Evidence map›Paper›PMID 34610971›Full record

ArticleInternational journal of gynecological cancer : official journal of the International Gynecological Cancer Society2021

Doxorubicin plus lurbinectedin in patients with advanced endometrial cancer: results from an expanded phase I study.

Rebecca Kristeleit, Victor Moreno, Valentina Boni, Eva M Guerra, Carmen Kahatt, Ignacio Romero, Emiliano Calvo, Neus Basté, José A López-Vilariño, Mariano Siguero and 3 more

Open access · hybridAbstract readClinical Trial, Phase IMulticenter Study
In one paragraph

Article in International journal of gynecological cancer : official journal of the International Gynecological Cancer Society, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
0.8field-weighted citation impact, top 25% 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

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

  1. Pooled it
  2. Trial
  3. Article
  4. Review
  5. Article
  6. Article
  7. Review
  8. 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

13 authors at 7 institutions in 2 countries.

Rebecca KristeleitGuy's and St Thomas' NHS Foundation Trust, London, UK rebecca.kristeleit@gstt.nhs.uk.
Victor MorenoSTART Madrid-FJD, Hospital Fundación Jiménez Díaz, Madrid, Spain.
Valentina BoniSTART Madrid-CIOCC, Centro Integral Oncológico Clara Campal, Madrid, Spain.
Eva M GuerraHospital Universitario Ramón y Cajal, Madrid, Spain.
Carmen KahattPharmaMar SA, Colmenar Viejo, Madrid, Spain.
Ignacio RomeroInstituto Valenciano de Oncología, Valencia, Spain.
Emiliano CalvoSTART Madrid-CIOCC, Centro Integral Oncológico Clara Campal, Madrid, Spain.
Neus BastéHospital Universitari Vall d'Hebron, Barcelona, Spain.
José A López-VilariñoPharmaMar SA, Colmenar Viejo, Madrid, Spain.
Mariano SigueroPharmaMar SA, Colmenar Viejo, Madrid, Spain.
Vicente AlfaroClinical Development, PharmaMar SA, Colmenar Viejo, Spain.ORCID 0000-0002-0150-2390
Ali ZeaiterPharmaMar SA, Colmenar Viejo, Madrid, Spain.
Martin ForsterNIHR UCLH Clinical Research Facility, London, UK.
PharmaMar (Spain) · ESFundación Instituto Valenciano de Oncología · ESGuy's and St Thomas' NHS Foundation Trust · GBHospital Universitario Fundación Jiménez Díaz · ESHospital Universitario Ramón y Cajal · ESUCL Biomedical Research Centre · GBVall d'Hebron Hospital Universitari · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveSecond-line treatment of endometrial cancer is an unmet medical need. We conducted a phase I study evaluating lurbinectedin and doxorubicin intravenously every 3 weeks in patients with solid tumors. The aim of this study was to characterise the efficacy and safety of lurbinectedin and doxorubicin for patients with endometrial cancer.

methodsThirty-four patients were treated: 15 patients in the escalation phase (doxorubicin 50 mg/m

resultsMedian age (range) was 65 (51-78) years. Eastern Cooperative Oncology Group performance status was up to 1 in 97% of patients. In the escalation phase, 4 (26.7%) of 15 patients had confirmed response: two complete and two partial responses (95% CI 7.8% to 55.1%). Median duration of response was 19.5 months. Median progression-free survival was 7.3 (2.5 to 10.1) months. In the expansion cohort, confirmed partial response was reported in 8 (42.1%) of 19 patients (95% CI 20.3% to 66.5%). Median duration of response was 7.5 (6.4 to not reached) months, median progression-free survival was 7.7 (2.0 to 16.7) months and median overall survival was 14.2 (4.5 to not reached) months. Fatigue (26.3% of patients), and transient and reversible myelosuppression (neutropenia, 78.9%; febrile neutropenia, 21.1%; thrombocytopenia, 15.8%) were the main grade 3 and higher toxicities in the expanded cohort.

conclusionsIn patients with recurrent advanced endometrial cancer treated with doxorubicin and lurbinectedin, response rates (42%) and duration of response (7.5 months) were favorable. Further evaluation of doxorubicin and lurbinectedin is warranted in this patient population.

Indexed as

AgedAntibiotics, AntineoplasticAntineoplastic Combined Chemotherapy ProtocolsCarbolinesDoxorubicinEndometrial NeoplasmsFemaleHeterocyclic Compounds, 4 or More RingsHumansMiddle AgedNeoplasm Recurrence, LocalProgression-Free SurvivalAntibiotics, AntineoplasticCarbolinesDoxorubicinHeterocyclic Compounds, 4 or More RingsPM 01183endometrial neoplasmsendometrium

Identifiers

PMID34610971
PMCPMC8573419
OpenAlexW3204593605

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.