Evidence map›Paper›PMID 31570517›Full record

ArticleThe oncologist2020

Regorafenib in Combination with First-Line Chemotherapy for Metastatic Esophagogastric Cancer.

Ryan H Moy, Gustavo Dos Santos Fernandes, Philip Jonsson, Joanne F Chou, Azfar Basunia, Geoffrey Y Ku, Sree B Chalasani, Michelle S Boyar, Zoe Goldberg, Avni M Desai and 12 more

Registry-linked trialOpen access · bronzeAbstract read
In one paragraph

Article in The oncologist, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01913639 (Phase II Study of FOLFOX Plus Regorafenib in Patients With Unresectable or Metastatic Esophagogastric Cancer), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.0field-weighted citation impact, top 20% 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.

NCT01913639 phase2completednot on this map

Phase II Study of FOLFOX Plus Regorafenib in Patients With Unresectable or Metastatic Esophagogastric Cancer

TypeinterventionalSponsorMemorial Sloan Kettering Cancer CenterRan2013 to 2019Enrolled39ConditionsEsophageal Cancer, Gastric CancerArmsRegorafenib, 5-Fluorouracil, Leucovorin, Oxaliplatin
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 10 citations in OpenAlex.

  1. Trial
  2. Review
  3. Review
  4. Article
  5. 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

22 authors at 3 institutions in 1 country.

Ryan H MoyDepartment of Medicine, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, New York, USA.
Gustavo Dos Santos FernandesDepartment of Medicine, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, New York, USA.
Philip JonssonMarie-Josée & Henry R. Kravis Center for Molecular Oncology, Memorial Sloan Kettering Cancer Center, New York, New York, USA.
Joanne F ChouDepartment of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York, USA.
Azfar BasuniaMarie-Josée & Henry R. Kravis Center for Molecular Oncology, Memorial Sloan Kettering Cancer Center, New York, New York, USA.
Geoffrey Y KuDepartment of Medicine, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, New York, USA.
Sree B ChalasaniDepartment of Medicine, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, New York, USA.
Michelle S BoyarDepartment of Medicine, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, New York, USA.
Zoe GoldbergDepartment of Medicine, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, New York, USA.
Avni M DesaiDepartment of Medicine, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, New York, USA.
Amelia GablerDepartment of Medicine, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, New York, USA.
Michael F BergerMarie-Josée & Henry R. Kravis Center for Molecular Oncology, Memorial Sloan Kettering Cancer Center, New York, New York, USA.
Laura H TangDepartment of Pathology, Memorial Sloan Kettering Cancer Center, New York, New York, USA.
Jaclyn F HechtmanDepartment of Pathology, Memorial Sloan Kettering Cancer Center, New York, New York, USA.
David P KelsenDepartment of Medicine, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, New York, USA.
Mark SchattnerDepartment of Medicine, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, New York, USA.
David H IlsonDepartment of Medicine, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, New York, USA.
David B SolitDepartment of Medicine, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, New York, USA.
Barry S TaylorMarie-Josée & Henry R. Kravis Center for Molecular Oncology, Memorial Sloan Kettering Cancer Center, New York, New York, USA.
Nikolaus SchultzMarie-Josée & Henry R. Kravis Center for Molecular Oncology, Memorial Sloan Kettering Cancer Center, New York, New York, USA.
Marinela CapanuDepartment of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York, USA.
Yelena Y JanjigianDepartment of Medicine, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, New York, USA.ORCID 0000-0002-5357-5858
Memorial Sloan Kettering Cancer Center · USCornell University · USMolecular Oncology (United States) · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4M
Investigational Cancer Therapeutics Training Program (ICTTP)T32CA009207 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Omar Abdel-Wahab, Alexander Drilon · 1985 to 2026
$13.7M
Institutional Career Development CoreKL2TR002385 · NCATS · WEILL MEDICAL COLL OF CORNELL UNIV · PI YUAN-SHAN ZHU · 2017 to 2026
$13.3M
Summer research experiences for medical students supervised by faculty mentorsR25CA020449 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Charlotte Eielson Ariyan · 1985 to 2026
$6.2M
NCATS NIH HHS KL2 TR002385NCI NIH HHS P30 CA008748NCI NIH HHS R25 CA020449NCI NIH HHS T32 CA009207
6 · The paper itself

Abstract

backgroundAngiogenesis is critical to gastroesophageal adenocarcinoma growth and metastasis. Regorafenib is a multikinase inhibitor targeting angiogenic and stromal receptor tyrosine kinases. We evaluated whether regorafenib augments the antitumor effect of first-line chemotherapy in metastatic esophagogastric cancer. MATERIALS AND

methodsPatients with previously untreated metastatic gastroesophageal adenocarcinoma received 5-fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) every 14 days and regorafenib 160 mg daily on days 4 to 10 of each 14-day cycle. The primary endpoint was 6-month progression-free survival (PFS). To identify predictive biomarkers of outcome, we examined correlations between genomic characteristics of sequenced pretreatment tumors and PFS.

resultsBetween August 2013 and November 2014, 36 patients with metastatic esophagogastric cancer were accrued to this single-center phase II study (NCT01913639). The most common grade 3-4 treatment-related adverse events were neutropenia (36%), leucopenia (11%) and hypertension (8%). The 6-month PFS was 53% (95% confidence interval [CI], 38%-71%), the objective response rate was 54% (95% CI, 37%-70%), and the disease control rate was 77% (95% CI, 67%-94%). Next-generation sequencing did not identify any genomic alterations significantly correlated with response, and there was no association between homologous recombination deficiency and PFS with platinum-based chemotherapy.

conclusionRegorafenib (one week on-one week off schedule) is well tolerated in combination with first-line FOLFOX but does not improve 6-month PFS relative to historical control. IMPLICATIONS FOR PRACTICE: Prognosis for metastatic esophagogastric cancer remains poor despite modern systemic therapy regimens. This phase II trial indicates that the combination of regorafenib and FOLFOX is well tolerated but does not add to the efficacy of first-line chemotherapy in metastatic esophagogastric cancer. Notably, recently reported data suggest potential synergy between regorafenib and the PD-1 inhibitor nivolumab. As this study demonstrates that regorafenib plus FOLFOX is safe, and combined chemotherapy and immunotherapy show favorable toxicity profiles, future studies combining immunotherapy with regorafenib and chemotherapy may be feasible.

Indexed as

AdultAgedEsophageal NeoplasmsFemaleHumansMaleMiddle AgedNeoplasm MetastasisPhenylurea CompoundsPyridinesStomach NeoplasmsYoung AdultPhenylurea CompoundsPyridinesregorafenibAngiogenesisEsophagogastric cancerRegorafenibTargeted therapy

Identifiers

PMID31570517
PMCPMC6964136
OpenAlexW2977967558

What OpenQuestion holds

Textmetadata
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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.