Evidence map›Paper›PMID 42735452›Full record

ArticleESMO open2026

Lurbinectedin plus irinotecan in pretreated gastroenteropancreatic neuroendocrine neoplasms: results of a phase II expansion cohort.

R Garcia-Carbonero, G M Cote, A Le Cesne, B Antón-Pascual, T Alonso-Gordoa, A Falcon, A Gil-Torralvo, S Martínez, C Kahatt, V Alfaro and 4 more

Registry-linked trialAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in ESMO open, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02611024 (Phase I/II, Multicenter, Open-label, Clinical and Pharmacokinetic Study of Lurbinectedin in Combination With Irinotecan in Pretreated Patients With Selected Advanced Solid Tumors), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
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.

NCT02611024 phase1 / phase2completednot on this map

Phase I/II, Multicenter, Open-label, Clinical and Pharmacokinetic Study of Lurbinectedin in Combination With Irinotecan in Pretreated Patients With Selected Advanced Solid Tumors

TypeinterventionalSponsorPharmaMarRan2016 to 2025Enrolled316ConditionsAdvanced Solid Tumors, Glioblastoma, Soft Tissue Sarcoma (Excluding GIST), Endometrial CarcinomaArmsLurbinectedin, Irinotecan
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Trial
  2. 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

14 authors.

R Garcia-CarboneroOncology Department, Hospital Universitario 12 de Octubre, IIS Imas12, Medicine Faculty, Universidad Complutense de Madrid, Madrid, Spain. Electronic address: rgcarbonero@gmail.com.
G M CoteOncology Department, Mass General Brigham Center Institute, Boston, USA.
A Le CesneOncology Department, Institute Gustave Roussy, Villejuif, France.
B Antón-PascualOncology Department, Hospital Universitario 12 de Octubre, IIS Imas12, Medicine Faculty, Universidad Complutense de Madrid, Madrid, Spain.
T Alonso-GordoaOncology Department, Ramon y Cajal University Hospital, Madrid, Spain.
A FalconOncology Department, Hospital Universitario Virgen del Rocio, Sevilla, Spain.
A Gil-TorralvoOncology Department, Hospital Universitario Virgen del Rocio, Sevilla, Spain.
S MartínezClinical R&D, PharmaMar, Madrid, Spain.
C KahattClinical R&D, PharmaMar, Madrid, Spain.
V AlfaroClinical R&D, PharmaMar, Madrid, Spain.
P ZubiaurClinical R&D, PharmaMar, Madrid, Spain.
J JimenezClinical R&D, PharmaMar, Madrid, Spain.
M SigueroClinical R&D, PharmaMar, Madrid, Spain.
J Molina-CerrilloOncology Department, Ramon y Cajal University Hospital, Madrid, Spain.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundA phase I/II trial (NCT02611024) evaluated the lurbinectedin 2.0 mg/m PATIENTS AND

methodsThirty-four patients with NENs (second line or greater) were included, 20 with poorly differentiated neuroendocrine carcinomas (NECs), and 14 with grade 2/3 well-differentiated neuroendocrine tumors (NETs) of digestive origin. The primary efficacy endpoint was objective response rate (ORR) according to RECIST v.1.1. Secondary endpoints included progression-free survival (PFS), overall survival (OS), safety, and pharmacokinetics.

resultsIn patients with NECs, the ORR with lurbinectedin plus irinotecan was 15.0% [95% confidence interval (CI) 3.2%-37.9%], the median PFS was 3.1 months (95% CI 1.4-5.6 months), and the median OS was 7.2 months (95% CI 2.9-17.8 months). In patients with NETs, the ORR with lurbinectedin plus irinotecan was 7.1% (95% CI 0.2%-33.9%), the median PFS was 3.4 months (95% CI 1.4-8.9 months), and the median OS was 16.6 months (95% CI 3.9 months-not reached). The most common treatment-related adverse events were gastrointestinal disorders (nausea, 61.8% of patients; diarrhea, 44.1%; and vomiting, 35.3%), fatigue (58.8%), and decreased appetite (20.6%); these events were mostly grades 1 and 2. Grade ≥3 neutropenia was observed in 47.1% of patients and febrile neutropenia in 5.9%. Grade ≥3 transaminase increases were the most common severe laboratory biochemical abnormalities reported during treatment regardless of relationship to study drugs.

conclusionsThe combination of lurbinectedin plus irinotecan with primary granulocyte colony-stimulating factor prophylaxis showed antitumor activity in GEP-NECs but limited activity in GEP-NETs. This combination had a predictable and manageable safety profile, with myelosuppression, gastrointestinal disorders, and fatigue as main toxicities. The lurbinectedin plus irinotecan combination deserves to be further explored in GEP-NECs after failure of platinum therapy.

Indexed as

irinotecanlurbinectedinneuroendocrine carcinomasphase II clinical trial

Identifiers

PMID42735452
PMCPMC13594731

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.