PMID- 36239858 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20221024 IS - 2730-6011 (Electronic) IS - 2730-6011 (Linking) VI - 13 IP - 1 DP - 2022 Oct 14 TI - Tumor Treating Fields (TTFields) therapy vs physicians' choice standard-of-care treatment in patients with recurrent glioblastoma: a post-approval registry study (EF-19). PG - 105 LID - 10.1007/s12672-022-00555-5 [doi] LID - 105 AB - PURPOSE: Tumor Treating Fields (TTFields) therapy, a noninvasive, anti-mitotic treatment modality, is approved for recurrent glioblastoma (rGBM) and newly diagnosed GBM based on phase III, EF-11 (NCT00379470) and EF-14 (NCT00916409) studies, respectively. The EF-19 study aimed to evaluate efficacy and safety of TTFields monotherapy (200 kHz) vs physicians' choice standard of care (PC-SOC; EF-11 historical control group) in rGBM. METHODS: A prospective, post-marketing registry study of adults with supratentorial rGBM treated with TTFields therapy was conducted. Primary endpoint was overall survival (OS; intent-to-treat [ITT] population) and secondary endpoint was OS per-protocol (PP). Subgroup and toxicity analyses were conducted. RESULTS: Median OS (ITT population) was comparable with TTFields monotherapy vs PC-SOC (7.4 vs 6.4 months, log-rank test P = 0.053; Cox test hazard ratio [HR] [95% CI], 0.66 [0.47-0.92], P = 0.016). The upper-bound HR (95% CI) was lower than pre-defined noninferiority (1.375 threshold). In the PP population, median OS was significantly longer for TTFields monotherapy vs PC-SOC (8.1 vs 6.4 months; log-rank test P = 0.017; Cox test HR [95% CI], 0.60 [0.42-0.85], P = 0.004). TTFields therapy showed increased benefit with extended use (>/= 18 h/day [averaged over 28 days]). TTFields therapy-related adverse events (AEs) by body system were lower vs PC-SOC: mainly mild-to-moderate skin AEs. CONCLUSION: In the real-world setting, TTFields monotherapy showed comparable (ITT population) and superior (PP population) OS vs PC-SOC in rGBM. In line with previous results, TTFields therapy showed a favorable safety profile vs chemotherapy, without new safety signals/systemic effects. TRIAL REGISTRATION: NCT01756729, registered December 20, 2012. CI - (c) 2022. The Author(s). FAU - Zhu, Jay-Jiguang AU - Zhu JJ AD - University of Texas Health Science Center in Houston (UTHealth)/Memorial Hermann Hospital at Texas Medical Center, 6400 Fannin St., Suite 2800, Houston, TX, 77030, USA. jay.jiguang.zhu@uth.tmc.edu. FAU - Goldlust, Samuel A AU - Goldlust SA AD - John Theurer Cancer Center, Hackensack, NJ, USA. FAU - Kleinberg, Lawrence R AU - Kleinberg LR AD - Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, USA. FAU - Honnorat, Jerome AU - Honnorat J AD - Department of Neuro-Oncology, Hopital Neurologique, Hospices Civils de Lyon, SynatAc Team, MELIS Institute, INSERM U1314/CNRS UMR5284, Universite Claude Bernard Lyon 1, Universite de Lyon, Lyon, France. AD - Department of Neuro-Oncology, East Group Hospital, Hospices Civils de Lyon, Lyon Cedex, France. FAU - Oberheim Bush, Nancy Ann AU - Oberheim Bush NA AD - Department of Neurological Surgery and Neurology, University of California, San Francisco, CA, USA. FAU - Ram, Zvi AU - Ram Z AD - Tel Aviv Medical Center, Tel Aviv University School of Medicine, Tel Aviv, Israel. LA - eng SI - ClinicalTrials.gov/NCT01756729 PT - Journal Article DEP - 20221014 PL - United States TA - Discov Oncol JT - Discover oncology JID - 101775142 PMC - PMC9568629 COIS- Jay-Jiguang Zhu has been supported by the following for-profit companies for clinical trials and contracted research with payments made to his institution: Denovo Biopharma, Novocure, Inc., Five Prime Therapeutics, Inc., Boston Biomedical of Sumitomo Dainippon Pharma Co., Ltd. Samuel A Goldlust has received honoraria for lectures, consultation or advisory board participation from the following: Daiichi Sankyo, Cellevolve, Sumitomo Dainippon Pharma Oncology, Physicians' Education Resource, Cornerstone Specialty Network, Novocure, Inc., Wex Pharmaceuticals, Bristol-Myers Squibb, Tocagen, Cortice Biosciences, and Boston Biomedical. SAG owns stock in COTA and received support for travel, accommodations, and expenses from the following: Wex Pharmaceuticals, Tocagen, Novocure, Inc., Boston Biomedical, Bristol-Myers Squibb, Cortice Biosciences, Caris Life Sciences, Kyowa Kirin International. The following have supported clinical trials and contracted research conducted by SAG with payments made to his institution: AbbVie, Acerta Pharma, Amgen, Boston Biomedical, Bristol-Myers Squibb, Cantex Pharmaceuticals, Celgene, Celldex, Cellularity, CNS Healthcare, Cortice Biosciences, Diffusion Pharmaceuticals, Immunocellular Therapeutics, Imvax, Karyopharm, Kazia, Merck, Northwest Biotherapeutics, Novocure, Novogen, Pfizer, Sanofi, Sumitomo Dainippon Pharma Oncology, Tocagen, Regeneron and Wex Pharmaceuticals. Lawrence Kleinberg has received honoraria for lectures, consultation, or advisory board from the following for-profit companies; Accuray and Novocure, Inc. The following for-profit companies have supported clinical trials and contracted research conducted by Lawrence Kleinberg with payments made to his institution: Arbor Pharmaceuticals, Accuray, Novartis, and Novocure, Inc. Jerome Honnorat has received honoraria for lectures and advisory board participation from the following for-profit companies: Bristol-Myers Squibb, AbbVie, and Novocure, Inc. Nancy Ann Oberheim Bush has received honoraria for lectures, consultation or advisory board participation from the following for-profit company: GLC. The following for-profit companies have supported clinical trials and contracted research conducted by NAOB with payments made to her institution: Merck and Ziopharm. Zvi Ram serves as a consultant to Novocure, Inc. EDAT- 2022/10/15 06:00 MHDA- 2022/10/15 06:01 PMCR- 2022/10/14 CRDT- 2022/10/14 11:19 PHST- 2022/06/29 00:00 [received] PHST- 2022/09/08 00:00 [accepted] PHST- 2022/10/14 11:19 [entrez] PHST- 2022/10/15 06:00 [pubmed] PHST- 2022/10/15 06:01 [medline] PHST- 2022/10/14 00:00 [pmc-release] AID - 10.1007/s12672-022-00555-5 [pii] AID - 555 [pii] AID - 10.1007/s12672-022-00555-5 [doi] PST - epublish SO - Discov Oncol. 2022 Oct 14;13(1):105. doi: 10.1007/s12672-022-00555-5.