@article{add97c93f6994115b0e519978cc51d04,
title = "Neoadjuvant systemic therapy in melanoma: recommendations of the International Neoadjuvant Melanoma Consortium",
abstract = "Advances in the treatment of metastatic melanoma have improved responses and survival. However, many patients continue to experience resistance or toxicity to treatment, highlighting a crucial need to identify biomarkers and understand mechanisms of response and toxicity. Neoadjuvant therapy for regional metastases might improve operability and clinical outcomes over upfront surgery and adjuvant therapy, and has become an established role for drug development and biomarker discovery in other cancers (including locally advanced breast cancer, head and neck squamous cell carcinomas, gastroesophageal cancer, and anal cancer). Patients with clinically detectable stage III melanoma are ideal candidates for neoadjuvant therapy, because they represent a high-risk patient population with poor outcomes when treated with upfront surgery alone. Neoadjuvant therapy is now an active area of research for melanoma with numerous completed and ongoing trials (since 2014) with disparate designs, endpoints, and analyses under investigation. We have, therefore, established the International Neoadjuvant Melanoma Consortium with experts in medical oncology, surgical oncology, pathology, radiation oncology, radiology, and translational research to develop recommendations for investigating neoadjuvant therapy in melanoma to align future trial designs and correlative analyses. Alignment and consistency of neoadjuvant trials will facilitate optimal data organisation for future regulatory review and strengthen translational research across the melanoma disease continuum.",
author = "Amaria, {Rodabe N.} and Menzies, {Alexander M.} and Burton, {Elizabeth M.} and Scolyer, {Richard A.} and Tetzlaff, {Michael T.} and Robert Antdbacka and Charlotte Ariyan and Roland Bassett and Brett Carter and Adil Daud and Mark Faries and Fecher, {Leslie A.} and Flaherty, {Keith T.} and Gershenwald, {Jeffrey E.} and Omid Hamid and Angela Hong and Kirkwood, {John M.} and Serigne Lo and Kim Margolin and Jane Messina and Postow, {Michael A.} and Helen Rizos and Ross, {Merrick I.} and Rozeman, {Elisa A.} and Saw, {Robyn P.M.} and Vernon Sondak and Sullivan, {Ryan J.} and Taube, {Janis M.} and Thompson, {John F.} and {van de Wiel}, {Bart A.} and Eggermont, {Alexander M.} and Davies, {Michael A.} and Andrews, {Miles C.} and Berry, {Donald A.} and Block, {Matthew S.} and Boland, {Genevieve M.} and Bollin, {Kathryn B.} and Carlino, {Matteo S.} and Carvajal, {Richard D.} and Jonathan Cohen and Diwakar Davar and Delman, {Keith A.} and Reinhard Dummer and Farwell, {Michael D.} and Fisher, {David E.} and Alberto Fusi and Glitza, {Isabella C.} and {de Gruijl}, {Tanja D.} and Gyorki, {David E.} and Axel Hauschild and Hieken, {Tina J.} and James Larkin and Lawson, {David H.} and Celeste Lebbe and Lee, {Jeffrey E.} and Lowe, {Michael C.} and Luke, {Jason J.} and McArthur, {Grant A.} and McDermott, {David F.} and McQuade, {Jennifer L.} and Mitchell, {Tara C.} and Petrella, {Teresa M.} and Prieto, {Peter A.} and Igor Puzanov and Caroline Robert and Salama, {April K.} and Shaneen Sandhu and Dirk Schadendorf and Shoushtari, {Alexander N.} and Sosman, {Jeffrey A.} and Swetter, {Susan M.} and Tanabe, {Ken K.} and Samra Turajlic and Tyler, {Douglas S.} and Woodman, {Scott E.} and Wright, {Frances C.} and Zager, {Jonathan S.} and Ascierto, {Paolo A.} and Spillane, {Andrew J.} and {van Akkooi}, {Alexander C.J.} and Wargo, {Jennifer A.} and Blank, {Christian U.} and Tawbi, {Hussein A.} and Long, {Georgina V.}",
note = "Funding Information: RNA receives grant funding from Bristol Myers-Squibb (BMS), Merck Sharpe & Dohme (MSD), Roche-Genentech, Array Biopharma, and Iovance Biotherapeutics, outside the submitted work. AMM reports personal fees as a consultant advisor to BMS, MSD, Novartis, Pierre-Fabre, and Roche. MTT reports personal fees from Novartis for advisory board roles associated with BRAF testing of clinical specimens; and personal fees from Myriad Genetics, Seattle Genetics, and Galderma, outside the submitted work. LAF receives trial research funding from BMS, MSD, Incyte, Merck Serono, and SU2C-MRA; and consultant fees from Elsevier (Via Oncology) and Hoosier Cancer Research Network, outside the submitted work. JEG reports personal fees from Novartis, MSD, BMS, Syndax, and Castle Biosciences, outside the submitted work. MAP reports consulting fees from BMS, MSD, Array BioPharma, Novartis, Incyte, NewLink Genetics, and Aduro, outside the submitted work; honoraria from BMS and Merck, outside the submitted work; and institutional Support from RGenix, Infinity, BMS, MSD, Array BioPharma, and Novartis, outside the submitted work. EAR reports travel support from NanoString and MSD, outside the submitted work. RPMS reports honoraria and service on advisory committees for Amgen, BMS, MSD, and Novartis, outside the submitted work. RJS reports grants and personal fees from Amgen and Merck, and personal fees from Novartis, Array, and Roche-Genentech, outside the submitted work. JMT is a consultant or adviser for BMS, MSD, Amgen, and Astra Zeneca; and reports grants from BMS. AME reports personal fees for a scientific advisory board or independent data monitoring committee membership from more than at last 3 years from Actelion, Bayer, BMS, CellDex, GlaxoSmithKline, HalioDX, Incyte, IO Biotech, ISA pharmaceuticals, Merck-Serono, MSD, Novartis, Polynoma, Sanofi, and Sellas. ZMAD reports personal fees from Novartis, BMS, AstraZeneca, MSD, Vaccinex, and Array; grants and personal fees from Roche-Genentech and Sanofi-Aventis; and consulting with Nanostring, all outside the submitted work. PAA has or had a consulting or an advisory role for BMS, Roche-Genentech, MSD, Array, Novartis, Merck Serono, Pierre Fabre, Incyte, Genmab, Newlink Genetics, Medimmune, AstraZeneca, Syndax, Sun Pharma, Sanofi, Idera, and Ultimovacs; and has received research funds from BMS, Roche-Genentech, and Array. ACJvA receives grant funding from Amgen and Novartis, and was part of the advisory board or received consultancy honoraria from Amgen, BMS, Novartis, MSD, Merck-Pfizer, and Roche, outside of the submitted work. JAW is an inventor on a US patent application (PCT/US17/53.717) submitted by the University of Texas MD Anderson Cancer Center that covers methods to enhance immune checkpoint blockade responses by modulating the microbiome; is a paid speaker for Imedex, Dava Oncology, Omniprex, Illumina, Gilead, MedImmune, and BMS; is a consultant or an advisory board member for Roche-Genentech, Novartis, Astra-Zeneca, GlaxoSmithKline, BMS, MSD, and Microbiome DX; receives clinical trial support from GlaxoSmithKline, Roche-Genentech, BMS, and Novartis; has received compensation for Speaker's Bureau and honoraria from Dava Oncology, BMS, and Illumina; and has served on advisory committees for GlaxoSmithKline, Roche-Genentech, Novartis, and AstraZeneca, outside submitted work. CUB receives funding from BMS, within the submitted work, and from MSD, Novartis, and NanoString, outside the submitted work; has advisory roles for BMS, MSD, Roche, Novartis, Pfizer, GlaxoSmithKline, Lilly, Pierre Fabre, and GenMab, through payments made to the Netherlands Cancer Institute. HAT receives personal fees from Novartis; grants and personal fees from BMS and Roche-Genentech; and grants from Merck and Celegene, outside the submitted work. GVL reports personal fees as a consultant adviser to Aduro, Amgen, Array, BMS, MSD, Novartis, Oncosec, Pierre-Fabre, and Roche, outside the submitted work. EMB, RAS, RA, CA, RB, BC, AD, MF, KTF, OH, AH, JMK, SL, KM, JM, HR, MIR, VS, JFT, BAvdW, and AJS have nothing to declare. Publisher Copyright: {\textcopyright} 2019 Elsevier Ltd",
year = "2019",
month = jul,
doi = "10.1016/S1470-2045(19)30332-8",
language = "English (US)",
volume = "20",
pages = "e378--e389",
journal = "The Lancet Oncology",
issn = "1470-2045",
publisher = "Lancet Publishing Group",
number = "7",
}