<p>Accurate information about locoregional breast cancer treatments following neoadjuvant systemic therapy (NST) is essential for meaningful interpretation of oncological outcomes but reporting is currently poor. We developed a core outcome set (COS) to improve the quality and consistency of locoregional outcome reporting in breast cancer NST trials. The COS was developed in three phases according to COS-STAD guidance, with the generation of a list of relevant outcome domains, prioritisation of outcomes through two rounds of an international online multi-stakeholder Delphi survey and a consensus meeting. 159 unique locoregional outcomes were classified into 101 outcome domains for inclusion in the Delphi survey, which was completed by 470 international professionals. The final 15-item COS, which included the pre-NST surgical plan, details of surgery performed following completion of treatment and details of radiation therapy, was agreed at an in-person consensus meeting. Widespread COS implementation will improve the quality and value of future NST trials.</p>

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A core outcome set for locoregional treatment reporting in neoadjuvant systemic breast cancer treatment trials

  • Shelley Potter,
  • Kerry Avery,
  • Rosina Ahmed,
  • Jana de Boniface,
  • Sanjoy Chatterjee,
  • David Dodwell,
  • Peter Dubsky,
  • Jingjing Federmann,
  • Sandra Finestone,
  • Michael Gnant,
  • Dominik Hlauschek,
  • Hiroji Iwata,
  • Michael Y. Jiang,
  • Orit Kaidar-Person,
  • Han-Byoel Lee,
  • Mairead MacKenzie,
  • Anne Meyn,
  • Philip Poortmans,
  • Fiorita Poulakaki,
  • Andrea L. Richardson,
  • Karla A. Sepulveda,
  • Andrew J. Spillane,
  • Alastair M. Thompson,
  • Gustavo Werutsky,
  • Philipp Wittmann,
  • Jean L. Wright,
  • Nicholas Zdenkowski,
  • Katherine Cowan,
  • Stuart A. McIntosh,
  • Nick Abbott,
  • Roxolyana Abdah-Bortnyak,
  • Khaled Abdelwahab,
  • Puteri Abdul Haris,
  • Stefan Aebi,
  • Gaurav Agarwal,
  • Cinta Albacar,
  • Manuel Algara,
  • Emmanouil Aligizakis,
  • Raphael Garcia,
  • Nikolay Amirov,
  • Saika Amreen,
  • María Belén Ancao,
  • Sofía Aragón,
  • Akif Enes Arikan,
  • Cynthia Aristei,
  • Farah Asif,
  • Marianne Aznar,
  • Selvamani Backianathan,
  • Hiroko Bando,
  • Maggie Banys-Paluchowski,
  • Vincent Barrette,
  • Peter Barry,
  • Carlotta Becherini,
  • Rossana Berardi,
  • Rinat Bernstein-Molho,
  • Aniwat Berpan,
  • Björn Beurer,
  • Indrani Bhattacharya,
  • Vesna Bjelic-Radisic,
  • Liesbeth Boersma,
  • Eduard-Alexandru Bonci,
  • Andrea Bonetti,
  • Elaine Borg,
  • Tony Branson,
  • Ursa Brown-Glaberman,
  • Eraldo Oreste Bucci,
  • Coralia Bueno,
  • Güney Cem Bülbüloğlu,
  • Brian Burnette,
  • Henry Cain,
  • Beth Campbell,
  • Alicia Cano-Jimenez,
  • Alp Ömer-Cantürk,
  • Ana Car Peterko,
  • Amtul Carmichael,
  • Cecilia Castillo,
  • Nancy Chan,
  • Samantha Chen,
  • Matthew Kin Liang Chiu,
  • Amit Choraria,
  • Juncal Claros,
  • John Collins,
  • Veronica Conde-Herrero,
  • Anastasia Constantinidou,
  • Suzanne Coopey,
  • Ellen Copson,
  • Stefanie Corradini,
  • Fabio Corsi,
  • Paulo Cortes,
  • Kyle Crawford,
  • Elisabetta Cretella,
  • Josefina Cruz,
  • Ramsey Cutress,
  • Massimiliano Daiuto,
  • Iskra Daskalova,
  • Mark Davies,
  • Alex De Caluwé,
  • Carolina De La Pinta,
  • Sonia Del Barca Berron,
  • Geoff P. Delaney,
  • Sarah Deschuymer,
  • Rosa Di Micco,
  • Ana Aurora Diaz-Gavela,
  • Dobromir Dimitrov,
  • Lutfi Dogan,
  • Vérène Dougoud-Chauvin,
  • Stergios Douvetzemis,
  • Dimitrios Dragoumis,
  • Frances Duane,
  • Florian Ebner,
  • Jenny Edge,
  • Inês Eiriz,
  • Elisabeth Elder,
  • Constanze Elfgen,
  • Beatrix Elsberger,
  • Arantxa Eraso,
  • Serap Erel,
  • Tamar Esakia,
  • Martin Espinosa-Bravo,
  • Maria Del Pilar Estevez-Diz,
  • Veronica Yamila Fabiano,
  • Waleed Fahmy,
  • Alessandro Fancellu,
  • Isaura Fernandez,
  • Luis Fernández-Morales,
  • Josefa Ferreiro,
  • Francesco Fiorica,
  • José Fougo,
  • Gianluca Franceschini,
  • Hugo Fuentes,
  • Niharika Garach,
  • Maria Luisa Gasparri,
  • Daniele Generali,
  • Matteo Ghilli,
  • Miguel Gil-Gil,
  • Henry Leonidas Gomez,
  • Gustavo Gössling,
  • Stephen Grobmyer,
  • Christoph Großmann,
  • Semra Gunay,
  • Tal Hadar,
  • Nawale Hajjaji,
  • Nisha Hariharan,
  • Grant Harris,
  • Gemma Hegarty,
  • Martin Heidinger,
  • Tarek Hijal,
  • Cary Hsu,
  • Thomas Hubbard,
  • Farhanul Huda,
  • Alessandra Huscher,
  • Rabia Ikram,
  • Jose Juan Illarramendi,
  • Gareth Irwin,
  • Reshma Jagsi,
  • Melissa James,
  • Guy Jerusalem,
  • Katarzyna Jerzak,
  • Carol Johnson,
  • Nathalie Johnson,
  • Kylie Jung,
  • Ji-Jung Jung,
  • Vishvak Chanthar,
  • Geeta Kadayaprath,
  • Ayfer Kamali Polat,
  • Taewoo Kang,
  • Lohita Krishna Kanyadhara,
  • Güldeniz Karadeniz Çakmak,
  • Andreas Karakatsanis,
  • Martin Karamanliev,
  • Mah Muneer Khan,
  • Alba Kihn-Alarcón,
  • Emma Kipps,
  • Cliona Kirwan,
  • Evelyn Klein,
  • Hyun Soo Ko,
  • Assia Konsoulova,
  • Apostolos Konstantis,
  • Michalis Kontos,
  • Antigoni Kretsi,
  • David Krug,
  • Ian Kunkler,
  • Siobhan Laws,
  • Sara Leal,
  • Jeeyeon Lee,
  • Rhea Liang,
  • Elisenda Llabres Valenti,
  • Michelle Ludwig,
  • Diana Lüftner,
  • Manjola Luzi,
  • Melanie Machiels,
  • Emma Macinnes,
  • Iain Macpherson,
  • Pedro Madeira,
  • John Maduro,
  • George Marios Makris,
  • Pablo Mando,
  • James Mansell,
  • Willam Mantilla,
  • Maja Maraldo,
  • Yiola Marcou,
  • Julie Margenthaler,
  • Gustavo Marta,
  • Karyne Martel,
  • Covadonga Marti,
  • Ana Isabel Martin-Quesada,
  • Tamara Martos,
  • Yazan Masannat,
  • Valeria Masiello,
  • Norikazu Masuda,
  • Christine I. Mau,
  • Shaurav Maulik,
  • Icro Meattini,
  • Bruno Meduri,
  • Tuomo Meretoja,
  • Sarkis Meterissian,
  • Alessandro Marco Minisini,
  • Shagun Misra,
  • Angel Montero,
  • Jenna Morgan,
  • Teresa Muñoz Migueláñez,
  • Elisabetta Munzone,
  • Dawid Murawa,
  • Karez Namiq,
  • María Alejandra Naranjo Sánchez,
  • Kazutaka Narui,
  • Toan Nguyen,
  • Dejan Nikolic,
  • Angeliki Nikopoulou,
  • Conor O’Neill,
  • Seamus O’Reilly,
  • Ira Oikonomou,
  • Roger Olofsson Bagge,
  • Amparo Oltra Ferrando,
  • Lazaros Papadopoulos,
  • Javier Pascual,
  • David Pasquier,
  • Alice Pellegrini,
  • Tamar Peretz-Yablonski,
  • Cristina Pérez Segura,
  • Antonio Piñero-Madrona,
  • Katarzyna Pogoda,
  • Razvan Popescu,
  • Matthew Poppe,
  • Mauro Porpiglia,
  • Daniel Portik,
  • Jose Fernando Prado Moura,
  • Elena Provenzano,
  • Marina Puchinskaya,
  • Paul Martin Putora,
  • Venkatraman Radhakrishnan,
  • Ishtiaq Ur Rahim,
  • Duvern Ramiah,
  • Smitha Rao,
  • Ivica Ratosa,
  • Evangelia Razis,
  • Rebecca Read,
  • Lia Rebaza,
  • Andrew Redfern,
  • Tomas Reinert,
  • Javier Retamales,
  • Margit Riis,
  • Neill Roberts,
  • Nicola Rocco,
  • Beatriz Rojas,
  • Chandeena Roshanlall,
  • Laurent Rosset,
  • Francesca Rovera,
  • Isabel T. Rubio,
  • Nicola Russell,
  • Natacha Ruyssers,
  • Jai Min Ryu,
  • Helena Sackey,
  • Sunita Saha,
  • Jorge Emilio Salinas,
  • Jose I. Sánchez-Méndez,
  • Constantinos Savva,
  • Lorenzo Scardina,
  • Margherita Serra,
  • Jiraporn Setakornnukul,
  • Mukesh Shanthilal,
  • Iman Sharawy,
  • Shelly Sharma,
  • Shashank Shenoy,
  • Preethi S. Shetty,
  • Mery Shoshkova,
  • Mark Sibbering,
  • Zacharoula Sidiropoulou,
  • Aumilto Silva,
  • Richard Simcock,
  • Bhawana Sirohi,
  • Fiona Smith,
  • Kylie Snook,
  • Enrique Soto Perez De Celis,
  • Philip Spanheimer,
  • Heidi Stranzl,
  • Kirsty Stuart,
  • Yisihak Suga,
  • Tommaso Susini,
  • Michael Swinden,
  • Megha Tandon,
  • Maria Saveria Tavoletta,
  • Donatienne Taylor,
  • Vitor Teixeira Liutti,
  • Evrim Tezcanli,
  • Wajana Thaweerat,
  • Jacqui Thomson,
  • Mangesh Thorat,
  • Marinos Tsiatas,
  • Pelagia Tsoutsou,
  • Tove Tvedskov,
  • Takayuki Ueno,
  • Jayant Vaidya,
  • Antonis Valachis,
  • Franchette Van Den Berkmortel,
  • Jos Van Der Hage,
  • Frederieke Van Duijnhoven,
  • Marissa C. Van Maaren,
  • Ad Vandermeulen,
  • Beatriz Vázquez-Barreiro,
  • Umesh Velu,
  • Ramachandran Venkitaraman,
  • Sergi Vidal-Sicart,
  • Lubna Vohra,
  • Ioannis Voutsadakis,
  • Tabassum Wadasadawala,
  • Melanie Walker,
  • Irene Wapnir,
  • Fredrik Warnberg,
  • Ericka Wiebe,
  • Stephanie Wong,
  • Lynda Wyld,
  • Sanjay Kumar,
  • Janice Yeh,
  • Anneza Yiallourou,
  • Hyun Jo Youn,
  • Jan Žatecký,
  • Gastón Zatta Cobos,
  • Amanda Zeko,
  • Marija Zivkovic,
  • Anagha Zope

摘要

Accurate information about locoregional breast cancer treatments following neoadjuvant systemic therapy (NST) is essential for meaningful interpretation of oncological outcomes but reporting is currently poor. We developed a core outcome set (COS) to improve the quality and consistency of locoregional outcome reporting in breast cancer NST trials. The COS was developed in three phases according to COS-STAD guidance, with the generation of a list of relevant outcome domains, prioritisation of outcomes through two rounds of an international online multi-stakeholder Delphi survey and a consensus meeting. 159 unique locoregional outcomes were classified into 101 outcome domains for inclusion in the Delphi survey, which was completed by 470 international professionals. The final 15-item COS, which included the pre-NST surgical plan, details of surgery performed following completion of treatment and details of radiation therapy, was agreed at an in-person consensus meeting. Widespread COS implementation will improve the quality and value of future NST trials.