ACCORD 12: Cap50 regimen improved DFS, did not increase toxicity in rectal cancer
2011 ASTRO Annual Meeting
MIAMI - Patients assigned to neoadjuvant chemoradiation for rectal cancer experienced improved 3-year DFS and lower rates of serious adverse events, said Jean Pierre Gerard, MD, a radiation oncologist at Centre Antoine-Lacassagne in Nice, France.
Gerard discussed results from the phase-3 ACCORD12 trial Monday during a press conference at the 2011 ASTRO Annual Meeting. He added that the treatment regimen did not improve local control or OS.
"We come to the conclusion that the Cap50 regimen should be standard in rectal cancer before surgery because it is easy, it is efficient and it is well-tolerated," he said.
For the trial, 598 patients diagnosed with locally advanced rectal cancer from 2005 to 2008. Patients were recruited at 50 clinics in France and randomly assigned to Cap45, capecitabine (Xeloda, Roche) plus oxaliplatin and 5 weeks of 45 Gy radiation therapy (n=299), or Capox50, capecitabine and five weeks of 50 Gy radiation therapy (n=299).
Oxaliplatin immediately increased side effects, including severe diarrhea, and increased the odds of local tumor sterilization. Gerard said oxaliplatin has not been shown to improve survival. Researchers did observe that the increased radiation was effective, well-tolerated and did not extend the duration of treatment.
Gerard said that, when viewing these results along with the Italian STAR01 and the American NSABP R04 randomized trials, Capox50 should be the standard treatment for locally advanced rectal cancer. Oral capecitabine is more convenient for patients than IV fluorouracil, he said; 50 Gy in 25 fractions over 5 weeks increases the chance of tumor sterilization and reduces risk for local recurrence to 5% or less.
"When we take all the trials together, the regimen we call Cap50, where we use 5 weeks of treatment at 50 Gy rather than 45 Gy, we sterilize more of the tumor. We have only 4% local recurrence," Gerard said. "We replace IV 5-FU with oral capecitabine which is more convenient and we delete oxaliplatin, which has been a disappointment."
For more information:
- Gerard JP. #3. Presented at: the 53rd ASTRO Annual Meeting; Oct. 2-6, 2011; Miami Beach, Fla.
Disclosure: Dr. Gerard is a Medical Advisor for Ariane Company, UK.
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