Organ Preservation in Patients With Rectal Adenocarcinoma Treated With Total Neoadjuvant Therapy OPRA orginal , page 1
Publication information
Journal of Clinical Oncology, 2022
Hypothesis:
Patients with stage II and III rectal adenocarcinoma treated with TNT followed by either TME or a selective watch-and-wait (WW) approach on the basis of tumor response will have better disease-free survival (DFS) compared with historical DFS in patients treated with a standard therapy of CRT, TME, and intended postoper- ative adjuvant chemotherapy.
Methods
Design
Randomized, nonblinded, phase II trial conducted at 18 US institutions
Inclusion
Stage 2 and 3
Procedure
Randomly assigned to: INCT-CRT or CRT-CNC. Chemotherapy was either FOLFOX or CAPOX Patients with incomplete response went for TME. Near complete or complete CR went into W&W.
Outcome
Primary DFS
Results
Population
360 patients 158 vs 166 2% died during TNT (5/6 due to toxicity)
Primary endpoint
The 3-year DFS rates, 76% for the INCT-CRT group and 76% in the CRT-CNCT group, did not differ when compared with the historical 3-year DFS rate of 75% Similar local recurrence free survival at 94% 26% underwent TME, 74% W&W 53% (CRT-CNC) vs 41% (INCT-CRT) organ preservation at 3 years
Takehome
Higher organ preservation rate in CRT-CNCR group.
OPRA 5 year follow up
Long-Term Results of Organ Preservation in Patients With Rectal Adenocarcinoma Treated With Total Neoadjuvant Therapy: The Randomized Phase II OPRA Trial OPRA 5y, page 1
Publication information
JAMA 2024
Methods
Assessment
8weeks +/- 4weeks - flexi + MRI + DRE → complete, near and incomplete
Outcome
DFS, DMFS, LRFS, OS, OP (organ preservation)
Results
Population
324 41% CCR, 37.5% NCCR, 21% ICR
CCR Local regrowth 22% Surgery in: 25/27 salvage TME Mets: 5.2% at 5 years
NCCR Surgery 50.9% (17.5% upfront, 82.5% offered W&W) 48, 51.1% of those offered had a local regrowth 38/48 underwent surgery
ICR 89% proceeded to TME
Primary endpoint
Organ preservation at 3 years - 47% overall, 77% for CCR, 40% NCCR Risk of local regrowth at two years was 20% in the CCR group and 49% in the NCCR
DFS 74% overall, 88% CCR, 69% NCCR, 56% ICR
DFS was similar for patients who underwent TME after restaging (64%) and patients in WW who underwent TME after regrowth (64%
Takehome
Consolidation is likely better for OP
- Total mesorectal excision-free survival was higher with the CRT-first approach (54% vs. 39% with induction chemotherapy at the 5-year follow-up)