Patients were required to give written informed consent before study-specific procedures were performed and to comply with protocol for the duration of the study. No intrapatient dose escalation was performed. The main exclusion criteria included previous treatment with adjuvant or palliative chemotherapy within 12 months prior to the study entry; concomitant hormonal therapy and radiation therapy of the only measurable lesion.
Patient preferences for oral versus intravenous palliative chemotherapy. If indicated, bone scans and X-rays were performed.
Oncologist 10 suppl 3: Based on its toxic profile and promising efficacy, vinorelbine has also been used in combination with other cytotoxic agents e. Patients were also excluded if they were pregnant or lactating, required a concurrent use of the antiviral sorivudine or a chemically related analogue such as brivudine, had clinical central nervous system CNS or leptomeningeal metastases, had a malabsorption disease that may affect absorption or oral chemotherapy, had possible hypersensitivity to fluoropyrimidine therapy, had participated in another clinical trial with any investigational drug within 30 days before study inclusion or had a history of another malignancy except cured basal-cell carcinoma of the skin or excised carcinoma in situ of the cervix.
Efficacy results of the treatment of patients in the study. Patients were ineligible if they had only local relapse, earlier chemotherapy in a metastatic setting, previous exposure to a vinca-alkaloid or capecitabine, serious illness or medical conditions such as cardiac disease, unstable diabetes, uncontrolled hypercalcaemia, severe peripheral neuropathy, active infection or previous organ allograft.
Subsequent trials showed that there was a substantial equivalence between the iv and the oral formulations of VRB, even if this latter was characterized by a higher rate of haematological toxicity [ 3 — 5 ]. Oral vinorelbine plus capecitabine combination in patients with advanced breast cancer.
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To view the fulltext, please log in. Clin Breast Cancer 7: Remissions were achieved at both dose levels. The majority of patients received further lines of treatment after discontinuation of study therapy: A total of cycles were administered median: Among the evaluable patients, 65 Baseline staging was performed with total body CT scan, ultra sound for abdomen, standard chest X-ray, or clinical examination.
Different studies have demonstrated that the metronomic treatment is active with an acceptable toxicity profile. For challenging patients such as those who relapse with visceral metastases lung, liver after an anthracycline-based treatment either in the adjuvant setting or in first-line metastatic diseasethe combination of oral vinorelbine and capecitabine is one of the few anthracycline-free combinations possible and is the only all-oral combination.
Change history Corrected online 16 November This is an open access article distributed under the Creative Commons Attribution Licensewhich permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Capecitabine in patients with advanced breast cancer, previously treated with anthracyclines and taxanes: Other non-hematological toxicities like paresthesia, diarrhea and constipation were moderate Table 3 and manageable.
In order to confirm the safety and efficacy, dose level 1 was extended to 24 patients. Prior neo- adjuvant chemotherapy b.