Evidence map›Paper›PMID 33555926›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2021

Randomized Phase III Study of FOLFOX Alone or With Pegilodecakin as Second-Line Therapy in Patients With Metastatic Pancreatic Cancer That Progressed After Gemcitabine (SEQUOIA).

J Randolph Hecht, Sara Lonardi, Johanna Bendell, Hao-Wen Sim, Teresa Macarulla, Charles D Lopez, Eric Van Cutsem, Andres J Muñoz Martin, Joon Oh Park, Richard Greil and 6 more

Open access · bronzeAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 75 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
75citing papers in PubMed, 3 pooled it
8.8field-weighted citation impact, top 1% 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

75 citing papers in PubMed, 3 syntheses or guidelines pooled it, 107 citations in OpenAlex.

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  12. KRAS: the Achilles' heel of pancreas cancer biology.The Journal of clinical investigation · 2025
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15 more citing papers are in PubMed but not listed here.

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

16 authors at 10 institutions in 7 countries.

J Randolph HechtDavid Geffen School of Medicine at UCLA, Santa Monica, CA.ORCID 0000-0003-2277-4157
Sara LonardiIstituto Oncologico Veneto IRCCS, Padova, Italy.ORCID 0000-0002-7593-8138
Johanna BendellSarah Cannon Research Institute/Tennessee Oncology, Nashville, TN.
Hao-Wen SimSt Vincent's Clinical School, University of New South Wales, Sydney, NSW, Australia.ORCID 0000-0002-2530-0523
Teresa MacarullaVall d'Hebrón University Hospital and Vall d'Hebrón Institute of Oncology (VHIO), IOB Quirón, Barcelona, Spain.
Charles D LopezOregon Health and Science University, Portland, OR.
Eric Van CutsemUniversity Hospitals Leuven and KULeuven, Leuven, Belgium.ORCID 0000-0002-6372-1230
Andres J Muñoz MartinInstituto de Investigaciόn Sanitaria Gregorio Marañόn, Universidad Complutense, Madrid, Spain.ORCID 0000-0001-6977-8249
Joon Oh ParkSamsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.ORCID 0000-0001-6502-2612
Richard GreilParacelsus Medical University Salzburg, Salzburg Cancer Research Institute-CCCIT and Cancer Cluster Salzburg, Salzburg, Austria.ORCID 0000-0002-4462-3694
Hong WangEli Lilly and Company, Indianapolis, IN.
Rebecca R HozakEli Lilly and Company, Indianapolis, IN.
Ivelina GueorguievaEli Lilly and Company, Indianapolis, IN.
Yong LinEli Lilly and Company, New York, NY.
Sujata RaoEli Lilly and Company, Indianapolis, IN.
Baek-Yeol RyooAsan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.ORCID 0000-0002-9052-833X
Eli Lilly (United States) · USHospital General Universitario Gregorio Marañón · ESIstituto Oncologico Veneto · ITKU Leuven · BEOregon Health & Science University · USParacelsus Medical University · ATSamsung Medical Center · KRSarah Cannon · USUlsan College · KRUNSW Sydney · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeSEQUOIA compared efficacy and safety of adding pegilodecakin (PEG), a pegylated recombinant human interleukin (IL)-10, with folinic acid, fluorouracil, and oxaliplatin (FOLFOX) in patients following progression on first-line gemcitabine-containing therapy with metastatic pancreatic ductal adenocarcinoma (PDAC). PATIENTS AND

methodsSEQUOIA, a randomized, global phase III study, compared FOLFOX with PEG + FOLFOX as second line in gemcitabine-refractory PDAC. Patients were randomly assigned 1:1 (PEG + FOLFOX:FOLFOX) and stratified by prior gemcitabine and region. Eligible patients had only one prior gemcitabine-containing treatment. Primary end point was overall survival (OS). Secondary end points included progression-free survival (PFS), response evaluation per Response Evaluation Criteria in Solid Tumor (RECIST) 1.1, and safety. Exploratory analyses included biomarkers related to immune activation.

resultsBetween March 1, 2017, and September 9, 2019, 567 patients were randomly assigned PEG + FOLFOX (n = 283) or FOLFOX (n = 284). Most (94.7%) patients received prior gemcitabine plus nab paclitaxel. OS was similar comparing PEG + FOLFOX versus FOLFOX (median: 5.8

conclusionPEG added to FOLFOX did not improve efficacy in advanced gemcitabine-refractory PDAC. Safety findings were consistent as previously observed from PEG with chemotherapy; toxicity was manageable and tolerable. Exploratory pharmacodynamic results were consistent with immunostimulatory signals of the IL-10R pathway.

Indexed as

AdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Pancreatic DuctalDeoxycytidineDisease ProgressionDrug Resistance, NeoplasmFatigueFemaleFluorouracilGemcitabineHumansInterleukin-10Kaplan-Meier EstimateLeucovorinDeoxycytidineFluorouracilGemcitabineInterleukin-10LeucovorinOxaliplatinpegilodecakinPolyethylene Glycols

Identifiers

PMID33555926
PMCPMC8078437
OpenAlexW3128707074

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.