Evidence map›Paper›PMID 38061339›Full record

ArticleOncology2024

RNA Expression-Based Analysis to Predict Response in Patients with Metastatic Mismatch Repair Proficient Colorectal Cancer Treated with Regorafenib and Nivolumab.

Ruoyu Miao, Dae Won Kim, James Yu, Mokenge Malafa, Rutika Mehta, Jonathan Strosberg, Iman Imanirad, Seema Iyer, Mark Uhlik, Laura Benjamin and 1 more

Registry-linked trialOpen access · greenAbstract read
In one paragraph

Article in Oncology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03712943 (Phase I Study of Regorafenib and Nivolumab in Mismatch Repair), 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
0.5field-weighted citation impact, top 29% 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.

NCT03712943 phase1completednot on this map

Phase I Study of Regorafenib and Nivolumab in Mismatch Repair (MMR) Proficient Advanced Refractory Colorectal Cancer

TypeinterventionalSponsorH. Lee Moffitt Cancer Center and Research InstituteRan2018 to 2024Enrolled52ConditionsColorectal Cancer, Metastatic Colorectal Cancer, Colon CancerArmsRegorafenib, Nivolumab
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 2 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

11 authors at 1 institution in 1 country.

Ruoyu MiaoDepartment of Gastrointestinal Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, USA.
Dae Won KimDepartment of Gastrointestinal Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, USA.
James YuDepartment of Gastrointestinal Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, USA.
Mokenge MalafaDepartment of Gastrointestinal Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, USA.
Rutika MehtaDepartment of Gastrointestinal Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, USA.
Jonathan StrosbergDepartment of Gastrointestinal Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, USA.
Iman ImaniradDepartment of Gastrointestinal Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, USA.
Seema IyerOncXerna Therapeutics, Inc., Waltham, Massachusetts, USA.
Mark UhlikOncXerna Therapeutics, Inc., Waltham, Massachusetts, USA.
Laura BenjaminOncXerna Therapeutics, Inc., Waltham, Massachusetts, USA.
Richard KimDepartment of Gastrointestinal Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, USA.
Moffitt Cancer Center · 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

introductionWe previously conducted a phase I/Ib study (NCT03712943) with regorafenib and nivolumab in patients with refractory metastatic mismatch repair proficient (pMMR) colorectal cancer (CRC). This study aimed to investigate the role of Xerna™ TME Panel in predicting the treatment response.

methodsTwenty-two archival pretreatment tumor samples were subjected to the Xerna™ TME Panel, a machine learning-based RNA-sequencing biomarker assay. The Xerna tumor microenvironment (TME) subtypes were evaluated for correlation with overall survival (OS), progression-free survival (PFS), disease control rate (DCR), and other biomarkers including KRAS, PD-L1, CD8 expression, and Treg cells in TME.

resultsBased on Xerna™ TME Panel, 4 patients with immune-active (IA) subtype and 6 patients with immune-suppressed subtype were classified as biomarker-positive, and five with angiogenic (A) subtype and seven with immune desert subtype were biomarker-negative. While not reaching statistical significance, Xerna TME biomarker-positive patients seemed to have longer median PFS (7.9 vs. 4.1 months, p = 0.254), median OS (15.75 vs. 11.9 months, p = 0.378), and higher DCR (70% vs. 58%, p = 0.675). The IA subtype in our cohort had higher levels of CD4+ FOXP3+ Treg cells, whereas the A subtype showed lower levels of Treg cells.

conclusionXerna™ TME Panel analysis in patients with refractory metastatic pMMR CRC who were treated with regorafenib plus nivolumab might be of value for predictive clinical benefit. Further studies are needed to evaluate the predictive role of Xerna™ TME Panel analysis in patients with refractory metastatic pMMR CRC.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsColorectal NeoplasmsDNA Mismatch RepairNivolumabPhenylurea CompoundsPyridinesTumor MicroenvironmentAdultAgedBiomarkers, TumorFemaleHumansMaleMiddle AgedProgression-Free SurvivalT-Lymphocytes, RegulatoryBiomarkers, TumorNivolumabPhenylurea CompoundsPyridinesregorafenibBiomarkerColorectal cancerNivolumabRegorafenibTumor microenvironment

Identifiers

PMID38061339
PMCPMC11216360
OpenAlexW4389455333

What OpenQuestion holds

Textmetadata
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.