Evidence map›Paper›PMID 23341531›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2013

Randomized phase III multi-institutional study of TNFerade biologic with fluorouracil and radiotherapy for locally advanced pancreatic cancer: final results.

Joseph M Herman, Aaron T Wild, Hao Wang, Phuoc T Tran, Kenneth J Chang, Gretchen E Taylor, Ross C Donehower, Timothy M Pawlik, Mark A Ziegler, Hongyan Cai and 9 more

Open access · bronzeAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 93 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
93citing papers in PubMed, 5 pooled it
9.9field-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.

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

93 citing papers in PubMed, 5 syntheses or guidelines pooled it, 182 citations in OpenAlex.

  1. Chemotherapy and radiotherapy for advanced pancreatic cancer.The Cochrane database of systematic reviews · 2024
    Pooled it
  2. Pooled it
  3. Pooled it
  4. Chemotherapy and radiotherapy for advanced pancreatic cancer.The Cochrane database of systematic reviews · 2018
    Pooled it
  5. Pooled it
  6. Trial
  7. Trial
  8. Trial
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  10. Trial
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  12. Review
  13. Review
  14. Four decades of adenovirus gene transfer vectors: History and current use.Molecular therapy : the journal of the American Society of Gene Therapy · 2025
    Article
  15. Current status of endoscopic ultrasound-guided antitumor treatment for pancreatic cancer.Digestive endoscopy : official journal of the Japan Gastroenterological Endoscopy Society · 2025
    Review
  16. Review
  17. Article
  18. Review
  19. Article
  20. Review

33 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

19 authors at 1 institution in 1 country.

Joseph M HermanDepartment of Radiation Oncology & Molecular Radiation Sciences, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins Hospital, 401 N. Broadway, Weinberg Suite 1440, Baltimore, MD 21231, USA. jherma15@jhmi.edu
Aaron T Wild
Hao Wang
Phuoc T Tran
Kenneth J Chang
Gretchen E Taylor
Ross C Donehower
Timothy M Pawlik
Mark A Ziegler
Hongyan Cai
Dionne T Savage
Marcia I Canto
Jason Klapman
Tony Reid
Raj J Shah
Sarah E Hoffe
Alexander Rosemurgy
Christopher L Wolfgang
Daniel A Laheru
Johns Hopkins University · US

Funding

Translational Research Central ServicesP30CA006973 · NCI · JOHNS HOPKINS UNIVERSITY · PI Rosalie Wollett · 1985 to 2026
$208.6M
NCI NIH HHS P30 CA006973
6 · The paper itself

Abstract

purposeTNFerade biologic is a novel means of delivering tumor necrosis factor alpha to tumor cells by gene transfer. We herein report final results of the largest randomized phase III trial performed to date among patients with locally advanced pancreatic cancer (LAPC) and the first to test gene transfer against this malignancy. PATIENTS AND

methodsIn all, 304 patients were randomly assigned 2:1 to standard of care plus TNFerade (SOC + TNFerade) versus standard of care alone (SOC). SOC consisted of 50.4 Gy in 28 fractions with concurrent fluorouracil (200 mg/m(2) per day continuous infusion). TNFerade was injected intratumorally before the first fraction of radiotherapy each week at a dose of 4 × 10(11) particle units by using either a percutaneous transabdominal or an endoscopic ultrasound approach. Four weeks after chemoradiotherapy, patients began gemcitabine (1,000 mg/m(2) intravenously) with or without erlotinib (100 to 150 mg per day orally) until progression or toxicity.

resultsThe analysis included 187 patients randomly assigned to SOC + TNFerade and 90 to SOC by using a modified intention-to-treat approach. Median follow-up was 9.1 months (range, 0.1 to 50.5 months). Median survival was 10.0 months for patients in both the SOC + TNFerade and SOC arms (hazard ratio [HR], 0.90; 95% CI, 0.66 to 1.22; P = .26). Median progression-free survival (PFS) was 6.8 months for SOC + TNFerade versus 7.0 months for SOC (HR, 0.96; 95% CI, 0.69 to 1.32; P = .51). Among patients treated on the SOC + TNFerade arm, multivariate analysis showed that TNFerade injection by an endoscopic ultrasound-guided transgastric/transduodenal approach rather than a percutaneous transabdominal approach was a risk factor for inferior PFS (HR, 2.08; 95% CI, 1.06 to 4.06; P = .032). The patients in the SOC + TNFerade arm experienced more grade 1 to 2 fever and chills than those in the SOC arm (P < .001) but both arms had similar rates of grade 3 to 4 toxicities (all P > .05).

conclusionSOC + TNFerade is safe but not effective for prolonging survival in patients with LAPC.

Indexed as

ChemoradiotherapyAdultAgedAntineoplastic Combined Chemotherapy ProtocolsChemotherapy, AdjuvantDeoxycytidineDisease-Free SurvivalDNADrug Administration ScheduleErlotinib HydrochlorideFemaleFluorouracilGemcitabineHumansInjections, IntralesionalKaplan-Meier EstimateDeoxycytidineDNAErlotinib HydrochlorideFluorouracilGemcitabineQuinazolinesTNFeraseBiologic

Identifiers

PMID23341531
PMCPMC4820756
OpenAlexW2130158346

What OpenQuestion holds

Textmetadata
LicenceTDM
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.