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document
Carboplatin and pegylated liposomal doxorubicin versus carboplatin and paclitaxel in very platinum-sensitive ovarian cancer patients : results from a subset analysis of the CALYPSO phase III trial . AIM To perform a subset analysis of patients with very platinum-sensitive recurrent ovarian cancer ( ROC ) enrolled in the phase III CALYPSO trial . PATIENTS AND METHODS The international non-inferiority trial enrolled women with ROC that relapsed > 6 months following first- or second-line platinum- and paclitaxel-based therapies . Patients were randomised to CD [ carboplatin-pegylated liposomal doxorubicin ( PLD ) ] or CP ( carboplatin-paclitaxel ) and stratified by treatment-free interval ( TFI ) . In this analysis , patients with a TFI > 24 months were analysed separately for progression free survival ( PFS ) , the primary endpoint of CALYPSO , overall survival ( OS ) and safety . RESULTS A total of 259 very platinum-sensitive patients were included ( n=131 , CD ; n=128 , CP ) . Median PFS was 12.0 months for the CD arm and 12.3 months for CP [ HR=1.05 ( 95 % CI , 0.79-1.40 ) ; P=0.73 for superiority ] and median OS was 40.2 months for CD and 43.9 for CP [ HR=1.18 ( 95 % CI 0.85-1.63 ) ; P=0.33 for superiority ] . Overall response rates were 42 % and 38 % , respectively ( P=0.46 ) . Toxicities were more common with CP versus CD , including grade 3/4 neutropenia ( 40.8 % versus 27.5 % ; P=0.025 ) , nausea ( 4.8 % versus 3.1 % ; P=0.47 ) , allergic reaction ( 8 % versus 3.1 % ; P=0.082 ) sensory neuropathy ( 4.8 % versus 2.3 % ; P=0.27 ) and grade 2 alopecia ( 88 % versus 9.2 % ; P < 0.001 ) . Grade 3/4 thrombocytopenia ( 12.2 % versus 3.2 % ; P=0.007 ) and mucositis ( 2.3 % versus 0 % ; P=0.089 ) were more common with CD . Grade 3/4 hand-foot syndrome occurred rarely with CD ( 3 patients versus 0 in CP arm ; P=0.089 ) . CONCLUSION CP and CD were equally effective treatment regimens for patients with very platinum-sensitive ROC . The favourable risk-benefit profile suggests carboplatin-PLD as treatment of choice for these patients .
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Intervention_Pharmacological
Carboplatin and pegylated liposomal doxorubicin
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Intervention_Pharmacological
carboplatin and paclitaxel
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Intervention_Pharmacological
platinum- and paclitaxel-based therapies
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Intervention_Pharmacological
CD [ carboplatin-pegylated liposomal doxorubicin ( PLD ) ]
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Intervention_Pharmacological
CP ( carboplatin-paclitaxel )
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Intervention_Pharmacological
CD
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Intervention_Pharmacological
CP
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Intervention_Pharmacological
CP
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Intervention_Pharmacological
CD
69432
Intervention_Pharmacological
CD
69433
Intervention_Pharmacological
CD
69434
Intervention_Pharmacological
carboplatin-PLD
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Outcome_Mortality
Median PFS
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Outcome_Mortality
median OS
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Outcome_Other
response rates
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Outcome_Adverse-effects
Toxicities
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Outcome_Adverse-effects
grade 3/4 neutropenia
69440
Outcome_Adverse-effects
nausea
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Outcome_Adverse-effects
allergic reaction
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Outcome_Adverse-effects
sensory neuropathy
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Outcome_Adverse-effects
grade 2 alopecia
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Outcome_Adverse-effects
Grade 3/4 thrombocytopenia
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Outcome_Adverse-effects
mucositis
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Outcome_Adverse-effects
Grade 3/4 hand-foot syndrome
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Participant_Condition
very platinum-sensitive ovarian cancer patients :
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Participant_Condition
subset analysis of the CALYPSO phase III trial
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Participant_Condition
patients with very platinum-sensitive recurrent ovarian cancer ( ROC ) enrolled in the phase III CALYPSO trial .
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Participant_Sample-size
total of 259
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Participant_Condition
platinum-sensitive patients were included (
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Participant_Condition
, CD ;
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Participant_Condition
, CP )
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Participant_Condition
patients with very platinum-sensitive ROC .