Long-term gemcitabine administration in heavily pretreated Japanese patients with metastatic breast cancer: additional safety analysis of a phase II study

• Published in: Breast cancer (Tokyo, Japan) Vol. 19; no. 4; pp. 335 - 342
• Main Authors: Takao, Shintaro, Tokuda, Yutaka, Saeki, Toshiaki, Funai, Jumpei, Ishii, Masami, Takashima, Shigemitsu
• Format: Journal Article
• Language: English
• Published: Japan Springer Japan 01.10.2012; Springer
• Subjects: Adult; Aged; Analysis; Anthracyclines; Anthracyclines - therapeutic use; Antimetabolites, Antineoplastic - administration & dosage; Antimetabolites, Antineoplastic - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Asian Continental Ancestry Group; Breast cancer; Breast Neoplasms - drug therapy; Breast Neoplasms - pathology; Cancer; Cancer patients; Cancer Research; Deoxycytidine - administration & dosage; Deoxycytidine - adverse effects; Deoxycytidine - analogs & derivatives; Drug Administration Schedule; Female; Heart Failure - chemically induced; Humans; Medicine; Medicine & Public Health; Metastasis; Middle Aged; Oncology; Oncology, Experimental; Original Article; Safety and security measures; Surgery; Surgical Oncology; Taxoids - therapeutic use; Unconsciousness - chemically induced; Gemcitabine; Metastatic breast cancer; Anthracycline and taxane pretreated
• ISSN: 1340-6868; 1880-4233
• DOI: 10.1007/s12282-011-0289-y

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.