Anew treatment for small-cell lung cancer holds promise of dramatically improving survival for patients with the disease, said Dr. Alan Sandler, director of Vanderbilt-Ingram Cancer Center’s Thoracic Oncology Program, and leader of a large US study to further evaluate the treatment’s ability to prolong survival in patients with small-cell lung cancer.
Japanese Study Results
A study conducted in Japan in 150 patients and published in a recent issue of the New England Journal of Medicine (346:85-91, 2002) found that treatment with irinotecan(Drug information on irinotecan) (CPT-11, Camptosar) and cisplatin(Drug information on cisplatin) was superior to standard therapy with cisplatin and etoposide(Drug information on etoposide). Patients receiving the irinotecan combination had a 55% improvement in 1-year survival and a 40% reduction in the risk of death, compared to patients being treated with cisplatin and etoposide; they were also four times more likely to be alive at 2 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. For the first time, I can look a patient in the eye and say, ‘You have a greater than 50% chance of being alive in a year.’"
Phase III US Trial
The Japanese study, conducted by the Japanese Cooperative Group, began in 1995 but was stopped in 1998 due to the striking difference in survival in patients receiving irinotecan. The ongoing phase III trial in the United States is designed to confirm the results of the Japanese study and to ensure that US patients have a comparable response to the drug.
Dr. Sandler is the primary national investigator for the study, which is also being led by investigators at the University of Colorado, Indiana University, and Fox Chase Cancer Center in Philadelphia. Funded by Pharmacia (manufacturer of irinotecan), the study is comparing irinotecan/cisplatin with standard cisplatin/etoposide therapy. Patients will be randomized to receive one or the other therapy, with two-thirds receiving the irinotecan/cisplatin combination. A total of 300 patients will be enrolled in the trial nationwide.