METRONOMIC CHEMOTHERAPY (CAPECITABINE) IN WOMEN WITH TRIPLE- NEGATIVE OPERABLE BREAST CANCER. - .

Background:- Triple-negative breast cancers are defined as tumors that lack expression of estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor 2 (HER2) which constitute 15%–20% of all breast cancers and characterized by high rates of relapse, visceral and central nervous system (CNS) metastasis. These Patients do not benefit from established targeted drugs with endocrine therapy or trastuzumab ,but cytotoxic chemotherapy is still the mainstay treatment.Metronomic chemotherapy ,is frequent administration of certain cytotoxic agents at low doses at close regular intervals with no prolonged drug-free interruptions ,can be given after standard adjuvant therapy in triple -negative disease Aim:- The aim of this study was to evaluate the tolerability and efficacy of metronomic capecitabine which given for one year after standard adjuvant treatment as an extended adjuvant therapy for women with triple-negative breast cancer Patients and Method:- Between January 2011 and November 2012, 22 women patients with pathologically proven operable breast cancer and immunohistochemistry proven triple negative{estrogen receptor (ER) ,progesterone receptor(PR) negative and HER 2 neu 0 or 1} , were enrolled to this prospective phase II study at Clinical Oncology Department and Nuclear Medicine , Zagazig University ,Egypt and Medical Oncology Department ,Zagazig University ,Egypt . The patients received standard adjuvant anthracycline based chemotherapy ( FAC, FEC,AC), or sequential anthracycline containing chemotherapy with taxanes followed by radiotherapy if indicated. Then the patients received 1 year of metronomic chemotherapy { oral capecitabine (Xeloda) } by a dose of (650 mg/m2 , twice daily ) which is discontinued if disease progression or major toxicities occured. The primary endpoints of this study were relapse-free survival (RFS) and safety profile. The secondary end point was overall survival (OS). Results:-At time of analysis,the median follow up duration was 34.5 months(range; 13-53 months) .Metronomic Capecitabine was well tolerated and no dose reduction needed in our study . The most common non hematological toxicity was handfoot syndrome which occurred in 4 (18.18%) patients ,two of them were G1/2 and the other two were G3/4 who needed dose delay for one week .The second most common toxicity was G1/2 nausea and vomiting which was occurred in 3(13.6%) patients .Two patients had G3 diarrhea(9.09%) who needed admission .Hematological toxicity occurred in five ( 22.7%) patients in the form of anaemia . No patients lost during follow up.One patient(4.5%) had locoregional recurrence.Distant metastasis occurred in 4 (18.18%) patients.Three patients (13.6%)died during the follow up period.2 and 3y OS was 86.4% for each . 2-3yDFS was 86.4% and 81% respectively. Conclusion:- The conclusion of this study that metronomic capecitabine is effective and well tolerated extended adjuvant treatment of patients with TNBC but I recommend to study the effect of this regimen in a randomized phase III study on larger number of patients and longer follow up period . - See more at: .