{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,26]],"date-time":"2026-09-26T10:53:57Z","timestamp":1790420037124,"version":"4.1.0"},"reference-count":34,"publisher":"MDPI AG","issue":"6","license":[{"start":{"date-parts":[[2021,12,7]],"date-time":"2021-12-07T00:00:00Z","timestamp":1638835200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Current Oncology"],"abstract":"<jats:p>Background: Adjuvant chemotherapy for Luminal B-like breast cancers usually includes anthracycline-based regimens. However, some patients are reluctant to receive chemotherapy because of side-effects, especially alopecia, and ask for a \u201cless intensive\u201d or personalized approach. Patients and methods: We conducted a phase II feasibility trial to evaluate pegylated liposomal doxorubicin (PLD, Caelyx\u00ae) as adjuvant chemotherapy. Patients who received surgery for pT1\u20133, any N, and luminal B-like early-stage breast cancer (EBC) candidates for adjuvant chemotherapy were included. PLD was administered intravenously at 20 mg\/m2 biweekly for eight courses. Endocrine therapy was given according to menopausal status. Trastuzumab was administered in HER2-positive disease. The primary endpoint was to evaluate the feasibility of this regimen, defined as the ability of a patient to achieve a relative dose intensity (RDI) of at least 85% of the eight cycles of treatment. Secondary endpoints included adverse events (AEs), tolerability, breast cancer-free survival, disease-free survival, and overall survival. Results: From March 2016 to July 2018, 63 patients were included in the trial. Median age was 49 years (range: 33\u201376), with mostly pre- and peri-menopausal (65%) and stage I\u2013II (94%). Only 5% of patients had HER2-positive EBC. Median RDI was 100% (range: 12.5\u2013100%; interquartile range, IQR: 87.5\u2013100%). The proportion of patients meeting the primary endpoint was 84% (95% confidence interval, CI: 73\u201392%). Overall, 55 out of 63 enrolled patients completed treatment (87%, 95% CI: 77\u201394%). Most common AEs were palmar-plantar erythrodysesthesia (12.2%), fatigue (10.4%), and mucositis (8.5%). Only 13% of patients had G3 AEs. None had alopecia. After a median follow-up of 3.9 years (range: 0.3\u20134.7) two distant events were observed, and all patients were alive at the date of last visit. Conclusions: The trial successfully met its primary endpoint: the regimen was feasible and well tolerated and could be considered for further evaluation as a treatment option for patients with contraindications to standard anthracyclines or requiring a personalized, less intensive approach.<\/jats:p>","DOI":"10.3390\/curroncol28060433","type":"journal-article","created":{"date-parts":[[2021,12,7]],"date-time":"2021-12-07T02:48:13Z","timestamp":1638845293000},"page":"5167-5178","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":16,"title":["Pegylated Liposomal Doxorubicin (Caelyx\u00ae) as Adjuvant Treatment in Early-Stage Luminal B-like Breast Cancer: A Feasibility Phase II Trial"],"prefix":"10.3390","volume":"28","author":[{"given":"Silvia","family":"Dellapasqua","sequence":"first","affiliation":[{"name":"Division of Medical Senology, IEO, European Institute of Oncology IRCCS, 20141 Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4341-003X","authenticated-orcid":false,"given":"Pamela","family":"Trillo Aliaga","sequence":"additional","affiliation":[{"name":"Division of Medical Senology, IEO, European Institute of Oncology IRCCS, 20141 Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3371-3878","authenticated-orcid":false,"given":"Elisabetta","family":"Munzone","sequence":"additional","affiliation":[{"name":"Division of Medical Senology, IEO, European Institute of Oncology IRCCS, 20141 Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vincenzo","family":"Bagnardi","sequence":"additional","affiliation":[{"name":"Department of Statistics and Quantitative Methods, University of Milan-Bicocca, 20126 Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eleonora","family":"Pagan","sequence":"additional","affiliation":[{"name":"Department of Statistics and Quantitative Methods, University of Milan-Bicocca, 20126 Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emilia","family":"Montagna","sequence":"additional","affiliation":[{"name":"Division of Medical Senology, IEO, European Institute of Oncology IRCCS, 20141 Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giuseppe","family":"Cancello","sequence":"additional","affiliation":[{"name":"Division of Medical Senology, IEO, European Institute of Oncology IRCCS, 20141 Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Raffaella","family":"Ghisini","sequence":"additional","affiliation":[{"name":"Division of Medical Senology, IEO, European Institute of Oncology IRCCS, 20141 Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Claudia","family":"Sangalli","sequence":"additional","affiliation":[{"name":"Division of Medical Senology, IEO, European Institute of Oncology IRCCS, 20141 Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mara","family":"Negri","sequence":"additional","affiliation":[{"name":"Division of Medical Senology, IEO, European Institute of Oncology IRCCS, 20141 Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Manuelita","family":"Mazza","sequence":"additional","affiliation":[{"name":"Division of Medical Senology, IEO, European Institute of Oncology IRCCS, 20141 Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Monica","family":"Iorfida","sequence":"additional","affiliation":[{"name":"Division of Medical Senology, IEO, European Institute of Oncology IRCCS, 20141 Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anna","family":"Cardillo","sequence":"additional","affiliation":[{"name":"Division of Medical Senology, IEO, European Institute of Oncology IRCCS, 20141 Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Angela","family":"Sciandivasci","sequence":"additional","affiliation":[{"name":"Division of Medical Senology, IEO, European Institute of Oncology IRCCS, 20141 Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5765-7765","authenticated-orcid":false,"given":"Nadia","family":"Bianco","sequence":"additional","affiliation":[{"name":"Division of Medical Senology, IEO, European Institute of Oncology IRCCS, 20141 Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ana Paula","family":"De Maio","sequence":"additional","affiliation":[{"name":"Division of Medical Senology, IEO, European Institute of Oncology IRCCS, 20141 Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Monica","family":"Milano","sequence":"additional","affiliation":[{"name":"Division of Medical Senology, IEO, European Institute of Oncology IRCCS, 20141 Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giuseppe Maria","family":"Campenn\u00ec","sequence":"additional","affiliation":[{"name":"Division of Medical Senology, IEO, European Institute of Oncology IRCCS, 20141 Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Loredana","family":"Sansonno","sequence":"additional","affiliation":[{"name":"Division of Medical Senology, IEO, European Institute of Oncology IRCCS, 20141 Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giuseppe","family":"Viale","sequence":"additional","affiliation":[{"name":"Department of Pathology, European Institute of Oncology IRCCS and University of Milan, 20141 Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anna","family":"Morra","sequence":"additional","affiliation":[{"name":"Division of Radiotherapy, European Institute of Oncology IRCCS, 20141 Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria Cristina","family":"Leonardi","sequence":"additional","affiliation":[{"name":"Division of Radiotherapy, European Institute of Oncology IRCCS, 20141 Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Viviana","family":"Galimberti","sequence":"additional","affiliation":[{"name":"Division of Senology, IEO, European Institute of Oncology IRCCS, 20141 Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paolo","family":"Veronesi","sequence":"additional","affiliation":[{"name":"Division of Senology, IEO, European Institute of Oncology IRCCS, 20141 Milan, 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