Evidence map›Paper›PMID 36463732›Full record

Trial reportESMO open2022

Final results of DIADEM, a phase II study to investigate the efficacy and safety of durvalumab in advanced pretreated malignant pleural mesothelioma.

S Canova, G L Ceresoli, F Grosso, P A Zucali, F Gelsomino, G Pasello, M Mencoboni, E Rulli, F Galli, I De Simone and 9 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in ESMO open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04115111 (A Phase II Study to Investigate the Activity and Safety of Anti-PD-L1 Antibody), which is not on this map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
1.1field-weighted citation impact, top 22% 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.

NCT04115111 phase2completednot on this map

A Phase II Study to Investigate the Activity and Safety of Anti-PD-L1 Antibody (Durvalumab) In ADvancEd Pretreated Malignant Pleural Mesothelioma - DIADEM Study

TypeinterventionalSponsorMario Negri Institute for Pharmacological ResearchRan2018 to 2019Enrolled57ConditionsPleura MesotheliomaArmsDurvalumab
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 7 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Review
  4. Article
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

19 authors at 2 institutions in 1 country.

S CanovaASST H S Gerardo, SC Medical Oncology, Monza.
G L CeresoliHumanitas Gavazzeni, Bergamo; Department of Oncology, Saronno Hospital, ASST Valle Olona, Saronno (VA).
F GrossoMesothelioma Unit, Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo, Alessandria.
P A ZucaliDepartment of Oncology, IRCCS Humanitas Research Hospital, Rozzano; Department of Biomedical Sciences, Humanitas University, Rozzano.
F GelsominoIRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna.
G PaselloDepartment of Surgery, Oncology and Gastroenterology, University of Padova, Padova; Medical Oncology 2, Istituto Oncologico Veneto IRCCS, Padova.
M MencoboniASL 3 Genovese-Ospedale Villa Scassi, Genova.
E RulliMethodology for Clinical Research Laboratory, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan.
F GalliMethodology for Clinical Research Laboratory, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan.
I De SimoneMethodology for Clinical Research Laboratory, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan.
L CarlucciMethodology for Clinical Research Laboratory, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan.
A De AngelisMesothelioma Unit, Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo, Alessandria.
M BellettiMesothelioma Unit, Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo, Alessandria.
M BonomiHumanitas Gavazzeni, Bergamo; Department of Oncology, ASST Cremona, Cremona, Italy.
A D'AveniHumanitas Gavazzeni, Bergamo; Department of Oncology, Saronno Hospital, ASST Valle Olona, Saronno (VA).
M PerrinoDepartment of Oncology, IRCCS Humanitas Research Hospital, Rozzano.
F BonoASST H S Gerardo, SC Medical Oncology, Monza.
D L CortinovisASST H S Gerardo, SC Medical Oncology, Monza. Electronic address: d.cortinovis@asst-monza.it.
DIADEM groupD
Azienda USL di Bologna · ITIRCCS Humanitas Research Hospital · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMalignant pleural mesothelioma (MPM) is a cancer with a high mortality rate and few therapeutic options. After platinum-pemetrexed combination, no further promising drug seems to be effective. Immune checkpoint inhibitors may have some activity in pretreated patients and no data are available in this population about durvalumab. MATERIALS AND

methodsDIADEM was a multicenter, open-label, single-arm, phase II trial aimed at evaluating the efficacy and safety of durvalumab. Patients with locally advanced/metastatic MPM who progressed after platinum-pemetrexed chemotherapy were enrolled to receive durvalumab (1500 mg, intravenously Q4W) for 12 months or until evidence of disease progression or unacceptable toxicity. The primary endpoint was the proportion of patients alive and free from progression at 16 weeks (PFS

resultsSixty-nine patients with a median age of 69 years (range 44-82 years) were enrolled; 62 patients (89.9%) had epithelioid histotype. As first-line treatment, all patients received platinum derivatives-pemetrexed combination (60.9% with carboplatin and 39.1% with cisplatin). As of March 2021, the median follow-up was 9.2 months (interquartile range 5.2-11.1 months). Six patients (8.7%) completed the 12-month treatment; 60 patients discontinued, of whom 42 for progressive disease, and 4 died. Seventeen patients (28.3%; 95% confidence interval 17.5% to 41.4%) were alive or free from progression at 16 weeks. Eleven patients (18.6%) had a grade 3 or 4 treatment-related adverse event (AE), and one (1.4%) had a grade ≥3 immune-related, treatment-related AE. There was one drug-related death.

conclusionDurvalumab alone in pretreated non-selected MPM did not reach a meaningful clinical activity, showing any new major safety issue signals.

Indexed as

MesotheliomaMesothelioma, MalignantPleural NeoplasmsAdultAgedAged, 80 and overAntibodies, MonoclonalAntineoplastic Combined Chemotherapy ProtocolsHumansMiddle AgedPemetrexedPlatinumAntibodies, MonoclonaldurvalumabPemetrexedPlatinumdurvalumabimmune checkpoint inhibitorsmalignant pleural mesotheliomasecond line

Identifiers

PMID36463732
PMCPMC9808442
OpenAlexW4311073100

What OpenQuestion holds

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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.