 Jan-Dec.