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.
A core outcome set for locoregional treatment reporting in neoadjuvant systemic breast cancer treatment trials / S. Potter, K. Avery, R. Ahmed, J. De Boniface, S. Chatterjee, D. Dodwell, P. Dubsky, J. Federmann, S. Finestone, M. Gnant, D. Hlauschek, H. Iwata, M.Y. Jiang, O. Kaidar-Person, H. Lee, M. Mackenzie, A. Meyn, P. Poortmans, F. Poulakaki, A.L. Richardson, K.A. Sepulveda, A.J. Spillane, A.M. Thompson, G. Werutsky, P. Wittmann, J.L. Wright, N. Zdenkowski, K. Cowan, S.A. Mcintosh, N. Null, N. Abbott, R. Abdah-Bortnyak, K. Abdelwahab, P.A. Haris, S. Aebi, G. Agarwal, C. Albacar, M. Algara, E. Aligizakis, R. Garcia, N. Amirov, S. Amreen, M.B. Ancao, S. Aragón, A.E. Arikan, C. Aristei, F. Asif, M. Aznar, S. Backianathan, H. Bando, M. Banys-Paluchowski, V. Barrette, P. Barry, C. Becherini, R. Berardi, R. Bernstein-Molho, A. Berpan, B. Beurer, I. Bhattacharya, V. Bjelic-Radisic, L. Boersma, E. Bonci, A. Bonetti, E. Borg, T. Branson, U. Brown-Glaberman, E.O. Bucci, C. Bueno, G.C. Bülbüloğlu, B. Burnette, H. Cain, B. Campbell, A. Cano-Jimenez, A. Ömer-Cantürk, A.C. Peterko, A. Carmichael, C. Castillo, N. Chan, S. Chen, M.K.L. Chiu, A. Choraria, J. Claros, J. Collins, V. Conde-Herrero, A. Constantinidou, S. Coopey, E. Copson, S. Corradini, F. Corsi, P. Cortes, K. Crawford, E. Cretella, J. Cruz, R. Cutress, M. Daiuto, I. Daskalova, M. Davies, A.D. Caluwé, C.D.L. Pinta, S.D.B. Berron, G.P. Delaney, S. Deschuymer, R.D. Micco, A.A. Diaz-Gavela, D. Dimitrov, L. Dogan, V. Dougoud-Chauvin, S. Douvetzemis, D. Dragoumis, F. Duane, F. Ebner, J. Edge, I. Eiriz, E. Elder, C. Elfgen, B. Elsberger, A. Eraso, S. Erel, T. Esakia, M. Espinosa-Bravo, M.D.P. Estevez-Diz, V.Y. Fabiano, W. Fahmy, A. Fancellu, I. Fernandez, L. Fernández-Morales, J. Ferreiro, F. Fiorica, J. Fougo, G. Franceschini, H. Fuentes, N. Garach, M.L. Gasparri, D. Generali, M. Ghilli, M. Gil-Gil, H.L. Gomez, G. Gössling, S. Grobmyer, C. Großmann, S. Gunay, T. Hadar, N. Hajjaji, N. Hariharan, G. Harris, G. Hegarty, M. Heidinger, T. Hijal, C. Hsu, T. Hubbard, F. Huda, A. Huscher, R. Ikram, J.J. Illarramendi, G. Irwin, R. Jagsi, M. James, G. Jerusalem, K. Jerzak, C. Johnson, N. Johnson, K. Jung, J. Jung, V. Chanthar, G. Kadayaprath, A.K. Polat, T. Kang, L.K. Kanyadhara, G.K. Çakmak, A. Karakatsanis, M. Karamanliev, M.M. Khan, A. Kihn-Alarcón, E. Kipps, C. Kirwan, E. Klein, H.S. Ko, A. Konsoulova, A. Konstantis, M. Kontos, A. Kretsi, D. Krug, I. Kunkler, S. Laws, S. Leal, J. Lee, R. Liang, E.L. Valenti, M. Ludwig, D. Lüftner, M. Luzi, M. Machiels, E. Macinnes, I. Macpherson, P. Madeira, J. Maduro, G.M. Makris, P. Mando, J. Mansell, W. Mantilla, M. Maraldo, Y. Marcou, J. Margenthaler, G. Marta, K. Martel, C. Marti, A.I. Martin-Quesada, T. Martos, Y. Masannat, V. Masiello, N. Masuda, C.I. Mau, S. Maulik, I. Meattini, B. Meduri, T. Meretoja, S. Meterissian, A.M. Minisini, S. Misra, A. Montero, J. Morgan, T.M. Migueláñez, E. Munzone, D. Murawa, K. Namiq, M.A.N. Sánchez, K. Narui, T. Nguyen, D. Nikolic, A. Nikopoulou, C. O'Neill, S. O'Reilly, I. Oikonomou, R.O. Bagge, A.O. Ferrando, L. Papadopoulos, J. Pascual, D. Pasquier, A. Pellegrini, T. Peretz-Yablonski, C.P. Segura, A. Piñero-Madrona, K. Pogoda, R. Popescu, M. Poppe, M. Porpiglia, D. Portik, J.F.P. Moura, E. Provenzano, M. Puchinskaya, P.M. Putora, V. Radhakrishnan, I.U. Rahim, D. Ramiah, S. Rao, I. Ratosa, E. Razis, R. Read, L. Rebaza, A. Redfern, T. Reinert, J. Retamales, M. Riis, N. Roberts, N. Rocco, B. Rojas, C. Roshanlall, L. Rosset, F. Rovera, I.T. Rubio, N. Russell, N. Ruyssers, J.M. Ryu, H. Sackey, S. Saha, J.E. Salinas, J.I. Sánchez-Méndez, C. Savva, L. Scardina, M. Serra, J. Setakornnukul, M. Shanthilal, I. Sharawy, S. Sharma, S. Shenoy, P.S. Shetty, M. Shoshkova, M. Sibbering, Z. Sidiropoulou, A. Silva, R. Simcock, B. Sirohi, F. Smith, K. Snook, E.S.P. De Celis, P. Spanheimer, H. Stranzl, K. Stuart, Y. Suga, T. Susini, M. Swinden, M. Tandon, M.S. Tavoletta, D. Taylor, V.T. Liutti, E. Tezcanli, W. Thaweerat, J. Thomson, M. Thorat, M. Tsiatas, P. Tsoutsou, T. Tvedskov, T. Ueno, J. Vaidya, A. Valachis, F.V.D. Berkmortel, J.V.D. Hage, F.V. Duijnhoven, M.C. Van Maaren, A. Vandermeulen, B. Vázquez-Barreiro, U. Velu, R. Venkitaraman, S. Vidal-Sicart, L. Vohra, I. Voutsadakis, T. Wadasadawala, M. Walker, I. Wapnir, F. Warnberg, E. Wiebe, S. Wong, L. Wyld, S. Kumar, J. Yeh, A. Yiallourou, H.J. Youn, J. Žatecký, G.Z. Cobos, A. Zeko, M. Zivkovic, A. Zope. - In: NPJ BREAST CANCER. - ISSN 2374-4677. - 11:1(2025 Oct 28), pp. 116.1-116.10. [10.1038/s41523-025-00824-w]
A core outcome set for locoregional treatment reporting in neoadjuvant systemic breast cancer treatment trials
F. Corsi;D. Generali;N. Rocco;
2025
Abstract
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.| File | Dimensione | Formato | |
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