Journal of the National Cancer Institute Advance Access originally published online on December 25, 2007
JNCI Journal of the National Cancer Institute 2008 100(1):11-12; doi:10.1093/jnci/djm299
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© Oxford University Press 2007.
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Reactive Oxygen Species May Have Antitumor Activity in Metastatic Melanoma
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An investigational drug that causes cells to produce excess reactive oxygen species (ROS) was associated with unexpectedly long progression-free survival in a small trial of patients with metastatic melanoma. The drug's mechanism of action, the trial design, and the trial outcome are all unusual in the field, but just how important they will be remains an open question, according to experts.
In the phase II trial, 81 patients with metastatic melanoma were randomly assigned to receive either paclitaxel plus the ROS-inducing agent elesclomol (formerly STA-4783) or paclitaxel alone. Patients taking elesclomol had a median progression-free survival of 3.7 months, compared with 1.8 months for those in the control arm—a statistically significant difference. Moreover, 35% of patients were progression free in the combination arm at 6 months versus 15% in the control arm.
"I think it is the first—in terms of randomized and placebo controlled—study in metastatic melanoma" to show improved
Interesting Trial Design
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  P. Hersey, L. Bastholt, V. Chiarion-Sileni, G. Cinat, R. Dummer, A. M. M. Eggermont, E. Espinosa, A. Hauschild, I. Quirt, C. Robert, et al. Small molecules and targeted therapies in distant metastatic disease Ann. Onc., August 1, 2009; 20(suppl_6): vi35 - vi40. [Abstract] [Full Text] [PDF]
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