Evidence map›Paper›PMID 35247871›Full record

Trial reportESMO open2022

Outcomes with durvalumab after chemoradiotherapy in stage IIIA-N2 non-small-cell lung cancer: an exploratory analysis from the PACIFIC trial.

S Senan, M Özgüroğlu, D Daniel, A Villegas, D Vicente, S Murakami, R Hui, C Faivre-Finn, L Paz-Ares, Y L Wu and 3 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in ESMO open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02125461 (A Phase III, Randomised, Double-blind, Placebo-controlled, Multi-centre, International Study of MEDI4736 as Sequential Therapy in Patients With Locally Advanced, Unresectable Non-Small Cell Lung Cancer), which is not on this map. Cited by 15 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 1 pooled it
2.7field-weighted citation impact, top 9% 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.

NCT02125461 phase3completednot on this map

A Phase III, Randomised, Double-blind, Placebo-controlled, Multi-centre, International Study of MEDI4736 as Sequential Therapy in Patients With Locally Advanced, Unresectable Non-Small Cell Lung Cancer (Stage III) Who Have Not Progressed Following Definitive, Platinum-based, Concurrent Chemoradiation Therapy (PACIFIC)

TypeinterventionalSponsorAstraZenecaRan2014 to 2023Enrolled713ConditionsNon-Small Cell Lung CancerArmsMEDI4736, PLACEBO
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 1 synthesis or guideline pooled it, 21 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Management of borderline resectable NSCLC: a narrative review.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
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  7. Stage III NSCLC treatment options: too many choices.Breathe (Sheffield, England) · 2024
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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

13 authors at 13 institutions in 8 countries.

S SenanDepartment of Radiation Oncology, Amsterdam University Medical Centers, Vrije Universiteit Amsterdam, Cancer Center Amsterdam, Amsterdam, The Netherlands. Electronic address: s.senan@amsterdamumc.nl.
M ÖzgüroğluIstanbul University-Cerrahpaşa, Cerrahpaşa School of Medicine, Istanbul, Turkey.
D DanielTennessee Oncology, Chattanooga, USA; Sarah Cannon Research Institute, Nashville, USA.
A VillegasCancer Specialists of North Florida, Jacksonville, USA.
D VicenteHospital Universitario Virgen Macarena, Seville, Spain.
S MurakamiKanagawa Cancer Center, Yokohama, Japan.
R HuiWestmead Hospital and the University of Sydney, Sydney, Australia.
C Faivre-FinnThe University of Manchester and The Christie NHS Foundation Trust, Manchester, UK.
L Paz-AresUniversidad Complutense, CiberOnc, CNIO and Hospital Universitario 12 de Octubre, Madrid, Spain.
Y L WuGuangdong Lung Cancer Institute, Guangdong Provincial People's Hospital & Guangdong Academy of Medical Sciences, Guangzhou, China.
H MannAstraZeneca, Cambridge, UK.
P A DennisAstraZeneca, Gaithersburg, USA.
S J AntoniaH. Lee Moffitt Cancer Center and Research Institute, Tampa, USA.
AstraZeneca (United Kingdom) · GBAstraZeneca (United States) · USFlorida Cancer Specialists & Research Institute · USGuangdong Provincial People's Hospital · CNHospital Universitario 12 De Octubre · ESHospital Universitario Virgen Macarena · ESIstanbul University-Cerrahpaşa · TRKanagawa Cancer CenterMoffitt Cancer Center · USTennessee Oncology · USThe University of Sydney · AUUniversity of Manchester · GBVrije Universiteit Amsterdam · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe phase III PACIFIC trial (NCT02125461) established consolidation durvalumab as standard of care for patients with unresectable, stage III non-small-cell lung cancer (NSCLC) and no disease progression following chemoradiotherapy (CRT). In some cases, patients with stage IIIA-N2 NSCLC are considered operable, but the relative benefit of surgery is unclear. We report a post hoc, exploratory analysis of clinical outcomes in the PACIFIC trial, in patients with or without stage IIIA-N2 NSCLC. MATERIALS AND

methodsPatients with unresectable, stage III NSCLC and no disease progression after ≥2 cycles of platinum-based, concurrent CRT were randomized 2 : 1 to receive durvalumab (10 mg/kg intravenously; once every 2 weeks for up to 12 months) or placebo, 1-42 days after CRT. The primary endpoints were progression-free survival (PFS; assessed by blinded independent central review according to RECIST version 1.1) and overall survival (OS). Treatment effects within subgroups were estimated by hazard ratios (HRs) from unstratified Cox proportional hazards models.

resultsOf 713 randomized patients, 287 (40%) had stage IIIA-N2 disease. Baseline characteristics were similar between patients with and without stage IIIA-N2 NSCLC. With a median follow-up of 14.5 months (range: 0.2-29.9 months), PFS was improved with durvalumab versus placebo in both patients with [HR = 0.46; 95% confidence interval (CI), 0.33-0.65] and without (HR = 0.62; 95% CI 0.48-0.80) stage IIIA-N2 disease. Similarly, with a median follow-up of 25.2 months (range: 0.2-43.1 months), OS was improved with durvalumab versus placebo in patients with (HR = 0.56; 95% CI 0.39-0.79) or without (HR = 0.78; 95% CI 0.57-1.06) stage IIIA-N2 disease. Durvalumab had a manageable safety profile irrespective of stage IIIA-N2 status.

conclusionsConsistent with the intent-to-treat population, treatment benefits with durvalumab were confirmed in patients with stage IIIA-N2, unresectable NSCLC. Prospective studies are needed to determine the optimal treatment approach for patients who are deemed operable.

Indexed as

Carcinoma, Non-Small-Cell LungLung NeoplasmsAntibodies, MonoclonalChemoradiotherapyDisease ProgressionHumansAntibodies, Monoclonaldurvalumabchemotherapyimmunotherapymultimodality therapyradiation therapysurgery

Identifiers

PMID35247871
PMCPMC9058904
OpenAlexW4214935792

What OpenQuestion holds

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LicenceCC BY
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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.