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Phase II gemcitabine and capecitabine combination therapy in recurrent or metastatic breast cancer patients pretreated with anthracycline and taxane

Authors
 Ji Soo Park  ;  Hei-Cheul Jeung  ;  Sun Young Rha  ;  Joong Bae Ahn  ;  Beodeul Kang  ;  Hong Jae Chon  ;  Min Hee Hong  ;  Seungtaek Lim  ;  Woo Ick Yang  ;  Chung Mo Nam  ;  Hyun Cheol Chung 
Citation
 CANCER CHEMOTHERAPY AND PHARMACOLOGY, Vol.74(4) : 799-808, 2014 
Journal Title
 CANCER CHEMOTHERAPY AND PHARMACOLOGY 
ISSN
 0344-5704 
Issue Date
2014
MeSH
Anthracyclines*/administration & dosage ; Anthracyclines*/adverse effects ; Antineoplastic Agents/administration & dosage ; Antineoplastic Agents/adverse effects ; Antineoplastic Combined Chemotherapy Protocols ; Breast Neoplasms*/drug therapy ; Breast Neoplasms*/mortality ; Breast Neoplasms*/pathology ; Bridged-Ring Compounds*/administration & dosage ; Bridged-Ring Compounds*/adverse effects ; Capecitabine ; Deoxycytidine/administration & dosage ; Deoxycytidine/adverse effects ; Deoxycytidine/analogs & derivatives* ; Disease Progression ; Disease-Free Survival ; Dose-Response Relationship, Drug ; Drug Administration Schedule ; Drug Screening Assays, Antitumor ; Female ; Fluorouracil/administration & dosage ; Fluorouracil/adverse effects ; Fluorouracil/analogs & derivatives* ; Hand-Foot Syndrome*/etiology ; Hand-Foot Syndrome*/physiopathology ; Hand-Foot Syndrome*/prevention & control ; Humans ; Middle Aged ; Neoplasm Recurrence, Local* ; Neoplasm Staging ; Neutropenia*/chemically induced ; Neutropenia*/physiopathology ; Neutropenia*/prevention & control ; Republic of Korea/epidemiology ; Severity of Illness Index ; Taxoids*/administration & dosage ; Taxoids*/adverse effects ; Treatment Outcome
Keywords
Breast cancer ; Metastatic ; Recurrent ; Gemcitabine ; Capecitabine ; Chemotherapy
Abstract
PURPOSE: We conducted a phase II study evaluating safety and efficacy of combination gemcitabine and capecitabine therapy for metastatic breast cancer patients following anthracycline and taxane treatment in Korea. METHODS: This was a single-arm, non-randomized phase II study. Patients received 1,000 mg/m(2) gemcitabine intravenously over 30 min on days 1 and 8, and 1,250 mg/m(2) capecitabine orally twice daily on days 1-14 until disease progression or intolerable toxicity occurred. This regimen was repeated every 3 weeks. The primary outcome assessed was overall response rate [ORR, complete response (CR) + partial response (PR) as the best response], and secondary outcomes were progression-free survival (PFS), overall survival (OS), disease control rate (DCR) [maintenance of CR + PR + stable disease (SD) for at least 3 months], drug toxicity, and predictive factors for response to this regimen. RESULTS: Of 41 patients, the ORR was 39.0% (CR 0%; PR 39.0%), and DCR was 78.0% using this chemotherapy. DCR for 6 and 12 months was 68.3 and 26.8%, respectively. Median PFS was 10.0 months [95% confidence interval (CI) 7.8-12.1], and median OS was 25.1 months (95% CI 18.2-32.1). Prominent toxicities were neutropenia and hand-foot syndrome. Most adverse events were well known, relatively moderate, and reversible. Taxane sensitivity [odds ratio (OR) 0.169; 95% CI 0.034-0.826; P = 0.028] and hepatic metastasis (OR 0.097; 95% CI 0.017-0.559; P = 0.009) were significantly predictive of response to gemcitabine and capecitabine combination. CONCLUSIONS: This study showed reproducible anticancer activity and tolerable toxicity of gemcitabine and capecitabine combination therapy in recurrent or metastatic Korean breast cancer patients previously treated with anthracycline and taxane.
Full Text
http://link.springer.com/article/10.1007%2Fs00280-014-2551-4
DOI
10.1007/s00280-014-2551-4
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Pathology (병리학교실) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Preventive Medicine and Public Health (예방의학교실) > 1. Journal Papers
Yonsei Authors
Kang, Beodeul(강버들) ORCID logo https://orcid.org/0000-0001-5177-8937
Nam, Jung Mo(남정모) ORCID logo https://orcid.org/0000-0003-0985-0928
Rha, Sun Young(라선영) ORCID logo https://orcid.org/0000-0002-2512-4531
Park, Ji Soo(박지수) ORCID logo https://orcid.org/0000-0002-0023-7740
Ahn, Joong Bae(안중배) ORCID logo https://orcid.org/0000-0001-6787-1503
Yang, Woo Ick(양우익) ORCID logo https://orcid.org/0000-0002-6084-5019
Lim, Seung Taek(임승택)
Chon, Hong Jae(전홍재)
Chung, Hyun Cheol(정현철) ORCID logo https://orcid.org/0000-0002-0920-9471
Jeung, Hei Cheul(정희철) ORCID logo https://orcid.org/0000-0003-0952-3679
Hong, Min Hee(홍민희) ORCID logo https://orcid.org/0000-0003-3490-2195
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/99814
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