Study concept and design: Stupp, Kirson, Weinberg, Palti, Ram.
Acquisition, analysis, or interpretation of data: All authors.
Drafting of the manuscript: Stupp, Kirson, Ram.
Critical revision of the manuscript for important intellectual content: All authors.
Statistical analysis: Steinberg.
Obtained funding: Palti.
Administrative, technical, or material support: Stupp, Kirson, Weinberg, Hegi, Ram.
Study supervision: Stupp, Kirson, Weinberg, Hegi, Ram.
Conflict of Interest Disclosures: The authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Stupp reported receiving travel assistance from Novocure for data review and presentation of the results at medical meetings; and receiving personal fees for serving on advisory boards for Roche/Genentech, Merck KGaA, Merck & Co, and Novartis. Dr Taillibert reported receiving personal fees from Mundipharma EDO and Roche. Dr Kanner reported receiving institutional grant funding and personal fees for speaking and device training from Novocure. Dr Kesari reported receiving institutional grant funding and personal fees for consulting and attending advisory meetings from Novocure. Dr Steinberg reported receiving consulting fees from Novocure for performing the statistical analysis. Dr Toms reported receiving personal fees from Novocure for serving on an advisory board. Dr Lieberman reported receiving institutional grant funding from Novocure. Dr Fink reported receiving personal fees from Novocure for serving on an advisory board; and receiving personal fees from Genetech for serving in the speakers program. Dr Zhu reported receiving institutional grant funding and personal fees from Novocure. Dr Engelhard reported receiving institutional grant funding and personal fees from Novocure. Dr Chen reported receiving grant funding, personal fees, nonfinancial support, and being a stock holder and chief oncology officer in Pharmo-kinesis; and receiving grant funding, personal fees, nonfinancial support, and being a stock holder in and CEO of NeOnc Technologies. Dr David Tran reported receiving grant funding from Celldex, NWBiotech, Novocure, and Merck; and receiving personal fees from Novocure and prIME Oncology. Dr Hottinger reported receiving travel reimbursement and speakers fees from Novocure and Merck Sharp & Dohme; and receiving personal fees for serving on an advisory board for Roche. Dr Landolfi reported receiving personal fees from Novocure for serving on an advisory board. Dr Honnorat reported receiving trial support from Novocure and serving on an advisory board for Novocure. Dr Idbaih reported receiving grants from Fondation ARC pour la recherche sur le Cancer; receiving research support from IntselChimos and Beta-Innov; receiving personal fees from Novartis for attending a conference; receiving travel reimbursement from Hoffmann-La Roche; and serving as an editorial advisory board member for Lettre du Cancérologue. Drs Kirson, Weinberg, and Palti reported being employees of Novocure. Dr Palti also reported holding 35 issued US patents and minority stock ownership in Novocure. Dr Hegi reported receiving institutional grant funding from Novocure, Merck Sharp & Dohme, Roche, and Merck-Serono; and nonfinancial support from MDxHealth for sample testing. Dr Ram reported receiving institutional grant funding from Novocure; and serving as a paid consultant for and holding stock options in Novocure. Drs Taylor, Silvani, Barnett, Henson, Sroubek, Nam Tran, Desai, Caroli, and Kew reported having no disclosures.
Funding/Support: The study was funded by Novocure Ltd.
Role of the Funder/Sponsor: Novocure Ltd had a role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication. The study was designed by the first and last authors (R.S. and Z.R.), together with representatives from Novocure (mainly E.D.K.). The study oversight was supported and monitored by a clinical research organization (CRO), who also holds the database. Data were collected by the investigators and monitored by the CRO. Device use data were downloaded monthly and transferred to the study investigators or their research staff by device support specialists from Novocure Ltd. The data were analyzed separately by the statistician of the independent data monitoring committee and the study statistician (D.M.S.). Data interpretation was the responsibility of the first and last authors (R.S. and Z.R.), together with the study sponsor representative and project lead (E.D.K.). These 3 physicians also jointly developed the first draft. A subsequent mature draft and a prefinal version were circulated among all authors who gave additional input, contributed to, and approved the manuscript. The first and last authors (R.S. and Z.R.) and E.D.K. had full access to all data, and also reviewed all patient profiles for consistency (R.S. and E.D.K.). The decision to publish the data followed the independent data and safety monitoring committee recommendation for data release, and was supported by all coauthors. The roles of employees of Novocure are described in the respective author contributions. Other employees’ involvement was limited to technical support of the device.
Additional Contributions: We thank the patients and their families for participating in the trial. We are grateful to all of the EF-14 investigators, who are listed in eAppendix 4 in Supplement 2, and the nursing staff for taking care of the patients.