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Xelox After Gastric Surgery Significantly Improves Disease-Free Survival

Oncology & Biotech News
Published: Wednesday, Aug 03, 2011
Yung-Jue Bang, MD

Yung-Jue Bang, MD

Patients with operable gastric cancer had significant improvement in disease-free survival (DFS) with adjuvant capecitabine plus oxaliplatin (Xelox) following definitive surgery, according to results of a large international trial.

When the study ended prematurely after an interim analysis, patients who received adjuvant chemotherapy had a 3-year DFS of 74% compared with 60% in patients who had only surgery. Overall survival data remain immature but showed a trend in favor of the chemotherapy arm, according to results presented at the ASCO meeting in June.

“The benefit of Xelox was observed for all disease stages,” said Yung-Jue Bang, MD, of Seoul National University in South Korea. “The safety of adjuvant Xelox in gastric cancer was consistent with the known safety profile of Xelox, with no new or unexpected findings.”

“[This trial] demonstrates the superior efficacy of adjuvant Xelox versus observation alone following D2 dissection,” he added. “The data presented support the use of adjuvant Xelox for gastric cancer.”

Surgery is the standard of care for operable gastric cancer, although recurrence rates range as high as 80%. Adjuvant chemotherapy can reduce the risk of recurrence, but no consensus exists about the optimal regimen.

Table. Stratified 3-Year Disease-Free Survival Rates

Category
Subgroup No.
Patients
HR Estimate
 
All
All
1035
0.58
 
Stage of disease
 
 
Stage II
Stage IIIA
Stage IIIB
515
377
143
0.55
0.56
0.57
 
Age group, y
 
<65
65
766
269
0.63
0.46
 
Sex
 
Female
Male
304
731
0.81
0.49
 
Nodal status
 
N0
N1/2
103
932
0.83
0.56
 
HR indicates hazard ratio; y, years.
Adapted from Bang et al. J Clin Oncol. 2011;29(suppl; abstr LBA4002).
Two previous studies demonstrated significant reductions in the risk of recurrence with perioperative or adjuvant chemotherapy (N Engl J Med. 2001;345:725-730 and N Engl J Med. 2006;355:11-20). However, gastric cancer specialists in Asia have questioned the adequacy of the surgery in the 2 trials, said Bang.

Conversely, some authorities consider perioperative or adjuvant therapy unnecessary following definitive (D2) dissection, he added.


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