Evidence map›Paper›PMID 37523661›Full record

ArticleThe oncologist2024

Characterization and Management of Adverse Reactions in Patients With Advanced Endometrial Cancer Receiving Lenvatinib Plus Pembrolizumab.

Nicoletta Colombo, Domenica Lorusso, Bradley J Monk, Brian Slomovitz, Kosei Hasegawa, Angélica Nogueira-Rodrigues, Melissa Zale, Chinyere E Okpara, Gianmaria Barresi, Jodi McKenzie and 1 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in The oncologist, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03517449 (A Multicenter, Open-label, Randomized, Phase 3 Trial to Compare the Efficacy and Safety of Lenvatinib in Combination With Pembrolizumab Versus Treatment of Physician's Choice in Participants With Advanced Endometrial Cancer), which is not on this 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
3.5field-weighted citation impact, top 7% 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.

NCT03517449 phase3completednot on this map

A Multicenter, Open-label, Randomized, Phase 3 Trial to Compare the Efficacy and Safety of Lenvatinib in Combination With Pembrolizumab Versus Treatment of Physician's Choice in Participants With Advanced Endometrial Cancer

TypeinterventionalSponsorEisai Inc.Ran2018 to 2025Enrolled827ConditionsEndometrial NeoplasmsArmsPembrolizumab, Lenvatinib, Paclitaxel, Doxorubicin
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 12 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. Review
  6. Article
  7. Histology-Specific Clinical Trial of Lenvatinib and Pembrolizumab in Patients with Sarcoma.Clinical cancer research : an official journal of the American Association for Cancer Research · 2024
    Article
  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

11 authors at 11 institutions in 6 countries.

Nicoletta ColomboGynecologic Oncology Department, European Institute of Oncology IRCCS, Milan, Italy.ORCID 0000-0003-2225-715X
Domenica LorussoDivision of Gynecologic Oncology, Fondazione Policlinico Universitario Agostino Gemelli IRCCS and Catholic University of Sacred Heart, Rome, Italy.
Bradley J MonkHonorHealth Research Institute, University of Arizona, Creighton University, Phoenix, AZ, USA.
Brian SlomovitzDivision of Gynecologic Oncology, Mount Sinai Medical Center, Miami Beach, FL, USA.
Kosei HasegawaDepartment of Gynecologic Oncology, Saitama Medical University International Medical Center, Hidaka, Saitama, Japan.
Angélica Nogueira-RodriguesUniversidade Federal de Minas Gerais (UFMG), Brazilian Group of Gynecologic Oncology (EVA), Grupo Oncoclínicas, DOM Oncologia, Brazil.
Melissa ZaleClinical Safety & Risk Management Late-Stage Oncology - Gynecologic Cancers, Merck & Co., Inc., Rahway, NJ, USA.
Chinyere E OkparaClinical Research, Eisai Ltd., Hatfield, UK.
Gianmaria BarresiMerck & Co., Inc., Switzerland.
Jodi McKenzieOncology Business Group, Eisai Inc., Nutley, NJ, USA.
Vicky MakkerDepartment of Medicine, Memorial Sloan Kettering Cancer Center; Weill Cornell Medical Center, New York, NY, USA.
Agostino Gemelli University Polyclinic · ITCreighton University · USEisai (United Kingdom) · GBEisai (United States) · USEuropean Institute of Oncology · ITMemorial Sloan Kettering Cancer Center · USMerck & Co., Inc., Rahway, NJ, USA (United States) · USMerck Serono (Switzerland) · CHMount Sinai Medical Center · USSaitama Medical University · JPUniversidade Federal de Minas Gerais · BR

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI SELWYN M VICKERS · 1985 to 2026
$347.4M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

backgroundLenvatinib plus pembrolizumab significantly improved efficacy compared with chemotherapy in patients with advanced endometrial cancer (aEC) regardless of microsatellite instability status or histologic subtype, who had disease progression following prior platinum-based therapy, in Study-309/KEYNOTE-775. The safety profile of the combination was generally consistent with that of each monotherapy drug and of the combination in patients with endometrial cancer and other solid tumors. Given the medical complexity of patients with aEC, this paper aims to characterize key adverse reactions (ARs) of the combination treatment and review management strategies, providing a guide for AR management to maximize anticancer benefits and minimize treatment discontinuation. MATERIALS AND

methodsIn Study-309/KEYNOTE-775, patients received lenvatinib (20 mg orally once daily) plus pembrolizumab (200 mg intravenously every 3 weeks) or chemotherapy (doxorubicin or paclitaxel). The incidence and median time to the first onset of ARs, dose modifications, and concomitant medications are described. Key ARs characterized include hypothyroidism, hypertension, fatigue, diarrhea, musculoskeletal disorders, nausea, decreased appetite, vomiting, stomatitis, weight decreased, proteinuria, and palmar-plantar erythrodysesthesia syndrome.

resultsAs expected, the most common any-grade key ARs included: hypothyroidism, hypertension, fatigue, diarrhea, and musculoskeletal disorders. Grades 3-4 key ARs with incidence ≥10% included: hypertension, fatigue, and weight decreased. Key ARs first occurred within approximately 3 months of treatment initiation. AR management strategies consistent with the prescribing information and the study protocol are discussed.

conclusionSuccessful AR management strategies for lenvatinib plus pembrolizumab include education of the patient and entire treatment team, preventative measures and close monitoring, and judicious use of dose modifications and concomitant medications. CLINICALTRIALS.GOV ID: NCT03517449.

Indexed as

Endometrial NeoplasmsHypertensionHypothyroidismMusculoskeletal DiseasesAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsDiarrheaFatigueFemaleHumansPhenylurea CompoundsQuinolinesAntibodies, Monoclonal, HumanizedlenvatinibpembrolizumabPhenylurea CompoundsQuinolinesadverse reactionsendometrial cancerlenvatinibpembrolizumab

Identifiers

PMID37523661
PMCPMC10769802
OpenAlexW4385410519

What Socratic holds

Textmetadata
LicenceCC BY
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 Socratic graph.