Protocol for a systematic review with prospective individual patient data meta-analysis in EGFR-mutant NSCLC with brain metastases to assess the effect of SRS+osimertinib compared to osimertinib alone: the STARLET Collaboration.

Autor:	Robledo KP; NHMRC Clinical Trials Centre, The University of Sydney, Camperdown, New South Wales, Australia kristy.robledo@sydney.edu.au., Lefresne S; BC Cancer Agency, Vancouver, British Columbia, Canada.; The University of British Columbia, Vancouver, British Columbia, Canada., Soon YY; NHMRC Clinical Trials Centre, The University of Sydney, Camperdown, New South Wales, Australia.; National University Cancer Institute, Singapore.; National University Health System, Singapore., Sahgal A; Princess Alexandra Hospital, Woolloongabba, Queensland, Australia., Pinkham MB; Radiation Oncology, Princess Alexandra Hospital, Woolloongabba, Queensland, Australia., Nichol A; BC Cancer Agency, Vancouver, British Columbia, Canada., Soo RA; National University Cancer Institute, Singapore.; National University Health System, Singapore., Parmar A; Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada., Hegi-Johnson F; Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia., Doherty M; St Vincent's University Hospital, Dublin, Dublin, Ireland., Solomon BJ; Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia., Shultz DB; Princess Margaret Cancer Centre, Toronto, Ontario, Canada., Tham IW; Mount Elizabeth Hospital, Singapore., Sacher AG; Princess Margaret Cancer Centre, Toronto, Ontario, Canada., Tey J; National University Cancer Institute, Singapore.; National University Health System, Singapore., Leong CN; National University Cancer Institute, Singapore.; National University Health System, Singapore., Koh WY; National University Cancer Institute, Singapore.; National University Health System, Singapore., Huang Y; National University Cancer Institute, Singapore.; National University Health System, Singapore., Ang YLE; National University Cancer Institute, Singapore.; National University Health System, Singapore., Low J; National University Cancer Institute, Singapore.; National University Health System, Singapore., Yong C; National University Health System, Singapore.; National University Hospital, Singapore., Lim MC; National University Health System, Singapore.; National University Hospital, Singapore., Tan AP; National University Health System, Singapore.; National University Hospital, Singapore., Lee CK; NHMRC Clinical Trials Centre, The University of Sydney, Camperdown, New South Wales, Australia., Ho C; BC Cancer Agency, Vancouver, British Columbia, Canada.; The University of British Columbia, Vancouver, British Columbia, Canada.
Jazyk:	angličtina
Zdroj:	BMJ open [BMJ Open] 2024 Jul 05; Vol. 14 (7), pp. e078335. Date of Electronic Publication: 2024 Jul 05.
DOI:	10.1136/bmjopen-2023-078335
Abstrakt:	Background: Patients with advanced non-small-cell lung cancer (NSCLC) with activating mutations in the epidermal growth factor receptor ( EGFR ) gene are a heterogeneous population who often develop brain metastases (BM). The optimal management of patients with asymptomatic brain metastases is unclear given the activity of newer-generation targeted therapies in the central nervous system. We present a protocol for an individual patient data (IPD) prospective meta-analysis to evaluate whether the addition of stereotactic radiosurgery (SRS) before osimertinib treatment will lead to better control of intracranial metastatic disease. This is a clinically relevant question that will inform practice. Methods: Randomised controlled trials will be eligible if they include participants with BM arising from EGFR- mutant NSCLC and suitable to receive osimertinib both in the first-line and second-line settings (P); comparisons of SRS followed by osimertinib versus osimertinib alone (I, C) and intracranial disease control included as an endpoint (O). Systematic searches of Medline (Ovid), Embase (Ovid), Cochrane Central Register of Controlled Trials (CENTRAL), CINAHL (EBSCO), PsychInfo, ClinicalTrials.gov and the WHO's International Clinical Trials Registry Platform's Search Portal will be undertaken. An IPD meta-analysis will be performed using methodologies recommended by the Cochrane Collaboration. The primary outcome is intracranial progression-free survival, as determined by response assessment in neuro-oncology-BM criteria. Secondary outcomes include overall survival, time to whole brain radiotherapy, quality of life, and adverse events of special interest. Effect differences will be explored among prespecified subgroups. Ethics and Dissemination: Approved by each trial's ethics committee. Results will be relevant to clinicians, researchers, policymakers and patients, and will be disseminated via publications, presentations and media releases. Prospero Registration: CRD42022330532. Competing Interests: Competing interests: SL: research funding and honoraria from AstraZeneca. YYS: honoraria from AstraZeneca and Janssen. AGS: research grants (institution) from Elekta AB, Varian, Seagen and BrainLAB; consulting fees from Varian, Elekta (Gamma Knife Icon), BrainLAB, Merck, Abbvie and Roche; honoraria from AstraZeneca, Elekta AB, Varian, BrainLAB, Accuray and Seagen. MBP: speaker fees from AZ, BMS, MSD and Roche. AN: research grants from Varian Medical Systems. RAS: advisory board with Amgen, Astra-Zeneca, Bayer, BMS, Boehringer Ingelheim, Janssen, Lily, Merck, Merck Serono, Novartis, Pfizer, Puma Biotechnology, Roche, Taiho, Takeda, Thermo Fisher and Yuhan Corporation; research grant from Astra-Zeneca and Boehringer Ingelheim. FHJ: clinical trial funding, received honoraria and participated in advisory boards for Astra Zeneca; received payments and honoraria from BeiGene and MSD for lectures and presentations; supported by the Peter Mac Foundation and the Victorian Cancer Agency. BJS: advisory board/honoraria from AstraZeneca, Pfizer, Novartis, Roche, Takeda, Merck, Bristol Mysers Squibb, Janssen, Amgen and Eli Lilly. IWKT: honorarium from Elekta and MSD. CH: advisory boards with Abbvie, Amgen, AstraZeneca, Bayer, BMS, Eisai, EMD Serono, Janssen, Jazz, Merck, Novartis, Pfizer, Roche, Sanofi and Takeda; research grants from AstraZeneca, EMD Serono and Roche. CKL: advisory board with Amgen, Astra Zeneca, GSK, Merck KGA, Norvatis, Pfizer, Roche, Takeda, Boehringer-Ingelheim and Yuhan; research funding (institution) from Astra Zeneca, Roche, Merck KGA and Amgen. KPR, AP, MD, DBS, AGS, JT, CNL, WYK, YH, YLEA, JL, CY, MCL and APT have no competing interests. CH, SL, FHJ, CKL, YYS, RAS and IWKT are study chairs on the included trials. (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
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