Role Of Capecitabine Research Articles

Shifting Paradigms in TNBC Treatment: Emerging Alternatives to Capecitabine in the Post-Neoadjuvant Setting.

Triple-negative breast cancer (TNBC) remains a clinically challenging subtype due to its aggressive nature and limited treatment options post-neoadjuvant failure. Historically, capecitabine has been the cornerstone of adjuvant therapy for TNBC patients not achieving a pathological complete response (pCR). However, the integration of new modalities such as immunotherapy and PARP inhibitors has prompted a re-evaluation of traditional post-neoadjuvant approaches. This review synthesizes data from pivotal clinical trials and meta-analyses to evaluate the efficacy of emerging therapies in the post-neoadjuvant setting. We focus on the role of immune checkpoint inhibitors (ICIs), PARP inhibitors (PARPis), and antibody-drug conjugates (ADCs) alongside or in place of capecitabine in TNBC treatment paradigms. The addition of ICIs like pembrolizumab to neoadjuvant regimens has shown increased pCR rates and improved event-free survival, posing new questions about optimal post-neoadjuvant therapies. Similarly, PARPis have demonstrated efficacy in BRCA-mutated TNBC populations, with significant improvements in disease-free survival (DFS) and overall survival (OS). Emerging studies on ADCs further complicate the adjuvant landscape, offering potentially efficacious alternatives to capecitabine, especially in patients with residual disease after neoadjuvant therapy. The challenge remains to integrate these new treatments into clinical practice effectively, considering factors such as drug resistance, patient-specific characteristics, and socio-economic barriers. This review discusses the implications of these therapies and suggests a future direction focused on personalized medicine approaches in TNBC. As the treatment landscape for TNBC evolves, the role of capecitabine is being critically examined. While it remains a viable option for certain patient groups, the introduction of ICIs, PARPis, and ADCs offers promising alternatives that could redefine adjuvant therapy standards. Ongoing and future trials will be pivotal in determining the optimal therapeutic strategies for TNBC patients with residual disease post-neoadjuvant therapy.

Fisetin and/or capecitabine causes changes in apoptosis pathways in capecitabine-resistant colorectal cancer cell lines

Capecitabine is recommended as one of the first-line chemotherapy treatments for advanced or metastatic colorectal cancer. Researches have been conducted on capecitabine’s impact on the viability of human colon cancer cells and its potential to induce apoptosis. However, even in cases initially responsive to treatment, the development of acquired resistance significantly limits its efficacy. Challenges still exist in effectively treating patients with chemotherapy, and developing new cytotoxic drugs is hindered by drug resistance. Fisetin alters the cell cycle, inducing apoptosis, inhibiting cancer cell proliferation, and enhancing the therapeutic effectiveness of chemotherapy drugs. This work aims to create a plan for reversing capecitabine resistance. For this purpose, the role of capecitabine and/or fisetin combinations in cell proliferation and apoptosis has been determined in both wild-type and capecitabine-resistant HT29 cells (CR/HT29). We developed capecitabine-resistant cell line from wild-type HT29 cells. This study demonstrated the effects of capecitabine, fisetin, and their combinations on both resistant and wild-type cells through experiments including cell survival skills, cell proliferation, wound healing, colony formation, hoechst staining, and western blot analysis. We established capecitabine-resistant cell lines. P-gp expression increased in CR/HT29 cells. Capecitabine effects on a CR/HT29 cells less than wild-type HT29 cells. The combination of fisetin and capecitabine in cell proliferation caused greater reductions in wild-type HT29 cells than in capecitabine-resistant cells. Fisetin has also additive effects on the apoptotic pathway in CR/HT29 cells. This study provides new perspectives on the combination of capecitabine and/or flavonoid treatment in resistant cells.Graphical abstract

Treatment options in early triple-negative breast cancer

SummaryWith a main focus on the early stage triple-negative breast cancer (TNBC), new data on immunotherapy in combination with chemotherapy, the role of capecitabine, the potential of circulating tumor DNA as a predictive tool in the postneoadjuvant setting and new treatment approaches were presented and discussed at the San Antonio Breast Cancer Symposium (SABCS) 2019.

Evaluation of antiangiogenic therapy with bevacizumab in addition to neoadjuvant chemotherapy in the treatment of locally advanced breast cancer.

e12115 Background: Anti-angiogenic therapy improves outcomes in cancer therapy; we hypothesized an improved outcome with the addition of bevacizumab to dose dense neoadjuvant chemotherapy (ddNAC) in the treatment of locally advanced breast cancer (LABC). Methods: We added bevacizumab to ddNAC in the pre-operative management of LABC. Eligible subjects signed an informed consent, had biopsy and radiographically confirmed stage II-III LABC and absence of major organ malfunction. ddNAC was comprised of docetaxel 35mg/M2 intravenous (IV) on days 1 and 8, capecitabine 800mg/M2 by mouth two times a day on days 1-14 and bevacizumab 15mg/kg IV repeated every 21 days for 4 cycles, followed with doxorubicin 60 mg/M2 and cyclophosphamide 600mg/M2IV with peg-filgrastim 6mg given subcutaneously on day 1, every 14 days for 4 cycles (TX/ddAC). Subsequently, subjects underwent surgery and adjuvant radiation and/or hormonal therapy as clinically indicated. The primary objective was the pathologic complete response rate (pCR). As a secondary end point, we compared the rates of pCR with our prior study of the same chemotherapy regimen without bevacizumab (n = 52). Lastly, we evaluated the safety and tolerability of the regimen. Results: 34 subjects were enrolled and 31 completed the study. Using a modified intent to treat analysis, pCR with residual in-situ carcinoma (pCRinv) was 3/31 (9.7%), total pCR 8/31 (25.8%), and residual invasive carcinoma 20/31 (64.5%). In comparison, our prior study results, presented at the 2006 San Antonio Breast Cancer Symposium, showed a pCRinv7/52 (13.5%), total pCR 27/52 (52%), and rate of residual invasive carcinoma of 25/52 (48%). Observed toxicities included hand/foot syndrome, alopecia, nausea/vomiting, mucositis, neutropenia, febrile neutropenia, nail changes and hyperlacrimation. There was one treatment related death. Conclusions: The addition of bevacizumab to chemotherapy (TX/ddAC) did not improve the observed rates of pCR. However, the role of capecitabine in the neoadjuvant setting needs to be explored further. Moreover a post hoc analysis of the efficacy of the regimen in LABC subtypes is ongoing, with biologic correlates.

Adjuvant capesitabine in combination with docetaxel (T), epirubicin (E), and cyclophosphamide (C) in the treatment of early breast cancer (BC): 10-year survival results from the randomized FinXX trial.

1001Background: The role of capecitabine (X) in the adjuvant treatment of BC is not established, and few long-term survival data are available. In an analysis of the Finland Capecitabine Trial (FinXX), based on a median FU of 59 months (JCO 2012;30:11-8), patients (pts) treated with X-containing adjuvant chemotherapy did not have significantly longer recurrence-free survival (RFS) as compared with the control group (HR 0.79, 95% CI 0.60-1.04, P= .087), but in an exploratory analysis a significant benefit emerged in the subset with triple negative BC (TNBC; ER-, PgR-, and HER2-; HR 0.48, 95% CI 0.26-0.88). Methods: Eligible pts had either axillary node-positive or high-risk node-negative BC (tumor >20 mm and PgR-). Pts were randomly assigned centrally either to 3 3-wkly cycles of docetaxel (T, 80 mg/m2) followed by 3 3-wkly cycles of C600 E75 F600 (T-CEF) or to 3 3-wkly cycles of TX (T60 , X1800 for dd. 1-15) followed by 3 3-wkly cycles of C600 E75 X1800 (TX-CEX). A total of 1,500 patients were entered to ...

Role of capecitabine in treating metastatic colorectal cancer in Chinese patients.

The China Food and Drug Administration approved the use of capecitabine in patients with metastatic colorectal cancer (mCRC) in 2004. This paper reviews the available information of capecitabine in Chinese patients with mCRC, focusing on its effectiveness and safety against mCRC. Identification of all eligible studies was made by searching the PubMed and Wanfang database from 2000 to 2013. Published data examining various aspects of clinical response and tolerability with capecitabine alone or in combination with other chemotherapeutic or biological agents for first- and second-line mCRC were examined. Capecitabine and its combination displayed high efficacy in Chinese patients with mCRC. Toxicities are generally manageable, and elderly patients can tolerate capecitabine well.

The Role of Capecitabine in Locally Advanced Rectal Cancer Treatment

Preoperative infusional 5-fluorouracil (5-FU) and concurrent radiation therapy (RT) followed by total mesorectal surgery is the current standard of care for locally advanced rectal cancer (LAR). When compared with postoperative 5-FU-based chemoradiation, this strategy is associated with significantly lower rates of local relapse, lower toxicity and better compliance. Capecitabine is a rationally designed oral prodrug that is converted into 5-FU by intracellular thymidine phosphorylase. Substitution of infusional 5-FU with capecitabine is an attractive option that provides a more convenient administration schedule and, possibly, increased efficacy. Indeed, incorporation of capecitabine in combined modality neoadjuvant therapy for LAR has been under intense investigation during the last 10 years. Phase I and II clinical trials showed that a regimen consisting of capecitabine 825mg/m(2) twice daily for 7 days/week continuous oral administration in combination with RT is an active and well tolerated regimen, thereby being the preferred concurrent regimen. The definitive demonstration that efficacy of capecitabine/RT is similar to 5-FU/RT has been provided by the NSABP-R-04 and the German Margit trials. One approach to improve outcomes in rectal cancer is to deliver a second RT-sensitizing drug with effective systemic activity. Oxaliplatin and irinotecan are therefore good candidates. However, two phase III trials demonstrated that incorporation of oxaliplatin to capecitabine with RT did not improve early outcomes and, by contrast, increased toxicity. Capecitabine has also been combined with irinotecan. This regimen showed encouraging results in phase I and II clinical trials, which led to an ongoing phase III clinical trial. New strategies with induction chemotherapy with or without chemoradiation prior to surgery are currently under investigation. Whether or not capecitabine has a role in this setting is being investigated in ongoing trials. Incorporation of agents directed towards new targets, such as anti-epidermal growth factor receptor (EGFR) antibodies or antiangiogenic agents, in combination preoperative regimens, is being hampered by results of early trials in which efficacy outcomes with cetuximab were poor and an excessive rate of surgical complications with bevacizumab was observed. The lack of improvements in efficacy with the addition of cetuximab or bevacizumab in the adjuvant treatment of colon cancer led to concerns about further development of these agents in rectal cancer. The role of capecitabine in the postoperative adjuvant setting is the aim of the ongoing Dutch SCRIPT trial. The prediction of response associated with capecitabine has been based on expression of thymidylate synthase and dihydropyrimidine dehydrogenase, as well as on gene expression arrays. All these procedures require further validation and should be considered as investigational. In conclusion, capecitabine can safely and effectively replace intravenous continuous infusion of 5-FU in the preoperative chemoradiation setting for rectal cancer management. The addition of other new antineoplastic agents to a fluoropyrimidine-based regimen remains investigational.

The Role of Capecitabine in Early Stage Breast Cancer

Adjuvant systemic therapy is partly responsible for the decrease in breast cancer mortality we have seen over the past two decades. Hormonal therapy and combination chemotherapy based on anthracyclines and taxanes represent the best current approach for early breast cancer patients. Primary as well as secondary development of resistance represents the major challenges to improve our results. Major benefits have been achieved as we recognized populations with particular molecular abnormalities (HER2 positive) and applied specific targeted agents (trastuzumab). However, the addition of other traditional chemotherapy agents has remained a challenge. With consistent data both as a single agent and as part of combinations in the treatment of advanced disease, capecitabine is being explored in over 20,000 early breast cancer patients currently participating in clinical trials. In this review, we discuss the available evidence for the incorporation of capecitabine in the (neo)-adjuvant treatment of patients with breast cancer.

Use of capecitabine in management of early colon cancer

Capecitabine (Xeloda®, Roche, Basel, Switzerland) is a pro-drug of 5-fluorouracil (5-FU), and it is converted to 5-FU in the cancer cell by enzymatic degradation. The role of capecitabine in colorectal cancer has evolved in the last 15 years. In early trials in the metastatic setting, capecitabine has shown superior response rates compared with those achieved with 5-FU (Mayo Clinic regimen) (26% vs 17%), with equivalent progression-free survival and overall survival. In the adjuvant setting, the Xeloda in Adjuvant Colon Cancer Therapy (X-ACT) trial demonstrated that capecitabine as a single agent led to improvement in relapse-free survival (hazard ratio: 0.86, 95% confidence interval: 0.74–0.99, P = 0.04) and was associated with significantly fewer adverse events than 5-FU plus leucovorin (LV, folinic acid). On the basis of the X-ACT trial, capecitabine was approved by the United States Food and Drug Administration, the National Institute for Clinical Excellence, and the Scottish Medicines Consortium as monotherapy for the adjuvant treatment of stage III colon cancer. The next step was to incorporate capecitabine into combination therapy. The XELOXA trial studied the combination of capecitabine and oxaliplatin (XELOX) vs 5-FU/LV and demonstrated 5-year disease-free survival of 66% for XELOX, compared with 60% for 5-FU/LV. The toxicity profile was also quite comparable in the two arms. So both the single agent use of capecitabine as well as in combination with oxaliplatin can be considered as part of the standard of care in management of early colon cancer in appropriately selected patient groups.

Use of capecitabine in management of early colon cancer

Use of capecitabine in management of early colon cancer H Hameed, J CassidyBeatson West of Scotland Cancer Centre, Glasgow, Scotland, UKAbstract: Capecitabine (Xeloda®, Roche, Basel, Switzerland) is a pro-drug of 5-fluorouracil (5-FU), and it is converted to 5-FU in the cancer cell by enzymatic degradation. The role of capecitabine in colorectal cancer has evolved in the last 15 years. In early trials in the metastatic setting, capecitabine has shown superior response rates compared with those achieved with 5-FU (Mayo Clinic regimen) (26% vs 17%), with equivalent progression-free survival and overall survival. In the adjuvant setting, the Xeloda in Adjuvant Colon Cancer Therapy (X-ACT) trial demonstrated that capecitabine as a single agent led to improvement in relapse-free survival (hazard ratio: 0.86, 95% confidence interval: 0.74–0.99, P = 0.04) and was associated with significantly fewer adverse events than 5-FU plus leucovorin (LV, folinic acid). On the basis of the X-ACT trial, capecitabine was approved by the United States Food and Drug Administration, the National Institute for Clinical Excellence, and the Scottish Medicines Consortium as monotherapy for the adjuvant treatment of stage III colon cancer. The next step was to incorporate capecitabine into combination therapy. The XELOXA trial studied the combination of capecitabine and oxaliplatin (XELOX) vs 5-FU/LV and demonstrated 5-year disease-free survival of 66% for XELOX, compared with 60% for 5-FU/LV. The toxicity profile was also quite comparable in the two arms. So both the single agent use of capecitabine as well as in combination with oxaliplatin can be considered as part of the standard of care in management of early colon cancer in appropriately selected patient groups.Keywords: 5-fluorouracil, 5-FU, leucovorin, folinic acid, LV, XELOX, oxaliplatin, FOLFOX

The role of capecitabine in the management of breast cancer in elderly patients

Abstract Breast cancer is frequently diagnosed in older women, yet treatment standards are based largely on clinical trials conducted in younger women. Survival outcomes for breast cancer in older women are suboptimal, partly because of underuse of appropriate therapy. Capecitabine is an oral fluoropyrimidine with a favorable side effect profile that is an attractive therapeutic option for older breast cancer patients. However, dose adjustments for renal function and careful monitoring of adherence, potential drug interactions, and toxicity are particularly important in this population. The article reviews the safety and efficacy data from studies with capecitabine monotherapy or capecitabine in combination with other therapies for breast cancer, with a particular focus on elderly patients.

Role of capecitabine and irinotecan combination therapy in advanced or metastatic gastric cancer

Gastric cancer is one of the most common cancers and the second leading cause of cancer-related death. So far, the only curative treatment for gastric cancer is surgery. However, approximately half of all patients present with nonoperable tumors. Therefore, combination chemotherapy regimens are being accepted nowadays as first-line treatment for this disease. Despite the numerous efforts of randomized trials on advanced gastric cancer, no globally accepted regimen has yet been established. Historically, the most widely adopted protocols use 5-fluorouracil or platinum-based therapy with a response rate not exceeding 50% in combination therapy with a high rate of toxicity. Recently, many new drugs have emerged on the market and have been used in treating advanced or metastatic gastric cancer allowing the creation of new combination regimens with better clinical benefit. The combination of irinotecan plus capecitabine is one of these new combinations that seem to provide an acceptable response rate and good toxicity profile. In this article, we review the efficacy, tolerability, and feasibility of this combination for the treatment of advanced or metastatic gastric cancer and we summarize the clinical trials using this regimen.

Targeting cancers in the gastrointestinal tract: role of capecitabine.

Capecitabine is currently the only novel, orally home-administered fluorouracil prodrug. It offers patients more freedom from hospital visits and less inconvenience and complications associated with infusion devices. The drug has been extensively studied in large clinical trials in many solid tumors, including breast cancer, colorectal cancer, gastric cancer, and many others. Furthermore, the drug compares favorably with fluorouracil in patients with such cancers, with a safe toxicity profile, consisting mainly of gastrointestinal and dermatologic adverse effects. Whereas gastrointestinal events and hand-foot syndrome occur often with capecitabine, the tolerability profile is comparatively favorable. Prompt recognition of severe adverse effects is the key to successful management of capecitabine. Ongoing and future clinical trials will continue to examine, and likely expand, the role of capecitabine as a single agent and/or in combination with other anticancer agents for the treatment of gastrointestinal as well as other solid tumors, both in the advanced palliative and adjuvant settings. The author summarizes the current data on the role of capecitabine in the management of gastrointestinal cancers.

Emerging Role of Capecitabine in Gastric Cancer

For many years, a regimen of fluorouracil and cisplatin has been the standard of care for the treatment of patients with metastatic gastric cancer. More recently, triplet regimens that incorporate fluorouracil and cisplatin with epirubicin (ECF) or docetaxel are being used in the management of patients with metastatic disease; ECF is also being used as preoperative treatment of resectable disease. Capecitabine, a prodrug of fluorouracil that can be taken orally, has been assessed as an alternative to intravenous fluorouracil and has demonstrated noninferiority to its parent compound. Several trials have demonstrated the safety and efficacy of regimens combining capecitabine with other known active drugs against gastric cancer in doublet and triplet combinations. Oral capecitabine appears to be more convenient to administer than infused fluorouracil because it may obviate the need for central venous access and its associated risk of complications. All of these findings support consideration of capecitabine among the available drug treatment options for patients with metastatic and those with operable gastric cancers.

The Role of Capecitabine in the Management of Tumors of the Digestive System

Capecitabine has been developed as a prodrug of FU, with the goal of improving tolerability and intratumor drug concentration through tumor-specific conversion to the active drug. The purpose of this article is to review the available information on capecitabine with respect to clinical efficacy for tumors of the digestive tract, adverse-effect profile, documented drug interactions, dosage and administration, and future directions of ongoing research. Relevant English-language literature was identified through searches of NCI, PubMed, ASCO.org and ESMO, ECCO meetings proceedings.

Phase I and pharmacokinetic study of vatalanib plus capecitabine in patients with advanced cancer

Angiogenesis inhibition is now a proven therapeutic strategy in treatment of several solid tumors. Vatalanib is a potent inhibitor of all known vascular endothelial growth factor receptor (VEGFR) tyrosine kinases. In view of the effectiveness of angiogenesis inhibitor therapy when combined with chemotherapy and the established role of capecitabine in treatment of colorectal and breast cancer, we undertook a phase I clinical trial of the combination of capecitabine and vatalanib with the goal of developing a combination oral regimen. The study objectives were to determine the maximally tolerated dose of vatalanib that could be safely administered daily with capecitabine given orally for 14 out of 21 days to patients with advanced cancer; to characterize the safety, tolerability, and pharmacokinetic profile of vatalanib given in combination with capecitabine; and to describe any pharmacokinetic interactions between the drugs. The study had an initial dose escalation phase followed by a dose expansion phase. During the dose escalation phase, cohorts of at least three patients each were treated with capecitabine and escalating doses of vatalanib until the maximally tolerated dose of vatalanib was determined. Vatalanib given continuously at a dose of 1,250 mg/day could be safely combined with capecitabine at a dose of 2,000 mg/m2/day given for 14 of 21 days. Dose-limiting toxicities of the combination included fatigue, hypertension, dizziness, and proteinuria. Vatalanib did not alter the pharmacokinetics of 5-FU, the active metabolite of capecitabine. Vatalanib and capecitabine can be safely combined without unexpected toxicities or significant pharmacokinetic interactions.

Capecitabine in the treatment of colorectal cancer

Capecitabine is an oral prodrug of 5-fluorouracil. It is being increasingly used in the treatment of colorectal cancer in both the adjuvant and metastatic settings. This review aims to explore the data in relation to the pharmacology and mode of action of capecitabine, followed by an in-depth review of the available clinical evidence for the use of capecitabine as a single agent, or in combination therapy, in the treatment of colorectal cancer. The pharmacoeconomic and medical resource use implications are also investigated. The future role of capecitabine in the treatment of colorectal cancer and the questions that remain to be answered with regard to its optimal use are considered.

The Role of Capecitabine in First-Line Treatment for Patients with Metastatic Breast Cancer

Capecitabine is an important drug in the therapeutic armamentarium for metastatic breast cancer. A comprehensive worldwide clinical trial program involving >10,000 patients with locally advanced and metastatic breast cancer has provided evidence for the current treatment strategies. On the basis of data demonstrating consistent activity across several trials in patients with heavily pretreated breast cancer, capecitabine was approved in the U.S. in 1998 for the treatment of patients with metastatic disease resistant to paclitaxel and anthracycline-containing therapy, with later European Union approval for single-agent capecitabine in the metastatic setting. Capecitabine plus docetaxel (XT) was approved by the U.S. Food and Drug Administration for the treatment of metastatic breast cancer in 2001 on the basis of the large phase III trial comparing XT with docetaxel alone, which showed a survival advantage for combination therapy compared with single-agent therapy. This was shortly followed by European approval for the combination in metastatic breast cancer. The clinical utility of capecitabine in the management of breast cancer is supported by its convenient oral dosing schedule and favorable safety profile, as well as its excellent clinical activity in primary and metastatic breast cancer. Recently, clinical trials have studied single-agent capecitabine as first-line treatment and evaluated other capecitabine-containing combinations with cytotoxic and novel targeted agents.

Capecitabine: effective oral fluoropyrimidine chemotherapy

Fluoropyrimidine chemotherapy, principally with 5-fluorouracil (5-FU), has been a standard of care for a range of solid tumours for many years. Capecitabine, a precursor of 5-FU, is an oral fluoropyrimidine cytotoxic agent developed with the aim of providing a more effective, less toxic alternative to 5-FU, with the added advantage of oral administration. In clinical trials, capecitabine has proven to be an effective substitute for 5-FU in colorectal and breast cancer, and has become an accepted standard treatment in these tumours, both as a single agent and as a component of combination chemotherapy. It is also effective in a number of other solid tumours and as a radiosensitising agent. Capecitabine has significantly less serious toxicity than 5-FU when used alone or in combination with other cytotoxic agents. It has been shown to be resource saving in comparison with accepted standard comparator regimens in breast and colorectal cancer. Ongoing and future clinical trials will continue to examine, and are likely to expand, the role of capecitabine in the treatment of breast and colorectal cancer, as well as a number of other malignancies, both in the advanced palliative and adjuvant curative settings. This will involve the use of capecitabine as a single agent and increasingly in combination with other new anticancer agents.

The role of Xeloda in metastasic breast cancer

Currently, breast cancer is the primary reason for death due to cancer in Spanish women aged between 35 and 64 years. Nevertheless, despite detecting an increased incidence, it is observed a decrease on mortality rates, in agreement with it is observed in other European countries. This issue is basically due to the development of programs to sift and the use of widespread systemic treatments, both on early and advanced stages of the disease. During the past decade breast cancer has benefited from incorporation of new antitumor drugs to treat this kind of cancer. These new drugs are able to control, in an effective way, the progress of metastatic disease and slow down or eradicate micrometastasis in early stages. Patients with metastatic disease have been useful in the study of new active agents and their combinations subsequently used in adjuvant regimens. Breast cancer treatment often achieves important objective responses with different durations of treatment, but these durations have an impact on patient survival. The median of survival in this group varies between 18 and 24 months, and the main objective for the treatment of metastatic breast cancer is palliation by means of the control of disease-related symptoms, with an adequate profile of toxicity, which provides an improvement in quality of life. There are currently several lines of work on the development of breast cancer treatments at different stages. These are expected to improve survival and quality of life parameters. These lines of development range from the incorporation of new active agents (cytotoxic and hormonal) to optimization of current schemes with active agents (old and new), by means of new combinations used for metastatic disease and use in early stages, even before surgery. Breast cancer is one of the most chemo sensible solid tumours, that respond to almost every cytotoxic drug used alone or in combination. These active agents include alkylating drugs (e.g. cyclophosphamide and the cisplatins) and antimetabolites (e.g. fluorouracil and methotrexate), which were used for the design of the first-line polychemotherapy schemes in solid tumours such as CMF. After this, the anthracyclines (doxorubicin and epirubicin) were substituted for methotrexate in the latter combination, giving us the FAC and FEC schemes, which were classic treatments until relatively recently. During the past decade, many new agents have been incorporated that have improved both response rates and patient survival, such as the taxanes (paclitaxel and docetaxel), vinorelbine, caelyx and, recently, gemcitabine; there have been used in new combinations or have even been used as isolated agents as second- and third-line treatments for with advanced disease. The main problem with these agents and their combinations is the complexity of administration, at day hospitals and through intravenous injections, which seriously impairs patient quality of life. However, the benefit in terms of survival parameters and symptom reduction offset these difficulties. Capecitabine (Xeloda), one of the most recently introduced active agents into treatment for metastatic breast cancer, has the same antitumoral activity as current agents but without many of their inconveniences, which is the reason why its incorporation into standard treatment for breast cancer patients is becoming increasingly common. It is orally administered, avoiding the difficulties associated with intravenous injection. Its mode of action is similar to that of 5-fluorouracyl in continuous infusion, without the need for infuser or central catheters. On the other hand, it has a synergistic action with the majority of cytotoxic drugs, in particular with docetaxel, leading to a better survival rates. The results of studies conducted in recent years have confirmed the important role of capecitabine in the treatment of advanced disease, and it have been the base for the studies with capecitabine on the adjuvant and neoadjuvant setting.