Please use this identifier to cite or link to this item:
http://hdl.handle.net/1942/40646
Title: | Re-Evaluation of Pathologic Complete Response as a Surrogate for Event-Free and Overall Survival in Human Epidermal Growth Factor Receptor 2-Positive, Early Breast Cancer Treated With Neoadjuvant Therapy Including Anti-Human Epidermal Growth Factor Receptor 2 Therapy | Authors: | Squifflet, Pierre D. Saad, Everardo Loibl, Sibylle T. van Mackelenbergh, Marion Untch, Michael Rastogi, Priya Gianni, Luca Schneeweiss, Andreas Conte, Pierfranco Piccart, Martine Bonnefoi, Herve Jackisch, Christian Nekljudova, Valentina Tang, Gong Valagussa, Pinuccia Neate, Colin Gelber, Richard Poncet, Coralie Heinzmann, Dominik Denkert, Carsten E. Geyer Jr, Charles Cortes, Javier Guarneri, Valentina de Azambuja, Evandro Cameron, David Ismael, Gustavo Wolmark, Norman Cortazar, Patricia BUYSE, Marc CTNeoBC Project |
Issue Date: | 2023 | Publisher: | LIPPINCOTT WILLIAMS & WILKINS | Source: | JOURNAL OF CLINICAL ONCOLOGY, 41 (16) , p. 2988 -+ | Abstract: | PURPOSEPathologic complete response (pCR) has prognostic importance and is frequently used as a primary end point, but doubts remain about its validity as a surrogate for event-free survival (EFS) and overall survival (OS) in human epidermal growth factor receptor 2 (HER2)-positive, early breast cancer.METHODSWe obtained individual-patient data from randomized trials of neoadjuvant anti-HER2 therapy that enrolled at least 100 patients, had data for pCR, EFS, and OS, and a median follow-up of at least 3 years. We quantified the patient-level association between pCR (defined as ypT0/Tis ypN0) and both EFS and OS using odds ratios (ORs, with ORs >1.00 indicating a benefit from achieving a pCR). We quantified the trial-level association between treatment effects on pCR and on EFS and OS using R-2 (with values above 0.75 considered as indicating strong associations).RESULTSEleven of 15 eligible trials had data for analysis (3,980 patients, with a median follow-up of 62 months). Considering all trials, we found strong patient-level associations, with ORs of 2.64 (95% CI, 2.20 to 3.07) for EFS and 3.15 (95% CI, 2.38 to 3.91) for OS; however, trial-level associations were weak, with an unadjusted R-2 of 0.23 (95% CI, 0 to 0.66) for EFS and 0.02 (95% CI, 0 to 0.17) for OS. We found qualitatively similar results when grouping trials according to different clinical questions, when analyzing only patients with hormone receptor-negative disease, and when using a more stringent definition of pCR (ypT0 ypN0).CONCLUSIONAlthough pCR may be useful for patient management, it cannot be considered as a surrogate for EFS or OS in neoadjuvant trials of HER2-positive, operable breast cancer. | Notes: | Saad, ED (corresponding author), Int Drug Dev Inst, Ave Provinciale 30, B-1340 Louvain La Neuve, Belgium. everardo.saad@iddi.com |
Keywords: | Humans;Female;Trastuzumab;Neoadjuvant Therapy;Disease-Free Survival;Receptor, ErbB-2;Progression-Free Survival;Antineoplastic Combined Chemotherapy Protocols;Breast Neoplasms | Document URI: | http://hdl.handle.net/1942/40646 | ISSN: | 0732-183X | e-ISSN: | 1527-7755 | DOI: | 10.1200/JCO.22.02363 | ISI #: | 001003990600012 | Category: | A1 | Type: | Journal Contribution |
Appears in Collections: | Research publications |
Show full item record
Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.