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A phase II study of combination chemotherapy in early relapsed epithelial ovarian cancer using gemcitabine and pegylated liposomal doxorubicin.
MedLine Citation:
PMID:  20638711     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVE: Treatment of epithelial ovarian cancer patients relapsing with a short treatment-free interval (TFI) after prior chemotherapy is unsatisfactory. This phase II trial evaluated the activity and feasibility of pegylated liposomal doxorubicin (PLD) plus gemcitabine in this setting.
METHODS: Patients who had received prior platinum and paclitaxel with a TFI 0-12 months received PLD 25 mg/m(2)day 1 plus gemcitabine 800 mg/m(2)day 1, 8 every 21 days. Gemcitabine was dose escalated to 1000 mg/m(2)day 1, 8 from course 2 in the absence of grade 3/4 toxicity. The primary endpoint was progression-free survival (PFS). Patients were stratified according to response to primary chemotherapy.
RESULTS: Seventy-nine patients (n=26 with CR on prior chemotherapy and TFI 6-12 months; n=20 with CR and TFI 0-6 months; n=33 with PR/SD and TFI 0-12 months) were enrolled. The median age was 59 years (range 31-77 years), and 33 patients had received ≥ 2 prior treatments. A median of five courses was delivered per patient (total 389 courses). Gemcitabine was dose escalated in 124 courses and reduced in 105 courses. No PLD dose reductions occurred. Grade 3/4 toxicities were febrile neutropenia (n=4), PPE (n=2), and mucositis (n=2). One toxic death occurred (pneumonitis/alveolitis). Responses were complete in 5.1%, partial in 27.9%, and stable disease in 55.7%. Median OS and PFS were 12.5 and 6.4 months, respectively.
CONCLUSIONS: The PLD-gemcitabine combination is an effective and well-tolerated salvage treatment for relapsed epithelial ovarian cancer and is a valid candidate for evaluation in a phase III trial.
Authors:
Mansoor Raza Mirza; Bente Lund; Jacob Christian Lindegaard; Nina Keldsen; Anders Mellemgaard; René Depont Christensen; Kamma Bertelsen
Publication Detail:
Type:  Clinical Trial, Phase II; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't     Date:  2010-07-17
Journal Detail:
Title:  Gynecologic oncology     Volume:  119     ISSN:  1095-6859     ISO Abbreviation:  Gynecol. Oncol.     Publication Date:  2010 Oct 
Date Detail:
Created Date:  2010-09-13     Completed Date:  2010-09-23     Revised Date:  2013-06-03    
Medline Journal Info:
Nlm Unique ID:  0365304     Medline TA:  Gynecol Oncol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  26-31     Citation Subset:  IM    
Copyright Information:
Copyright © 2010 Elsevier Inc. All rights reserved.
Affiliation:
Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark. mansoor@rh.regionh.dk
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MeSH Terms
Descriptor/Qualifier:
Adult
Aged
Antineoplastic Combined Chemotherapy Protocols / adverse effects,  therapeutic use*
Cystadenocarcinoma, Serous / drug therapy
Deoxycytidine / administration & dosage,  adverse effects,  analogs & derivatives
Disease-Free Survival
Dose-Response Relationship, Drug
Doxorubicin / administration & dosage,  adverse effects,  analogs & derivatives
Female
Humans
Middle Aged
Ovarian Neoplasms / drug therapy*
Polyethylene Glycols / administration & dosage,  adverse effects
Survival Rate
Chemical
Reg. No./Substance:
0/Polyethylene Glycols; 0/pegylated liposomal doxorubicin; 23214-92-8/Doxorubicin; 951-77-9/Deoxycytidine; B76N6SBZ8R/gemcitabine

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


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