Related Pages Search for Clinical Trials 1 NCI's PDQ® registry of cancer clinical trials. Lung Cancer Home Page 2 NCI's gateway for information about lung cancer. Drug Information Summaries 3 NCI's drug information summaries provide consumer-friendly information about certain drugs that are approved by the U.S. Food and Drug Administration (FDA) to treat cancer or conditions related to cancer. Highlights from ASCO 2008 4 A collection of links to material summarizing some of the important clinical trial results announced at the 2008 annual meeting of the American Society of Clinical Oncology (ASCO).

Adapted from the NCI Cancer Bulletin, vol. 5/no. 12, June 10, 2008 (see the current issue ⁵).

Patients with advanced non-small-cell lung cancer (NSCLC) who received cetuximab ⁶ (Erbitux) plus chemotherapy lived on average 5 weeks longer than patients who received chemotherapy alone, according to results ⁷ reported at the ASCO annual meeting.

In the phase III FLEX trial, 1,125 patients with all types of NSCLC were randomly assigned to receive standard platinum-based chemotherapy alone or chemotherapy plus cetuximab. Nearly all of the patients had stage IV disease. Overall survival was higher for those who received cetuximab plus chemotherapy (11.3 months) compared with those who received chemotherapy alone (10.1 months).

The benefit of the combination therapy was seen in patients with all histological subtypes of NSCLC, including adenocarcinoma and squamous cell carcinoma, the two most common subtypes. The main side effect was an acne-like skin rash that could be managed.

"Patients with advanced NSCLC have limited treatment options and life expectancy is short, so the survival increase shown in this study is an important step for these patients," noted Dr. Robert Pirker, an associate professor of medicine at the Medical University of Vienna in Austria and the study's lead author.

The only other final-stage randomized trial to show a survival benefit in lung cancer was a 2005 study ⁸ of bevacizumab ⁹ (Avastin) plus chemotherapy. Unlike the current study, that trial did not include patients with squamous cell carcinoma.

Dr. Thomas Lynch of Massachusetts General Hospital, who commented on the findings at ASCO, said the study was well done and produced "a clinically meaningful benefit for a large population."

Glossary Terms

Cancer that begins in cells that line certain internal organs and that have gland-like (secretory) properties.

A study to compare the results of people taking a new treatment with the results of people taking the standard treatment (for example, which group has better survival rates or fewer side effects). In most cases, studies move into phase III only after a treatment seems to work in phases I and II. Phase III trials may include hundreds of people.

A metal that is an important component of some anticancer drugs, such as cisplatin and carboplatin.

Cancer that begins in squamous cells, which are thin, flat cells that look like fish scales. Squamous cells are found in the tissue that forms the surface of the skin, the lining of the hollow organs of the body, and the passages of the respiratory and digestive tracts. Also called epidermoid carcinoma.