This study was designed to evaluate the efficacy and safety of single-agent gemcitabine for the treatment of patients with anthracycline- and taxane-pretreated metastatic breast cancer (MBC). Eligible patients were required to have bidimensionally measurable MBC that had been treated with 2-4 prior chemotherapy regimens that included an anthracycline and a taxane. Gemcitabine was delivered at a dose of 800 mg/m2 on days 1, 8, and 15 of a 28-day cycle until evidence of disease progression.
Twenty-two patients were enrolled and included in the safety analysis; 18 patients were evaluable for response. The median age of patients was 54 years (range, 36-70 years). The mean number of prior chemotherapy regimens for metastatic disease was 2.3, and the mean dose of gemcitabine delivered was 911 mg/m2 (range, 600-1600 mg/m2).
Overall, gemcitabine was well tolerated with minimal grade 3 toxicities; the only grade 4 toxicity was 1 case of pulmonary embolus. Three patients had evidence of partial tumor regression (17%; 95% CI, 4%-41%), and 1 patient had a 41% decrease in tumor volume, including liver metastasis.
Gemcitabine is active and well tolerated as monotherapy given in heavily pretreated patients with MBC after anthracyclines and taxanes. The activity and safety reported in this trial are consistent with previous reports in similar patients.
"Gemcitabine as a single agent has induced overall response rates of 0 – 37% in first-line treatment, whereas the response rates in the second-or third-line therapy were 26 and 13% (Brodowicz et al, 2000; Spielmann et al, 2001; Blackstein et al, 2002; Heinemann, 2003, 2005; Modi et al, 2005). In studies limited to second-or third-line therapy after anthracycline and/or taxane exposure, response rates of 0 – 29% and median time to progression of 2 – 6 months were achieved (Spielmann et al, 2001; Modi et al, 2005; Heinemann et al, 2006; Seo et al, 2007). Several considerations support the use of gemcitabine and a platinum salt in the salvage treatment of metastatic breast cancer (MBC): First, in vitro studies indicate additive or synergistic activity that was most pronounced in platinum-resistant cell lines and was found to be due to an increased formation and an impaired repair of platinum – DNA adducts (Peters et al, 1995; van Moorsel et al, 1997). "
[Show abstract][Hide abstract] ABSTRACT: An increasing proportion of patients are exposed to anthracyclines and/or taxanes in the adjuvant or neoadjuvant setting. Re-exposure in the metastatic stage is limited by drug resistance, thus evaluation of non-cross-resistant regimens is mandatory.
Anthracycline-pretreated patients were randomly assigned to three gemcitabine-based regimens. Chemotherapy consisted of gemcitabine 1.000 mg m(-2) plus vinorelbin 25 mg m(-2) on days 1+8 (GemVin), or plus cisplatin 30 mg m(-2) on days 1+8 (GemCis), or plus capecitabine 650 mg m(-2) b.i.d. orally days 1-14 (GemCap), q3w. The primary end point was response rate.
A total of 141 patients were recruited on the trial. The overall response rates were 39.0% (GemVin), 47.7% (GemCis) and 34.7% (GemCap). Median progression-free survival was estimated with 5.7, 6.9 and 8.3 months, respectively. Corresponding median survival times were 17.5 (GemVin), 13.0 (GemCis) and 19.4 months (GemCap). Neutropenia ≥grade 3 occurred in 16.7% (Gem/Vin), 4.4% (GemCis) and 0% (Gem/Cap), whereas non-haematological toxicities were rarely severe except grade 3 hand-foot syndrome in 2.0% of the GemCap patients (per patient analysis).
This randomised phase II trial has revealed comparable results for three gemcitabine-based regimens regarding treatment efficacy and toxicity. Gemcitabine-based chemotherapy appears to be a worthwhile treatment option for pretreated patients with metastatic breast cancer.
British Journal of Cancer 03/2011; 104(7):1071-8. DOI:10.1038/bjc.2011.86 · 4.84 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Wire and cable are the backbone of modern telecommunications and are present in everything from household to automotive and electronic devices. They have come under increased scrutiny in Europe, the US and Japan due to NGO and government concerns over the materials found in them. Greiner Environmental and the Toxics Use Reduction Institute have been involved in research in this area that includes a review of up-to-date literature on the subject, phone interviews, a focus group meeting of Massachusetts' representatives of the wire and cable supply chain, and a report summarizing the issues. The key finding of this research is that under increasing customer and regulatory pressures, a growing number of companies in the United States are developing new, cleaner alternatives to materials of concern in coated wire and cable, including lead, halogenated flame retardants, and phthalates. The paper outlines a five-step approach for companies with wire components in their products to address the issue.
Electronics and the Environment, 2002 IEEE International Symposium on; 02/2002
[Show abstract][Hide abstract] ABSTRACT: Gemcitabine is a nucleoside analogue with proven activity in advanced and metastatic breast cancer. Its action is associated with a favourable toxicity profile which is mainly hematological. Its unique mechanism of action along with not overlapping toxicity is particularly useful both in combination treatment with other active drugs and a sequential therapy in the palliative setting.
Phase II studies of gemcitabine performed over the last decade were reviewed.
Despite some conflicting results in some trials, gemcitabine confirmed to be a useful drug to treat this condition.
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