الفهرس 
Epidemiology and PathogenesisOnly 14 pages are availabe for public view
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Abstract
Most women with metastatic disease have been initially diagnosed with early stage breast cancer, treated with curative intent, and then experienced metastases or recurrence. About 10% of newly diagnosed breast cancer patients have metastatic disease at presentation; this proportion is far higher in areas where screening programs are not available.
Chemotherapy, targeted therapy and hormonal therapy, in addition to some surgical and radiotherapy maneuvers are the tools used either individually or combined; concomitantly or sequentially to control the metastatic disease according to a wide spectrum of clinical and pathological criteria.
The rational of combining capecitabine and vinorelbine is the non-overlapping toxicity profiles and the preclinical synergy as like many other agents vinorelbine upgrades thymidine phosphorylase (TP), which has a critical role in the step-3 conversion to 5-FU inside the tumor cells.
Lower dose capecitabine [less than 2000 (range 1000-2000) mg/m²/day] has a more favorable therapeutic index in metastatic breast cancer in retrospective analysis of patients treated at M. D. Anderson Cancer Center; patients started at this dose range of capecitabine did not have poorer response rates or shorter time to progression.
The Current phase III prospective single institution two arms trial was conducted in order to investigate the clinical activity and tolerability of capecitabine in a low dose (750 mg/m² BID days 1-14) compared to the standard dose (1250 mg/m²/day BID days 1-14) in combination with vinorelbine (25 mg/m² days 1 and 8) in metastatic breast cancer patients previously treated with anthracyclins and/or taxanes.
This study included one hundred (100) eligible patients with MBC randomized to two arms (50 patients in each arm) for the 2nd or 3rd line treatment of MBC.
As Regard efficacy both regimen were active as in arm I (low dose capecitabine arm) 30.4% of patients (14 patients) achieved PR, 41.3% of patients (19 patients) showed SD, 28.2% of patients (13 patients) had PD and the CB (PR+SD) was 71.7%. While in arm II (the high dose capecitabine arm) 31.9% of patients (15 patients) achieved PR, 38.3% of patients (18 patients) showed SD, 29.8% of patients (14 patients) had Progressive Disease (PD)and the CB (PR+SD) was 70.2%, with no statistical differences between the two arms as regard PR,SD and CB (p value = 1.0).
The One year overall survival was 56.52% and 57.31% and the median TTP was 7.9 and 8.1 months (95% CI 7.85- 9.48) for arm I and arm II respectively.
In conclusion, the study has found low dose capecitabine combined with vinorelbine to be an effective line of treatment for anthracyclines-taxanes pretreated metastatic breast cancer patients with impressive results safety profile and superiority over the usage of the same combination with the standard dose of capecitabine as regard the toxicity profile especially neutropenia, HFS, gastrointestinal toxicities, cost benefit and compared to other lines of therapies. Also the current results matched the published results of other anthracyclines-taxanes pretreated MBC patients’ chemotherapeutic combinations whether international or local.
However, because of the small size and patient selection of these studies, the findings should be validated in a larger well randomized phase III studies which is also warranted to directly compare this regimen with widely used regimens to substantiate the best options for the treatment of patients in this setting.