A more intensive postoperative chemotherapy regimen for high-risk gastric cancer patients did not improve their survival, according to a randomized controlled trial in the April 18 Journal of the National Cancer Institute.
The five-year survival rate for gastric cancer patients who undergo radical surgery is typically between 15 and 32 percent. Efforts to improve survival with new therapies, including postoperative chemotherapy, have yet to yield statistically significant results.
Stefano Cascinu, M.D, of the Universita Politecnica delle Marche in Ancona, Italy, and colleagues conducted a multi-center, randomized phase III trial of 397 high-risk gastric cancer patients who were given either eight weekly treatments of five chemotherapy drugs or six monthly treatments of only two of the drugs. After their treatment, the patients were followed for a median of 54 months.
The researchers found no significant difference in survival between the two groups. The five-drug regimen did not reduce the risk of death or relapse. Both groups had about a 50 percent five-year survival rate, which is much higher than previous studies have shown.
"The unexpectedly long survival time in our trial may be due to several factors, among them, the high quality of surgery…observed in our trial," the authors write. "Furthermore, toxicity associated with postoperative chemotherapy as reported in our trial and in other studies…suggest that it may be preferable to move toward preoperative approaches."
In an accompanying editorial, Susan Ellenberg, Ph.D., and Weijing Sun, M.D., of the University of Pennsylvania School of Medicine in Philadelphia, discuss the lessons to be learned from this negative result. "Unfortunately, some legislators, pushed by patient advocacy groups, seem willing to ignore the lessons of the past and are pushing for an extensive rollback of regulatory policy such that drugs for cancer and other life-threatening diseases could be marketed without being shown to be beneficial in a rigorously designed and conducted trial such as this study's authors have described. This trial provides an important reminder of how much patients have to lose should such efforts prevail," the authors write.
Contact:
Article: Marisa Carnevali, m.carnevali@ao-umbertoprimo.marche.it, +39 0715964878 or 0715963107
Editorial: Karen Kreeger, University of Pennsylvania, karen.kreeger@uphs.upenn.edu, (215) 349-5658
Citation:
Article: Cascinu S, Labianca R, Barone C, Santoro A, Carnaghi C, et al. Adjuvant Treatment of High-Risk, Radically Resected Gastric Cancer Patients with 5-Fluorouracil, Leucovorin, Cisplatin, and Epidoxorubicin in a Randomized Controlled Trial. J Natl Cancer Inst 2007; 99: 601-607
Editorial: Ellenberg SS, Sun W. Adjuvant Therapy for Gastric Cancer: How Negative Results Can Help Patients. J Natl Cancer Inst 2007; 99: 580-582
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Journal
JNCI Journal of the National Cancer Institute