2f:I[703058,["/_next/static/immutable/chunks/3bhq_5eh1d760.js","/_next/static/immutable/chunks/1855-ogyi8eh4.js","/_next/static/immutable/chunks/2pfsjpn6k6zlg.js","/_next/static/immutable/chunks/26c7v3_3uwnwu.js","/_next/static/immutable/chunks/25a3ozcrvi1ff.js","/_next/static/immutable/chunks/2r4wx50nvjh_4.js","/_next/static/immutable/chunks/23fsw06hsi5b1.js","/_next/static/immutable/chunks/06_yt270h41rg.js","/_next/static/immutable/chunks/3ezsiz-7shkna.js","/_next/static/immutable/chunks/20x2y96ldu5wx.js","/_next/static/immutable/chunks/2lxntcm3pd1_h.js","/_next/static/immutable/chunks/00dgco8irq3jw.js","/_next/static/immutable/chunks/00nwe-kq0rboc.js","/_next/static/immutable/chunks/2051ffx3xzio9.js"],"PaperListPageClient"] 30:T6f5,Patients with stage II/III human epidermal growth factor receptor 2 (HER2)-positive or triple-negative breast cancer (TNBC) frequently receive neoadjuvant therapy (NAT). Although pathologic complete response (pCR) correlates with improved outcomes, many non-pCR patients have long-term survival. Circulating tumor-DNA (ctDNA) minimal residual disease (MRD) assessment may provide additional or superior risk stratification. Pathologic Response Evaluation and Detection in Circulating Tumor-DNA is a prospective, multicenter study evaluating ctDNA as a biomarker of treatment response using a tumor-informed, ultrasensitive (<100 parts per million) assay. The primary objective was to determine whether the negative predictive value (NPV) of post-NAT ctDNA for pCR was ≥90%. A prespecified secondary objective for the TNBC cohort was to assess associations between ctDNA and 5-year invasive disease-free survival (IDFS). ctDNA was evaluated at baseline, after NAT before surgery, and after surgery. Of 227 enrolled patients, 220 were evaluable for pCR (48% HER2-positive; 52% TNBC) and 91 patients (41%) had pCR. The primary objective was not met. Although all patients with pCR were ctDNA-negative after NAT, 40% of non-pCR patients were also ctDNA-negative (NPV, 60% [95% CI, 0.50 to 0.69]). However, the prespecified secondary objective was met. Detectable ctDNA after NAT was prognostic for recurrence (hazard ratio [HR], 8.9 [95% CI, 2.4 to 33]; In HER2-positive breast cancer and TNBC, ctDNA after NAT does not discriminate pCR from non-pCR. However, ctDNA provides markedly superior prognostic stratification, identifying patients with exceptional outcomes and those at extreme risk. These findings support ctDNA-guided therapeutic de-escalation and escalation strategies.31:Tb03, PURPOSE Patients with stage II/III human epidermal growth factor receptor 2 (HER2)–positive or triple-negative breast cancer (TNBC) frequently receive neoadjuvant therapy (NAT). Although pathologic complete response (pCR) correlates with improved outcomes, many non-pCR patients have long-term survival. Circulating tumor-DNA (ctDNA) minimal residual disease (MRD) assessment may provide additional or superior risk stratification. METHODS Pathologic Response Evaluation and Detection in Circulating Tumor-DNA is a prospective, multicenter study evaluating ctDNA as a biomarker of treatment response using a tumor-informed, ultrasensitive (<100 parts per million) assay. The primary objective was to determine whether the negative predictive value (NPV) of post-NAT ctDNA for pCR was ≥90%. A prespecified secondary objective for the TNBC cohort was to assess associations between ctDNA and 5-year invasive disease-free survival (IDFS). ctDNA was evaluated at baseline, after NAT before surgery, and after surgery. RESULTS Of 227 enrolled patients, 220 were evaluable for pCR (48% HER2-positive; 52% TNBC) and 91 patients (41%) had pCR. The primary objective was not met. Although all patients with pCR were ctDNA-negative after NAT, 40% of non-pCR patients were also ctDNA-negative (NPV, 60% [95% CI, 0.50 to 0.69]). However, the prespecified secondary objective was met. Detectable ctDNA after NAT was prognostic for recurrence (hazard ratio [HR], 8.9 [95% CI, 2.4 to 33]; P = .001), independent of pCR. Additionally, detectable ctDNA after surgery identified patients at extremely high recurrence risk (HR, 128 [95% CI, 15 to 1,083]; P < .001), while ctDNA-negative patients after surgery had 94% 5-year IDFS. CONCLUSION In HER2-positive breast cancer and TNBC, ctDNA after NAT does not discriminate pCR from non-pCR. However, ctDNA provides markedly superior prognostic stratification, identifying patients with exceptional outcomes and those at extreme risk. These findings support ctDNA-guided therapeutic de-escalation and escalation strategies. 25:[[["$","script","0",{"type":"application/ld+json","dangerouslySetInnerHTML":{"__html":"{\"@context\":\"https://schema.org\",\"@type\":\"CollectionPage\",\"name\":\"Neoadjuvant Therapy: modality Research & Clinical Takeaways\",\"description\":\"Explore peer-reviewed papers on Neoadjuvant Therapy (modality). Clinician-written summaries and actionable practice insights. 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Key predictors of longer delays included Medicaid insurance (5/6 cancers), lowest-quartile income (6/6), Black race (5/6), greater travel distance (4/6), care in the West (6/6), treatment at academic institutions (6/6), and use of robotic surgery (5/5 nonbreast cancers).","limitations":"- Retrospective design using administrative/registry data (National Cancer Database) limits causal inference and may not capture unmeasured confounders.\n- Full text is under embargo; detailed methodology and multivariable model specifications could not be reviewed.\n- The 85% female composition reflects heavy representation of breast cancer patients, which may skew overall pooled estimates.","practice_takeaway":"Surgical wait times for major cancers have risen steadily over a decade and are longest at academic centers and for referred, lower-income, or Black patients — clinicians and health systems should proactively track and address these gaps. Robotic surgery adoption is also independently linked to longer delays and warrants operational scrutiny."}},{"doi":"10.1038/s41585-026-01172-5","pmid":"42426291","title":"Neoadjuvant intraprostatic immunotherapy for high-risk localized prostate cancer","journal_title":"Nature Reviews Urology","journal_issn":"1759-4812","published_at":"2026-07-09T00:00:00.000Z","url":"https://doi.org/10.1038/s41585-026-01172-5","source_score":12,"is_retracted":false,"is_open_access":false,"raw_metadata":{"pubmed":true,"crossref":true,"unpaywall":true},"created_at":"2026-07-13T17:42:39.545Z","updated_at":"2026-07-13T17:42:39.545Z","tags":[{"paper_doi":"10.1038/s41585-026-01172-5","tag_type":"age_group","value":"adult","value_numeric":null},{"paper_doi":"10.1038/s41585-026-01172-5","tag_type":"category","value":"Urology & Nephrology","value_numeric":null},{"paper_doi":"10.1038/s41585-026-01172-5","tag_type":"condition","value":"High-Risk Localized Prostate Cancer","value_numeric":null},{"paper_doi":"10.1038/s41585-026-01172-5","tag_type":"condition","value":"Prostate Cancer","value_numeric":null},{"paper_doi":"10.1038/s41585-026-01172-5","tag_type":"impact_flag","value":"limited_evidence","value_numeric":null},{"paper_doi":"10.1038/s41585-026-01172-5","tag_type":"level_of_evidence","value":"5","value_numeric":null},{"paper_doi":"10.1038/s41585-026-01172-5","tag_type":"modality","value":"Intraprostatic Immunotherapy","value_numeric":null},{"paper_doi":"10.1038/s41585-026-01172-5","tag_type":"modality","value":"Neoadjuvant Therapy","value_numeric":null},{"paper_doi":"10.1038/s41585-026-01172-5","tag_type":"modality","value":"Viral Vector Gene Therapy","value_numeric":null},{"paper_doi":"10.1038/s41585-026-01172-5","tag_type":"sex","value":"male","value_numeric":null},{"paper_doi":"10.1038/s41585-026-01172-5","tag_type":"study_design","value":"Narrative Review","value_numeric":null},{"paper_doi":"10.1038/s41585-026-01172-5","tag_type":"warning","value":"'Clinical efficacy remains unproven' per the authors — clinicians should interpret any immune activation findings as mechanistic, not practice-changing signals.","value_numeric":null},{"paper_doi":"10.1038/s41585-026-01172-5","tag_type":"warning","value":"The study design is described as a review of 'early-phase clinical experience'; the level of evidence reflects the review format but underlying trials are phase I/II only.","value_numeric":null},{"paper_doi":"10.1038/s41585-026-01172-5","tag_type":"warning","value":"This is a narrative review, not a primary study — no original patient-level data or pooled analysis is reported; sample sizes and specific trial results are not detailed in the abstract.","value_numeric":null}],"summaries":{"what_studied":"This review evaluates intraprostatic immunotherapy as a neoadjuvant strategy for high-risk localized prostate cancer, focusing on viral-vector-based gene therapies designed to modulate the tumour microenvironment and induce systemic antitumour responses prior to surgery.","key_result":"Early-phase clinical studies found intraprostatic immunotherapy to be safe and technically feasible, with evidence of local and systemic immune activation; however, PSA responses and pathological tumour regression were variable, and clinical efficacy remains unproven.","limitations":"- Only early-phase (proof-of-concept) data are available; no established efficacy endpoints met.\n- Lack of standardized biological and clinical endpoints across studies limits cross-trial comparisons.\n- No head-to-head comparison with existing neoadjuvant approaches (e.g., androgen deprivation therapy).","practice_takeaway":"Intraprostatic immunotherapy before radical prostatectomy is safe and biologically active in early trials, but should not yet change clinical practice for high-risk localized prostate cancer. Clinicians should watch for upcoming trials with standardized endpoints before considering this approach outside a research setting."}},{"doi":"10.1245/s10434-026-19990-7","pmid":"42319588","title":"Assessing Response and Outcomes to Modern Multiagent Neoadjuvant Therapy for Pancreatic Ductal Adenocarcinoma","journal_title":"Annals of Surgical Oncology","journal_issn":"1068-9265","published_at":"2026-06-19T00:00:00.000Z","url":"https://doi.org/10.1245/s10434-026-19990-7","source_score":5,"is_retracted":false,"is_open_access":true,"raw_metadata":{"pubmed":true,"crossref":true,"unpaywall":true},"created_at":"2026-06-27T13:27:55.522Z","updated_at":"2026-06-27T13:27:55.522Z","tags":[{"paper_doi":"10.1245/s10434-026-19990-7","tag_type":"age_group","value":"adult","value_numeric":null},{"paper_doi":"10.1245/s10434-026-19990-7","tag_type":"category","value":"Surgery","value_numeric":null},{"paper_doi":"10.1245/s10434-026-19990-7","tag_type":"condition","value":"Pancreatic Ductal Adenocarcinoma","value_numeric":null},{"paper_doi":"10.1245/s10434-026-19990-7","tag_type":"impact_flag","value":"practice_changing","value_numeric":null},{"paper_doi":"10.1245/s10434-026-19990-7","tag_type":"level_of_evidence","value":"3","value_numeric":null},{"paper_doi":"10.1245/s10434-026-19990-7","tag_type":"modality","value":"Multiagent Chemotherapy","value_numeric":null},{"paper_doi":"10.1245/s10434-026-19990-7","tag_type":"modality","value":"Neoadjuvant Therapy","value_numeric":null},{"paper_doi":"10.1245/s10434-026-19990-7","tag_type":"sample_size","value":"n=166","value_numeric":166},{"paper_doi":"10.1245/s10434-026-19990-7","tag_type":"sex","value":"mixed","value_numeric":null},{"paper_doi":"10.1245/s10434-026-19990-7","tag_type":"study_design","value":"Retrospective Cohort Study","value_numeric":null},{"paper_doi":"10.1245/s10434-026-19990-7","tag_type":"warning","value":"CA 19-9 non-secretor status is not addressed in the abstract; the 83% biochemical response rate may not reflect the full patient population.","value_numeric":null},{"paper_doi":"10.1245/s10434-026-19990-7","tag_type":"warning","value":"Specific neoadjuvant regimens (e.g., FOLFIRINOX, gemcitabine/nab-paclitaxel) are not detailed in the abstract; the 'multiagent' label covers a heterogeneous treatment group spanning 16 years, which may affect interpretation of response rates.","value_numeric":null},{"paper_doi":"10.1245/s10434-026-19990-7","tag_type":"warning","value":"The impact_flag 'practice_changing' is applied based on the finding that imaging response should not guide surgical decision-making — this is a meaningful shift, but comes from a single-center retrospective study; confirmation in prospective data is needed.","value_numeric":null}],"summaries":{"what_studied":"Single-center retrospective review of 166 patients with resectable or borderline-resectable PDAC treated with multiagent neoadjuvant therapy (NAT) between 2008–2024, evaluating whether radiographic (RECIST 1.1), biochemical (CA 19-9), or histopathologic (CAP score) response predicts overall survival (OS) and progression-free survival (PFS).","key_result":"Histopathologic response (CAP 0–2) was the only measure independently associated with improved PFS (aHR 0.57, 95% CI 0.34–0.96; p = 0.034); neither radiographic nor CA 19-9 response predicted PFS or OS. Notably, 88% of patients with stable/progressive disease on imaging still achieved biochemical response, and 68% had at least partial histopathologic response — imaging alone badly underestimates treatment effect.","limitations":"- Single-center retrospective design limits generalizability.\n- Only 73% of enrolled patients underwent resection, introducing selection bias in histopathologic analyses.\n- CA 19-9 is non-secreted in a subset of patients, which may confound biochemical response rates.","practice_takeaway":"Do not use imaging response alone to triage PDAC patients off surgery after neoadjuvant therapy — stable or even progressive disease on CT does not rule out meaningful histopathologic response. Prioritize resection when feasible, as pathologic response remains the strongest surrogate for long-term survival."}},{"doi":"10.1200/jco-25-02934","pmid":"41805422","title":"The Pathologic Response Evaluation and Detection in Circulating Tumor-DNA Study: Ultrasensitive Circulating Tumor-DNA Assessment of Breast Cancer Minimal Residual Disease","journal_title":"Journal of Clinical Oncology","journal_issn":"0732-183X","published_at":"2026-03-10T00:00:00.000Z","url":"https://doi.org/10.1200/jco-25-02934","source_score":54,"is_retracted":false,"is_open_access":false,"raw_metadata":{"ooir":{"day":"2026-05-08","doi":"10.1200/jco-25-02934","days":"7","issn":"0732-183X","rank":"3","field":"Clinical Medicine","score":"54","category":"Oncology","categories":["Oncology"],"_categories":["Oncology"]},"pubmed":{"doi":"10.1200/JCO-25-02934","title":"The Pathologic Response Evaluation and Detection in Circulating Tumor-DNA Study: Ultrasensitive Circulating Tumor-DNA Assessment of Breast Cancer Minimal Residual Disease.","journal":"Journal of clinical oncology : official journal of the American Society of Clinical Oncology","methods":"","results":"Of 227 enrolled patients, 220 were evaluable for pCR (48% HER2-positive; 52% TNBC) and 91 patients (41%) had pCR. The primary objective was not met. Although all patients with pCR were ctDNA-negative after NAT, 40% of non-pCR patients were also ctDNA-negative (NPV, 60% [95% CI, 0.50 to 0.69]). However, the prespecified secondary objective was met. Detectable ctDNA after NAT was prognostic for recurrence (hazard ratio [HR], 8.9 [95% CI, 2.4 to 33]; ","abstract":"$30","keywords":[],"pubmed_id":"41805422","conclusions":"In HER2-positive breast cancer and TNBC, ctDNA after NAT does not discriminate pCR from non-pCR. However, ctDNA provides markedly superior prognostic stratification, identifying patients with exceptional outcomes and those at extreme risk. These findings support ctDNA-guided therapeutic de-escalation and escalation strategies.","publication_date":"2026-03-10T00:00:00"},"crossref":{"DOI":"10.1200/jco-25-02934","URL":"https://doi.org/10.1200/jco-25-02934","ISSN":["0732-183X","1527-7755"],"link":[{"URL":"https://ascopubs.org/doi/pdfdirect/10.1200/JCO-25-02934","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"page":"1283-1295","type":"journal-article","issue":"14","score":1,"title":["The Pathologic Response Evaluation and Detection in Circulating Tumor-DNA Study: Ultrasensitive Circulating Tumor-DNA Assessment of Breast Cancer Minimal Residual Disease"],"author":[{"given":"Natasha B.","family":"Hunter","sequence":"first","affiliation":[{"name":"Fred Hutchinson Cancer Center, University of Washington, Seattle, WA"}]},{"given":"Heather A.","family":"Parsons","sequence":"additional","affiliation":[{"name":"Fred Hutchinson Cancer Center, University of Washington, Seattle, WA"},{"name":"Dana Farber Cancer Institute, Boston, MA"}]},{"given":"Leslie","family":"Cope","sequence":"additional","affiliation":[{"name":"Johns Hopkins University, Baltimore, MD"}]},{"given":"Jenna V.","family":"Canzoniero","sequence":"additional","affiliation":[{"name":"Johns Hopkins University, Baltimore, MD"}]},{"given":"Fabio C.P.","family":"Navarro","sequence":"additional","affiliation":[{"name":"Personalis, Fremont, CA"}]},{"given":"Sherif","family":"El-Refai","sequence":"additional","affiliation":[{"name":"Personalis, Fremont, CA"}]},{"given":"Jesus D.","family":"Anampa","sequence":"additional","affiliation":[{"name":"Montefiore Einstein Comprehensive Cancer Center, Bronx, NY"}]},{"given":"Joseph A.","family":"Sparano","sequence":"additional","affiliation":[{"name":"Montefiore Einstein Comprehensive Cancer Center, Bronx, NY"}]},{"given":"Mothaffar","family":"Rimawi","sequence":"additional","affiliation":[{"name":"Baylor College of Medicine, Houston, TX"}]},{"given":"Anna Maria","family":"Storniolo","sequence":"additional","affiliation":[{"name":"Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis, IN"}]},{"given":"Candace","family":"Mainor","sequence":"additional","affiliation":[{"name":"Medstar Georgetown University-Hospital-Lombardi Comprehensive Cancer Center, Washington, DC"}]},{"given":"Rita","family":"Nanda","sequence":"additional","affiliation":[{"name":"University of Chicago, Chicago, IL"}]},{"given":"Angela","family":"DeMichele","sequence":"additional","affiliation":[{"name":"University of Pennsylvania, Philadelphia, PA"}]},{"given":"Gaorav P.","family":"Gupta","sequence":"additional","affiliation":[{"name":"University of North Carolina, Chapel Hill, NC"}]},{"given":"Erica J.","family":"Stringer-Reasor","sequence":"additional","affiliation":[{"name":"University of Alabama at Birmingham, Birmingham, AL"}]},{"given":"Filipa","family":"Lynce","sequence":"additional","affiliation":[{"name":"Dana Farber Cancer Institute, Boston, MA"},{"name":"Medstar Georgetown University-Hospital-Lombardi Comprehensive Cancer Center, Washington, DC"}]},{"given":"Erin F.","family":"Cobain","sequence":"additional","affiliation":[{"name":"Rogel Cancer Center, University of Michigan, Ann Arbor, MI"}]},{"given":"Shannon","family":"Puhalla","sequence":"additional","affiliation":[{"name":"University of Pittsburgh, UPMC Hillman Cancer Center, Pittsburgh, PA"}]},{"given":"Rachel","family":"Jankowitz","sequence":"additional","affiliation":[{"name":"University of Pennsylvania, Philadelphia, PA"},{"name":"University of Pittsburgh, UPMC Hillman Cancer Center, Pittsburgh, PA"}]},{"given":"Brent","family":"Rexer","sequence":"additional","affiliation":[{"name":"Vanderbilt University Medical Center, Nashville, TN"}]},{"given":"Ingrid","family":"Mayer","sequence":"additional","affiliation":[{"name":"Vanderbilt University Medical Center, Nashville, TN"}]},{"given":"E. Shelley","family":"Hwang","sequence":"additional","affiliation":[{"name":"Duke University and Duke Cancer Institute, Durham, NC"}]},{"given":"Kimberly","family":"Blackwell","sequence":"additional","affiliation":[{"name":"Duke University and Duke Cancer Institute, Durham, NC"}]},{"given":"Walid","family":"El Ayass","sequence":"additional","affiliation":[{"name":"Tidal Health, Peninsula Regional Medical Center, Salisbury, MD"}]},{"given":"Young","family":"Lee","sequence":"additional","affiliation":[{"name":"Anne Arundel Medical Center, Annapolis, MD"}]},{"given":"Carol","family":"Tweed","sequence":"additional","affiliation":[{"name":"Anne Arundel Medical Center, Annapolis, MD"}]},{"given":"Mary","family":"Wilkinson","sequence":"additional","affiliation":[{"name":"Johns Hopkins University, Baltimore, MD"},{"name":"Inova Schar Cancer, Fairfax, VA"}]},{"given":"Angela","family":"Pennisi","sequence":"additional","affiliation":[{"name":"Inova Schar Cancer, Fairfax, VA"}]},{"given":"Bonnie","family":"Sun","sequence":"additional","affiliation":[{"name":"Johns Hopkins University, Baltimore, MD"}]},{"given":"Pamela","family":"Wright","sequence":"additional","affiliation":[{"name":"Johns Hopkins University, Baltimore, MD"}]},{"given":"Julie R.","family":"Gralow","sequence":"additional","affiliation":[{"name":"Fred Hutchinson Cancer Center, University of Washington, Seattle, WA"}]},{"given":"Richard","family":"Chen","sequence":"additional","affiliation":[{"name":"Personalis, Fremont, CA"}]},{"given":"Sean M.","family":"Boyle","sequence":"additional","affiliation":[{"name":"Personalis, Fremont, CA"}]},{"given":"Vered","family":"Stearns","sequence":"additional","affiliation":[{"name":"Johns Hopkins University, Baltimore, MD"}]},{"given":"Antonio C.","family":"Wolff","sequence":"additional","affiliation":[{"name":"Johns Hopkins University, Baltimore, MD"}]},{"given":"Ben Ho","family":"Park","sequence":"additional","affiliation":[{"name":"Vanderbilt University Medical Center, Nashville, TN"}]}],"issued":{"date-parts":[[2026,5,10]]},"member":"233","prefix":"10.1200","source":"Crossref","volume":"44","created":{"date-time":"2026-03-10T20:00:11Z","timestamp":1773172811000,"date-parts":[[2026,3,10]]},"indexed":{"date-time":"2026-05-07T09:59:44Z","timestamp":1778147984958,"date-parts":[[2026,5,7]]},"subject":[],"abstract":"$31","language":"en","relation":{},"resource":{"primary":{"URL":"https://ascopubs.org/doi/10.1200/JCO-25-02934"}},"subtitle":[],"assertion":[{"name":"received","group":{"name":"publication_history","label":"Publication History"},"label":"Received","order":0,"value":"2025-12-08"},{"name":"revised","group":{"name":"publication_history","label":"Publication History"},"label":"Revised","order":1,"value":"2025-12-12"},{"name":"accepted","group":{"name":"publication_history","label":"Publication 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Disease","updated":"2026-03-12T12:36:34+00:00","published_date":"2026-03-10","best_oa_location":null}},"created_at":"2026-05-10T13:20:49.720Z","updated_at":"2026-05-14T15:13:26.918Z","tags":[{"paper_doi":"10.1200/jco-25-02934","tag_type":"age_group","value":"adult","value_numeric":null},{"paper_doi":"10.1200/jco-25-02934","tag_type":"category","value":"Oncology","value_numeric":null},{"paper_doi":"10.1200/jco-25-02934","tag_type":"condition","value":"HER2-Positive Breast Cancer","value_numeric":null},{"paper_doi":"10.1200/jco-25-02934","tag_type":"condition","value":"Triple-Negative Breast Cancer","value_numeric":null},{"paper_doi":"10.1200/jco-25-02934","tag_type":"impact_flag","value":"practice_changing","value_numeric":null},{"paper_doi":"10.1200/jco-25-02934","tag_type":"level_of_evidence","value":"2","value_numeric":null},{"paper_doi":"10.1200/jco-25-02934","tag_type":"modality","value":"Circulating Tumor DNA (ctDNA) Assay","value_numeric":null},{"paper_doi":"10.1200/jco-25-02934","tag_type":"modality","value":"Minimal Residual Disease Testing","value_numeric":null},{"paper_doi":"10.1200/jco-25-02934","tag_type":"modality","value":"Neoadjuvant Therapy","value_numeric":null},{"paper_doi":"10.1200/jco-25-02934","tag_type":"sample_size","value":"n=220","value_numeric":220},{"paper_doi":"10.1200/jco-25-02934","tag_type":"sex","value":"female","value_numeric":null},{"paper_doi":"10.1200/jco-25-02934","tag_type":"study_design","value":"Prospective Cohort Study","value_numeric":null},{"paper_doi":"10.1200/jco-25-02934","tag_type":"warning","value":"Sex was not explicitly reported in the abstract; 'female' was inferred given the breast cancer population.","value_numeric":null},{"paper_doi":"10.1200/jco-25-02934","tag_type":"warning","value":"The extremely wide confidence interval for post-surgery ctDNA HR (15–1,083) suggests very small event numbers in that subgroup; the point estimate should be interpreted cautiously.","value_numeric":null},{"paper_doi":"10.1200/jco-25-02934","tag_type":"warning","value":"The paper is published in JCO with a listed date of 2026-03-10, which is slightly ahead of today's date (May 10, 2026) — content appears to be a 2026 advance publication and may still be in-press or recently published.","value_numeric":null},{"paper_doi":"10.1200/jco-25-02934","tag_type":"warning","value":"The prespecified secondary IDFS endpoint was defined only for the TNBC cohort; prognostic data reported for the combined HER2-positive and TNBC population should be interpreted with caution regarding generalizability.","value_numeric":null}],"summaries":{"what_studied":"Prospective multicenter study (PREDICT ctDNA) evaluating an ultrasensitive, tumor-informed ctDNA assay (<100 ppm) as a biomarker of minimal residual disease in 220 evaluable patients with stage II/III HER2-positive or TNBC receiving neoadjuvant therapy (NAT), with ctDNA measured at baseline, post-NAT, and post-surgery; primary endpoint was NPV of post-NAT ctDNA for pCR ≥90%, and a prespecified secondary endpoint assessed ctDNA vs. 5-year invasive disease-free survival (IDFS) in the TNBC cohort.","key_result":"Primary objective not met: post-NAT ctDNA NPV for pCR was only 60% (95% CI, 0.50–0.69), as 40% of non-pCR patients were ctDNA-negative. However, detectable ctDNA after NAT strongly predicted recurrence (HR 8.9, 95% CI 2.4–33; P=.001), and detectable ctDNA after surgery conferred extreme recurrence risk (HR 128, 95% CI 15–1,083; P<.001); ctDNA-negative patients post-surgery achieved 94% 5-year IDFS.","limitations":"- TNBC and HER2-positive cohorts were analyzed together for the primary endpoint, which may mask subgroup differences.\n- The secondary IDFS endpoint was prespecified only for the TNBC cohort, limiting generalizability of prognostic findings to HER2-positive disease.\n- Relatively small sample size (n=220 evaluable) may limit precision of high-risk subgroup estimates, as reflected by the very wide CI for post-surgery HR (15–1,083).","practice_takeaway":"Post-NAT ctDNA cannot replace pathologic assessment for confirming pCR, but a positive ctDNA result after NAT or surgery flags patients at markedly elevated recurrence risk who may benefit from treatment escalation. ctDNA-negative status after surgery identifies a low-risk group (94% 5-year IDFS) where de-escalation strategies could be considered."}}],"initialOffset":4,"fetchConfig":{"kind":"tags","tags":[{"tag_type":"modality","value":"Neoadjuvant Therapy"}]},"breadcrumbItems":[{"name":"Home","href":"/"},{"name":"Research Hub","href":"/hub"},{"name":"Modalities","href":"/hub/tag/modality"},{"name":"Neoadjuvant Therapy"}],"hrefConfig":{"basePath":"/hub/papers","webViewQueryParams":{"hub_ctx":"tag","hub_tag_type":"modality","hub_tag_value":"Neoadjuvant Therapy"}}}]]

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