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Low-dose Z-100 extended OS in locally advanced cervical cancer
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Women with locally advanced cervical cancer survived longer after treatment with low-dose Z-100 than with placebo, according to results of a randomized, double blind, phase 3 trial.
Results from a prior study indicated low-dose (0.2 mcg) treatment with the immunomodulator Z-100 was associated with longer OS than higher-dose treatment (40 mcg) in women with locally advanced cervical cancer who received radiotherapy.
In the current study, researchers randomly assigned 249 patients to either 0.2 mcg Z-100 or placebo administered subcutaneously twice a week during radiotherapy. Patients also received maintenance therapy of their assigned therapy once every 2 weeks until disease progression.
Researchers reported 5-year OS rates of 75.7% (95% CI, 66.4-82.8) in the Z-100 arm and 65.8% (95% CI, 56.2-73.8) in the placebo arm (HR=0.65; 95% CI, 0.40-1.04). The survival benefit associated with Z-100 was observed regardless of whether patients received chemoradiation or radiation alone.
Researchers reported no differences in adverse events between the two arms.
Disclosure: See the study for a full list of the researchers’ relevant financial disclosures.
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