Neoadjuvant chemoradiotherapy followed by local excision may be an organ-preserving alternative in certain patients with clinical T2N0 rectal cancer who opt out of or are not candidates for transabdominal resection, a new study published online ahead of print in the journal The Lancet Oncology has shown.1
Although local excision is an organ-preserving alternative to transabdominal resection for patients with stage 1 rectal cancer, local excision alone is associated with a higher risk of local recurrence and mortality than transabdominal rectal resection. Therefore, researchers sought to investigate the outcomes of chemoradiotherapy followed by local excision in patients with stage T2N0 rectal cancer.
For the multicenter, single-arm, open-label, phase 2 trial, researchers enrolled 79 patients with clinically staged T2N0 distal rectal adenocarcinoma treated with chemoradiotherapy.
Neoadjuvant chemoradiotherapy consisted of capecitabine 825 mg/m2 twice daily on days 1-14 and 22-35, oxaliplatin 50 mg/m2 on weeks 1, 2, 4, and 5, and radiation 1.8 Gy/day 5 days per week for 5 weeks to a dose of 45 Gy, followed by a 9 Gy boost. A total of 76 patients then underwent local excision.
Results showed that among the 72 evaluable patients, the estimated 3-year disease-free survival was 86.9% (95% CI, 79.3 – 95.3) after a median follow-up of 56 months.
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In regard to safety, 29% of all patients experienced grade 3 gastrointestinal adverse events, 15% had grade 3-4 pain, and 15% had grade 3-4 hematological adverse events during treatment with chemoradiation.
Of the 77 patients who underwent surgery, 8% experienced grade 3 pain, 4% had grade 3-4 hemorrhage, and 4% had gastrointestinal side effects.
- Garcia-Aguilar J, Renfro LA, Chow OS, et al. Organ preservation for clinical T2N0 distal rectal cancer using neoadjuvant chemoradiotherapy and local excision (ACOSOG Z6041): results of an open-label, single-arm, multi-institutional, phase 2 trial [published online ahead of print October 13, 2015]. Lancet Oncol. doi: 10.1016/S1470-2045(15)00215-6.