(RxWiki News) Drug research takes years of development, and there comes a day when hard data reveals whether the drug actually works the way it did in the lab.
In a presentation at the annual meeting of the American Society of Clinical Oncology, scientists presented the latest results from their trial on Votrient (pazopanib), as a treatment for advanced soft tissue sarcomas.
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The study, led by professor Winette T.A. Van Der Graaf, MD, from the Department of Medical Oncology at Radboud University Nijmegen Medical Centre in Nijmegen, showcased the results of testing Votrient in a randomized trial, a comparison against no treatment at all for soft tissue sarcomas.
While the drug showed that it did have some effect in stopping the growth of the cancer for a while, the final analysis of overall survival times showed no difference, meaning that the treatment did not extend lifespan in the patients.
Thirteen weeks of treatment with either Votrient (pazopanib) or placebo was followed by 25 months of observation, with the trial enrolling 369 patients with advanced soft tissue sarcoma who had received prior chemotherapy.
The scientists published that the time before the cancer started to grow again was, on average, over four months for the Votrient group, and one month for patients on placebo.
The researchers concluded that the over all survival times for the patients was not longer for either group.
Votrient was approved by the U.S. Food and Drug Administration back in April for patients with advanced soft tissue cancers that had already had chemotherapy, citing early results from this study. Votrient was first approved in October 2009 for the treatment of advanced kidney cancer.
“Soft tissue sarcomas are a diverse group of tumors and the approval of Votrient for this general class of tumors is the first in decades,” said Richard Pazdur, MD, in a statement from the FDA’s Center for Drug Evaluation and Research.
“Drug development for sarcomas has been especially challenging because of the limited number of patients and multiple subtypes of sarcomas.”
Votrient works by stopping new blood vessel development, which tumors need to fuel their growth.
Another group of researchers, at the same conference, presented the results of their Votrient trial in kidney cancer patients. They found that in terms of side effects, it was easier on patients than the current standard, Sutent (sunitinib). However, the researchers did not compare the effectiveness of Votrient to Sutent.
The report from the FDA listed the most common side effects as fatigue, diarrhea, nausea, weight loss, high blood pressure, decreased appetite, vomiting, tumor and muscle pain, hair color changes, headache, a distorted sense of taste, shortness of breath, and skin discoloration.
Votrient has a black-box warning saying there is a serious risk of possibly fatal liver damage in patients who have liver problems, and that liver health should be monitored when the drug is used.
Despite the results, the president of the company is still enthusiastic about Votrient's potential in treating soft tissue cancers.
“It is such a great moment to bring forth this treatment option for patients, as it represents one of the few new medical options to be provided to patients with advanced soft tissue sarcoma over the last thirty years,” said Paolo Paoletti, MD and president of GSK Oncology.
GlaxoSmithKline (GSK) is the drug's manufacturer.
Dr. Paoletti continued, saying that, “GSK Oncology feels fortunate to have collaborated with the European Organization for Research and Treatment of Cancer (EORTC) in completing a rigorous Phase III trial in such a rare cancer.”
Researchers involved in the study disclosed financial and professional ties to over a dozen pharmaceutical corporations.