The use of combination chemotherapy following surgery did not improve survival in patients with gastric cancer, according to a randomized clinical trial.
The only potentially curative therapy currently available for non-metastatic gastric cancer is surgery. Recent studies have suggested that a combination of cisplatin, epirubicin, 5-fluorouracil and leucovorin (PELF) improves outcome in patients with metastatic gastric cancer.
To test the PELF combination in patients with localized disease, Francesco Di Costanzo, M.D., of the University Hospital Careggi in Florence, Italy, and colleagues in the Italian Oncology Group for Cancer Research conducted a randomized controlled trial in which 258 patients were treated with surgery or surgery followed by chemotherapy.
With a median follow-up of 72.8 months, there was no significant difference in disease-free survival or overall survival between the two trial arms. Specifically, 47.7 percent of the patients treated with chemotherapy had progressive disease compared with 51.6 percent of patients in the control arm. Overall survival was similar; at the end of the follow-up period, 47 percent of the patients in the chemotherapy were still alive compared with 45.3 percent in the surgery-only arm.
"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," the authors write. Considering the negative results in this trial and other recent adjuvant chemotherapy trials in gastric cancer, the authors write, "Adjuvant chemotherapy alone remains a controversial approach in operable gastric cancer."
In an accompanying editorial, Aiwen Wu, M.D., and Jiafu Ji, M.D., of the Beijing Cancer Hospital and Institute in China discuss the conflicting results obtained from recent trials that tested the value of chemotherapy and radiation in localized gastric cancer.
Despite the inconsistency of the overall data, the editorialists conclude that chemotherapy, radiation, or a combination of the two should be used in patients with gastric cancer. "Surgery alone is no longer the standard treatment for patients with resectable gastric cancer, independent of the patient population or the practice location," they write.
Journal reference: Di Costanzo F, Gasperoni S, Manzione L, Bisagni G, Labianca R, et al. Adjuvant Chemotherapy in Completely Resected Gastric Cancer: A Randomized Phase III Trial Conducted by GOIRC. J Natl Cancer Inst 2008; 100: 388 -- 398
Editorial reference: Wu A, Ji J. Adjuvant Chemotherapy for Gastric Cancer or Not: A Dilemma? J Natl Cancer Inst 2008; 100:376-377
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