PMID- 34940072 OWN - NLM STAT- MEDLINE DCOM- 20220324 LR - 20220324 IS - 1718-7729 (Electronic) IS - 1198-0052 (Print) IS - 1198-0052 (Linking) VI - 28 IP - 6 DP - 2021 Dec 7 TI - Pegylated Liposomal Doxorubicin (Caelyx((R))) as Adjuvant Treatment in Early-Stage Luminal B-like Breast Cancer: A Feasibility Phase II Trial. PG - 5167-5178 LID - 10.3390/curroncol28060433 [doi] AB - 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 "less intensive" or personalized approach. PATIENTS AND METHODS: We conducted a phase II feasibility trial to evaluate pegylated liposomal doxorubicin (PLD, Caelyx((R))) as adjuvant chemotherapy. Patients who received surgery for pT1-3, any N, and luminal B-like early-stage breast cancer (EBC) candidates for adjuvant chemotherapy were included. PLD was administered intravenously at 20 mg/m(2) 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: 33-76), with mostly pre- and peri-menopausal (65%) and stage I-II (94%). Only 5% of patients had HER2-positive EBC. Median RDI was 100% (range: 12.5-100%; interquartile range, IQR: 87.5-100%). The proportion of patients meeting the primary endpoint was 84% (95% confidence interval, CI: 73-92%). Overall, 55 out of 63 enrolled patients completed treatment (87%, 95% CI: 77-94%). 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: 0.3-4.7) 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. FAU - Dellapasqua, Silvia AU - Dellapasqua S AD - Division of Medical Senology, IEO, European Institute of Oncology IRCCS, 20141 Milan, Italy. FAU - Trillo Aliaga, Pamela AU - Trillo Aliaga P AD - Division of Medical Senology, IEO, European Institute of Oncology IRCCS, 20141 Milan, Italy. FAU - Munzone, Elisabetta AU - Munzone E AUID- ORCID: 0000-0003-3371-3878 AD - Division of Medical Senology, IEO, European Institute of Oncology IRCCS, 20141 Milan, Italy. FAU - Bagnardi, Vincenzo AU - Bagnardi V AD - Department of Statistics and Quantitative Methods, University of Milan-Bicocca, 20126 Milan, Italy. FAU - Pagan, Eleonora AU - Pagan E AD - Department of Statistics and Quantitative Methods, University of Milan-Bicocca, 20126 Milan, Italy. FAU - Montagna, Emilia AU - Montagna E AD - Division of Medical Senology, IEO, European Institute of Oncology IRCCS, 20141 Milan, Italy. FAU - Cancello, Giuseppe AU - Cancello G AD - Division of Medical Senology, IEO, European Institute of Oncology IRCCS, 20141 Milan, Italy. FAU - Ghisini, Raffaella AU - Ghisini R AD - Division of Medical Senology, IEO, European Institute of Oncology IRCCS, 20141 Milan, Italy. FAU - Sangalli, Claudia AU - Sangalli C AD - Division of Medical Senology, IEO, European Institute of Oncology IRCCS, 20141 Milan, Italy. FAU - Negri, Mara AU - Negri M AD - Division of Medical Senology, IEO, European Institute of Oncology IRCCS, 20141 Milan, Italy. FAU - Mazza, Manuelita AU - Mazza M AD - Division of Medical Senology, IEO, European Institute of Oncology IRCCS, 20141 Milan, Italy. FAU - Iorfida, Monica AU - Iorfida M AD - Division of Medical Senology, IEO, European Institute of Oncology IRCCS, 20141 Milan, Italy. FAU - Cardillo, Anna AU - Cardillo A AD - Division of Medical Senology, IEO, European Institute of Oncology IRCCS, 20141 Milan, Italy. FAU - Sciandivasci, Angela AU - Sciandivasci A AD - Division of Medical Senology, IEO, European Institute of Oncology IRCCS, 20141 Milan, Italy. FAU - Bianco, Nadia AU - Bianco N AUID- ORCID: 0000-0001-5765-7765 AD - Division of Medical Senology, IEO, European Institute of Oncology IRCCS, 20141 Milan, Italy. FAU - De Maio, Ana Paula AU - De Maio AP AD - Division of Medical Senology, IEO, European Institute of Oncology IRCCS, 20141 Milan, Italy. FAU - Milano, Monica AU - Milano M AD - Division of Medical Senology, IEO, European Institute of Oncology IRCCS, 20141 Milan, Italy. FAU - Campenni, Giuseppe Maria AU - Campenni GM AD - Division of Medical Senology, IEO, European Institute of Oncology IRCCS, 20141 Milan, Italy. FAU - Sansonno, Loredana AU - Sansonno L AD - Division of Medical Senology, IEO, European Institute of Oncology IRCCS, 20141 Milan, Italy. FAU - Viale, Giuseppe AU - Viale G AD - Department of Pathology, European Institute of Oncology IRCCS and University of Milan, 20141 Milan, Italy. FAU - Morra, Anna AU - Morra A AD - Division of Radiotherapy, European Institute of Oncology IRCCS, 20141 Milan, Italy. FAU - Leonardi, Maria Cristina AU - Leonardi MC AD - Division of Radiotherapy, European Institute of Oncology IRCCS, 20141 Milan, Italy. FAU - Galimberti, Viviana AU - Galimberti V AD - Division of Senology, IEO, European Institute of Oncology IRCCS, 20141 Milan, Italy. FAU - Veronesi, Paolo AU - Veronesi P AD - Division of Senology, IEO, European Institute of Oncology IRCCS, 20141 Milan, Italy. FAU - Colleoni, Marco AU - Colleoni M AD - Division of Medical Senology, IEO, European Institute of Oncology IRCCS, 20141 Milan, Italy. LA - eng PT - Clinical Trial, Phase II PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20211207 PL - Switzerland TA - Curr Oncol JT - Current oncology (Toronto, Ont.) JID - 9502503 RN - 0 (liposomal doxorubicin) RN - 3WJQ0SDW1A (Polyethylene Glycols) RN - 80168379AG (Doxorubicin) SB - IM MH - *Breast Neoplasms/drug therapy MH - Doxorubicin/analogs & derivatives MH - Feasibility Studies MH - Female MH - Humans MH - Middle Aged MH - Polyethylene Glycols PMC - PMC8700739 OTO - NOTNLM OT - Caelyx(R) OT - adjuvant chemotherapy OT - early breast cancer OT - luminal B-like subtypes OT - pegylated liposomal doxorubicin (PLD) COIS- Silvia Dellapasqua-Travel, Accommodations, Expenses: Lilly, Novartis, Pfizer. Emilia Montagna-Consulting or Advisory Role: Pierre Fabre. Giuseppe Viale-Honoraria: MSD Oncology, Pfizer, Daiichi Sankyo Europe GmbH; Consulting or Advisory Role: Dako, Roche/Genentech, Novartis, Bayer; Daiichi Sankyo, MSD Oncology, Menarini; Speakers' Bureau: Roche/Genentech; Research Funding: Roche/Genentech, Ventana Medical Systems, Dako/Agilent Technologies, Cepheid Recipient; Travel, Accommodations, Expenses: Roche. Marco Colleoni-Research Grant from Roche. The remaining uthors declare no conflict of interest. EDAT- 2021/12/24 06:00 MHDA- 2022/03/25 06:00 PMCR- 2021/12/07 CRDT- 2021/12/23 12:42 PHST- 2021/10/17 00:00 [received] PHST- 2021/11/19 00:00 [revised] PHST- 2021/11/30 00:00 [accepted] PHST- 2021/12/23 12:42 [entrez] PHST- 2021/12/24 06:00 [pubmed] PHST- 2022/03/25 06:00 [medline] PHST- 2021/12/07 00:00 [pmc-release] AID - curroncol28060433 [pii] AID - curroncol-28-00433 [pii] AID - 10.3390/curroncol28060433 [doi] PST - epublish SO - Curr Oncol. 2021 Dec 7;28(6):5167-5178. doi: 10.3390/curroncol28060433.