Circulating Tumor DNA After Neoadjuvant Chemotherapy in Breast Cancer Is Associated With Disease Relapse.

Detection of circulating tumor DNA (ctDNA) after neoadjuvant chemotherapy in patients with early-stage breast cancer may allow for early detection of relapse. In this study, we analyzed ctDNA using a personalized, tumor-informed multiplex polymerase chain reaction-based next-generation sequencing assay. Plasma samples (n = 157) from 44 patients were collected before neoadjuvant therapy (baseline), after neoadjuvant therapy and before surgery (presurgery), and serially postsurgery including a last follow-up sample. The primary end point was event-free survival (EFS) analyzed using Cox regression models. Thirty-eight (86%), 41 (93%), and 38 (86%) patients had baseline, presurgical, and last follow-up samples, respectively. Twenty patients had hormone receptor-positive/human epidermal growth factor receptor 2-negative, 13 had triple-negative breast cancer, and 11 had human epidermal growth factor receptor 2-positive disease. Baseline ctDNA detection was observed in 22/38 (58%) patients and was significantly associated with Ki67 > 20% ( The presence of ctDNA after neoadjuvant chemotherapy is associated with relapse in early-stage breast cancer, supporting interventional trials for testing the clinical utility of ctDNA monitoring in this setting.

Déclaration de conflit d'intérêts

<b>Elisa Agostinetto</b><b>Honoraria:</b> Lilly, Sandoz<b>Travel, Accommodations, Expenses:</b> Novartis, Genetic <b>Matteo Lambertini</b><b>Consulting or Advisory Role:</b> Roche, Novartis, Lilly, AstraZeneca, Pfizer, MSD, Exact Sciences, Gilead Sciences, Seattle Genetics<b>Speakers' Bureau:</b> Takeda, Roche, Lilly, Novartis, Pfizer, Sandoz, Ipsen, Knight Therapeutics, Libbs<b>Travel, Accommodations, Expenses:</b> Gilead Sciences <b>Hsin-Ta Wu</b><b>Employment:</b> Natera<b>Stock and Other Ownership Interests:</b> Natera<b>Travel, Accommodations, Expenses:</b> Natera <b>Mustafa Balcioglu</b><b>Employment:</b> Natera<b>Stock and Other Ownership Interests:</b> Natera <b>Ekaterina Kalashnikova</b><b>Employment:</b> Natera<b>Stock and Other Ownership Interests:</b> Natera<b>Travel, Accommodations, Expenses:</b> Natera <b>Andrea Gombos</b><b>Consulting or Advisory Role:</b> AstraZeneca (Inst)<b>Travel, Accommodations, Expenses:</b> Pfizer <b>Ahmad Awada</b><b>Consulting or Advisory Role:</b> Roche, Lilly, Amgen, Eisai, Bristol Myers Squibb, Pfizer, Novartis, MSD, Genomic Health, Ipsen, AstraZeneca, Bayer, LEO Pharma, Merck Serono, Daiichi Sankyo/Lilly, Pierre Fabre, Seattle Genetics, Hengrui Therapeutics, Innate Pharma <b>Himanshu Sethi</b><b>Employment:</b> Natera<b>Stock and Other Ownership Interests:</b> Natera<b>Research Funding:</b> Natera<b>Patents, Royalties, Other Intellectual Property:</b> Patents<b>Travel, Accommodations, Expenses:</b> Natera <b>Alexey Aleshin</b><b>Employment:</b> Natera<b>Leadership:</b> Natera<b>Stock and Other Ownership Interests:</b> Natera<b>Consulting or Advisory Role:</b> Mission Bio<b>Travel, Accommodations, Expenses:</b> Natera <b>Christos Sotiriou</b><b>Consulting or Advisory Role:</b> Astellas Pharma, Cepheid, Vertex, Puma Biotechnology, Seattle Genetics, Amgen, Merck<b>Speakers' Bureau:</b> Eisai, Prime Oncology, Teva, Foundation Medicine, Genmic Health<b>Patents, Royalties, Other Intellectual Property:</b> Epigenetic portraits of human Breast Cancer, PCT/EP2012/050836, WO2012/098215, A companion diagnostic for CDK4/CDK6 inhibitory drugs based on CDK4 Phosphorylation. Which patient to be treated and how. PCT/EP2017/061780<b>Travel, Accommodations, Expenses:</b> Roche, Roche/Genentech <b>Michail Ignatiadis</b><b>Consulting or Advisory Role:</b> Seattle Genetics, Novartis<b>Research Funding:</b> Roche/Genentech (Inst), Pfizer (Inst), Natera (Inst)<b>Patents, Royalties, Other Intellectual Property:</b> Patent entitled method for determining sensitivity to a CDK4/6 inh filed the 18 05 16 by Universite Libre de Bruxelles, Application No/Patent No 16170146.1-1403<b>Travel, Accommodations, Expenses:</b> RocheNo other potential conflicts of interest were reported.