The use of breast ultrasound for prediction of pathologic complete response in different subtypes of early breast cancer within the WSG-ADAPT subtrials.

Objective: We assessed the value of breast ultrasound (US) performed at week 3 and 6 and at the end (EOT) of neoadjuvant therapy (NAT) for prediction of pathologic complete response (pCR, ypT0/is ypN0) in patients with HR+/HER2+, HR-/HER2-or HR-/HER2+ early breast cancer enrolled in the WSG-ADAPT subtrials.
Methods: US was performed at week 3 and 6 of NAT and at EOT in 401, 517, and 553 patients, respectively. Tumors with complete or partial response by US (RECIST 1.1) were classified as responders and those with stable or progressive disease as non-responders.
Results: pCR rate was higher in US responders than in non-responders. US tended to yield the highest positive predictive value in HR-/HER2+ (69%) and HR-/HER2-tumors (65%) at week 3, and the highest negative predictive value in HR+/HER2+ tumors at week 6 and at EOT (88.9% and 86.9%, respectively) and in HR-/HER2-tumors at EOT (87.9%). Multivariable analysis of patients with US at week 3 and 6 identified tumor subtype (HR-/HER2+ vs HR+/HER2+; odds ratio (OR) 2.77, 95%CI 1.45-5.29, and OR 4.17, 95%CI 2.26-7.68, respectively) and each 10% change in lesion dimension on US from baseline (OR 1.15, 95%CI 1.08-1.24, and OR 1.25, 95%CI 1.16-1.35, respectively) as parameters associated with pCR.
Conclusions: Our data support the use of week 3 and EOT US for prediction of pCR in response-guided NAT and in planning of breast-conserving surgery. Change in tumor diameter on US as a continuous variable could be a valuable alternative to categorical RECIST 1.1 criteria.
Competing Interests: Declaration of competing interest Dr. Graeser reports personal fees from AstraZeneca, non-financial support from Daiichi Sanyko, outside the submitted work. Dr. Harbeck reports ownership interest for WSG Study Group, personal fees from Amgen, AstraZeneca, Genomic Health, Novartis, Pfizer, Pierre Fabre, Roche, Zodiac Pharma, consulting/advisory role for Agendia, AstraZeneca, Celgene, Daiichi Sankyo, Lilly, Merck Sharp & Dohme, Novartis, Odonate Therapeutics, Pfizer, Pierre Fabre, Roche/Genentech, Sandoz, Seattle Genetics, West German Study Group (Institution), grants from Lilly (Institution), Merck Sharp & Dohme (Institution), Novartis (Institution), Pfizer (Institution), Roche/Genentech (Institution), outside the submitted work. Dr. Gluz reports ownership interest for WSG Study Group, personal fees from Genomic Health, Roche, Celgene, Pfizer, Novartis, NanoString Technologies, AstraZeneca, consulting/advisory role for Celgene, Exact Sciences, Lilly, MSD Brazil, Novartis pharma SAS, Pfizer Pharmaceuticals Israel, Roche, grants from Roche, outside the submitted work. Dr. Wuerstlein reports non-financial support and consulting/advisory role for Agendia, Amgen, Aristo, Astra Zeneca, Boeringer Ingelheim, Carl Zeiss, Celgene, Clinsol, Daiichi-Sankyo, Esai, Genomic Health, Glaxo Smith Kline, Hexal, Lilly, Medstrom Medical, MSD, Mundipharma, Nanostring, Novartis, Odonate, Paxman, Palleos, Pfizer, Pierre Fabre, PumaBiotechnolgogy, Riemser, Roche, Sandoz/Hexal, Seattle Genetics, Tesaro Bio, Teva, outside the submitted work. Dr. zu Eulenburg has nothing to disclose. Dr. Schumacher reports grants from Roche (Institution), Novartis (Institution), Boehringer (Institution), outside the submitted work. Dr. Grischke has nothing to disclose. Dr. Forstbauer reports personal fees, non-financial support and consulting/advisory role for Roche, Celgene, Amgen, outside the submitted work. Dr. Dimpfl has nothing to disclose. Dr. Braun reports personal fees from AstraZeneca, Exact Sciences, Novartis, Pfizer, Roche, Teva, consulting/advisory role for AstraZeneca, Exact Sciences, Novartis, Puma, Roche, non-financial support from AstraZeneca, Celgene, Medac, Novartis, Roche, outside the submitted work. Dr. Christgen has nothing to disclose. Dr. Kreipe reports personal fees from Roche, Novartis, AstraZeneca, Genomic Health, consulting/advisory role for AstraZeneca, Genomic Health, Novartis pharma SAS, Roche Pharma AG, non-financial support from AstraZeneca, Genomic Health, Novartis pharma SAS, Roche Pharma AG, outside the submitted work. Dr. Potenberg has nothing to disclose. Dr. von Schumann has nothing to disclose. Dr. Aktas reports personal fees from Pfizer, Roche Pharma, Novartis Pharma, AstraZeneca, Amgen, Tesaro Bio Germany, PharmaMar, Eisei, consulting/advisory role for Novartis Pharma, Roche Pharma, Pfizer, Tesaro Bio, non-financial support from AstraZeneca, Amgen, Roche Pharma, Pfizer, Novartis Pharma, Tesaro Bio Germany, PharmaMar, Eisei, outside the submitted work. Dr. Kolberg-Liedtke reports ownership interest for Theraklion (Institution), Phaon Scientific (Institution), personal fees from Roche, AstraZeneca, Celgene, Novartis, Pfizer, Lilly, Hexal, Amgen, SonoScape, Pfizer (Institution), Novartis (Institution), Roche (Institution), Genomic Health (Institution), Amgen (Institution), AstraZeneca (Institution), Riemser (Institution), Carl Zeiss MediTec (Institution), TEVA Pharmaceuticals Industries (Institution), Theraklion (Institution), Janssen-Cilag (Institution), GlaxoSmithKline (Institution), LIV Pharma (Institution), consulting/advisory role for Roche, Novartis, Pfizer, Celgene, Phaon Scientific, Pfizer (Institution), Novartis (Institution), SurgVision (Institution), CarlZeissMeditec (Institution), Amgen (Institution), Onkowissen (Institution), grants from Roche, Novartis, Pfizer, non-financial support from Roche, Daiichi Sankyo, Novartis, Carl Zeiss Meditec (Institution), LIV Pharma (Institution), Novartis (Institution), Amgen (Institution), Pfizer (Institution), Daiichi Sankyo (Institution), outside the submitted work. Dr. Kümmel reports ownership interest for West German Study Group, consulting/advisory role for Roche, Genomic Health, Novartis, AstraZeneca, Amgen, Celgene, SOMATEX Medical Technologies, Daiichi Sankyo, pfm medical, Pfizer, MSD, Lilly, Sonoscape, non-financial support from Roche, Daiichi Sankyo, Sonoscope, outside the submitted work. Dr. Nitz reports other from West German Study Group, personal fees from Agendia, Amgen, Celgene, Genomic Health, NanoString Technologies, Novartis pharma SAS, Pfizer Pharmaceuticals Israel, Roche/Genentech, Teva, other from Genomic Health, Roche, grants from Agendia (Institution), Amgen (Institution), Celgene (Institution), Genomic Health (Institution), NanoString Technologies (Institution), Roche (Institution), Sanofi (Institution), non-financial support from Genomic Health, Pfizer Pharmaceuticals Israel, Roche, outside the submitted work.
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