Evidence map›Paper›PMID 32590747›Full record

Trial reportMedicine2020

Activity of regorafenib in advanced pretreated soft tissue sarcoma: Results of a single-center phase II study.

Andrea Marrari, Alexia Bertuzzi, Silvia Bozzarelli, Nicolò Gennaro, Laura Giordano, Vittorio Quagliuolo, Rita De Sanctis, Simona Sala, Luca Balzarini, Armando Santoro

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

Trial report in Medicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02307500 (An Open-label Phase II Study of Regorafenib in Patients With Metastatic Solid Tumors Who Have Progressed After Standard Therapy - RESOUND), 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
1.3field-weighted citation impact, top 17% 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.

NCT02307500 phase2completednot on this map

An Open-label Phase II Study of Regorafenib in Patients With Metastatic Solid Tumors Who Have Progressed After Standard Therapy - RESOUND

TypeinterventionalSponsorIstituto Clinico HumanitasRan2014 to 2020Enrolled82ConditionsPancreas Cancer, Ovarian Cancer, Melanoma, SarcomaArmsRegorafenib
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 13 citations in OpenAlex.

  1. Review
  2. Article
  3. Review
  4. Immune checkpoint inhibitor resistance in soft tissue sarcoma.Cancer drug resistance (Alhambra, Calif.) · 2022
    Review
  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

10 authors at 2 institutions in 3 countries.

Andrea MarrariMedical Oncology and Hematology Unit.
Alexia BertuzziMedical Oncology and Hematology Unit.
Silvia BozzarelliMedical Oncology and Hematology Unit.
Nicolò GennaroDepartment of Radiology.
Laura GiordanoBiostatistics Unit, Humanitas Cancer Center.
Vittorio QuagliuoloDepartment of Surgery, Humanitas Clinical and Research Center, IRCCS, Rozzano (Milan), Italy.
Rita De SanctisMedical Oncology and Hematology Unit.
Simona SalaMedical Oncology and Hematology Unit.
Luca BalzariniDepartment of Radiology.
Armando SantoroMedical Oncology and Hematology Unit.ORCID 0000-0003-1709-9492
Sprint (United States) · USHumanitas University · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRegorafenib, a multitargeted tyrosine kinase inhibitor, proved to be active in patients with soft tissue sarcomas (STS).

methodsWe conducted an open-label, non-randomized, single-center phase II study in advanced pretreated STS patients. Patients received regorafenib 160 mg daily on days 1 enrule 21 of a 28-day cycle. The primary endpoint was the progression-free survival (PFS) at 8 weeks. Toxicity was registered.

resultsBetween April 2015 and November 2016, 21 patients were enrolled in the trial. A total of 13 out of 21 evaluable patients (61.9%) were progression-free at 8 weeks. Median PFS was 3.8 months (95% CI: 2.1-9.4). Median overall survival was 14.8 months (95% CI: 7.7-27.8). In the intention-to-treat population, we reported a PFS of 66.7% at 3 months (95% CI: 40.4-83.4) and 16.7% at 12 months (95% CI: 4.1-36.5). As per the RECIST criteria, the response rate was 4.7% (1 partial response out of 21 evaluable patients) with a clinical benefit rate of 61.9%; no complete response was observed. Treatment was well tolerated.

conclusionRegorafenib shows signs of clinical activity in patients with advanced STS. CLINICAL

trial registrationClinicalTrials.gov NCT02307500.

Indexed as

Ovarian NeoplasmsPancreatic NeoplasmsPhenylurea CompoundsPyridinesSarcomaThymomaAntineoplastic AgentsDrug MonitoringEnzyme InhibitorsFemaleHumansMaleMiddle AgedProgression-Free SurvivalResponse Evaluation Criteria in Solid TumorsTreatment OutcomeAntineoplastic AgentsEnzyme InhibitorsPhenylurea CompoundsPyridinesregorafenib

Identifiers

PMID32590747
PMCPMC7328961
OpenAlexW3037252775

What OpenQuestion holds

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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.