Evidence map›Paper›PMID 22773551›Full record

Trial reportGut2013

Gemcitabine plus erlotinib followed by capecitabine versus capecitabine plus erlotinib followed by gemcitabine in advanced pancreatic cancer: final results of a randomised phase 3 trial of the 'Arbeitsgemeinschaft Internistische Onkologie' (AIO-PK0104).

Volker Heinemann, Ursula Vehling-Kaiser, Dirk Waldschmidt, Erika Kettner, Angela Märten, Cornelia Winkelmann, Stefan Klein, Georgi Kojouharoff, Thomas C Gauler, Ludwig Fischer von Weikersthal and 11 more

Open access · greenAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Gut, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 54 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
54citing papers in PubMed, 6 pooled it
5.9field-weighted citation impact, top 3% 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

54 citing papers in PubMed, 6 syntheses or guidelines pooled it, 120 citations in OpenAlex.

  1. Chemotherapy and radiotherapy for advanced pancreatic cancer.The Cochrane database of systematic reviews · 2024
    Pooled it
  2. Chemotherapy and radiotherapy for advanced pancreatic cancer.The Cochrane database of systematic reviews · 2018
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  15. New Therapeutic Targets in RAS Wild-type Pancreatic Cancer.Current treatment options in oncology · 2024
    Review
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  18. Three-month life expectancy as inclusion criterion for clinical trials in advanced pancreatic cancer: is it really a valid tool for patient selection?Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2024
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

21 authors at 15 institutions in 1 country.

Volker HeinemannDepartment of Internal Medicine III and Comprehensive Cancer Center, Klinikum Grosshadern, Ludwig-Maximilians University of Munich, Marchioninistr. 15, D-81377 Munich, Germany. volker.heinemann@med.uni-muenchen.de
Ursula Vehling-Kaiser
Dirk Waldschmidt
Erika Kettner
Angela Märten
Cornelia Winkelmann
Stefan Klein
Georgi Kojouharoff
Thomas C Gauler
Ludwig Fischer von Weikersthal
Michael R Clemens
Michael Geissler
Tim F Greten
Susanna Hegewisch-Becker
Oleg Rubanov
Gerold Baake
Thomas Höhler
Yon D Ko
Andreas Jung
Sascha Neugebauer
Stefan Boeck
Ludwig-Maximilians-Universität München · DEBayreuth Medical Center · DEHeidelberg University · DEJohanniter-Krankenhaus Bonn · DEKlinikum Darmstadt · DEKlinikum Esslingen · DEKlinikum Magdeburg · DEKlinikum St. Marien Amberg · DEMedizinische Hochschule Hannover · DEMSH Medical School Hamburg – University of Applied Sciences and Medical University · DEProsper Hospital · DETrier University of Applied Sciences · DEUniversity of Applied Sciences Landshut · DEUniversity of Cologne · DEUniversity of Duisburg-Essen · DE

Funding

Clinical protocols for the treatment of GI cancerZIABC011343 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI GRETEN, TIM · 2010 to 2025
$4.8M
Intramural NIH HHS Z99 CA999999
6 · The paper itself

Abstract

objectiveAIO-PK0104 investigated two treatment strategies in advanced pancreatic cancer (PC): a reference sequence of gemcitabine/erlotinib followed by 2nd-line capecitabine was compared with a reverse experimental sequence of capecitabine/erlotinib followed by gemcitabine.

methods281 patients with PC were randomly assigned to 1st-line treatment with either gemcitabine plus erlotinib or capecitabine plus erlotinib. In case of treatment failure (eg, disease progression or toxicity), patients were allocated to 2nd-line treatment with the comparator cytostatic drug without erlotinib. The primary study endpoint was time to treatment failure (TTF) after 1st- and 2nd-line therapy (TTF2; non-inferiority design). KRAS exon 2 mutations were analysed in archival tumour tissue from 173 of the randomised patients.

resultsOf the 274 eligible patients, 43 had locally advanced and 231 had metastatic disease; 140 (51%) received 2nd-line chemotherapy. Median TTF2 was estimated with 4.2 months in both arms; median overall survival was 6.2 months with gemcitabine/erlotinib followed by capecitabine and 6.9 months with capecitabine/erlotinib followed by gemcitabine, respectively (HR 1.02, p=0.90). TTF for 1st-line therapy (TTF1) was significantly prolonged with gemcitabine/erlotinib compared to capecitabine/erlotinib (3.2 vs 2.2 months; HR 0.69, p=0.0034). Skin rash was associated with both TTF2 (rash grade 0/1/2-4:2.9/4.3/6.7 months, p<0.0001) and survival (3.4/7.0/9.6 months, p<0.0001). Each arm showed a safe and manageable toxicity profile during 1st- and 2nd-line therapy. A KRAS wild-type status (52/173 patients, 30%) was associated with an improved overall survival (HR 1.68, p=0.005).

conclusionBoth treatment strategies are feasible and demonstrated comparable efficacy; KRAS may serve as biomarker in patients with advanced PC treated with erlotinib.

Indexed as

AdolescentAdultAgedAlgorithmsAntineoplastic Combined Chemotherapy ProtocolsCapecitabineDeoxycytidineErlotinib HydrochlorideFeasibility StudiesFemaleFluorouracilGemcitabineGermanyHumansMaleMiddle AgedCapecitabineDeoxycytidineErlotinib HydrochlorideFluorouracilGemcitabineQuinazolines

Identifiers

PMID22773551
PMCPMC6309814
OpenAlexW2096385798

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.