Vinorelbine Plus Capecitabine as First Line Treatment in Patients with Metastatic Breast Cancer
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- Category: Vol. 81, September 2013
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Vinorelbine Plus Capecitabine as First Line Treatment in Patients with Metastatic Breast Cancer, WAEL EL-SADDA and MANAL SALAH-ELDIN
Abstract
Background: Breast cancer is the most frequent malig-nancy in women and the second most common cause of cancer relate death. Despite early diagnosis of breast cancer patients (40%) will develop metastatic disease that is incurable. Currently, there is no standard treatment for metastatic breast cancer after failure of anthracyline and taxane containing treatment and consequently, there is a need to find an effective schedule that is non cross resistant with these drugs. Capecit-abine and navelbine have shown a high level of antitumor activity and are well tolerated in this setting. The combination of xeloda and navelbine would be a reasonable choice for chemotherapy of MBC, due to their different toxicity profile and synergistic effect of both drugs. The aim of the study was to evaluate the efficacy, tolerability and safety of capecitabine and navelbine combination and its implication on survival in patients with MBC previously treated with anthracycline containing regimens.
Patients and Methods: Sixty female patients with meta-static breast cancer who attended at Mansoura University Hospital, Department of Clinical Oncology & Nuclear Med-icine in the period between October 2009 and October 2011 were enrolled in this prospective study. All with measurable disease (clinical and/or radiological), ECOG PS 0-2, adequate bone marrow, liver and renal function. Age >18 years and <65 years, life expectancy >6 months, negative pregnancy test, prior adjuvant chemotherapy with anthracyclines and adjuvant hormonal therapy were allowed, no prior treatment with chemotherapy for metastatic breast cancer. Treatment protocol was given as a 3 weekly schedule of capecitabine 850mg/m2 PO twice daily on days 1-14. Vinorelbine was given in a dose of 25mg/m2 on D1 & D8. Tumor response was assessed according to WHO criteria every 2 cycles and then every 2 months after completion of treatment, toxicity was assessed each cycle. Patients showing an objective re-sponse CR, PR or SD continued the treatment for a maximum of 8 cycles.
Results: All patients were evaluable for response, toxicity, and survival. The median age was 49 years (range 29-64 years), 60% of patients were ECOG PS 1, 40% of patients were premenopausal and 60% were postmenopausal 66.7% of patients were hormone receptors positive. Fifty per cent of patients had one metastatic site while 40% had two sites. The main metastatis site was the liver in 35 patients (58.3%), lung metastasis in 20%, skin nodules in 20%, bone metastasis in 40%, and nodes in 30% of patients. The overall response rate was 65% (CR 15%, PR 50%), 15 patients had stable disease (25%), and 6 patients (10%) had PD. Median time to progression and median survival were 13 months and 18 months respectively. Toxicity was manageable (hematologic and non hematologic), only G3 neutropenia in 4 patients (6.6%) and no G4 toxicities were noted.
Conclusion: Capecitabine in combination with navelbine showed promising efficacy and safety in MBC patients pre-treated with anthracycline with ORR (65%). It is likely that oral navelbine can be used, providing a more convenient fully oral combination regimen for patients with MBC.