Adding docetaxel to the most commonly used combination chemotherapy improved tumor regression rate, delayed tumor growth and prolonged survival for patients with advanced stomach cancer, according to interim results of a Phase III international clinical trial presented at the annual meeting of the American Society of Clinical Oncology. From University of Texas M. D. Anderson Cancer Center :New chemotherapy combination lengthens survival in late stage stomach cancer patients
CHICAGO — Adding docetaxel to the most commonly used combination chemotherapy improved tumor regression rate, delayed tumor growth and prolonged survival for patients with advanced stomach cancer, according to interim results of a Phase III international clinical trial presented at the annual meeting of the American Society of Clinical Oncology.
The findings are expected to change the way stomach cancer is managed, says a researcher from The University of Texas M. D. Anderson Cancer Center, who led the 14-nation clinical trial, the largest ever conducted on advanced stomach cancer.
While stomach cancer is relatively rare in the United States ? accounting for 25,000 new diagnoses and approximately 12,000 deaths annually ? it is the second most common cause of cancer death in the world.
“There have been few advances in the treatment of late stage stomach cancer in the last 20 years, but this new treatment regimen marks the first time one-year survival approaches 50 percent for these patients,” says Jaffer Ajani, M.D., a professor in the Department of Gastrointestinal Medical Oncology at M. D. Anderson.
“Late stage stomach cancer is not curable, but this regimen offers several advantages such as reduced risk of tumor growth, higher chance of tumor shrinkage and a longer life span,” he says.
Analyzing results from 223 patients with metastatic gastric cancer, Ajani and his research team found that adding docetaxel (also known by the trade name Taxotere) to the commonly used chemotherapy regimen of cisplatin and 5-Fluorouracil resulted in an 80 percent higher chance of tumor shrinkage compared to patients who received standard treatment. It showed that the chance of cancer growth was reduced by 70 percent for patients who received new treatment and more than 50 percent of patients survived beyond 10.2 months versus 8.5 months using standard treatment.
The investigators specifically found that the overall tumor shrinkage rate was 39 percent and the probability of surviving without cancer growth was nearly doubled at the six-month mark (46 percent versus 26 percent) and that probability nearly tripled at nine months (31 percent versus 11 percent), comparing the new combination with commonly used chemotherapy.
The chemotherapy agents used in the new regimen all have different mechanisms of action “which attack cancer cells in three different ways,” Ajani says.
Moreover, “there is known synergism between docetaxel and 5-FU, although it is not well understood,” he says. Docetaxel, derived from the needles of the Pacific yew tree, has also been approved for use in breast, lung and ovarian cancers.
Ajani cautions that patients need to be carefully selected before they are treated with docetaxel and managed aggressively.
“We hope these results will change practice for treating late stage stomach cancer,” he continues. The results on all 460 patients will be analyzed by mid-August this year.