Authors: | Modi, S.; Currie, V. E.; Seidman, A. D.; Bach, A. M.; Panageas, K. S.; Theodoulou, M.; Moasser, M. M.; D'Andrea, G. M.; Lake, D. E.; Choi, J.; Norton, L.; Hudis, C. A. |
Article Title: | A phase II trial of gemcitabine in patients with metastatic breast cancer previously treated with an anthracycline and taxane |
Abstract: | Purpose: 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. Patients and methods: 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). Results: 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. Conclusions: 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. |
Keywords: | adult; clinical article; controlled study; treatment outcome; aged; bone neoplasms; middle aged; survival analysis; clinical trial; constipation; drug tolerability; fatigue; neutropenia; salvage therapy; doxorubicin; cancer growth; drug efficacy; drug safety; hypophosphatemia; monotherapy; liver neoplasms; gemcitabine; paclitaxel; cancer patient; neoadjuvant therapy; neoplasm staging; anorexia; edema; controlled clinical trial; drug eruption; infection; liver toxicity; pain; phase 2 clinical trial; sensory neuropathy; breast cancer; anemia; bone marrow suppression; skin neoplasms; tumor volume; nausea; stomatitis; thrombocytopenia; vomiting; antineoplastic combined chemotherapy protocols; lung neoplasms; drug administration schedule; antineoplastic activity; tumor regression; dose-response relationship, drug; breast neoplasms; abdominal pain; coughing; dyspnea; febrile neutropenia; fever; lung embolism; drug fatality; liver metastasis; lung metastasis; thrombosis; hyperbilirubinemia; taxoids; taxane derivative; anthracycline; drug dose regimen; anthracyclines; deoxycytidine; alopecia; infusions, intravenous; granulocyte colony stimulating factor; soft tissue neoplasms; bridged compounds; radiographic tumor assessment |
Journal Title: | Clinical Breast Cancer |
Volume: | 6 |
Issue: | 1 |
ISSN: | 1526-8209 |
Publisher: | Elsevier Inc. |
Date Published: | 2005-04-01 |
Start Page: | 55 |
End Page: | 60 |
Language: | English |
PUBMED: | 15899073 |
PROVIDER: | scopus |
DOI/URL: | |
Notes: | --- - "Cited By (since 1996): 36" - "Export Date: 24 October 2012" - "CODEN: CBCLB" - "Source: Scopus" |