Can Elderly Patients With Recurrent Ovarian Cancer (Roc) Be Treated With A Platinum-Based Doublet? Results From The Calypso Trial

5031 Background: In the CALYPSO trial, carboplatin (C)-pegylated liposomal doxorubicin (PLD) demonstrated a superior therapeutic index (TI) versus C-paclitaxel (P) in patients (pts) with ROC >6 mo after 1st- or 2nd-line platinum-based therapy. The aim of this analysis was to evaluate efficacy and tolerability of C-based doublets in the subset of elderly pts (≥ 70 y). Methods: 976 pts with taxane-pretreated ROC were randomized between C-PLD [C AUC 5 IV + PLD 30 mg/m2 IV] d1 q4 wk, or C-P [C AUC 5 IV + P 175 mg/m2 IV] d1 q3 wk × ≥ 6 cycles. Results: 157 (16%) pts were ≥ 70 y: 71 in C-PLD arm (median age 74, range 70-82.4) and 86 in C-P arm (median age 73, range 70.2-82). Pts characteristics including geriatric parameters (body mass index, comorbidity) were well balanced between arms. The median PFS was 11.6 and 10.3 months in C-PLD and C-P arms, respectively. Elderly pts completed ≥ 6 planned cycles at the same rate as younger pts (82% C-PLD, 78% C-P). Myelosuppression did not differ with age. Nonhematologic toxicities are summarized in the Table. Compared to younger pts, elderly experienced less allergic reactions (5.8% vs. 14.0%, p=0.005), but significantly more grade > 2 neurotoxicity (24.7% vs. 15.6%, p=0.006). Conclusions: This subanalysis of the CALYPSO trial, the first reported for elderly ROC pts treated with C-based doublets, showed a similar TI for elderly pts versus younger pts. Overall, less hypersensitivity reactions and more neuropathy were observed in elderly versus younger pts. Based on these findings, C-PLD appears to be the more preferable treatment option in elderly ROC pts. Grade ≥ 2 nonhematologic toxicities Age < 70 Age ≥ 70 C-P (%)n=416 C-PLD (%)n=393 C-P (%)n=86 C-PLD (%)n=71 Alopecia 83.7 6.4 86.9 11.4 Sensory neuropathy 26.2 4.3 36.9 10 Allergy 21.4 6.1 7.1 4.3 Arthralgia/myalgia 19 4.3 22.1 2.9 Hand-foot syndrome 2.2 12 2.4 14.3 Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Schering-Plough Schering-Plough