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CALYPSO

Pegylated liposomal Doxorubicin and Carboplatin compared with Paclitaxel and Carboplatin for patients with platinum-sensitive ovarian cancer in late relapse

Date of Publication:

July 10, 2010

Pubmed Link:
https://www.ncbi.nlm.nih.gov/pubmed/20498395
Hypothesis:

Is carbo/doxil non-inferior to carbo/paclitaxel in women with platinum sensitive recurrent ovarian cancer?

Control Arm(s):

Carboplatin AUC 5 + paclitaxel 175 mg/m2  

q3 weeks x6 cycles

Experimental Arm(s):

Carboplatin AUC 5 + Pegylated Liposomal Doxirubicin 30 mg/m2

q4 weeks x6 cycles

Primary End Point:

PFS

Inclusion Criteria:

Measurable ovarian cancer

Recurrence >6months after first or second line platinum with taxane

Exclusion Criteria:

Pre-existing neuropathy or cardiomyopathy

Results:

carbo/doxil vs carbo/taxol:
median f/u: 22 mos

PFS: 11.3 vs 9.4 mos (SS)

Neutropenia (G3/G4): 35% vs 45% (SS)

Thrombocytopenia (G3/G4): 15.9% vs 6.2% (SS)

Anemia (G3/G4): 7.9% vs 5.4% (NS)

Alopecia (≥G2): 7% vs 83.6% (SS)

Nausea/Vomiting: 22-35% vs 15-24% (SS)

Conclusions:

Carbo/Doxil is non-inferior to Carbo/Taxol in recurrent platinum-sensitive ovarian cancer with a favorable side effect profile

Reviewer:
Kevin McCool, OTF