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PredicateObject
rdf:type
lifeskim:mentions
pubmed:dateCreated
2005-4-20
pubmed:abstractText
Many patients with advanced ovarian cancer will develop recurrent disease. For those patients who have recurrence of disease at least 6 months after initial therapy, the paclitaxel-platinum combination has been shown to be a superior treatment to platinum monotherapy. However, many patients develop clinically relevant neurotoxicity, frequently resulting in treatment discontinuation. The efficacy and safety of an alternative regimen that does not show significant neurotoxicity were evaluated by comparing gemcitabine-carboplatin with carboplatin in platinum-sensitive recurrent ovarian cancer patients in a Gynecologic Cancer InterGroup trial of the Arbeitsgemeinschaft Gynakologische Onkologie Ovarian Cancer Study Group, the National Cancer Institute of Canada Clinical Trials Group, and the European Organisation for Research and Treatment of Cancer Gynaecological Cancer Group. Participants with recurrent platinum-sensitive ovarian cancer were randomly assigned to receive either gemcitabine-carboplatin or carboplatin every 21 days. The primary objective was to compare progression-free survival (PFS) between the groups. From September 1999 to April 2002, 356 patients (178 participants received gemcitabine-carboplatin, 178 received carboplatin only) were randomized to treatment. Patients received six cycles of either gemcitabine-carboplatin or carboplatin. With a median follow-up of 17 months, median PFS was 8.6 months for gemcitabine-carboplatin (95% confidence interval [CI] 7.9-9.7 months) and 5.8 months for carboplatin (95% CI 5.2-7.1 months; hazard ratio [HR] 0.72 [95% CI 0.58-0.90; P = 0.0032]). The response rate for the gemcitabine-carboplatin group was 47.2% (95% CI 39.9-54.5%) and 30.9% for carboplatin group (95% CI 24.1-37.7%; P = 0.0016). The HR for overall survival was 0.96 (95% CI 0.75-1.23; P = 0.7349). Patients treated with gemcitabine-carboplatin reported significantly faster palliation of abdominal symptoms and a significantly improved global quality of life. Gemcitabine-carboplatin treatment significantly improves the PFS of patients with platinum-sensitive recurrent ovarian cancer.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:issn
1048-891X
pubmed:author
pubmed:issnType
Print
pubmed:volume
15 Suppl 1
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
36-41
pubmed:dateRevised
2006-11-15
pubmed:meshHeading
pubmed:articleTitle
Combination therapy with gemcitabine and carboplatin in recurrent ovarian cancer.
pubmed:affiliation
Klinik für Gynäkologie und Geburtshilfe Campus Kiel, Universitätsklinikum Schleswig-Holstein, Kiel Germany. jpfisterer@email.uni-kiel.de
pubmed:publicationType
Journal Article, Clinical Trial, Randomized Controlled Trial, Research Support, Non-U.S. Gov't, Multicenter Study, Clinical Trial, Phase III