Evidence map›Paper›PMID 37774508›Full record

Trial reportESMO open2023

Phase II study of capecitabine-based concomitant chemoradiation followed by durvalumab as a neoadjuvant strategy in locally advanced rectal cancer: the PANDORA trial.

E Grassi, C Zingaretti, E Petracci, J Corbelli, G Papiani, I Banchelli, I Valli, G L Frassineti, A Passardi, M Di Bartolomeo and 12 more

Open access · goldAbstract readMulticenter StudyClinical Trial, Phase II
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. Cited by 29 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 5 pooled it
8.5field-weighted citation impact, top 2% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

29 citing papers in PubMed, 5 syntheses or guidelines pooled it, 37 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

22 authors at 6 institutions in 1 country.

E GrassiMedical Oncology Unit, "Degli Infermi" Hospital, AUSL della Romagna, Faenza.
C ZingarettiUnit of Biostatistics and Clinical Trials, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Meldola.
E PetracciUnit of Biostatistics and Clinical Trials, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Meldola.
J CorbelliMedical Oncology Unit, "Degli Infermi" Hospital, AUSL della Romagna, Faenza.
G PapianiMedical Oncology Unit, "Santa Maria delle Croci" Hospital, AUSL della Romagna, Ravenna.
I BanchelliPathology Unit, "Santa Maria delle Croci" Hospital, AUSL della Romagna, Ravenna.
I ValliUnit of Biostatistics and Clinical Trials, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Meldola.
G L FrassinetiDepartment of Medical Oncology, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Meldola.
A PassardiDepartment of Medical Oncology, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Meldola.
M Di BartolomeoGastroenterological Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan.
F PietrantonioGastroenterological Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan.
F GelsominoDepartment of Oncology and Hematology, Division of Oncology, University Hospital of Modena, Modena.
I CarandinaDepartment of Medical Oncology, "Sant'Anna" University Hospital of Ferrara, Ferrara.
M BanziMedical Oncology Unit, "Santa Maria Nuova" Hospital, AUSL-IRCCS di Reggio Emilia, Reggio Emilia.
L MartellaDepartment of Medical Oncology, "Sant'Anna" University Hospital of Ferrara, Ferrara.
A V BonettiDepartment of Medical Oncology, "Mater Salutis" Hospital, Legnago.
A BoccaccinoMedical Oncology Unit, "Santa Maria delle Croci" Hospital, AUSL della Romagna, Ravenna.
C MolinariBiosciences Laboratory, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Meldola.
G MarisiBiosciences Laboratory, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Meldola.
G UgoliniGeneral Surgery Unit, "Santa Maria delle Croci" Hospital, AUSL della Romagna, Ravenna, Italy.
O NanniUnit of Biostatistics and Clinical Trials, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Meldola.
S TamberiMedical Oncology Unit, "Degli Infermi" Hospital, AUSL della Romagna, Faenza; Medical Oncology Unit, "Santa Maria delle Croci" Hospital, AUSL della Romagna, Ravenna. Electronic address: stefano.tamberi@auslromagna.it.
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori · ITOspedale "Santa Maria delle Croci" di Ravenna · ITFondazione IRCCS Istituto Nazionale dei Tumori · ITOspedale per gli Infermi · ITSanta Maria Nuova Hospital · ITUniversity of Modena and Reggio Emilia · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis study investigated the efficacy of chemoradiotherapy (CRT) followed by durvalumab as neoadjuvant therapy of locally advanced rectal cancer. PATIENTS AND

methodsThe PANDORA trial is a prospective, phase II, open-label, single-arm, multicenter study aimed at evaluating the efficacy and safety of preoperative treatment with durvalumab (1500 mg every 4 weeks for three administrations) following long-course radiotherapy (RT) plus concomitant capecitabine (5040 cGy RT in 25-28 fractions over 5 weeks and capecitabine administered at 825 mg/m

resultsBetween November 2019 and August 2021, 60 patients were accrued, of which 55 were assessable for the study's objectives. Two patients experienced disease progression during treatment. Nineteen out of 55 eligible patients achieved a pCR (34.5%, 95% confidence interval 22.2% to 48.6%). Regarding toxicity related to durvalumab, grade 3 adverse events (AEs) occurred in four patients (7.3%) (diarrhea, skin toxicity, transaminase increase, lipase increase, and pancolitis). Grade 4 toxicity was not observed. In 20 patients (36.4%), grade 1-2 AEs related to durvalumab were observed. The most common were endocrine toxicity (hyper/hypothyroidism), dermatologic toxicity (skin rash), and gastrointestinal toxicity (transaminase increase, nausea, diarrhea, constipation).

conclusionThis study met its primary endpoint showing that CRT followed by durvalumab could increase pCR with a safe toxicity profile. This combination is a promising, feasible strategy worthy of further investigation.

Indexed as

Neoadjuvant TherapyRectal NeoplasmsAntibodies, MonoclonalCapecitabineChemoradiotherapyDiarrheaHumansProspective StudiesTransaminasesAntibodies, MonoclonalCapecitabinedurvalumabTransaminasesdurvalumabimmunotherapylocally advanced rectal cancerneoadjuvant strategy

Identifiers

PMID37774508
PMCPMC10594026
OpenAlexW4387083500

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.