Abstract

ABSTRACT Aim: The aim of the present study was to compare the effectiveness of cyclophosphamide-methotrexate ‘metronomic’ chemotherapy with the same regimen plus Imatinib in the palliative treatment of patients with metastatic breast cancer. Metronomic chemotherapy -the chronic administration of chemotherapy at relatively low, minimally toxic doses on a frequent schedule of administration at close regular intervals, with no prolonged drug-free breaks- is a potentially novel approach to the control of advanced cancer disease. Unfortunately our research has revealed late presentation of women with breast cancer. Causes of the late detection are the latent course of the disease, the similarity of cancer symptoms with those of other diseases and the lack oncologic alertness in primary care physicians. Methods: Patients with advanced breast cancer were randomized to receive oral C (cyclophosphamide 50 mg daily) and M (methotrexate 2.5 mg twice daily on days 1 and 4) (arm A) or the same regimen plus lapatinib (800 mg daily) (arm B). Results: In 171 evaluable patients we observed seven complete responses (CR) in both arms A and B, 7 partial responses (PR) in arm A and 15 in arm B, for an overall response of 11.8% (95% confidence interval (CI) 5.8% to 20.6%) in arm A and 20.9% [95% CI 12.9% to 31%] in arm B. The clinical benefit (CR + PR + SD ≥ 24 weeks) was 41.5% for B arms. Toxicity was generally mild. Neurological toxicity (2% versus 5%; P Conclusions: Metronomic low-dose CM with lapatinib combination was effective and minimally toxic. The addition of lapatinib improves results. Disclosure: All authors have declared no conflicts of interest.

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