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Preoperative chemoradiotherapy improved local control in advanced rectal cancer
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Preoperative chemoradiotherapy produced superior local control compared with postoperative therapy but did not improve survival for patients with advanced rectal cancer, according to phase 3 results from the CAO/ARO/AIO-94 trial.
Researchers assigned 406 patients with stage II/stage III disease to the preoperative protocol and 393 to postoperative therapy. Of those assigned to the postoperative arm, 145 patients did not receive chemoradiotherapy (CRT) because of a variety of factors. Some were excluded because they had been diagnosed with stage 0 to I or stage IV disease.
Median follow-up was 134 months for a total of 450 patients as of December 2010. There were 341 deaths in that time, 223 of which could be attributed to rectal cancer or complications arising from treatment, researchers said.
Twenty-two patients who underwent preoperative CRT experienced recurrence compared with 38 in the postoperative group. That translates into a 10-year rate of recurrence of 6.8% in the preoperative arm vs. 10.5% in the postoperative arm (HR=0.54; 95% CI, 0.3-0.9).
There was no similar effect in distant metastases in the intent-to-treat population. Cumulative incidence at 10 years was 29.8% in the preoperative group vs. 29.6% in the postoperative group.
There was no significant difference in 10-year OS between the two groups — 59.6% in the preoperative arm and 59.9% in the postoperative arm (HR=0.98; 95% CI, 0.79-1.21). When researchers analyzed performance by actual treatment arm, OS was 60.1% in the preoperative group vs. 59.3% in the postoperative group (HR=0.95; 95% CI, 0.77-1.17).
In an accompanying editorial, Harvey J. Mamon, MD, PhD, clinical director of the department of radiation oncology at Dana-Farber Cancer Institute, said these results confirm the superiority of neoadjuvant therapy and could have implications for combined modality therapy in other cancers.
“Most of the theoretical advantages of preoperative therapy have been confirmed, whereas most of the concerns have proven not to be clinically significant problems,” he wrote. “The failure of two US attempts to complete a randomized trial of preoperative vs. postoperative chemoradiotherapy is a reason for caution, yet the success of the German investigators to complete the trial, and now to provide confirmatory long-term follow-up data, demonstrates that such trials can be completed and that the results can be paradigm changing.”
References:
- Sauer R. J Clin Oncol. 2012;doi:10.1200/JCO.2011.40.1836.