Evidence map›Paper›PMID 24901360›Full record

Trial reportAnnals of surgery2014

A single-arm, nonrandomized phase II trial of neoadjuvant gemcitabine and oxaliplatin in patients with resectable pancreas adenocarcinoma.

Eileen M OʼReilly, Anna Perelshteyn, William R Jarnagin, Mark Schattner, Hans Gerdes, Marinela Capanu, Laura H Tang, Joseph LaValle, Corinne Winston, Ronald P DeMatteo and 10 more

3 registry-linked trialsAbstract readClinical Trial
In one paragraph

Trial report in Annals of surgery, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 57 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
57citing papers in PubMed, 7 pooled it
3.8field-weighted citation impact, top 6% 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.

NCT00536874 phase2completednot on this map

A Phase II Study of Neoadjuvant Gemcitabine and Oxaliplatin in Patients With Potentially Resectable Previously Untreated Pancreatic Adenocarcinoma

TypeinterventionalSponsorMemorial Sloan Kettering Cancer CenterRan2007 to 2017Enrolled39ConditionsPancreatic CancerArmsgemcitabine hydrochloride, oxaliplatin, protein expression analysis, proteomic profiling, diagnostic laboratory biomarker analysis
NCT02749136 phase2completednot on this mapstarted 2016, after this paper: background citation

Phase 2 Study of Neoadjuvant Modified FOLFIRINOX in Patients With Borderline Resectable Pancreas Adenocarcinoma

TypeinterventionalSponsorAsan Medical CenterRan2016 to 2019Enrolled44ConditionsPancreatic AdenocarcinomaArmsPreoperative modified FOLFIRINOX and postoperative gemcitabine
NCT03167112 phase2unknown statusnot on this mapstarted 2017, after this paper: background citation

A Study of Preoperative FOLFIRINOX For Potentially Curable Pancreatic Cancer

TypeinterventionalSponsorPetr KavanRan2017 to 2018Enrolled20ConditionsPancreatic CancerArmsOxaliplatin, Irinotecan, Leucovorin, Fluorouracil
3 · Its place in the literature

Who cites it

57 citing papers in PubMed, 7 syntheses or guidelines pooled it, 135 citations in OpenAlex.

  1. Is Complete Pathologic Response in Pancreatic Cancer Overestimated? A Systematic Review of Prospective Studies.Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract · 2020
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  19. Fifty years of pancreas cancer care.Journal of surgical oncology · 2022
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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

20 authors at 3 institutions in 1 country.

Eileen M OʼReilly*Gastrointestinal Oncology Service †Department of Medicine ‡Hepatopancreaticobiliary Surgery Service §Gastroenterology and Nutrition Service Departments of ¶Epidemiology and Biostatistics ‖Pathology **Radiology ††Surgery; and ‡‡Gastric and Mixed Tumor Service, Memorial Sloan-Kettering Cancer Center, New York, NY.
Anna Perelshteyn
William R Jarnagin
Mark Schattner
Hans Gerdes
Marinela Capanu
Laura H Tang
Joseph LaValle
Corinne Winston
Ronald P DeMatteo
Michael DʼAngelica
Robert C Kurtz
Ghassan K Abou-Alfa
David S Klimstra
Maeve A Lowery
Murray F Brennan
Daniel G Coit
Diane L Reidy
T Peter Kingham
Peter J Allen
American Society for Gastrointestinal Endoscopy · USFood and Nutrition Service · USCancer Research And Biostatistics · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

backgroundThe role for neoadjuvant systemic therapy in resectable pancreas adenocarcinoma remains undefined.

objectiveWe evaluated the efficacy of gemcitabine and oxaliplatin administered as preoperative therapy in patients with resectable pancreas adenocarcinoma.

methodsEligible patients were screened using computed tomography-pancreas angiography, laparoscopy, endoscopic ultrasonography, and fine-needle aspiration cytology to identify 38 patients who received 4 cycles of neoadjuvant gemcitabine 1000 mg/m intravenously over 100 minutes and oxaliplatin 80 mg/m intravenously over 2 hours, every 2 weeks. Patients whose tumors remained resectable at restaging proceeded to operation and subsequently received 5 cycles of adjuvant gemcitabine (1000 mg/m intravenously over 30 minutes days 1, 8, and 15 every 4 weeks). The primary endpoint was 18-month overall survival and secondary endpoints included radiological, tumor marker and pathological response to neoadjuvant therapy, time to recurrence, patterns of failure, and feasibility of obtaining preoperative core biopsies.

resultsThirty-five of 38 patients (92%) completed neoadjuvant therapy. Twenty-seven patients underwent tumor resection (resectability rate 71%), of which 26 initiated adjuvant therapy for a total of 23 patients (60.5%) who completed all planned therapy. The 18-month survival was 63% (24 patients alive). The median overall survival for all 38 patients was 27.2 months (95% confidence interval: 17-NA) and the median disease-specific survival was 30.6 months (95% confidence interval: 19-NA).

conclusionsThis study met its endpoint and provided a signal suggesting that exploration of neoadjuvant systemic therapy is worthy of further investigation in resectable pancreas adenocarcinoma. Improved patient selection and more active systemic regimens are key. Clinical trials identification: NCT00536874.

Indexed as

AdenocarcinomaAdultAgedAged, 80 and overAntineoplastic AgentsBiopsyDeoxycytidineDose-Response Relationship, DrugDrug Therapy, CombinationFemaleFollow-Up StudiesGemcitabineHumansMaleMiddle AgedNeoadjuvant TherapyAntineoplastic AgentsDeoxycytidineGemcitabineOrganoplatinum CompoundsOxaliplatinRibonucleotide Reductases

Identifiers

PMID24901360
PMCPMC4520299
OpenAlexW1987355037

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.