Evidence map›Paper›PMID 35325225›Full record

ArticleThe oncologist2022

Phase I Study of Lenvatinib and Capecitabine with External Radiation Therapy in Locally Advanced Rectal Adenocarcinoma.

Rutika Mehta, Jessica Frakes, Jongphil Kim, Andrew Nixon, Yingmiao Liu, Lauren Howard, Maria E Martinez Jimenez, Estrella Carballido, Iman Imanirad, Julian Sanchez and 7 more

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

Article in The oncologist, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02935309 (Phase I Study of Pre-operative Capecitabine and Lenvatinib With External Radiation Therapy in Locally Advanced Rectal Adenocarcinoma), 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
0.4field-weighted citation impact, top 39% 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.

NCT02935309 phase1completednot on this map

Phase I Study of Pre-operative Capecitabine and Lenvatinib With External Radiation Therapy in Locally Advanced Rectal Adenocarcinoma

TypeinterventionalSponsorH. Lee Moffitt Cancer Center and Research InstituteRan2016 to 2020Enrolled20ConditionsRectal Cancer, Rectal AdenocarcinomaArmsLenvatinib, Capecitabine, External Radiation Therapy (XRT)
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 4 citations in OpenAlex.

  1. Review
  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

17 authors at 3 institutions in 1 country.

Rutika MehtaDepartment of Gastrointestinal Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA.
Jessica FrakesDepartment of Radiation Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA.
Jongphil KimDepartment of Biostatistics and Bioinformatics H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA.
Andrew NixonDepartment of Medicine, Duke University Medical Center, Durham, NC, USA.
Yingmiao LiuDepartment of Medicine, Duke University Medical Center, Durham, NC, USA.
Lauren HowardDepartment of Biostatistics and Bioinformatics, Duke University, Durham, NC, USA.
Maria E Martinez JimenezDepartment of Gastrointestinal Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA.
Estrella CarballidoDepartment of Gastrointestinal Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA.
Iman ImaniradDepartment of Gastrointestinal Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA.
Julian SanchezDepartment of Gastrointestinal Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA.
Sophie DessureaultDepartment of Gastrointestinal Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA.
Hao XieDepartment of Gastrointestinal Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA.
Seth FelderDepartment of Gastrointestinal Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA.
Ibrahim SahinDepartment of Gastrointestinal Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA.
Sarah HoffeDepartment of Radiation Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA.
Mokenge MalafaDepartment of Gastrointestinal Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA.
Richard KimDepartment of Gastrointestinal Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA.ORCID 0000-0002-8448-844X
Moffitt Cancer Center · USDuke Medical Center · USDuke University · US

Funding

Novel Therapy to Inhibit IPMN ProgressionR01CA263575 · NCI · H. LEE MOFFITT CANCER CTR & RES INST · PI BATRA, SURINDER K., MALAFA, MOKENGE P. · 2022 to 2024
$2.1M
NCI NIH HHS R01 CA263575
6 · The paper itself

Abstract

backgroundNeoadjuvant chemoradiation with fluoropyrimidine followed by surgery and adjuvant chemotherapy has been the standard treatment of locally advanced stages II and III rectal cancer for many years. There is a high risk for disease recurrence; therefore, optimizing chemoradiation strategies remains an unmet need. Based on a few studies, there is evidence of the synergistic effect of VEGF/PDGFR blockade with radiation.

methodsIn this phase I, dose-escalation and dose-expansion study, we studied 3 different dose levels of lenvatinib in combination with capecitabine-based chemoradiation for locally advanced rectal cancer.

resultsA total of 20 patients were enrolled, and 19 were eligible for assessment of efficacy. The combination was well tolerated, with an MTD of 24 mg lenvatinib. The downstaging rate for the cohort and the pCR was 84.2% and 37.8%, respectively. Blood-based protein biomarkers TSP-2, VEGF-R3, and VEGF correlated with NAR score and were also differentially expressed between response categories. The NAR, or neoadjuvant rectal score, encompasses cT clinical tumor stage, pT pathological tumor stage, and pN pathological nodal stage and provides a continuous variable for evaluating clinical trial outcomes.

conclusionThe combination of lenvatinib with capecitabine and radiation in locally advanced rectal cancer was found to be safe and tolerable, and potential blood-based biomarkers were identified. CLINICAL

trial registrationNCT02935309.

Indexed as

AdenocarcinomaChemoradiotherapyNeoplasm Recurrence, LocalRectal NeoplasmsCapecitabineFluorouracilHumansNeoadjuvant TherapyNeoplasm StagingPhenylurea CompoundsQuinolinesTreatment OutcomeVascular Endothelial Growth Factor ACapecitabineFluorouracillenvatinibPhenylurea CompoundsQuinolinesVascular Endothelial Growth Factor Alenvatanibradiationrectal cancer

Identifiers

PMID35325225
PMCPMC9355805
OpenAlexW4206172728

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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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.