Clinical benefits and economic analysis of pegylated liposomal doxorubicin/vincristine/dexamethasone versus doxorubicin/vincristine/dexamethasone in patients with newly diagnosed multiple myeloma.

Pegylated liposomal doxorubicin has reduced toxicity compared with conventional doxorubicin. In a noninferiority trial randomizing patients to receive pegylated liposomal doxorubicin 40 mg/m(2) and vincristine 1.4 mg/m(2) (maximum, 2 mg) intravenously on day 1 plus reduced-dose dexamethasone 40 mg orally on days 1-4 (DVd; n = 97) or conventional doxorubicin 9 mg/m(2) per day and vincristine 0.4 mg per day continuous intravenous infusion on days 1-4 plus reduced-dose dexamethasone (VAd; n = 95) for >/= 4 cycles. Treatment was repeated every 4 weeks until maximal response, disease progression, unacceptable toxicity, or until patients underwent transplantation. Treatment cost was estimated by applying standard US costs in 2004 to recorded health-care resource utilization units. Outcome measures included response, toxicity, and treatment cost. Objective response rates (DVd, 44%; VAd, 41%), progression-free survival (hazard ratio, 1.11; P = 0.69), and overall survival (hazard ratio, 0.88; P = 0.67) were similar between treatment groups. DVd was associated with significantly less grade 3/4 neutropenia or neutropenic fever (10% vs. 24%; P = 0.01), less sepsis, antibiotic use, growth factor support, and alopecia, but more hand-foot syndrome. Study drug costs were significantly higher for DVd versus VAd; however, lower costs for drug administration and supportive care more than offset this difference, resulting in nominally lower overall study drug treatment costs for DVd (DVd, $34,442; VAd, $35,846; P = 0.76). The DVd regimen demonstrated similar efficacy and cost with less toxicity and supportive care compared with VAd. This should improve clinical utility and optimize the opportunity for transplantation.