Evidence map›Paper›PMID 36871393›Full record

Trial reportESMO open2023

The value of post-operative chemotherapy after chemoradiotherapy in patients with high-risk locally advanced rectal cancer-results from the RAPIDO trial.

E A Dijkstra, W H Zwart, P J Nilsson, H Putter, A G H Roodvoets, E Meershoek-Klein Kranenbarg, J E Frödin, P Nygren, L Østergaard, C Kersten and 11 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in ESMO open, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01558921 (Randomized Multicentre Phase III Study of Short Course Radiation Therapy Followed by Prolonged Pre-operative Chemotherapy and Surgery in Primary High Risk Rectal Cancer Compared to Standard Chemoradiotherapy and Surgery and Optional Adjuvant Chemotherapy.), which is not on this map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
3.5field-weighted citation impact, top 7% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01558921 phase3active not recruitingnot on this map

Randomized Multicentre Phase III Study of Short Course Radiation Therapy Followed by Prolonged Pre-operative Chemotherapy and Surgery in Primary High Risk Rectal Cancer Compared to Standard Chemoradiotherapy and Surgery and Optional Adjuvant Chemotherapy.

TypeinterventionalSponsorUniversity Medical Center GroningenRan2011 to 2026Enrolled920ConditionsRectal CancerArmsM1 scheme, standard long course chemoradiotherapy
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 15 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

21 authors at 11 institutions in 7 countries.

E A DijkstraDepartment of Medical Oncology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands. Electronic address: e.a.dijkstra@umcg.nl.
W H ZwartDepartment of Medical Oncology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.
P J NilssonDepartment of Surgery, Karolinska University Hospital, Stockholm, Sweden.
H PutterDepartments of Medical Statistics and Bioinformatics, Leiden University Medical Center, Leiden, the Netherlands.
A G H RoodvoetsDepartments of Surgery, Leiden University Medical Center, Leiden, the Netherlands.
E Meershoek-Klein KranenbargDepartments of Surgery, Leiden University Medical Center, Leiden, the Netherlands.
J E FrödinDepartment of Oncology-Pathology, Karolinska University Hospital, Uppsala.
P NygrenDepartment of Immunology, Genetics and Pathology, Uppsala University, Uppsala, Sweden.
L ØstergaardDepartment of Clinical Medicine, Aalborg University Hospital, Aalborg, Denmark.
C KerstenDepartment of Research, Sørlandet Hospital Trust, Kristiansand, Norway.
I VerbienéDepartment of Oncology, Uppsala University, Uppsala, Sweden.
A CervantesDepartment of Medical Oncology, Biomedical Research Institute Incliva, University of Valencia, Valencia, Spain.
M P HendriksDepartment of Medical Oncology, Northwest Clinics, Alkmaar, the Netherlands.
J CapdevilaDepartment of Medical Oncology, Vall Hebron Institute of Oncology (VHIO), Vall Hebron University Hospital. Autonomous University of Barcelona (UAB), Barcelona, Spain.
I EdhemovicDepartment of Surgical Oncology, Institute of Oncology Ljubljana, Ljubljana, Slovenia.
C J H van de VeldeDepartments of Surgery, Leiden University Medical Center, Leiden, the Netherlands.
C A M MarijnenDepartment of Radiation Oncology, Netherlands Cancer Institute, Amsterdam; Department of Radiation Oncology, Leiden University Medical Center, Leiden.
B van EttenDepartment of Surgery, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.
G A P HospersDepartment of Medical Oncology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.
B GlimeliusDepartment of Immunology, Genetics and Pathology, Uppsala University, Uppsala, Sweden.
collaborative investigators
Leiden University Medical Center · NLUniversity Medical Center Groningen · NLUppsala University · SEKarolinska University Hospital · SEAalborg University Hospital · DKInstitute of Oncology Ljubljana · SINorthwest Hospital · USSørlandet Sykehus · NOUniversitat Autònoma de Barcelona · ESUniversitat de València · ESUniversity of Groningen · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPre-operative chemoradiotherapy (CRT) rather than radiotherapy (RT) has resulted in fewer locoregional recurrences (LRRs), but no decrease in distant metastasis (DM) rate for patients with locally advanced rectal cancer (LARC). In many countries, patients receive post-operative chemotherapy (pCT) to improve oncological outcomes. We investigated the value of pCT after pre-operative CRT in the RAPIDO trial. PATIENTS AND

methodsPatients were randomised between experimental (short-course RT, chemotherapy and surgery) and standard-of-care treatment (CRT, surgery and pCT depending on hospital policy). In this substudy, we compared curatively resected patients from the standard-of-care group who received pCT (pCT+ group) with those who did not (pCT- group). Subsequently, patients from the pCT+ group who received at least 75% of the prescribed chemotherapy cycles (pCT ≥75% group) were compared with patients who did not receive pCT (pCT-/- group). By propensity score stratification (PSS), we adjusted for the following unbalanced confounders: age, clinical extramural vascular invasion, distance to the anal verge, ypT stage, ypN stage, residual tumour, serious adverse event (SAE) and/or readmission within 6 weeks after surgery and SAE related to pre-operative CRT. Cumulative probability of disease-free survival (DFS), DM, LRR and overall survival (OS) was analysed by Cox regression.

resultsIn total, 396/452 patients had a curative resection. The number of patients in the pCT+, pCT >75%, pCT- and pCT-/- groups was 184, 112, 154 and 149, respectively. The PSS-adjusted analyses for all endpoints demonstrated hazard ratios between approximately 0.7 and 0.8 (pCT+ versus pCT-), and 0.5 and 0.8 (pCT ≥75% versus pCT-/-). However, all 95% confidence intervals included 1.

conclusionsThese data suggest a benefit of pCT after pre-operative CRT for patients with high-risk LARC, with approximately 20%-25% improvement in DFS and OS and 20%-25% risk reductions in DM and LRR. Compliance with pCT additionally reduces or improves all endpoints by 10%-20%. However, differences are not statistically significant.

Indexed as

Rectal NeoplasmsChemoradiotherapyDisease-Free SurvivalHumansInfantNeoadjuvant TherapyNeoplasm Recurrence, Localadjuvant chemotherapylocally advanced rectal canceroncological outcomespost-operative chemotherapypropensity score stratification

Identifiers

PMID36871393
PMCPMC10163161
OpenAlexW4323033685

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.