When Cancer Drug Trials Are Flawed

Lung cancer combination therapy study reported to have errors

/ Author:  / Reviewed by: Joseph V. Madia, MD

(RxWiki News) Chemotherapy drugs like docetaxel stop or slow cancer cell growth. Adding another medication to the chemo that blocks blood vessel growth may help patients live longer.

A recent study shows that lung cancer patients who are given the antibody bavituximab plus docetaxel (brand name Taxotere) might live longer compared to those who receive only docetaxel.

This was big news when it was first reported, because the results were impressive. But there were some major problems with the research.

Peregrine Pharmaceuticals, the drug’s manufacturer, recently reported these errors in the research data, calling into question the results of the study.

"Look carefully into research results about new drugs."

Angiogenesis is the formation of new blood vessels. Bavituximab is an angiogenesis inhibitor for treatment of tumors, including non-small cell lung cancer (NSCLC). The drug helps stop the tumor blood vessel growth but doesn’t affect healthy blood vessels, which can help the immune system fight the tumor.

David Gerber, MD, an assistant professor of internal medicine at The University of Texas Southwestern Medical Center in Dallas who specializes in lung cancer treatment, and his colleagues studied 121 cancer patients. They found median overall survival was 11.1 months in patients treated with docetaxel and bavituximab compared with 5.6 months for patients who received only docetaxel.

Investigators also noted that patients taking the bavituximab had no obvious side effects.

Results of the study, however, are now being called into question. “Major discrepancies” were found between some patient results and how the patients were identified by codes.

The coding errors indicate that the company may not know with certainty which patients received the bavituximab and which received a placebo.

Further testing of bavituximab with more controls and oversight will now be required to confirm the benefits of using the drug in combination with chemotherapy.

That study was presented in early September at the 2012 Chicago Multidisciplinary Symposium in Thoracic Oncology. This symposium is sponsored by the American Society of Clinical Oncology (ASCO), the American Society for Radiation Oncology (ASTRO), the International Association for the Study of Lung Cancer (IASLC) and The University of Chicago.

By the end of September, Peregrine Pharmaceuticals issued a statement that cancer trial data was erroneous.

Reviewed by: 
Review Date: 
October 15, 2012
Last Updated:
July 5, 2013