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Up to 20% of breast cancer overexpress HER2 protein, making it a reliable target for antibody-based treatments. In early HER2-positive breast cancer avoiding anthracycline-based chemotherapy is a challenge. Based on the single-arm phase II APT trial results, adjuvant paclitaxel/trastuzumab is an accepted regimen for patients with stage I HER2-positive disease. In our retrospective study of 240 patients, the median tumor size was 12.0 mm (IQR 9 -15), and 204 (85%) had estrogen receptor-positive disease. After a median follow-up of 4.6 years, 3-year real-world disease-free survival, distant DFS, and overall survival were 98.8% (95% confidence interval (CI), 96.2-99.6), 99.2% (95% CI, 96.7-99.8), and 98.3% (95% CI, 96.2-99.6), respectively. In a real-world setting, an adjuvant paclitaxel/trastuzumab regimen was associated with low recurrence rates among women with stage I, HER2-positive breast cancer. Additionally, we reviewed other treatment optimization strategies attempted or ongoing in HER2-positive breast cancer., Competing Interests: Declaration of Competing Interest VD, MS, FJ, MM, MP, IS, WH: none. GNM: Travel grants for meetings from Roche and Bayer, outside the submitted work. EA: Speaking fee/consultancy: Eli Lilly, Sandoz, AstraZeneca. Support to attend medical conferences from Eli Lilly, Roche, Novartis, Genetics, Istituto Gentili, Daiichi Sankyo (all outside the present work). CM: receive fees from Novartis and Lilly outside the submitted work.Ugo De Giorgi received honoraria for advisory boards or speaker fees for Pfizer, BMS, MSD, PharmaMar, Astellas, Bayer, Ipsen, Roche, Novartis, Clovis, GSK, AstraZeneca, Institutional research grants from AstraZeneca, Sanofi and Roche all outside the submitted work. UDG: Advisory boards: Astellas, Bayer, BMS, Ipsen, MSD, Novartis, Pfizer, PharmaMar, Roche; Institutional research grant: AstraZeneca, Roche, Sanofi. AS: Advisory Board: BMS (BRISTOL-MYERS-SQUIBB), Servier,Gilead, Pfizer, Eisai, Bayer, MSD (MERCK SHARP & DOHME); Consultancy: Arqule, Sanofi, Incyte; Speaker’s Bureau: Takeda, BMS, Roche, Abbvie, Amgen, Celgene, Servier, Gilead, Astrazeneca, Pfizer, Arqule, Lilly, Sandoz, Eisai, Novartis, Bayer, MSD. DT: advisory board: Agendia, AstraZeneca, Daiichi Sankyo, Eli Lilly, Medscape, MSD, Novartis, Roche; Travel: AstraZeneca,Pfizer, Roche. FPD: Advisory Board: Amgen, AstraZeneca, Daiichi Sankyo, Gilead Sceince, Lilly, Novartis, Pfizer, Pierre Fabre, Roche, Seagen; Contracted Research: Fondation belge contre le cancer; Institutional grant: AstraZeneca. AB: Advisory board: Argen, BMS, Eli-Lilly, MSD, Novartis, Pfizer, Roche. GB: Advisory board: BMS, Eli Lilly, MSD, Novartis, Pfizer, Roche; Travel: BMS, Eli Lilly, MSD, Novartis, Pfizer, Roche. ML: reports advisory role for Roche, Lilly, Novartis, Astrazeneca, Pfizer, Seagen, Gilead, MSD and Exact Sciences; speaker honoraria from Roche, Lilly, Novartis, Pfizer, Sandoz, Libbs, Daiichi Sankyo and Takeda; Travel Grants from Gilead; Research funding (to the Institution) from Gilead outside the submitted work. EdA: Honoraria and/or advisory board from Roche/GNE, Novartis, SeaGen, Zodiac, Libbs, Pierre Fabre, Lilly, Astra-Zeneca; travel grants from Roche/GNE and Astra-Zeneca; Research grant to my institution from Roche/GNE, AstraZeneca, and GSK/Novartis. MP: Board Member (Scientific Board): Oncolytics; Consultant (honoraria): AstraZeneca, Camel-IDS/Precirix, Gilead, Immunomedics, Lilly, Menarini, MSD, Novartis, Pfizer, Roche-Genentech, Seattle Genetics, Immutep, Seagen, NBE Therapeutics, Frame Therapeutics; Research grants to my Institute: AstraZeneca, Immunomedics, Lilly, Menarini, MSD, Novartis, Pfizer, Radius, Roche-Genentech, Servier, Synthon., (Copyright © 2023 Elsevier B.V. All rights reserved.)

Aims and Background: Capecitabine is the reference treatment for anthracycline- and/or taxane-pretreated metastatic breast cancer (MBC). This study examined its efficacy, tolerability and impact on the quality of life of elderly patients with MBC., Materials and Methods: Between January 2002 and December 2009, 75 consecutive elderly patients with MBC received first-line chemotherapy with capecitabine 1000 mg/m2 twice daily for 14 days every 3 weeks. Endpoints were efficacy, tolerability and clinical-benefit response measured every 3 cycles., Results: Median age was 76 years (range 65-88); median ECOG performance status was 1 (range 0-2); 51 patients (68%) had received adjuvant chemotherapy and all patients had received hormonal therapy. Median exposure was 6 cycles. After 3 cycles, 11 patients (14.7%) had a partial response, one patient experienced a complete response, and 49 patients (65.3%) had stable disease, amounting to a disease control rate of 81.3%. Stable disease was maintained in 45 patients (60%) after 6 cycles, in 21 patients (28%) after 9 cycles, and in 13 patients (17.3%) after 12 cycles. A clinical-benefit response was experienced by 42 patients (56%), indicating a positive impact on quality of life. Treatment was well tolerated, the most common grade 3 events being diarrhea (12%) hand-foot syndrome (8%), and mucositis (8%). Adverse events were managed with dose adjustments and supportive therapy when required., Conclusions: Our results indicate that capecitabine is active and well tolerated in elderly patients with MBC. This dosing regimen warrants further study in the first-line setting for patients with less aggressive MBC who are not candidates for combination therapy.