A randomized phase III clinical trial found that carboplatin/pegylated liposomal doxorubicin (Doxil) was not superior in prolonging progression compared to the standard carboplatin/paclitaxel as first-line therapy of patients with advanced ovarian cancer. The carboplatin/liposomal doxorubicin regimen, however, “can be considered a reasonable alternative for first-line treatment of advanced ovarian cancer, particularly in patients at high risk of neurotoxicity or wishing to avoid alopecia,” the trial’s investigators concluded. “This choice, of course,” they noted, “should take into account patient’s [preferences] and consider limitations as a result of the lack of regulatory approval of [pegylated liposomal doxorubicin] for first-line treatment and its cost.”
In the Multicentre Italian Trials in Ovarian Cancer-2 (MITO-2), carboplatin/liposomal doxorubicin produced a response rate similar to the standard carboplatin/paclitaxel in chemotherapy-naive patients with stage IC to IV ovarian cancer. The patients were ≤ 75 years old with an Eastern Cooperative Oncology Group performance status ≤ 2.
“The favorable prognostic characteristics of the enrolled patients (significant proportion of patients with early-stage disease and of patients without residual disease after surgery)” resulted in “a dramatic decrease in the incidence of [progression-free survival] events,” the study investigators reported. Because getting the planned number of events would have required much more time and “non–ovarian cancer deaths might dilute [progression-free survival] differences,” the final MITO-2 analysis was performed with fewer events than planned, “but it is unlikely that this affected the results,” the researchers stated. Those results showed that median progression-free survival was 16.8 months in the standard arm and 19.0 months in the experimental arm.
“In multivariable analysis adjusted by stage, performance status, residual disease, age, and size of the institution, the difference between treatments remained not significant,” the authors wrote.
“Nonhematologic toxicity significantly differed between the arms, with hair loss and neurotoxicity being drastically less frequent in the experimental arm, but with this arm having more skin toxicity and stomatitis. Hematologic toxicity was also worse with experimental treatment but within acceptable limits for clinical practice,” they added. ■
Pignata S, et al: J Clin Oncol 29:3628-3635, 2011.