© 2015 INTM, Italy. Published by Wichtg Publishing TJ ISSN 0300-8916 Tumori 2015; 101(4): 418-423 ORIGINAL RESEARCH ARTICLE beter results, many diferent monotherapy or combined chemotherapy regimens have been studied in the frst-line setng in MBC (2). Patents with more aggressive tumors (i.e., triple nega- tve), who may present with symptomatc visceral metastases, are shown to respond beter to combinaton chemotherapy regimens, whereas patents with more slowly progressing dis- ease are suggested to beneft more from single-agent chemo- therapy (3, 4). Cochrane collaboraton meta-analysis showed that combinaton chemotherapy protocols ofer a beneft in overall survival (OS), tme to progression, and response over traditonal single-agent chemotherapy, including cyclophos- phamide, fuorouracil (FU), and epirubicin (5). However, this meta-analysis did not compare the more recent agents, in- cluding capecitabine and taxanes. Indeed, recent studies sup- port the use of single-agent therapy because this strategy is generally less toxic, improves quality of life, and provides survival rates similar to those achieved with combinaton regi- mens (6-9). One of the oral single-agent therapies used as a frst-line monotherapy for MBC is capecitabine. Capecitabine is a safe DOI: 10.5301/tj.5000332 Efcacy of capecitabine monotherapy as the frst-line treatment of metastatc HER2-negatve breast cancer Taner Babacan 1 , Orhan Efe 1 , Ahmet S. Hasirci 1 , Fath Demirci 1 , Hakan Buyukhatpoglu 2 , Ozan Balakan 2 , Furkan Sarici 1 , Neyran Kertmen 1 , Ece Esin 1 , Serkan Akin 1 , Ozturk Ates 1 , Sercan Aksoy 1 , Ali R. Sever 3 , Kadri Altundag 1 1 Department of Medical Oncology, Hacetepe University Cancer Insttute, Ankara - Turkey 2 Department of Medical Oncology, Gaziantep University School of Medicine, Gaziantep - Turkey 3 Department of Radiology, Hacetepe University Faculty of Medicine, Ankara - Turkey Introducton For the vast majority of patents, metastatc breast cancer (MBC) is an incurable disease and systemic treatment aims to prolong survival, provide symptom palliaton, and improve patents’ quality of life. There are several factors that need to be considered in the treatment strategies of MBC, such as pa- tent age, presence of symptoms, tumor characteristcs (e.g., estrogen receptor, progesterone receptor, or human epider- mal receptor 2 [HER2] status), disease-free intervals, disease extent, and previous treatments (1). In order to achieve ABSTRAcT Aims and Background: Capecitabine is a potent and safe agent that can be used afer anthracycline and taxane treatment in patents with metastatc breast cancer (MBC). The purpose of this study was to investgate the ef- fcacy and safety of capecitabine monotherapy as a frst-line treatment in human epidermal receptor 2 (HER2)- negatve patents with MBC. Methods and Study design: In this single-center trial, a total of 109 HER2-negatve patents with MBC who re- ceived capecitabine monotherapy as frst-line treatment between 2003 and 2014 were retrospectvely analyzed. Kaplan-Meier survival analysis was carried out for progression-free survival (PFS) and for overall survival (OS). Two-sided p values of <0.05 were considered statstcally signifcant. Results: Median PFS was 7.0 ± 0.67 (confdence interval (CI) 5.6-8.3) months and median OS was 30 ± 4.1 (CI 21.8- 38.1) months. First-line capecitabine treatment for HER2-negatve MBC was more efectve in the estrogen recep- tor (ER)-positve patent populaton compared to the ER-negatve group (median PFS 9 vs 4 months (p = 0.002), median OS 33 vs 21 months (p = 0.01)). Indeed, the overall response rate in the ER-negatve group was 16%, while this was calculated as 38% for ER-positve cases. While most of our patent populaton was treated with a higher dose (1250 mg/m 2 ), the observed grade 3-4 toxicites were lower compared to some previously reported phase II and phase III capecitabine studies. conclusions: Capecitabine monotherapy is an efectve and safe regimen for ER-positve, HER2-negatve patents with MBC. Its low toxicity profle compared to other intravenous cytotoxic agents and the ease of its oral admin- istraton make this agent a preferable opton for both physicians and patents. Keywords: Capecitabine monotherapy, Metastatc breast cancer, Overall survival, Progression-free survival Accepted: February 24, 2015 Published online: April 27, 2015 corresponding author: Kadri Altundag, MD Hacetepe University Cancer Insttute 06100 Sihhiye Ankara, Turkey drkadri@usa.net