Abstract
BackgroundMany emerging new drugs have recently been trialled for treatment of early and advanced breast cancer. Among these new agents paclitaxel and gemcitabine play a crucial role, mostly in patients with relapsed and metastatic disease after failure of chemotherapy with antracyclines.MethodsA phase II study was started in order to evaluate the activity and toxicity of a combination of paclitaxel and gemcitabine in a biweekly schedule on metastatic breast cancer patients previously treated with antracyclines.ResultsTwenty-five patients received paclitaxel (150 mg/mq) by 3-hours infusion, followed by gemcitabine (2000 mg/mq) given as a 60 min i.v. infusion (day 1–14) for a maximum of eight cycles. In all patients treatment was evaluated for toxicity and efficacy; four patients (16%) achieved a complete response, 12 (48%) a partial response giving an overall objective response rate of 64%. Stable disease was documented in 5 patients (20%) and progressive disease occurred in 4 patients (16%).ConclusionThe schedule of treatment was safe and tolerable from a haematological and non-haematological point of view. These data confirm that the combination of gemcitabine and paclitaxel on a biweekly basis is an effective and well-tolerated regimen in breast cancer patients with prior therapeutic exposure to antracyclines.
Highlights
Many emerging new drugs have recently been trialled for treatment of early and advanced breast cancer
In metastatic breast cancer (MBC) this combination has been evaluated in phase II studies using a three -weekly schedule of treatment with paclitaxel given at 175 mg/mq on day 1 and gemcitabine given at 1000–1250 mg/mq on days 1,8, showing an interesting response rate ranging from 45% to 55% [11,12]
Stable disease was documented in 5 patients (20%) while progressive disease occurred in 4 patients(16%)
Summary
Many emerging new drugs have recently been trialled for treatment of early and advanced breast cancer Among these new agents paclitaxel and gemcitabine play a crucial role, mostly in patients with relapsed and metastatic disease after failure of chemotherapy with antracyclines. Novel drugs have emerged as important agents in the treatment of MBC patients, because of their safety and efficacy in generating symptom relief, in reducing disease progression and in prolonging survival. Among these new agents, taxanes have become the standard therapy in patients pretreated with antracyclines. A number of newer cytotoxic agents have been introduced in clinical trials to evaluate novel, safe and active taxane-based combinations in the treatment of MBC, extensively pretreated with antracyclines
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