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Clinical Trial Results

Summaries of Newsworthy Clinical Trial Results
  • Posted: 04/17/2007

Surgery Does Not Improve Survival for Advanced NSCLC Patients

Adapted from the NCI Cancer Bulletin 1.

Patients with stage IIIA-N2 non-small-cell lung cancer (NSCLC) who had surgery following induction chemotherapy did not have better overall or progression-free survival than patients who received radiotherapy following chemotherapy. These results are published in the March 21, 2007, Journal of the National Cancer Institute (see the journal abstract).

Dr. Jan P. van Meerbeeck of the University Hospital Ghent in Belgium and colleagues conducted a multicenter prospective randomized trial that included 579 eligible patients with stage IIIA NSCLC and positive lymph nodes (N2) from 41 institutions of the European Organisation for Research and Treatment of Cancer-Lung Cancer Group from December 1, 1994, to December 1, 2002 (see the protocol summary 2).

Patients were given induction chemotherapy, which consisted of three cycles of cisplatin 3 or carboplatin, with at least one other chemotherapy drug. Of the 579 eligible patients, 332 patients were randomly assigned to surgical resection or thoracic radiotherapy. One hundred fifty-four patients in each arm completed treatment as assigned. 

Researchers found that surgery didn't improve overall or progression-free survival in patients. The median survival time was 17.5 months in the radiotherapy arm and 16.4 months in the surgery arm. The five-year overall survival rate was 14 percent for patients who received radiotherapy and 15.7 percent for those who had surgery, a difference that was not statistically significant.

In an editorial, Drs. David H. Johnson, Valerie W. Rusch, and Andrew T. Turrisi noted that the "data indicate that chemoradiation therapy remains an appropriate therapeutic strategy for the subset of IIIA NSCLC patients with preoperatively detected N2 disease. The results also emphasize the importance of careful patient selection for surgery and of the type of lung resection." They also commented, "As we move forward, it is our dream to also focus on prospectively validating putative molecular markers of prognosis, drug sensitivity, and resistance. Hopefully, these promising technologies can be used to guide patient selection and treatment decisions in the future."

Related Pages



Glossary Terms

induction therapy (in-DUK-shun THAYR-uh-pee)
Initial treatment used to reduce a cancer. Induction therapy is followed by other treatments, such as chemotherapy, radiation therapy, and hormone therapy to get rid of cancer that remains. Also called first-line therapy, primary therapy, and primary treatment.
progression-free survival (pruh-GREH-shun ... ser-VY-vul)
The length of time during and after treatment in which a patient is living with a disease that does not get worse. Progression-free survival may be used in a clinical study or trial to help find out how well a new treatment works.
randomized clinical trial (RAN-duh-mized KLIH-nih-kul TRY-ul)
A study in which the participants are assigned by chance to separate groups that compare different treatments; neither the researchers nor the participants can choose which group. Using chance to assign people to groups means that the groups will be similar and that the treatments they receive can be compared objectively. At the time of the trial, it is not known which treatment is best. It is the patient's choice to be in a randomized trial.
resected (ree-SEK-ted)
Removed by surgery.
statistically significant (stuh-TIS-tih-kuh-lee sig-NIH-fih-kunt)
Describes a mathematical measure of difference between groups. The difference is said to be statistically significant if it is greater than what might be expected to happen by chance alone. Also called significant.

Table of Links

1http://www.cancer.gov/ncicancerbulletin
2http://www.cancer.gov/clinicaltrials/EORTC-08941
3http://www.cancer.gov/cancertopics/druginfo/cisplatin
4http://www.cancer.gov/clinicaltrials/search
5http://www.cancer.gov/cancertopics/types/lung