Evidence map›Paper›PMID 35419649›Full record

Observational studyAdvances in therapy2022

Observational Study in a Real-World Setting of Targeted Therapy in the Systemic Treatment of Progressive Unresectable or Metastatic Well-Differentiated Pancreatic Neuroendocrine Tumors (pNETs) in France: OPALINE Study.

Denis Smith, Côme Lepage, Eric Vicaut, Sophie Dominguez, Romain Coriat, Olivier Dubreuil, Thierry Lecomte, Eric Baudin, Laurence Venat Bouvet, Emmanuelle Samalin and 5 more

Registry-linked trialOpen access · hybridAbstract readObservational Study
In one paragraph

Observational study in Advances in therapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02264665 (AN OBSERVATIONAL REAL-WORLD STUDY OF THE SYSTEMIC TREATMENT OF WELL-DIFFERENTIATED, UNRESECTABLE OR METASTATIC, PROGRESSIVE PANCREATIC NEUROENDOCRINE TUMOURS), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.2field-weighted citation impact, top 21% 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.

NCT02264665 completednot on this map

An observational real-world study of the systemic treatment of well-differentiated, unresectable or metastatic, progressive pancreatic neuroendocrine tumours (pnet): a study of morbidity and mortality at 2 years

TypeobservationalSponsorPfizerRan2015 to 2019Enrolled144ConditionsPancreatic Neuroendocrine Tumor, Well Differentiated and ProgressiveArmssunitinib, everolimus, chemotherapies recommended in france
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 8 citations in OpenAlex.

  1. Review
  2. Article
  3. Article
  4. Review
  5. Review
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

15 authors at 13 institutions in 1 country.

Denis SmithOncologie digestive, Centre médico-chirurgical Magellan, Hôpital Universitaire de Bordeaux, Hôpital Haut-Lévèque, 33604, Pessac Cedex, France.
Côme LepageHépato-gastro-entérologie, Hôpital Universitaire Le Bocage, Dijon, France.
Eric VicautUnité de Recherche Clinique, Hôpital Lariboisière APHP, Paris, France.
Sophie DominguezHôpitaux Catholiques de Lille, Département d'Onco-hématologie, Université Catholique de Lille, Hôpital St Vincent de Paul, Lille, France.
Romain CoriatUnité de Gastro-entérologie, Hôpital Cochin, APHP Centre, Université de Paris, Paris, France.
Olivier DubreuilOncologie médicale, Groupe Hospitalier Diaconesses Croix Saint-Simon, Paris, France.
Thierry LecomteDépartement d' Hépato-gastro-entérologie et Oncologie digestive, CHRU de Tours, Tours, France.
Eric BaudinInstitut Gustave Roussy, Service de Médecine Nucléaire, Villejuif, France.
Laurence Venat BouvetDépartement d'Oncologie, Hôpital Dupuytren, Limoges, France.
Emmanuelle SamalinDépartement d'Oncologie médicale, Institut du Cancer de Montpellier (ICM), Université de Montpellier, Montpellier, France.
Alexandre SantosNovartis Oncology, Rueil-Malmaison, France. alexandre.santos@novartis.com.ORCID http://orcid.org/0000-0003-1519-3231
Odile BoriePfizer Oncology, Paris, France.
Ségolène Bisot-LocardNovartis Oncology, Rueil-Malmaison, France.
Bernard GoichotDépartement de Médecine interne, Hôpital Universitaire Hautepierre, Strasbourg, France.
Catherine Lombard-BohasService d'Oncologie Médicale Hôpital Edouard Herriot, GHC, Hospices Civils de Lyon, Lyon, France.
Novartis (France) · FRAssistance Publique – Hôpitaux de Paris · FRCentre Hospitalier Universitaire de Tours · FRGroupe Hospitalier Diaconesses Croix Saint-Simon · FRHôpital Cardiologique du Haut-Lévêque · FRHôpital d'Hautepierre · FRHôpital Dupuytren · FRHospices Civils de Lyon · FRInstitut Gustave Roussy · FRPfizer (France) · FRUniversité Catholique de Lille · FRUniversité de Montpellier · FRUniversité Paris Cité · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionApproval of sunitinib and everolimus for the treatment of progressive, unresectable or metastatic well-differentiated pancreatic neuroendocrine tumors (pNETs) was obtained in France in 2011 and 2012, respectively. OPALINE was set up as an observational study to evaluate the efficacy of sunitinib and everolimus compared to usual pNET treatments of chemotherapies and somatostatin analogues that had been previously recommended by the health authorities.

methodsThe OPALINE study assessed the efficacy of everolimus and sunitinib in terms of survival, disease progression and tolerance. Patients (N = 144) were enrolled from May 2015 to September 2017, and their disease characteristics were analyzed from diagnosis to 2 years post-enrollment.

resultsAt inclusion most patients had comorbidities, and about 95% presented metastases. Patients received on average 3.2 lines of treatment from diagnosis to inclusion and two lines throughout the 2-year follow-up. Seventy-nine patients (59.0%) received at least one targeted therapy (TT) during their care path. For these patients, the overall survival (OS) was approximatively 176.5 months (95% CI: 97.2-not evaluable), with a 2-year survival rate estimated at 93.6% (SD 2.6%). Similar survival rates were observed whether the TTs were prescribed sooner or later in the treatment path. The main reasons for discontinuation of TTs were disease progression (54 patients) and adverse events (26 patients). Most patients receiving TTs did not change their dose during the follow-up reflecting the good treatment tolerability over time. No new safety alert was reported for everolimus and sunitinib during this study.

conclusionGiven their good tolerance and positive impact on estimated OS, the two TTs have an important role to play in the care path of patients with pNETs. CLINICALTRIALS: GOV NATIONAL CLINICAL TRIAL NUMBER: NCT02264665.

Indexed as

Antineoplastic AgentsNeoplasms, Second PrimaryNeuroectodermal Tumors, PrimitiveNeuroendocrine TumorsPancreatic NeoplasmsDisease ProgressionEverolimusHumansSunitinibAntineoplastic AgentsEverolimusSunitinib2-Year morbi-mortalityAmbispective studyEverolimusPancreatic neuroendocrine tumorpNETSunitinib

Identifiers

PMID35419649
PMCPMC9123044
OpenAlexW4223969537

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.