The 38-month follow-up data of the phase 3 OPERA trial showed that non-surgical treatment is feasible for patients with distal-middle, cT2-cT3a-b rectal cancer (RC). In patients who need surgery, this treatment can be administered without comprising the chance of a cure.
The OPERA trial (NCT02505750) randomised 142 patients with cT2-cT3a-b RC 1:1 to external beam chemoradiotherapy (EBCRT) with capecitabine and external beam radiotherapy (EBRT) boosts of 9Gy, 5 fractions, every 5 days (arm A) or to EBCRT followed by targeted radiotherapy using contact X-ray brachytherapy 50 kV (CXB), 90 Gy, 3 fractions, every 4 weeks (arm B) . Prof. Arthur Sun Myint (Clatterbridge Cancer Centre, UK) presented the results.
After 24 weeks, the investigators observed a clinical complete response in 92% of the patients in arm B and in 64% of the patients in arm A. After a median follow-up time 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 tumours <3 cm was 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 for well selected patients (T2-T3a-b) and those who needed surgery could be saved without a decreased chance of cure,” concluded Prof. Sun Myint. Contact X-ray is, however, not feasible everywhere.
- Sun Myint A, et al. Do nonoperative modality (NOM) treatments of rectal cancer compromise the chance of cure? Final surgical salvage results from OPERA phase 3 randomised trial (NCT02505750). Abstract 6, ASCO GI 2023, 19–21 January, San Francisco, CA, USA.
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Table of Contents: ASCO GI 2023
Letter from the Editor
ASCO GI 2023 Highlights Podcast
Oesophageal and Gastric Cancer
Zolbetuximab plus mFOLFOX6 successful in CLDN18.2-positive subgroup of gastric cancer
Regorafenib offers survival benefit for patients with pre-treated gastric cancer
Radiotherapy or not in locally advanced oesophageal or junctional cancer?
Neoadjuvant immunotherapy is safe and efficacious in a phase 2 gastric cancer trial
S-1 adjuvant chemotherapy: 4 or 8 courses in stage 2 gastric cancer?
LATG/LAPG demonstrates excellent long-term efficacy in stage 1 gastric cancer
3-year follow-up data confirms benefits of nivolumab plus chemotherapy
Long-term results for nivolumab plus chemotherapy and nivolumab plus ipilimumab in oesophageal cancer
Promising phase 2 results for HER-Vaxx in gastric cancer
Anal and Colorectal Cancer
IMbrave 151 missed primary endpoint in advanced BTC
Combination botensilimab plus balstilimab demonstrates promising activity in heavily pre-treated MSS CRC
Mutation-based selection to identify patients suitable for panitumumab treatment
Fucoidan associated with quality-of-life benefits in patients with rectal cancer receiving CCRT
ctDNA appears useful in monitoring patients with anal cancer undergoing CRT
SUNLIGHT trial meets primary endpoint in refractory metastatic CRC
Does cell-free DNA influence MRD testing in post-operative colon cancer?
OPERA: surgery may be avoided with adequate therapy in rectal cancer
Can we improve total neoadjuvant therapy for rectal cancer?
Palliative radiation therapy improves hepatic pain in HCC and liver metastasis
Improved survival following postoperative sorafenib plus TACE in HCC
Quality-of-life benefits for tislelizumab in uHCC
Stereotactic body radiation therapy beneficial for patients with locally advanced HCC
SWOG 1815, first-ever phase 3 trial in BTC, fails
Acceptable safety profile and encouraging efficacy of nanvuranlat in BTC
First-line NALIRIFOX superior to standard treatment in mPDAC
Novel approach delivers quality-of-life benefits for patients with pancreatic cancer