New results presented at the 33rd Congress of the European Society for Medical Oncology (ESMO) in Stockholm reveal that women with recurrent ovarian cancer can be helped by giving an investigational drug in combination with chemotherapy.
Dr. Bradley Monk, a UC Irvine gynecologic oncologist who led the worldwide phase III clinical trial, said trabectedin is the most recent addition to a short list of active drug therapies for recurrent ovarian cancer.
"These are exciting results because positive trials in recurrent ovarian cancer are rare and have almost always led to federally approved treatments," said Monk, an associate professor who studies and treats ovarian cancers at the Chao Family Comprehensive Cancer Center at UC Irvine.
"This treatment undoubtedly will be evaluated carefully by the U.S. Food and Drug Administration and, if approved, will give women with ovarian cancer another much needed option," Monk added.
Phase III studies are multicenter trials on large patient groups designed to be the definitive assessment of a drug's effectiveness. Such a study is often the last step before a drug is reviewed by a regulatory agency like the FDA for approval as a safe, effective treatment.
In the latest trial, an international group of researchers treated 672 women whose ovarian cancer had progressed after first-line treatment. Half the women received a combination therapy of trabectedin and a chemotherapy drug called pegylated liposomal doxorubicin.
The other half received the chemotherapy drug alone, which is standard treatment in these cases.
In patients on the combination therapy, researchers found no progression of the cancer for an average of 7.3 months, as 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 time was 9.2 months for the combination treatment, as compared to 7.5 months for the other patients.
Trabectedin is a synthetic version of a compound isolated from the sea squirt, a tubular sea animal used in a number of medical studies. It binds to the DNA of a cancer cell and blocks its ability to multiply, thus killing the cells and shrinking tumors.