Evidence map›Paper›PMID 27022826›Full record

Trial reportBritish journal of cancer2016

Final analysis of a phase II study of modified FOLFIRINOX in locally advanced and metastatic pancreatic cancer.

Stacey M Stein, Edward S James, Yanhong Deng, Xiangyu Cong, Jeremy S Kortmansky, Jia Li, Carol Staugaard, Doddamane Indukala, Ann Marie Boustani, Vatsal Patel and 5 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in British journal of cancer, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01523457 (Phase II Study of Modified FOLFIRINOX in Advanced Pancreatic Cancer), which is not on this map. Cited by 122 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
122citing papers in PubMed, 9 pooled it
12.9field-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.

NCT01523457 phase2completednot on this map

Phase II Study of Modified FOLFIRINOX in Advanced Pancreatic Cancer

TypeinterventionalSponsorYale UniversityRan2011 to 2015Enrolled75ConditionsMetastatic Pancreatic Cancer, Pancreatic CancerArmsFolfirinox
3 · Its place in the literature

Who cites it

122 citing papers in PubMed, 9 syntheses or guidelines pooled it, 212 citations in OpenAlex.

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  14. Clinical Assessment of 5-Fluorouracil/Leucovorin, Nab-Paclitaxel, and Irinotecan (FOLFIRABRAX) in Untreated Patients with Gastrointestinal Cancer UsingClinical cancer research : an official journal of the American Association for Cancer Research · 2020
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62 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

15 authors at 2 institutions in 1 country.

Stacey M SteinDepartment of Medicine, Section of Medical Oncology, Yale School of Medicine, 333 Cedar Street, New Haven, CT 06510, USA.
Edward S JamesDepartment of Medicine, Section of Medical Oncology, Yale School of Medicine, 333 Cedar Street, New Haven, CT 06510, USA.
Yanhong DengYale School of Public Health, 300 George Street, New Haven, CT 06510, USA.
Xiangyu CongYale School of Public Health, 300 George Street, New Haven, CT 06510, USA.
Jeremy S KortmanskyDepartment of Medicine, Section of Medical Oncology, Yale School of Medicine, 333 Cedar Street, New Haven, CT 06510, USA.
Jia LiDepartment of Medicine, Section of Medical Oncology, Yale School of Medicine, 333 Cedar Street, New Haven, CT 06510, USA.
Carol StaugaardDepartment of Medicine, Section of Medical Oncology, Yale School of Medicine, 333 Cedar Street, New Haven, CT 06510, USA.
Doddamane IndukalaDepartment of Diagnostic Radiology, Yale School of Medicine, 333 Cedar Street, New Haven, CT 06510, USA.
Ann Marie BoustaniDepartment of Diagnostic Radiology, Yale School of Medicine, 333 Cedar Street, New Haven, CT 06510, USA.
Vatsal PatelDepartment of Diagnostic Radiology, Yale School of Medicine, 333 Cedar Street, New Haven, CT 06510, USA.
Charles H ChaDepartment of Surgery, Yale School of Medicine, 333 Cedar Street, New Haven, CT 06510, USA.
Ronald R SalemDepartment of Surgery, Yale School of Medicine, 333 Cedar Street, New Haven, CT 06510, USA.
Bryan ChangDepartment of Therapeutic Radiology, Yale School of Medicine, 333 Cedar Street, New Haven, CT 06510, USA.
Howard S HochsterDepartment of Medicine, Section of Medical Oncology, Yale School of Medicine, 333 Cedar Street, New Haven, CT 06510, USA.
Jill LacyDepartment of Medicine, Section of Medical Oncology, Yale School of Medicine, 333 Cedar Street, New Haven, CT 06510, USA.
Yale University · USVA Connecticut Healthcare System · US

Funding

Yale Pathology Tissue Services Shared ResourceP30CA016359 · NCI · YALE UNIVERSITY · PI DAVID L RIMM · 1985 to 2026
$85.0M
NCI NIH HHS P30 CA016359NCI NIH HHS P30CA016359
6 · The paper itself

Abstract

backgroundModifications of FOLFIRINOX are widely used despite the absence of prospective data validating efficacy in metastatic disease (metastatic pancreatic cancer (MPC)) or locally advanced pancreatic cancer (LAPC). We conducted a multicentre phase II study of modified FOLFIRINOX in advanced pancreatic cancer to assess the impact of dose attenuation in MPC and efficacy in LAPC.

methodsPatients with untreated MPC or LAPC received modified FOLFIRINOX (irinotecan and bolus 5-fluorouracil reduced by 25%). Adverse events (AEs) were compared with full-dose FOLFIRINOX. Response rate (RR), median progression-free survival (PFS) and median overall survival (OS) were determined.

resultsIn total, 31 and 44 patients with LAPC and MPC were enrolled, respectively. In MPC, efficacy of modified FOLFIRINOX was comparable with FOLFIRINOX with RR 35.1%, OS 10.2 months (95% CI 7.65-14.32) and PFS 6.1 months (95% CI 5.19-8.31). In LAPC, efficacy was notable with RR 17.2%, resection rate 41.9%, PFS 17.8 months (95% CI 11.0-23.9) and OS 26.6 months (95% CI 16.7, NA). Neutropenia (P<0.0001), vomiting (P<0.001) and fatigue (P=0.01) were significantly decreased. [(18)F]-Fluorodeoxyglucose positron emission tomography imaging response did not correlate with PFS or OS.

conclusionsIn this first prospective study of modified FOLFIRINOX in MPC and LAPC, we observed decreased AEs compared with historical control patients. In MPC, the efficacy appears comparable with FOLFIRINOX. In LAPC, PFS and OS were prolonged and support the continued use of FOLFIRINOX in this setting.

Indexed as

AdenocarcinomaAdultAgedAntineoplastic Combined Chemotherapy ProtocolsCamptothecinFemaleFluorouracilFollow-Up StudiesHumansIrinotecanLeucovorinLiver NeoplasmsLung NeoplasmsLymphatic MetastasisMaleMiddle AgedCamptothecinFluorouracilIrinotecanLeucovorinOrganoplatinum CompoundsOxaliplatin

Identifiers

PMID27022826
PMCPMC4984865
OpenAlexW2323248054

What OpenQuestion holds

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LicenceCC BY-NC-SA
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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.