Evidence map›Paper›PMID 35970013›Full record

Trial reportESMO open2022

Prognostic and predictive value of CA 19-9 in locally advanced pancreatic cancer treated with multiagent induction chemotherapy: results from a prospective, multicenter phase II trial (NEOLAP-AIO-PAK-0113).

I Hartlapp, D Valta-Seufzer, J T Siveke, H Algül, E Goekkurt, G Siegler, U M Martens, D Waldschmidt, U Pelzer, M Fuchs and 12 more

Erratum issued Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
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. An erratum has been issued. It is linked to trial NCT02125136 (Prospective Randomized Multicenter Phase II Trial to Investigate Intensified Neoadjuvant Chemotherapy in Locally Advanced Pancreatic Cancer), which is not on this map. Cited by 26 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 1 pooled it
3.0field-weighted citation impact, top 7% 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.

NCT02125136 phase2completednot on this map

Prospective Randomized Multicenter Phase II Trial to Investigate Intensified Neoadjuvant Chemotherapy in Locally Advanced Pancreatic Cancer

TypeinterventionalSponsorAIO-Studien-gGmbHRan2014 to 2020Enrolled168ConditionsDuctal Adenocarcinoma of the PancreasArmsGem/nab-Pac, FOLFIFINOX
3 · Its place in the literature

Who cites it

26 citing papers in PubMed, 1 synthesis or guideline pooled it, 33 citations in OpenAlex.

  1. Pooled it
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  8. Strategy for early diagnosis of pancreatic cancer.Frontiers in gastroenterology (Lausanne, Switzerland) · 2026
    Review
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  13. Efficacy of compression therapy for prevention of peripheral neuropathy caused by taxane-based chemotherapy: a single-center retrospective observational study.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2025
    Observational
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

22 authors at 16 institutions in 1 country.

I HartlappDepartment of Internal Medicine II, Medical Oncology and Comprehensive Cancer Center Mainfranken, University Hospital Würzburg, Würzburg, Germany.
D Valta-SeufzerDepartment of Internal Medicine II, Medical Oncology and Comprehensive Cancer Center Mainfranken, University Hospital Würzburg, Würzburg, Germany.
J T SivekeDepartment of Medical Oncology, Bridge Institute of Experimental Tumor Therapy, University Medicine Essen, Essen, Germany; Division of Solid Tumor Translational Oncology (DKTK Partner Site Essen, DKFZ Heidelberg), West German Cancer Center, University Medicine Essen, Essen, Germany.
H AlgülComprehensive Cancer Center Munich (CCCM(TUM)) at the Klinikum rechts der Isar, Department of Internal Medicine II, Technical University Munich, Munich, Germany.
E GoekkurtHämatologisch-Onkologische Praxis Eppendorf (HOPE), Hamburg and University Cancer Center Hamburg (UCCH), Hamburg, Germany.
G SieglerDepartment of Internal Medicine 5, Hematology and Medical Oncology, Paracelsus Medical University, Nürnberg, Germany.
U M MartensDepartment of Internal Medicine III, SLK-Clinics Heilbronn GmbH, Heilbronn, Germany.
D WaldschmidtDepartment of Gastroenterology and Hepatology, University Hospital Cologne, Cologne, Germany.
U PelzerDivision of Oncology and Hematology, Charité Campus Mitte, Charité - Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Berlin, Germany.
M FuchsClinic for Gastroenterology, Hepatology and GI-Oncology, München Klinik Bogenhausen, Munich, Germany.
F KullmannDepartment of Internal Medicine I, Kliniken Nordoberpfalz AG, Klinikum Weiden, Weiden, Germany.
S BoeckDepartment of Medical Oncology and Comprehensive Cancer Center, Ludwig Maximilians University-Grosshadern, Munich, Germany.
T J EttrichDepartment of Internal Medicine I, Ulm University Hospital, Ulm, Germany.
S HeldDepartment of Biometrics, ClinAssess GmbH, Leverkusen, Germany.
R KellerClinical Research, AIO Studien gGmbH, Berlin, Germany.
F AngerDepartment of General, Visceral, Transplantation, Vascular and Pediatric Surgery and Comprehensive Cancer Center Mainfranken Würzburg, University Hospital Würzburg, Würzburg, Germany.
C T GermerDepartment of General, Visceral, Transplantation, Vascular and Pediatric Surgery and Comprehensive Cancer Center Mainfranken Würzburg, University Hospital Würzburg, Würzburg, Germany.
A StangDepartment of Haematology, Oncology and Palliative Care Medicine, Asklepios Hospital Barmbek, Hamburg, Germany.
B KimmelDepartment of Internal Medicine II, Medical Oncology and Comprehensive Cancer Center Mainfranken, University Hospital Würzburg, Würzburg, Germany.
V HeinemannDepartment of Medical Oncology and Comprehensive Cancer Center, Ludwig Maximilians University-Grosshadern, Munich, Germany.
V KunzmannDepartment of Internal Medicine II, Medical Oncology and Comprehensive Cancer Center Mainfranken, University Hospital Würzburg, Würzburg, Germany. Electronic address: kunzmann_v@ukw.de.
German Pancreatic Cancer Group (AIO-PAK) and NEOLAP investigators
Comprehensive Cancer Center Mainfranken · DELudwig-Maximilians-Universität München · DEUniversitätsklinikum Würzburg · DEAIO Studien gGmbH · DEAsklepios Klinik Barmbek · DECharité - Universitätsmedizin Berlin · DEClinAssess (Germany) · DEHeidelberg University · DEKlinikum rechts der Isar · DEKlinikum Weiden · DEMünchen Klinik Bogenhausen · DEParacelsus Medizinische Privatuniversität · DESLK-Kliniken Heilbronn · DEUniversity Cancer Center Hamburg · DEUniversity Hospital Cologne · DEUniversity Hospital Ulm · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe prognostic and predictive value of carbohydrate antigen 19-9 (CA 19-9) in locally advanced pancreatic cancer (LAPC) has not yet been defined from prospective randomized controlled trials (RCTs). PATIENTS AND

methodsA total of 165 LAPC patients were treated within the NEOLAP RCT for 16 weeks with multiagent induction chemotherapy [ICT; either nab-paclitaxel/gemcitabine alone or nab-paclitaxel/gemcitabine followed by FOLFIRINOX (combination of fluorouracil, leucovorin, irinotecan, and oxaliplatin)] followed by surgical exploration of all patients without evidence of disease progression. CA 19-9 was determined at baseline and after ICT and correlated with overall survival (OS) and secondary R0 resection rate.

resultsFrom the NEOLAP study population (N = 165) 133 patients (81%) were evaluable for CA 19-9 at baseline and 81/88 patients (92%) for post-ICT CA 19-9 response. Median OS (mOS) in the CA 19-9 cohort (n = 133) was 16.2 months [95% confidence interval (CI) 13.0-19.4] and R0 resection (n = 31; 23%) was associated with a significant survival benefit [40.8 months (95% CI 21.7-59.8)], while R1 resected patients (n = 14; 11%) had no survival benefit [14.0 (95% CI 11.7-16.3) months, hazard ratio (HR) 0.27; P = 0.001]. After ICT most patients showed a CA 19-9 response (median change from baseline: -82%; relative decrease ≥55%: 83%; absolute decrease to ≤50 U/ml: 43%). Robust CA 19-9 response (decrease to ≤50U/ml) was significantly associated with mOS [27.8 (95% CI 18.4-37.2) versus 16.5 (95% CI 11.7-21.2) months, HR 0.49; P = 0.013], whereas CA 19-9 baseline levels were not prognostic for OS. Multivariate analysis demonstrated that a robust CA 19-9 response was an independent predictive factor for R0 resection. Using a CA 19-9 decrease to ≤61 U/ml as optimal cut-off (by receiver operating characteristic analysis) yielded 72% sensitivity and 62% specificity for successful R0 resection, whereas CA 19-9 nonresponders (<20% decrease or increase) had no chance for successful R0 resection.

conclusionsCA 19-9 response after multiagent ICT provides relevant prognostic and predictive information and is useful in selecting LAPC patients for explorative surgery. CLINICAL TRIAL NUMBER: ClinicalTrials.govNCT02125136; https://clinicaltrials.gov/ct2/show/NCT02125136; EudraCT 2013-004796-12; https://www.clinicaltrialsregister.eu/ctr-search/trial/2013-004796-12/results.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsCA-19-9 AntigenPancreatic NeoplasmsHumansPrognosisProspective StudiesCA-19-9 AntigenCA 19-9locally advanced pancreatic cancermultiagent induction chemotherapyNEOLAPR0 resection rate

Identifiers

PMID35970013
PMCPMC9434418
OpenAlexW4290960434

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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.