New Treatment Extends Life For Patients With Small-Cell Lung Cancer

Dr. Alan Sandler, director of Vanderbilt-Ingram’s Thoracic Oncology Program, is leading a large U.S. study to further evaluate the treatment’s ability to prolong survival in patients with small-cell lung cancer, following publication of a Japanese trial in this week’s issue of The New England Journal of Medicine. The research in Japan, involving about 150 patients, found that treatment with CPT-11 (Camptosar or irinotecan) and cisplatin was superior to the standard therapy of cisplatin and etoposide. Patients receiving the CPT-11 combination had a 55 percent improvement in one-year survival, a 40 percent reduction in the risk of dying from their lung cancer than patients treated with the cisplatin and etoposide arm and were four times more likely to be alive at two years.

"Up until this study, no treatment had been identified that increases survival to this extent.," said Dr. Sandler. "This is the first to show a dramatic difference."

Lung cancer is the leading cause of cancer death in the United States. Each year more people will die of lung cancer than breast, prostate and colorectal cancers combined. Small cell lung cancer is a particularly aggressive form of lung cancer, and two-thirds of patients are diagnosed when the cancer is already spread extensively. As a result, the median survival (the point at which half of patients live longer and half of them live a shorter amount of time) after diagnosis has been only about eight to nine months.

"For the first time, I can look a patient in the eye and say, ‘you have a greater than 50 percent chance of being alive in a year,’" Sandler said. "For these patients, it may mean they get to see the next wedding anniversary or the birth of a grandchild or a high school graduation that they otherwise would have missed."

CPT-11 works by interfering with the multiplication of cancer cells. It blocks an enzyme called topoisomerase that is necessary for the successful replication of a cell’s DNA as it divides into two cells. Based on its approval in April 2000 by the Food and Drug Administration, CPT-11 is the standard of care for the first-line treatment of metastatic or relapsed colon cancer and is being evaluated in earlier stages of that disease.

The Japanese study, conducted by the Japanese Cooperative Group, began in 1995 and was stopped in 1998 because of the dramatic difference in survival in patients receiving CPT-11.

The ongoing Phase III trial in the United States is designed to confirm the results of the Japanese study and to ensure that American patients have a comparable response to the drug. Sandler is the primary national investigator in the study, which is also being led by investigators at the University of Colorado, Indiana University and Fox Chase Cancer Center in Philadelphia. The study, which is funded by Pharmacia, the maker of CPT-11, opened at these and 25 other locations earlier this year.

The study compares CPT-11 and cisplatin with the standard therapy using cisplatin and etoposide. Patients will be assigned by chance to receive one or the other therapy, with two-thirds of the patients receiving the CPT-11/cisplatin therapy. A total of 300 patients will be enrolled in the trial nationwide.

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For more information, contact Vanderbilt-Ingram’s Cancer Information Program at 1-800-811-8480. The Vanderbilt-Ingram Cancer Center is the only Comprehensive Cancer Center designated by the National Cancer Institute in Tennessee, and one of only 41 nationwide. This designation, the highest ranking awarded to cancer centers by the world is foremost authority on cancer, recognizes research excellence in cancer causes, development, treatment and prevention, as well as a demonstrated commitment to community education, information and outreach.