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Summaries of Newsworthy Clinical Trial Results

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    Posted: 09/07/2001
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Stomach (Gastric) Cancer Home Page
NCI's gateway for information about stomach (gastric) cancer.
Radiation and Chemotherapy After Surgery Improves Survival in Stomach Cancer

Postoperative chemotherapy and radiation treatment extended survival by an average of nine months in patients with operable cancer of the stomach or esophageal junction, according to research from a multicenter clinical trial published in the September 6, 2001, issue of the New England Journal of Medicine. An initial report of this trial was presented at the May 2000 meeting of the American Society of Clinical Oncology (ASCO).

John Macdonald The trial, conducted by the Southwest Oncology Group, involved 556 patients with cancer of the stomach or esophageal junction that could be removed by surgery. About 85 percent of patients in each group had cancer that spread to the lymph nodes in the gut, the first place stomach cancer tends to spread.

Study participants were randomly assigned to receive either surgery alone or surgery followed by chemotherapy with the drugs fluorouracil and leucovorin plus five weeks of radiation treatment.

After an average of five years of follow-up, average overall survival was 36 months in patients who received the adjuvant (additional) therapy, compared with 27 months in patients treated with surgery alone. Survival without return of stomach cancer was 30 months on average in the group receiving adjuvant therapy compared with 19 months in the surgery-only group.

Forty to 65 percent of patients suffer recurrences of cancer in the gastrointestinal region following surgery for stomach cancer. This high relapse rate makes it important to consider adjuvant therapy. However, in previous studies, adjuvant postoperative chemotherapy did not improve survival. Several small studies did suggest that postoperative radiation might extend survival.

In the current trial, the duration of survival in the surgery-only group was similar to that seen in other studies. "The apparent benefit of adjuvant therapy could not be the result of shorter-than-expected survival in the surgery-only group," principal investigator John S. Macdonald, M.D., and his colleagues reported.

Although adjuvant therapy extended patients' average overall survival by nine months, long-term survival was still low. Of the 281 patients who received adjuvant therapy, 169 died during the trial follow-up period, compared with 197 of the 275 patients who received surgery alone. Over half of the patients in the combination treatment group suffered toxic effects from the chemotherapy and radiation, and three patients died from those toxicities.

Among patients whose stomach cancer is detected at a very early stage, about 65 percent survive for 10 years, according to data from the National Cancer Data Base. Among patients with more advanced disease, 10-year survival ranges from 3 to 42 percent, depending on the extent of disease. Approximately 21,700 new cases of stomach cancer will be diagnosed among Americans in 2001, with men being at a slightly higher risk than women.

"Adjuvant treatment with fluorouracil plus leucovorin and radiation should be considered for all patients with high-risk gastric cancer," the researchers conclude. Current clinical trials continue to evaluate further ways of improving treatment for gastric cancer, including studying newer drugs and giving treatments prior to surgery.

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