RAPIDO original
Short-course radiotherapy followed by chemotherapy before total mesorectal excision (TME) versus preoperative chemoradiotherapy, TME, and optional adjuvant chemotherapy in locally advanced rectal cancer (RAPIDO): a randomised, open-label, phase 3 trial RAPDIO, page 1
Publication information
Lancet, 2020 Dutch Colorectal Cancer Group (DCCG) and the Nordic Gastrointestinal Tumour Adjuvant Therapy Group (NGTATG)
Hypothesis:
Aim to reduce disease related treatment failure at 3 years
Methods
Design
54 centres in the Netherlands, Sweden, Spain, Slovenia, Denmark, Norway, and the USA
Inclusion
One of: cT4a or cT4b, EMVI, cN2, involved mesorectal fascia (tumour or lymph node ≤1 mm from the mesorectal fascia), or enlarged lateral lymph nodes considered to be metastatic.
Primary
Disease-related treatment failure DRTF: locoregional failure, distant metastasis, a new primary colorectal tumour, or treatment-related death. Locoregional failure included locally progressive disease leading to an unresectable tumour, local R2 resection, or local recurrence after an R0–R1 resection
Procedure
SCT + CAPOX/FOLFOX vs LCCRT + TME
Outcome
Results
Population
920 overall. 462 Experimental, 450 Standard of care Majority stage 3
Endpoint
DRTF: 23.7% (vs 30.4% ) HR 0.75, p = 0.019 Locoregion al failure: 8.3% (vs 6.0%) HR 1.42, p = 0.12 Distant metastases: 3 years cumulative probability 20.0% (vs 26.8%) HR 0.69, p = 0.0048 3y OS: 89.1% (vs 88.8%) HR 0.92, p = 0.59 pCR: 28% (vs 14%) OR 2.37, p < 0.0001 Proceeded to surgery: 92% (89%) p 0.086 Metastatic disease: Exp 86/128 (67%) vs Standard 123/152 (81%) LR recurrence: Exp 22/128 (17%) vs Standard 13/152 (10%)
Take home
RAPIDO 5 years
Locoregional Failure During and After Short-course Radiotherapy Followed by Chemotherapy and Surgery Compared With Long-course Chemoradiotherapy and Surgery A 5-Year Follow-up of the RAPIDO Trial RAPIDO 5y, page 1
Publication information
Annals of Surgery, 2023
Hypothesis:
To analyze risk and patterns of locoregional failure (LRF) in patients of the RAPIDO trial at 5 years.
Outcome
Results
Primary endpoint
LRF 11.7% exp vs 8.1% standard LRR (recurrence) - 10.2% vs 6.1% 5y DRTF 27.8% vs 34% 5y mets 23% vs 30.4% 5y OS 81.7% vs 80.2% More mesorectal plane breach in exp group.
Take home
Worse loco-regional control at 5 years although favourable systemic control. Limitation with SCRT maintaining loco-regional control although positive for TNT regarding systemic control.