Evidence map›Paper›PMID 33351187›Full record

ArticleCancer2021

A phase 1b expansion study of TAS-102 with oxaliplatin for refractory metastatic colorectal cancer.

Michael Cecchini, Jeremy S Kortmansky, Can Cui, Wei Wei, Jaykumar Ranchobdhai Thumar, Nataliya V Uboha, Navid Hafez, Jill Lacy, Neal A Fischbach, Kert D Sabbath and 4 more

Open access · greenAbstract readClinical Trial, Phase I
In one paragraph

Article in Cancer, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
0.6field-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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 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. Review
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

14 authors at 3 institutions in 1 country.

Michael CecchiniDepartment of Internal Medicine (Medical Oncology), Yale University School of Medicine, New Haven, Connecticut.ORCID 0000-0003-3504-0128
Jeremy S KortmanskyDepartment of Internal Medicine (Medical Oncology), Yale University School of Medicine, New Haven, Connecticut.
Can CuiDepartment of Biostatistics, Yale School of Public Health, New Haven, Connecticut.
Wei WeiDepartment of Biostatistics, Yale School of Public Health, New Haven, Connecticut.
Jaykumar Ranchobdhai ThumarDepartment of Internal Medicine (Medical Oncology), Yale University School of Medicine, New Haven, Connecticut.
Nataliya V UbohaHematology-Oncology Section, Department of Medicine, University of Wisconsin Carbone Cancer Center, Madison, Wisconsin.
Navid HafezDepartment of Internal Medicine (Medical Oncology), Yale University School of Medicine, New Haven, Connecticut.
Jill LacyDepartment of Internal Medicine (Medical Oncology), Yale University School of Medicine, New Haven, Connecticut.
Neal A FischbachDepartment of Internal Medicine (Medical Oncology), Yale University School of Medicine, New Haven, Connecticut.
Kert D SabbathDepartment of Internal Medicine (Medical Oncology), Yale University School of Medicine, New Haven, Connecticut.
Christina M GomezDepartment of Internal Medicine (Medical Oncology), Yale University School of Medicine, New Haven, Connecticut.
Jonathan Reed SpornDepartment of Internal Medicine (Medical Oncology), Yale University School of Medicine, New Haven, Connecticut.
Stacey SteinDepartment of Internal Medicine (Medical Oncology), Yale University School of Medicine, New Haven, Connecticut.
Howard S HochsterRutgers Cancer Institute of New Jersey, New Brunswick, New Jersey.
Yale University · USRutgers, The State University of New Jersey · USUniversity of Wisconsin Carbone Cancer Center · US

Funding

Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
YALE CANCER CENTER CALABRESI IMMUNO-ONCOLOGY TRAINING PROGRAMK12CA215110 · NCI · YALE UNIVERSITY · PI Harriet M. Kluger · 2018 to 2026
$6.1M
NCATS NIH HHS UL1 TR001863NCI NIH HHS K12 CA215110
6 · The paper itself

Abstract

backgroundTAS-102, a novel antimetabolite, is approved for treatment of refractory metastatic colorectal cancer (CRC). This study sought to determine whether the addition of TAS-102 to oxaliplatin (TAS-OX) was safe and effective in metastatic CRC previously treated with oxaliplatin.

methodsThis investigator-initiated, open-label, single-arm phase 1b study enrolled patients with metastatic CRC previously treated with 5-fluorouracil, irinotecan, and oxaliplatin. In dose escalation, TAS-102 was given at 3 dose levels: 25, 30, and 35 mg/m

resultsForty-one patients were treated with TAS-OX. No dose-limiting toxicities were observed in the 11 patients treated in escalation. The recommended dose for expansion was 35 mg/m

conclusionsTAS-OX is safe with no unexpected toxicities at standard doses of each agent. The combination did not result in a clinically meaningful ORR, although progression-free survival and overall survival were encouraging in this heavily pretreated population. LAY SUMMARY: For metastatic colorectal cancer, the treatment combination of TAS-102 and oxaliplatin was found to be well-tolerated and revealed no unexpected side effects. Twelve of 41 patients had reductions in the size of their tumor, and the study treatment delayed the time to tumor growth as opposed to what would be expected.

Indexed as

AdultAgedAged, 80 and overAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsColorectal NeoplasmsDrug Administration ScheduleDrug CombinationsDrug Resistance, NeoplasmFemaleFluorouracilHumansIrinotecanLeucovorinMaleMiddle AgedAntineoplastic AgentsDrug CombinationsFluorouracilIrinotecanLeucovorinOrganoplatinum CompoundsOxaliplatinPyrrolidinesThymineTrifluridinetrifluridine tipiracil drug combinationclinical trialscolorectal cancerneutropeniaoxaliplatinphase 1TAS-102

Identifiers

PMID33351187
PMCPMC8085021
OpenAlexW3118214896

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.