BACKGROUND: CALYPSO (CAeLYx in Platinum Sensitive Ovarian) patients compared carboplatin-pegylated liposomal doxorubicin (C-PLD) with carboplatin-paclitaxel (C-P) in patients with late-relapsing recurrent ovarian cancer (ROC). We analyzed outcomes in patients <70 years.
PATIENTS AND METHODS: Nine hundred and seventy-six patients with taxane-pretreated ROC relapsing >6 months after first- or second-line platinum-based therapy were randomly assigned to 4-weekly C area under the curve (AUC) 5 plus PLD 30 mg/m(2) or 3-weekly C AUC 5 plus P 175 mg/m(2) for six or more cycles.
RESULTS: One hundred and fifty-seven (16%) patients <70 years (median: 74 years, C-PLD; 73 years, C-P; range 70-82 years) were included (n=71, C-PLD; n=86, C-P). In comparing elderly and younger, elderly patients experienced fewer grade ?2 allergic reactions (P=0.005) but more grade ?2 sensory neuropathy (P=0.007). Myelosuppression did not differ with age. Elderly patients completed planned treatment as frequently as younger (79%, C-PLD; 82%, C-P). In comparing arms within elderly patients, C-P was associated with more grade 2 alopecia, sensory neuropathy, arthralgia/myalgia (P?<0.001 for all), severe leukopenia plus febrile neutropenia; C-PLD was associated with more grade 2 hand-foot syndrome (P=0.005). Median progression-free survival was 11.6 months (C-PLD) and 10.3 months (C-P; P=0.44).
CONCLUSIONS: Patients <70 years experienced more neuropathy, with a higher incidence in the C-P arm. Similar to all study patients, C-PLD provided a better therapeutic index with less toxicity than C-P in elderly women with platinum-sensitive ROC.