Evidence map›Paper›PMID 32740235›Full record

Trial reportAnnals of surgery2020

Surgical Outcome Results From SWOG S1505: A Randomized Clinical Trial of mFOLFIRINOX Versus Gemcitabine/Nab-paclitaxel for Perioperative Treatment of Resectable Pancreatic Ductal Adenocarcinoma.

Syed A Ahmad, Mai Duong, Davendra P S Sohal, Namita S Gandhi, Muhammad Shaalan Beg, Andrea Wang-Gillam, James L Wade, Elena Gabriela Chiorean, Katherine A Guthrie, Andrew M Lowy and 2 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Annals of surgery, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02562716 (A Randomized Phase II Study of Perioperative mFOLFIRINOX Versus Gemcitabine/Nab-Paclitaxel as Therapy for Resectable Pancreatic Adenocarcinoma), which is not on this map. Cited by 142 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
142citing papers in PubMed, 5 pooled it
12.6field-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.

NCT02562716 phase2completednot on this map

A Randomized Phase II Study of Perioperative mFOLFIRINOX Versus Gemcitabine/Nab-Paclitaxel as Therapy for Resectable Pancreatic Adenocarcinoma

TypeinterventionalSponsorSWOG Cancer Research NetworkRan2016 to 2022Enrolled147ConditionsPancreatic Adenocarcinoma, Resectable Pancreatic CarcinomaArmsFluorouracil, Gemcitabine Hydrochloride, Irinotecan Hydrochloride, Oxaliplatin, Paclitaxel Albumin-Stabilized Nanoparticle Formulation
3 · Its place in the literature

Who cites it

142 citing papers in PubMed, 5 syntheses or guidelines pooled it, 228 citations in OpenAlex.

  1. Pooled it
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  5. SEOM clinical guidelines for pancreatic and biliary tract cancer (2020).Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2021
    Guideline
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  10. Body composition measurements and clinical outcomes in patients with resectable pancreatic adenocarcinoma - analysis from SWOG S1505.Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract · 2024
    Trial
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82 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors at 9 institutions in 1 country.

Syed A AhmadUniversity of Cincinnati, Cincinnati, Ohio.
Mai DuongSWOG Statistical and Data Management Center, Seattle, Washington.
Davendra P S SohalUniversity of Cincinnati, Cincinnati, Ohio.
Namita S GandhiCleveland Clinic, Cleveland, Ohio.
Muhammad Shaalan BegUT Southwestern Medical Center, Dallas, Texas.
Andrea Wang-GillamWashington University Siteman Cancer Center, St. Louis, Missouri.
James L WadeHeartland NCORP/Cancer Care Specialists of Illinois, Decatur, Illinois.
Elena Gabriela ChioreanUniversity of Washington, Fred Hutchinson Cancer Research Center, Seattle, Washington.
Katherine A GuthrieSWOG Statistical and Data Management Center, Seattle, Washington.
Andrew M LowyUniversity of California, San Diego, La Jolla, California.
Philip A PhilipWayne State University/Karmanos Cancer Institute, Detroit, Michigan.
Howard S HochsterRutgers Cancer Institute of New Jersey, New Brunswick, New Jersey.
University of Cincinnati · USCancer Care Specialists of Illinois · USCleveland Clinic · USRutgers Cancer Institute of New JerseySouthwestern Medical CenterThe Barbara Ann Karmanos Cancer Institute · USUniversity of California, San Diego · USUniversity of Washington · USWashington University in St. Louis · US

Funding

Member Site CoreU10CA180821 · NCI · BRIGHAM AND WOMEN'S HOSPITAL · PI Evanthia Galanis · 2014 to 2026
$177.3M
Project-006U10CA180820 · NCI · ECOG-ACRIN MEDICAL RESEARCH FOUNDATION · PI Peter J ODwyer, MITCHELL D. SCHNALL · 2014 to 2026
$167.6M
SWOG Network Group Operations Center of the NCTNU10CA180888 · NCI · UNIVERSITY OF CALIFORNIA AT DAVIS · PI PRIMO N. LARA · 2014 to 2026
$152.1M
SWOG Statistics & Data Management Center complex - extension supplement for GY06U10CA180819 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI MEGAN OTHUS · 2014 to 2026
$115.2M
Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
Kaiser Permanente NCI National Community Oncology Research Program, NCORPUG1CA189821 · NCI · KAISER FOUNDATION RESEARCH INSTITUTE · PI Jennifer Marie Suga · 2014 to 2026
$44.4M
Heartland Cancer Research NCORPUG1CA189830 · NCI · DECATUR MEMORIAL HOSPITAL · PI Bryan A. Faller · 2014 to 2026
$40.9M
Southeast Clinical Oncology Research Consortium, Inc. (SCOR)UG1CA189858 · NCI · SOUTHEAST CLINICAL ONCOL RES CONSORTIUM · PI Judith O Hopkins, William J Irvin · 2014 to 2026
$38.8M
Michigan Cancer Research Consortium NCORPUG1CA189971 · NCI · SAINT JOSEPH MERCY HEALTH SYSTEM · PI Tareq Al baghdadi · 2014 to 2026
$36.6M
The Pacific Cancer Research Consortium (PCRC), an NCORP Community SiteUG1CA189953 · NCI · SWEDISH MEDICAL CENTER, FIRST HILL · PI Alison Katherine Conlin, Charles Drescher · 2014 to 2026
$27.4M
The NCI Community Oncology Research Program: The New Mexico NCORPUG1CA189856 · NCI · UNIVERSITY OF NEW MEXICO HEALTH SCIS CTR · PI Carolyn Y. Muller, Bernard Tawfik · 2014 to 2026
$20.6M
Carle Cancer Center NCI Community Oncology Research Progran (NCORP)UG1CA189861 · NCI · CARLE FOUNDATION · PI KENDRITH Martin ROWLAND · 2014 to 2026
$20.4M
NCATS NIH HHS UL1 TR001863NCI NIH HHS N01 CA013612NCI NIH HHS U10 CA013612NCI NIH HHS U10 CA180798NCI NIH HHS U10 CA180801NCI NIH HHS U10 CA180819NCI NIH HHS U10 CA180820NCI NIH HHS U10 CA180821NCI NIH HHS U10 CA180888NCI NIH HHS UG1 CA189821NCI NIH HHS UG1 CA189822NCI NIH HHS UG1 CA189830NCI NIH HHS UG1 CA189848NCI NIH HHS UG1 CA189856NCI NIH HHS UG1 CA189858NCI NIH HHS UG1 CA189861NCI NIH HHS UG1 CA189873NCI NIH HHS UG1 CA189953NCI NIH HHS UG1 CA189954NCI NIH HHS UG1 CA189957NCI NIH HHS UG1 CA189958NCI NIH HHS UG1 CA189971NCI NIH HHS UG1 CA189972NCI NIH HHS UG1 CA233160NCI NIH HHS UG1 CA233163NCI NIH HHS UG1 CA233230NCI NIH HHS UG1 CA239767
6 · The paper itself

Abstract

objectiveThe optimal neoadjuvant therapy for resectable pancreatic ductal adenocarcinoma (PDA) and the impact on surgical outcomes remains unclear.

methodsS1505 (NCT02562716) was a randomized phase II study of perioperative chemotherapy with mFOLFIRINOX (Arm 1) or gemcitabine/nab-paclitaxel (Arm 2). Measured parameters included resection rate, margin positivity, pathologic response, and toxicity.

resultsBetween 2015 and 2018, 147 patients were randomized. Of these, 44 (30%) were deemed ineligible (43 by central review). Of the 103 eligible patients, 77 (76%) completed preoperative therapy and underwent surgery; reasons patients did not undergo surgery included toxicity related to preoperative therapy (n = 9), progression (n = 9), or other (n = 7). Of the 77, 73 (95%) underwent successful resection; 21 (29%) required vascular reconstruction, 62 (85%) had negative (R0) margins, and 24 (33%) had a complete or major pathologic response to therapy. The grade 3-5 postoperative complication rate was 16%. Of the 73 patients completing surgery, 57 (78%) started and 46 (63%) completed postoperative therapy. This study represents the first prospective trial evaluating modern systemic therapy delivered in a neoadjuvant/perioperative format for resectable PDA.

conclusionsWe have demonstrated: (1) Based on the high percentage of enrolled, but ineligible patients, it is clear that adherence to strict definitions of resectable PDA is challenging; (2) Patients can tolerate modern systemic therapy and undergo successful surgical resection without prohibitive perioperative complications; (3) Completion of adjuvant therapy in the perioperative format is difficult; (4) Major pathologic response rate of 33% is encouraging.

Indexed as

PancreatectomyAgedAlbuminsAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Pancreatic DuctalCombined Modality TherapyDeoxycytidineFemaleFluorouracilFollow-Up StudiesGemcitabineHumansImmunosuppressive AgentsIrinotecanLeucovorin130-nm albumin-bound paclitaxelAlbuminsAntineoplastic AgentsDeoxycytidineFluorouracilfolfirinoxGemcitabineImmunosuppressive AgentsIrinotecanLeucovorinOxaliplatinPaclitaxel

Identifiers

PMID32740235
PMCPMC7856053
OpenAlexW3047136679

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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.