|Clinical Trial of Gefitinib for Advanced Lung
Cancer Closes Early
Researchers have closed a randomized clinical trial comparing
gefitinib (Iressa) vs. placebo following chemotherapy and
radiation for patients with non-small cell lung cancer (NSCLC)
that had spread only to nearby tissues or lymph nodes. Review of
interim data indicated that gefitinib would not improve survival.
The clinical trial was sponsored by the National Cancer Institute
(NCI), part of the National Institutes of Health in Bethesda, Maryland,
and was conducted by a network of researchers led by the Southwest
Oncology Group (SWOG), Ann Arbor, Mich. AstraZeneca Pharmaceuticals
LP, Wilmington, Del., which manufactures gefitinib, provided the
agent for the trial under the Clinical Trials Agreement with NCI
for the development of gefitinib. Iressa is a drug that inhibits
an enzyme (tyrosine kinase) present in lung cancer cells, as well
as other cancers and normal tissues, that appears to be important
to the growth of cancer cells.
Based on a review of the limited data available from the Phase
III clinical trial, the Data Monitoring Committee overseeing the
trial (known as S0023*) recommended the
closure, as the trial would not meet its primary endpoint of improved
survival. Detailed results from the study will be presented at
the American Society of Clinical Oncology Annual Meeting (ASCO)
on May 14, 2005.
The study was designed to assess whether maintenance therapy with
gefitinib gefitinib given to help keep cancer in control would
improve overall survival and progression-free survival as compared
to placebo in patients with stable or responding disease. These
patients had inoperable stage III NSCLC and already had completed
the combined chemotherapy regimen of cisplatin and etoposide with
radiation, followed by docetaxel. A total of 672 patients in this
study were to be randomized to one of two treatment arms following
chemotherapy and radiation: one arm would receive gefitinib daily
and the other arm would receive a placebo daily. As of March 10,
2005, 611 patients were entered and 276 were randomized to one
of the two arms.
“The interim analysis indicates that even with accrual of more
patients or with longer follow-up, the gefitinib arm would not
improve survival,” said Laurence Baker, D.O., chairman of SWOG
and a professor of internal medicine and pharmacology at the University
of Michigan in Ann Arbor. This analysis did confirm, however, the
favorable survival seen with the chemotherapy and radiation regimen
previously reported by SWOG**, and thus patients currently entered
in the trial are being advised to complete this part of their treatment.
“Based on the analysis, the use of gefitinib following chemotherapy
and radiation should not be prescribed for this group of patients,” said
Scott Saxman, M.D., who oversees lung cancer clinical trials for
An estimated 172,570 people will be diagnosed with lung cancer
in the United States in 2005. Lung cancer is the second most commonly
diagnosed cancer and the leading cause of cancer-related death
in both men and women in this country. An estimated 163,510 deaths
from lung cancer will occur in 2005 in the United States, accounting
for about 29 percent of all cancer-related deaths in the nation.
For more information about cancer, visit the NCI Web site at http://www.cancer.gov or
call NCI's Cancer Information Service at 1-800-4 CANCER (1-800-422-6237).
*S0023 A Phase III Trial of Cisplatin/Etoposide/Radiotherapy
with Consolidation Docetaxel Followed by Maintenance Therapy with
ZD 1839 or Placebo in Patients with Inoperable Locally Advanced Stage
III Non-Small Cell Lung Cancer.
**Gandara DR, Chansky K, Albain
KS, Leigh BR, Gaspar LE, Lara PN Jr, Burris H, Gumerlock P, Kuebler
JP, Bearden JD, Crowley J, Livingston R. Consolidation docetaxel
after concurrent chemoradiotherapy in stage IIIB non-small-cell
lung cancer: phase II Southwest Oncology Group study S9504. J
Clin Oncol 21(10):2004-2010, 2003.