The 38-month follow-up data of the phase 3 OPERA trial showed that non-surgical treatment is feasible for patients with cT2-cT3a-b rectal cancer (RC). In patients who needed surgery, this treatment can be administered without compromising the chance of a cure.

The OPERA trial randomized 142 patients with cT2-cT3a-b RC 1:1 to external beam chemoradiotherapy (EBCRT) with capecitabine and EBRT boosts of 9Gy, five fractions, every 5 days (arm A) or to EBCRT followed by targeted radiotherapy using contact X-ray brachytherapy 50 kV (CXB), 90 Gy, three fractions, every 4 weeks  (arm B).¹ Prof. Arthur Sun Myint (Clatterbridge Cancer Centre, UK) presented the results at ASCO-GI 2023.

After 24 weeks, the investigators observed a clinical complete response in 92% of patients in arm B and in 64% in arm A. After a median follow-up of 38.2 months, 46 patients had received surgery in arm A—either total mesorectal excision (TME) or local excision—compared with 20 patients in arm B. In addition, the TME rate was 39% in arm A and 19% in arm B (HR, 0.36; P=0.004). Importantly, the organ preservation rates in patients with tumors smaller than 3 cm were 63% in arm A and 97% in arm B (HR, 0.072; P=0.01) and the 3-year overall survival rates with organ preservation were 57% in arm A and 79% in arm B (P=0.0026).

“In short, non-surgical treatment was feasible in this patient population and those who needed surgery could be saved without a decreased chance of cure,“ concluded Prof. Sun Myint.

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