Long-term gemcitabine administration in heavily pretreated Japanese patients with metastatic breast cancer: additional safety analysis of a phase II study.
Summary of "Long-term gemcitabine administration in heavily pretreated Japanese patients with metastatic breast cancer: additional safety analysis of a phase II study."
BACKGROUND:
Recently gemcitabine has been approved for treatment of metastatic or recurrent breast cancer in Japan; however, no systematically investigated safety study of long-term gemcitabine monotherapy has been reported despite its wide use globally for multiple indications. PATIENTS AND
METHODS:
In a previously reported phase II study, 62 Japanese metastatic breast cancer patients with progressive disease after treatment with anthracyclines and taxanes were treated with gemcitabine 1250 mg/m(2) on days 1 and 8 of a 21-day cycle. For this report we re-analyzed the safety profiles for the 13 patients who received 10 or more cycles of the therapy.
RESULTS:
Most grade 3/4 adverse events seen after 10 cycles were hematological toxicities. These were similar to those seen before the 10th cycle; however, 2 patients showed grade 3 nonhematological severe adverse events including acute cardiac failure and loss of consciousness. All adverse events were reversible and manageable. One patient received gemcitabine treatment for up to 54 cycles without unmanageable toxicities.
CONCLUSION:
Toxicities seen in long-term gemcitabine treatment were reversible and manageable in this setting of heavily pretreated Japanese metastatic breast cancer patients.
Affiliation
Department of Breast Surgery, Hyogo Cancer Center, 13-70 Kitaouji-cho, Akashi, Hyogo, 673-8558, Japan, takao1001@gmail.com.
Journal Details
This article was published in the following journal.
Name: Breast cancer (Tokyo, Japan)
ISSN: 1880-4233
Pages:
Links
- PubMed Source: http://www.ncbi.nlm.nih.gov/pubmed/21751001
- DOI: http://dx.doi.org/10.1007/s12282-011-0289-y
Medical and Biotech [MESH] Definitions
Encephalitis Virus, Murray Valley
A species of FLAVIVIRUS, one of the Japanese encephalitis virus group (ENCEPHALITIS VIRUSES, JAPANESE), found in Australia and New Guinea. It causes a fulminating viremia resembling Japanese encephalitis (ENCEPHALITIS, JAPANESE).
Encephalitis Virus, Japanese
A species of FLAVIVIRUS, one of the Japanese encephalitis virus group (ENCEPHALITIS VIRUSES, JAPANESE), which is the etiological agent of Japanese encephalitis found in Asia, southeast Asia, and the Indian subcontinent.
Insurance, Long-term Care
Health insurance to provide full or partial coverage for long-term home care services or for long-term nursing care provided in a residential facility such as a nursing home.
Hiv Long-term Survivors
Persons who have experienced prolonged survival of HIV infection. This includes the full spectrum of untreated, HIV-infected long-term asymptomatics to those with AIDS who have survived due to successful treatment.
Infusions, Intravenous
The long-term (minutes to hours) administration of a fluid into the vein through venipuncture, either by letting the fluid flow by gravity or by pumping it.
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