Abstract
Background: Anthracycline- and taxane-based regimens form the mainstay of chemotherapy treatment in metastatic breast cancer. In patients who develop resistance to these agents, management options are limited and there is no standard of care. Thus, investigation into other chemotherapeutic agents is warranted. Methods: In this non-randomised prospective trial, patients with human epidermal growth factor 2 (HER-2)-negative locally advanced or metastatic breast cancer that were anthracycline- and taxane-resistant were treated with carboplatin at a dose equivalent to an area under the concentration–time curve of 4.5 mg/ml.min on day 1 and gemcitabine 1500 mg/m2 on day 2 of every 2-week cycle. The primary end point was overall response rate. Results: A total of five patients were enrolled prior to early termination due to difficulty in recruitment. The principal reason for recruitment difficulty was mandating anthracycline and taxane pre-treatment and HER-2 negativity. One patient had a complete response, one had a partial response, one had stable disease and two had progressive disease. Grade 4 neutropenia occurred in two patients. Conclusions: In this patient population, inclusion criteria that are too stringent may result in difficulties reaching recruitment targets. Carboplatin in combination with gemcitabine appears to be a safe option for treatment of patients with locally advanced or metastatic breast cancer. Due to the small sample size, it is not possible to draw firm conclusions regarding efficacy from this trial. Registration: EU Clinical Trials Register ID 2005-005164-83, registered on 10 April 2006.
Highlights
Breast cancer is the most prevalent cancer in women, with over 1.5 million cases diagnosed annually worldwide[1]
Anthracycline- or taxane-based regimens form the mainstay of chemotherapy treatment in metastatic breast cancer; after failure of these firstline therapies, management of progressive disease is difficult and response rates for salvage therapies are as low as 25%4–6
Gemcitabine is an excellent agent in polychemotherapy, as demonstrated by its potential for synergistic interactions with platinum agents[8,9]
Summary
Breast cancer is the most prevalent cancer in women, with over 1.5 million cases diagnosed annually worldwide[1] Of these patients, 20 to 50% will develop metastatic disease[2], with which only 25% will survive to 5 years[3]. Anthracycline- or taxane-based regimens form the mainstay of chemotherapy treatment in metastatic breast cancer; after failure of these firstline therapies, management of progressive disease is difficult and response rates for salvage therapies are as low as 25%4–6. Anthracycline- and taxane-based regimens form the mainstay of chemotherapy treatment in metastatic breast cancer. Methods: In this non-randomised prospective trial, patients with human epidermal growth factor 2 (HER-2)-negative locally advanced or metastatic breast cancer that were anthracycline- and taxaneresistant were treated with carboplatin at a dose equivalent to an area under the concentration–time curve of 4.5 mg/ml.min on day 1 and gemcitabine 1500 mg/m2 on day 2 of every 2-week cycle. Grade 4 neutropenia occurred in two Invited Reviewers 1 version 1
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