Evidence map›Paper›PMID 36028483›Full record

Trial reportNature communications2022

The CCTG PA.7 phase II trial of gemcitabine and nab-paclitaxel with or without durvalumab and tremelimumab as initial therapy in metastatic pancreatic ductal adenocarcinoma.

Daniel J Renouf, Jonathan M Loree, Jennifer J Knox, James T Topham, Petr Kavan, Derek Jonker, Stephen Welch, Felix Couture, Frederic Lemay, Mustapha Tehfe and 13 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Nature communications, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02879318 (A Randomized Phase II Trial of Gemcitabine and Nab-Paclitaxel vs Gemcitabine, Nab-Paclitaxel, Durvalumab and Tremelimumab as 1st Line Therapy in Metastatic Pancreatic Adenocarcinoma), which is not on this map. Cited by 109 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
109citing papers in PubMed, 8 pooled it
11.6field-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.

NCT02879318 phase2completednot on this map

A Randomized Phase II Trial of Gemcitabine and Nab-Paclitaxel vs Gemcitabine, Nab-Paclitaxel, Durvalumab and Tremelimumab as 1st Line Therapy in Metastatic Pancreatic Adenocarcinoma

TypeinterventionalSponsorCanadian Cancer Trials GroupRan2016 to 2025Enrolled180ConditionsPancreatic AdenocarcinomaArmsGemcitabine, Nab-paclitaxel, Durvalumab, Tremelimumab
3 · Its place in the literature

Who cites it

109 citing papers in PubMed, 8 syntheses or guidelines pooled it, 124 citations in OpenAlex.

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49 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

23 authors at 18 institutions in 1 country.

Daniel J RenoufPancreas Centre BC, Vancouver, BC, Canada. drenouf@bccancer.bc.ca.ORCID 0000-0002-7597-6089
Jonathan M LoreeDivision of Medical Oncology, BC Cancer, Vancouver, BC, Canada.ORCID 0000-0001-8189-2132
Jennifer J KnoxPrincess Margaret Cancer Centre, UHN, University of Toronto, Toronto, ON, Canada.
James T TophamPancreas Centre BC, Vancouver, BC, Canada.
Petr KavanDepartment of Medicine and Oncology, Sir Mortimer B. Davis Jewish General Hospital, Segal Cancer Centre, McGill University, Montreal, QC, Canada.
Derek JonkerThe Ottawa Hospital, University of Ottawa, Ottawa, ON, Canada.
Stephen WelchLondon Regional Cancer Program, London, ON, Canada.
Felix CoutureCHU de Quebec Research Centre and Faculty of Medicine, Laval University, Quebec City, QC, Canada.
Frederic LemayFaculty of Medicine and Health Sciences, University of Sherbrooke, Sherbrooke, QC, Canada.
Mustapha TehfeHematology and Medical Oncology Division, Centre Hospitalier Universitaire de Montreal, University of Montreal, Montreal, QC, Canada.
Mohammed HarbThe Moncton City Hospital, Moncton, NB, Canada.
Nathalie AucoinHopital Cite-de-la-Sante, Laval, QC, Canada.
Yoo-Joung KoDepartment of Medicine, Sunnybrook Odette Cancer Centre, Toronto, ON, Canada.
Patricia A TangUniversity of Calgary, Calgary, AB, Canada.
Ravi RamjeesinghNova Scotia Cancer Centre and Dalhousie University, Halifax, NS, Canada.ORCID 0000-0001-5584-3505
Brandon M MeyersJuravinski Cancer Centre, Hamilton, ON, Canada.
Christina A KimCancerCare Manitoba, Winnipeg, MB, Canada.ORCID 0000-0003-3847-2583
Pan DuPredicine, Inc., Hayward, CA, USA.
Shidong JiaPredicine, Inc., Hayward, CA, USA.
David F SchaefferPancreas Centre BC, Vancouver, BC, Canada.
Sharlene GillDivision of Medical Oncology, BC Cancer, Vancouver, BC, Canada.ORCID 0000-0003-3306-3617
Dongsheng TuCanadian Cancer Trials Group, Queen's University, Kingston, ON, Canada.
Chris J O'CallaghanCanadian Cancer Trials Group, Queen's University, Kingston, ON, Canada.
Queen's University · CABausch Health (Canada) · CABC Cancer Agency · CACancerCare Manitoba · CACancer Care Ontario · CACentre Hospitalier de l’Université de Montréal · CADalhousie University · CAJewish General Hospital · CAJuravinski Cancer Centre · CAMoncton Hospital · CAPancreas Centre (Canada) · CASunnybrook Health Science Centre · CAUniversité de Sherbrooke · CAUniversité Laval · CAUniversity of British Columbia · CAUniversity of Calgary · CAUniversity of Ottawa · CAUniversity of Toronto · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Immunotherapy-based monotherapy treatment in metastatic pancreatic ductal adenocarcinoma (mPDAC) has shown limited benefit outside of the mismatch repair deficiency setting, while safety and efficacy of combining dual-checkpoint inhibitor immunotherapy with chemotherapy remains uncertain. Here, we present results from the CCTG PA.7 study (NCT02879318), a randomized phase II trial comparing gemcitabine and nab-paclitaxel with and without immune checkpoint inhibitors durvalumab and tremelimumab in 180 patients with mPDAC. The primary endpoint was overall survival. Secondary endpoints included progression-free survival and objective response rate. Results of the trial were negative as combination immunotherapy did not improve survival among the unselected patient population (p = 0.72) and toxicity was limited to elevation of lymphocytes in the combination immunotherapy group (p = 0.02). Exploratory baseline circulating tumor DNA (ctDNA) sequencing revealed increased survival for patients with KRAS wildtype tumors in both the combination immunotherapy (p = 0.001) and chemotherapy (p = 0.004) groups. These data support the utility of ctDNA analysis in PDAC and the prognostic value of ctDNA-based KRAS mutation status.

Indexed as

AdenocarcinomaPancreatic NeoplasmsAlbuminsAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsDeoxycytidineGemcitabineHumansPaclitaxelProto-Oncogene Proteins p21(ras)130-nm albumin-bound paclitaxelAlbuminsAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedDeoxycytidinedurvalumabGemcitabinePaclitaxelProto-Oncogene Proteins p21(ras)tremelimumab

Identifiers

PMID36028483
PMCPMC9418247
OpenAlexW4293109639

What OpenQuestion holds

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LicenceCC BY
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.