The combination, which importantly does not include a platinum drug, challenges the current standard of treatment for women whose cancer recurs at least 6 months after first-line treatment, said Associate Prof. Bradley J. Monk from the University of California Irvine Medical Center.
“This trial, which included almost two-thirds such women, challenges this traditional paradigm and suggests that a non-platinum doublet is also effective in this setting,” he said. “Trabectedin represents a ‘new chemical entity’ in North America and if approved by the FDA, would be an important new option for women with recurrent ovarian cancer.”
Trabectedin, a synthetic version of a compound first isolated from sea-squirts, has been granted marketing approval in Europe for the treatment of patients with advanced soft tissue sarcoma.
In the latest trial, an international group of researchers studied the combination in 672 women whose ovarian cancer had progressed after first-line therapy. Half the women received pegylated liposomal doxorubicin 30 mg/m2 over 60 min plus trabectedin 1.1mg/m2 over 3 hours every 3 weeks, the remainder received pegylated liposomal doxorubicin 50 mg/m2 alone every 4 weeks.
The median length of progression-free survival for women on the combination therapy was 7.3 months, the researchers found, compared to 5.8 months for those treated with the single drug. For those who had relapsed more than six months after the first-line therapy, the median progression-free survival time was 9.2 months for the combination treatment, compared to 7.5 months for patients in the other arm.
“This drug appears active in all sub-groups included in the trial, but like all agents is most active among those with longer time intervals since their front-line chemotherapy treatment,” Prof. Monk said.
“Positive trials in recurrent ovarian cancer are rare and have almost always led to newly approved therapeutic regimens,” he said. “This combination will undoubtedly be carefully evaluated by the FDA and if approved would give women with ovarian cancer another much-needed option.”
Vanessa Pavinato | alfa
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