Gastric Cancer Patient Survival not Improved by Postoperative Chemotherapy

The use of combination chemotherapy that includes cisplatin, epirubicin, 5-fluorouracil, and leucovorin (PELF) following metastatic gastric cancer surgery does not improve patient survival, claims a new study.

Researchers at University Hospital Careggi (Florence, Italy), and colleagues from other institutions participating in the Italian oncology group for cancer research conducted a randomized controlled trial in which 258 patients were randomly assigned to chemotherapy following surgery (130) or to surgery alone (128) between January 1995 to September 2000. Overall survival (OS) and disease-free survival (DFS) were compared between the treatment arms using Kaplan-Meier analysis and a Cox proportional-hazards regression model.

Study results showed that with a median follow-up of 72.8 months, 128 patients (49.6%) experienced recurrence and 139 (53.9%) deaths were observed. There was no significant difference in disease-free survival or overall survival between the two trial arms; 47.7% of the patients treated with chemotherapy had progressive disease compared with 51.6% of patients in the control arm. Overall survival was similar; at the end of the follow-up period, 47% of the patients in the chemotherapy were still alive compared with 45.3% in the surgery-only arm. The study was published online ahead of print on March 11, 2008, in the Journal of the National Cancer Institute.

"Our study confirms that a dose-intense regimen like PELF, which showed very promising results in advanced gastric cancer, is not effective in an adjuvant setting,” concluded Francesco Di Costanzo, M.D., of Careggi University Hospital, and colleagues. "Considering the negative results in this trial and other recent adjuvant chemotherapy trials in gastric cancer, adjuvant chemotherapy alone remains a controversial approach in operable gastric cancer.”

The researchers estimated that the effect of chemotherapy (i.e., a 10% reduction in the hazard of death or relapse) is modest and consistent with the results of meta-analyses of adjuvant chemotherapy without platinum agents.


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