Researchers affiliated with a multicenter international randomized trial have reported that a short course of preoperative radiotherapy is effective treatment for patients with operable rectal cancer. The details of this randomized trial were published in the March 7, 2009 issue of the Lancet.[1]
Surgery is the standard treatment for patients with operable rectal cancer. There is also evidence that adjuvant therapy with radiation and/or chemotherapy improves survival and local control. More recently, neoadjuvant radiotherapy or chemoradiotherapy has been shown in Phase II studies to possibly be superior to adjuvant therapy. However, the optimal neoadjuvant or adjuvant therapy for patients with operable rectal cancer remains to be defined.
The current study compared preoperative radiotherapy to selective postoperative chemoradiotherapy in 1,350 patients with operable rectal cancer. Patients randomly allocated to receive preoperative radiation therapy received 25 Gy in five fractions. Patients randomly allocated to receive postoperative chemoradiotherapy only received treatment if the surgical specimen showed “involvement of circumferential resection margin.” Adjuvant therapy consisted of 45 Gy of radiation in 25 fractions and concurrent 5-FU. The median follow-up of surviving patients was four years. The following table summarizes the main findings of this trial:
Table 1: Neoadjuvant Radiotherapy Versus Adjuvant Chemoradiotherapy in Rectal Cancer
| Neoadjuvant Radiotherapy | Adjuvant Chemoradiotherapy |
Number of Patients | 674 | 676 |
Local Recurrences | 27 | 72 |
% Local Recurrences at 3 years | 6.2% | 10.6% |
Hazard Ratio for Local Recurrence | 0.39 | 1.0 |
3-year Disease-free Survival | 77.5% | 71.5% |
Hazard Ratio for Survival | 0.91 | 1.0 (p=0.40) |
Comments: These data confirm the effectiveness of preoperative radiation therapy decreasing local recurrences in patients with operable rectal cancer. These findings are similar to those of the German Rectal Cancer Study Group, which previously reported that preoperative chemoradiotherapy was associated with improved local control and reduced toxicity when compared with postoperative chemoradiotherapy in patients with locally advanced rectal cancer. However, preoperative chemoradiotherapy did not appear to improve overall survival. Thus one issue is whether to administer preoperative radiotherapy alone or with chemotherapy.
Reference:
[1] Sebag-Montefiore D, Stephens RJ, Steele R, et al. Preoperative radiotherapy versus selective postoperative chemoradiotherapy in patients with rectal cancer (MRC CR07 and NCIC-CTG C016): a multicentre, randomized trial. Lancet. 2009;373:811-820.
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