Document Detail


Weekly paclitaxel and carboplatin (PC-W) for patients with primary advanced ovarian cancer: results of a multicenter phase-II study of the NOGGO.
MedLine Citation:
PMID:  17393164     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVES: To study the toxicity and efficacy of weekly paclitaxel and carboplatin (PC-W) in women with primary ovarian cancer METHODS: This investigation extended a phase-I dose finding study and was approved by the institutional review boards of all participating institutions. Between 1999 and 2003, women with radically resected ovarian cancer of FIGO stages II B to IV were enrolled at 17 German centres. Patients received weekly paclitaxel at a dose of 100 mg/m2, followed by carboplatin AUC 2. After a first treatment block consisting of six cycles of chemotherapy, patients had a treatment-free interval of 14 days, followed by a second block of six cycles. Treatment was completed by a 28-days break and a final block of six cycles. RESULTS: Altogether, 129 women with a mean age of 59 +/- standard deviation 11 years entered the study. Most patients (82.9%) had serous papillary carcinoma of FIGO stage III (72.9%) and IV (20.9%). Participants received 1,851 cycles of chemotherapy; averaging 14.3 +/- 4.3 cycles each patient. PC-W produced low rates of peripheral neuropathy (grade 3: 2.3%, 95% confidence interval [CI] 0.5-6.6%), with rapid recovery after 3 months. However, 72 patients had grade III/IV anaemia (55.8%, 95% CI 46.8-64.5%). There were 36 events of grade III/IV leukopenia (27.9%, 95% CI 20.4-36.5%). One patient sustained neutropenic fever. CA-125- and objective response was noted in 73.9% (95% CI 64.7-81.8%) and 55.6% (95% CI 41.4-69.1%) of patients. Median progression free and overall survival was 21 and 43 months, respectively. CONCLUSIONS: PC-W is feasible; a randomized study is warranted to compare this new regimen with conventional 3-weekly treatment.
Authors:
Jalid Sehouli; Dirk Stengel; Alexander Mustea; Oumar Camara; Elke Keil; Dirk Elling; Peter Ledwon; Bernd Christiansen; Peter Klare; Gerhard Gebauer; Marina Schwarz; Werner Lichtenegger;
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Publication Detail:
Type:  Clinical Trial, Phase II; Journal Article; Multicenter Study     Date:  2007-03-29
Journal Detail:
Title:  Cancer chemotherapy and pharmacology     Volume:  61     ISSN:  0344-5704     ISO Abbreviation:  Cancer Chemother. Pharmacol.     Publication Date:  2008 Feb 
Date Detail:
Created Date:  2007-11-20     Completed Date:  2008-01-23     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  7806519     Medline TA:  Cancer Chemother Pharmacol     Country:  Germany    
Other Details:
Languages:  eng     Pagination:  243-50     Citation Subset:  IM    
Affiliation:
Department of Gynaecology and Gynaecologic Oncology, Charité Virchow University Hospital, Augustenburger Platz 1, 13353 Berlin, Germany. Sehouli@aol.com
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MeSH Terms
Descriptor/Qualifier:
Aged
Aged, 80 and over
Alopecia / chemically induced
Antineoplastic Agents / administration & dosage
Antineoplastic Agents, Phytogenic / administration & dosage
Antineoplastic Combined Chemotherapy Protocols / administration & dosage*,  adverse effects,  therapeutic use*
Area Under Curve
Blood Cell Count
Body Surface Area
Carboplatin / administration & dosage
Female
Humans
Middle Aged
Neurotoxicity Syndromes / physiopathology
Ovarian Neoplasms / drug therapy*,  pathology
Paclitaxel / administration & dosage
Regression Analysis
Survival Analysis
Chemical
Reg. No./Substance:
0/Antineoplastic Agents; 0/Antineoplastic Agents, Phytogenic; 33069-62-4/Paclitaxel; 41575-94-4/Carboplatin

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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