The evidence supporting the use of this protocol comes from a randomised, multicenter, phase III trial comparing the efficacy and safety of the combination of pegylated liposomal doxorubicin with carboplatin (CD) compared with standard carboplatin and paclitaxel (CP) in patients with platinum-sensitive relapsed/recurrent ovarian cancer.
Between April 2005 and September 2007, a total of 976 patients were randomly assigned, 467 to pegylated liposomal doxorubicin 30 mg/m2 with carboplatin AUC 5 every 4 weeks and 509 to paclitaxel 175 mg/m2 and carboplatin AUC 5 every 3 weeks.
The primary end point was progression-free survival (PFS) and secondary end points were toxicity, quality of life, and overall survival.r
Efficacy
After a median follow-up of 22 months, PFS for the CD arm was statistically superior to the CP arm (HR=0.821; p=0.005) with a median PFS of 11.3 versus 9.4 months respectively.
Progression-free survivalr
© Journal of Clinical Oncology 2010
Toxicity
More patients in the CP arm experienced grade 3-4 neutropenia compared with the CD arm (45.7% vs 35.2%; p<0.01) whilst more patients in the CD arm experienced grade 3-4 thrombocytopenia (15.9% vs 6.2%; p<0.001).
Overall, severe non-haematologic toxicity (36.8% vs 28.4%; p<0.01) leading to early discontinuation (15% vs 6%; p<0.001) occurred more frequently in the CP arm. More frequent grade 2 or greater alopecia (83.6% vs 7%), hypersensitivity reactions (18.8% vs 5.6%) and sensory neuropathy (26.9% vs 4.9%) were observed in the CP arm; whilst more hand-foot syndrome (grade 2 to 3, 12.0% vs 2.2%), nausea (35.2% vs 24.2%) and mucositis (grade 2 to 3, 13.9% vs 7%) were observed in the CD arm.r
Adverse events r
© Journal of Clinical Oncology 2010