Pegylated liposomal doxorubicin and carboplatin compared with paclitaxel and carboplatin for patients with platinum-sensitive ovarian cancer in late relapse

Pujade-Lauraine, Eric, Wagner, Uwe, Aavall-Lundqvist, Elisabeth, Gebski, Val, Heywood, Mark, Vasey, Paul A., Volgger, Birgit, Vergote, Ignace, Pignata, Sandro, Ferrero, Annamaria, Sehouli, Jalid, Lortholary, Alain, Kristensen, Gunnar, Jackisch, Christan, Joly, Florence, Brown, Chris, Le Fur, Nathalie and du Bois, Andreas (2010) Pegylated liposomal doxorubicin and carboplatin compared with paclitaxel and carboplatin for patients with platinum-sensitive ovarian cancer in late relapse. Journal of Clinical Oncology, 28 20: 3323-3329. doi:10.1200/JCO.2009.25.7519


Author Pujade-Lauraine, Eric
Wagner, Uwe
Aavall-Lundqvist, Elisabeth
Gebski, Val
Heywood, Mark
Vasey, Paul A.
Volgger, Birgit
Vergote, Ignace
Pignata, Sandro
Ferrero, Annamaria
Sehouli, Jalid
Lortholary, Alain
Kristensen, Gunnar
Jackisch, Christan
Joly, Florence
Brown, Chris
Le Fur, Nathalie
du Bois, Andreas
Title Pegylated liposomal doxorubicin and carboplatin compared with paclitaxel and carboplatin for patients with platinum-sensitive ovarian cancer in late relapse
Journal name Journal of Clinical Oncology   Check publisher's open access policy
ISSN 0732-183X
1527-7755
Publication date 2010-07
Sub-type Article (original research)
DOI 10.1200/JCO.2009.25.7519
Open Access Status
Volume 28
Issue 20
Start page 3323
End page 3329
Total pages 7
Place of publication Alexandria, United States
Publisher American Society of Clinical Oncology
Collection year 2011
Language eng
Formatted abstract
Purpose
This randomized, multicenter, phase III noninferiority trial was designed to test the efficacy and safety
of the combination of pegylated liposomal doxorubicin (PLD) with carboplatin (CD) compared with
standard carboplatin and paclitaxel (CP) in patients with platinum-sensitive relapsed/recurrent ovarian
cancer (ROC).
Patients and Methods
Patients with histologically proven ovarian cancer with recurrence more than 6 months after first- or
second-line platinum and taxane-based therapies were randomly assigned by stratified blocks to CD
(carboplatin area under the curve [AUC] 5 plus PLD 30 mg/m2) every 4 weeks or CP (carboplatin AUC
5 plus paclitaxel 175 mg/m2) every 3 weeks for at least 6 cycles. Primary end point was progressionfree
survival (PFS); secondary end points were toxicity, quality of life, and overall survival.
Results
Overall 976 patients were recruited. With median follow-up of 22 months, PFS for the CD arm was
statistically superior to the CP arm (hazard ratio, 0.821; 95% CI, 0.72 to 0.94; P = .005); median
PFS was 11.3 versus 9.4 months, respectively. Although overall survival data are immature for final
analysis, we report here a total of 334 deaths. Overall severe nonhematologic toxicity (36.8% v
28.4%; P < .01) leading to early discontinuation (15% v 6%; P < .001) occurred more frequently
in the CP arm. More frequent grade 2 or greater alopecia (83.6% v 7%), hypersensitivity reactions
(18.8% v 5.6%), and sensory neuropathy (26.9% v 4.9%) were observed in the CP arm; more
hand-foot syndrome (grade 2 to 3, 12.0% v 2.2%), nausea (35.2% v 24.2%), and mucositis (grade
2-3, 13.9% v 7%) in the CD arm.
Conclusion
To our knowledge, this trial is the largest in recurrent ovarian cancer and has demonstrated
superiority in PFS and better therapeutic index of CD over standard CP. 
© 2010 by American Society of Clinical Oncology.
Keyword Recurrent epithelial ovarian
Phase-III trial
Southwest-oncology-group
Randomized-trial
Q-Index Code C1
Q-Index Status Confirmed Code
Institutional Status UQ

Document type: Journal Article
Sub-type: Article (original research)
Collections: Official 2011 Collection
School of Medicine Publications
 
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Created: Sun, 25 Jul 2010, 00:05:38 EST