{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,24]],"date-time":"2026-09-24T22:20:48Z","timestamp":1790288448896,"version":"4.1.0"},"reference-count":26,"publisher":"MDPI AG","issue":"21","license":[{"start":{"date-parts":[[2025,11,2]],"date-time":"2025-11-02T00:00:00Z","timestamp":1762041600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Cancers"],"abstract":"<jats:p>Background: Pembrolizumab combined with neoadjuvant chemotherapy significantly improves pCR in early TNBC, but the effect of treatment intensity and baseline clinical factors has been insufficiently explored in real-world settings. Methods: We retrospectively included 169 consecutive patients with stage II\u2013III TNBC treated across 11 Italian oncology centers (January 2022\u2013January 2025) with the KEYNOTE-522 regimen. Clinical, pathological, and treatment data were collected, including relative dose intensity (RDI), dose modifications, and toxicities. The primary endpoint was pCR (ypT0\/is ypN0). Results: The overall pCR rate was 65.7%, which is consistent with clinical trial data. Dose reductions occurred in 40% of patients and chemotherapy was discontinued in 18%. Patients maintaining RDI \u226585% achieved higher pCR (79.3% vs. 51.2%, p &lt; 0.001). Similarly, patients without dose reductions (72.5% vs. 55.2%, p = 0.031) and those completing all cycles (73.1% vs. 41.0%, p &lt; 0.001) had superior outcomes. Dose modifications occurred mainly during the taxane\/carboplatin phase and were predominantly due to hematological toxicities (anemia 44%, neutropenia 30%, and thrombocytopenia 15%), neuropathy (18%), and gastrointestinal events (36%). Higher TILs correlated with increased pCR (70.6% vs. 60.7%, p = 0.049), while BRCA mutations showed a favorable trend. ECOG, BMI, pregnancy history, and comorbidities were not significantly associated with pCR. Conclusions: In this multicenter real-world cohort, maintaining chemotherapy dose intensity (RDI \u2265 85%) and completing all planned cycles were strongly associated with higher pCR rates, reinforcing the clinical importance of minimizing dose reductions and discontinuations during pembrolizumab-based neoadjuvant therapy for TNBC.<\/jats:p>","DOI":"10.3390\/cancers17213554","type":"journal-article","created":{"date-parts":[[2025,11,3]],"date-time":"2025-11-03T14:40:48Z","timestamp":1762180848000},"page":"3554","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["Impact of Chemotherapy Dose Intensity on Pathological Complete Response in Pembrolizumab-Treated Early Triple-Negative Breast Cancer: A Real-World Multicenter Analysis"],"prefix":"10.3390","volume":"17","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7437-4676","authenticated-orcid":false,"given":"Palma","family":"Fedele","sequence":"first","affiliation":[{"name":"Oncology Unit, Dario Camberlingo Hospital, Francavilla Fontana, 72021 Brindisi, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2063-1435","authenticated-orcid":false,"given":"Stefania Luigia","family":"Stucci","sequence":"additional","affiliation":[{"name":"Breast Care Unit, University Hospital Consortium Policlinico of Bari, 70124 Bari, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0591-9799","authenticated-orcid":false,"given":"Matteo","family":"Landriscina","sequence":"additional","affiliation":[{"name":"U.O. Medical Oncology and Biomolecular Therapy, Department of Medical and Surgical Sciences, University of Foggia, 71100 Foggia, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria","family":"Morritti","sequence":"additional","affiliation":[{"name":"Oncology Unit, Fondazione \u201cCasa Sollievo della Sofferenza\u201d, IRCCS, San Giovanni Rotondo, 71013 Foggia, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francesco","family":"Giuliani","sequence":"additional","affiliation":[{"name":"Oncology Unit, San Paolo Hospital, 70123 Bari, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lucia","family":"Moraca","sequence":"additional","affiliation":[{"name":"Oncology Unit, Teresa Masselli Mascia Hospital, San Severo, 71013 Foggia, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giuseppe","family":"Cairo","sequence":"additional","affiliation":[{"name":"Oncology Unit, Vito Fazzi Hospital, 73100 Lecce, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6268-9198","authenticated-orcid":false,"given":"Raffaele","family":"Ardito","sequence":"additional","affiliation":[{"name":"Day Hospital Oncologico IRCCS CROB, Rionero in Vulture, 85028 Potenza, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0009-9426-400X","authenticated-orcid":false,"given":"Marianna","family":"Giampaglia","sequence":"additional","affiliation":[{"name":"Oncology Unit, San Carlo Hospital, 85100 Potenza, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Domenico","family":"Bilancia","sequence":"additional","affiliation":[{"name":"Oncology Unit, San Carlo Hospital, 85100 Potenza, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Assunta","family":"Melaccio","sequence":"additional","affiliation":[{"name":"Oncology Unit, San Paolo Hospital, 70123 Bari, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Antonella","family":"Terenzio","sequence":"additional","affiliation":[{"name":"U.O. Medical Oncology and Biomolecular Therapy, Department of Medical and Surgical Sciences, University of Foggia, 71100 Foggia, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Antonio","family":"Gnoni","sequence":"additional","affiliation":[{"name":"Oncology Unit, Sacro Cuore di Ges\u00f9 Hospital, Gallipoli, 73014 Lecce, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Antonella","family":"Licchetta","sequence":"additional","affiliation":[{"name":"Oncology Unit, Sacro Cuore di Ges\u00f9 Hospital, Gallipoli, 73014 Lecce, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Federica","family":"Fumai","sequence":"additional","affiliation":[{"name":"Oncology Unit, Dario Camberlingo Hospital, Francavilla Fontana, 72021 Brindisi, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laura","family":"Lanotte","sequence":"additional","affiliation":[{"name":"Oncology Unit, Mons. Dimiccoli Hospital, 70051 Barletta, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5257-8678","authenticated-orcid":false,"given":"Alessandro","family":"Rizzo","sequence":"additional","affiliation":[{"name":"S.S.D. C.O.r.O. Bed Management Presa in Carico, TDM, IRCCS Istituto Tumori \u201cGiovanni Paolo II\u201d, 70124 Bari, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7120-8747","authenticated-orcid":false,"given":"Gennaro","family":"Gadaleta-Caldarola","sequence":"additional","affiliation":[{"name":"Oncology Unit, Mons. Dimiccoli Hospital, 70051 Barletta, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2025,11,2]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"674","DOI":"10.1038\/nrclinonc.2016.66","article-title":"Triple-negative breast cancer: Challenges and opportunities of a heterogeneous disease","volume":"13","author":"Bianchini","year":"2016","journal-title":"Nat. Rev. Clin. Oncol."},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"1938","DOI":"10.1056\/NEJMra1001389","article-title":"Triple-negative breast cancer","volume":"363","author":"Foulkes","year":"2010","journal-title":"N. Engl. J. 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