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Perioperative Chemotherapy Improves Gastric Cancer Outcome
SUTTON, England - A perioperative chemotherapy regimen improved progression-free and overall survival in potentially curable gastric cancer, researchers here reported.
SUTTON, England, July 6 - A perioperative chemotherapy regimen improved progression-free and overall survival for potentially curable gastric cancer, according to researchers here.
Compared with patients given surgery alone, patients who had three preoperative and three postoperative chemotherapy cycles of epirubicin, cisplatin and fluorouracil (ECF) had a significantly higher likelihood of survival and a significantly better five-year progression free survival, found David Cunningham, M.D., and colleagues of Royal Marsden Hospital.
Patients in the study had resectable adenocarcinoma of the stomach, esophagogastric junction, or lower esophagus, the investigators reported in the July 6 issue of the New England Journal of Medicine.
The two hundred and fifty patients randomized to the chemotherapy arm underwent three pre-operative and three post-operative cycles of intravenous epirubicin (50 mg/m2) and cisplatin (60 mg/ m2) on day one and continuous intravenous infusion of fluorouracil (200 mg/m2 /day) for 21 days.
The median age of patients was 62, and 82% of patients in the chemotherapy arm were men as were 75.5% of patients in the surgery arm.
Among the findings:
- In the chemotherapy group 229 of 250 patients underwent surgery, while 244 of 253 randomized to surgery alone underwent surgery.
- Five year survival rate was 36.3% (95% CI 29.5% to 43.0%) for patients in the perioperative chemotherapy group versus 23.0% (95% CI 16.6% to 29.4%) in the surgery-alone arm.
- Compared with the surgery-alone group, the hazard ratio for progression of disease was 0.66; 95% CI 0.53 to 0.81 P<0.001) for patients in the perioperative chemotherapy group.
- Hazard ratio for death was 0.75 (95% CI 0.60-0.93; P<0.009).
- One hundred and four patients (49.5%) completed all six cycles of chemotherapy.
- Perioperative chemotherapy was associated with acceptable rates of adverse events. Excluding patients with neutropenia (23%), less than 12% of patients had serious (grade 3 or 4) toxic effects. Although 15 of 237 patients (6%) discontinued treatment, mainly because of toxic effects, most patients were safely treated with chemotherapy followed by gastrectomy.
In an editorial that accompanied the study, John S. Macdonald, M.D., of St. Vincent's Comprehensive Cancer Center in New York wrote that the ECF regimen used in the study was developed in the late 1980s. He cited newer and less complex chemotherapy regimens with activity against advanced gastric cancer.
But more studies are needed to determine if those newer regimens are as good as or better than ECF in patients with localized, resectable gastric cancer, he added.
Dr. Macdonald said that many patients undergo gastrectomy before being evaluated by a medical oncologist. The Cunningham study, he wrote, suggests the need to call in the oncologists before surgery.
Meanwhile Dr. Macdonald wrote that the study by Dr. Cunningham and colleagues was "well designed and well executed, and clinicians can have confidence in the solid evidence that perioperative therapy with a regiment of ECF improves the outcome for patients with respectable gastric cancer identified before gastrectomy."
