Evidence map›Paper›PMID 29325521›Full record

Trial reportBMC cancer2018

Adjuvant treatment of resectable biliary tract cancer with cisplatin plus gemcitabine: A prospective single center phase II study.

Alexander R Siebenhüner, Heike Seifert, Helga Bachmann, Burkhardt Seifert, Thomas Winder, Jonas Feilchenfeldt, Stefan Breitenstein, Pierre-Alain Clavien, Roger Stupp, Alexander Knuth and 2 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase II
In one paragraph

Trial report in BMC cancer, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01073839 (Adjuvant Treatment of Resectable Cholangiocellular Carcinoma), which is not on this map. Cited by 21 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 2 pooled it
4.0field-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.

NCT01073839 phase1 / phase2completednot on this map

Adjuvant Treatment of Resectable Cholangiocellular Carcinoma (CCC) With Cisplatin Plus Gemcitabine. A Prospective Single Center Phase Ib-II Study.

TypeinterventionalSponsorUniversity of ZurichRan2008 to 2015Enrolled33ConditionsCholangiocellular CarcinomaArmsCisplatin and Gemcitabine
3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 2 syntheses or guidelines pooled it, 36 citations in OpenAlex.

  1. Guideline
  2. Postoperative adjuvant chemotherapy for resectable cholangiocarcinoma.The Cochrane database of systematic reviews · 2021
    Pooled it
  3. Article
  4. Clinical vulnerability to chemotherapy in cholangiocarcinoma: impact of nutritional status, frailty, and systemic inflammation.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026
    Article
  5. Article
  6. Article
  7. Article
  8. Article
  9. Review
  10. Article
  11. Article
  12. Article
  13. Article
  14. Article
  15. Management of Intrahepatic Cholangiocarcinoma.Journal of clinical medicine · 2021
    Review
  16. Article
  17. Article
  18. Role of Adjuvant Chemotherapy in Resected T2N0 Gall Bladder Cancer.Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract · 2019
    Article
  19. Article
  20. Article
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

12 authors at 4 institutions in 2 countries.

Alexander R SiebenhünerDepartment of Medical Oncology, University Hospital Zurich, Rämistrasse 100, 8091, Zurich, CH, Switzerland. alexander.siebenhuener@usz.ch.
Heike SeifertDepartment of Medical Oncology, University Hospital Zurich, Rämistrasse 100, 8091, Zurich, CH, Switzerland.
Helga BachmannDepartment of Medical Oncology, University Hospital Zurich, Rämistrasse 100, 8091, Zurich, CH, Switzerland.
Burkhardt SeifertEpidemiology, Biostatistics and Prevention Institute, University of Zurich, Hirschengraben 84, 8001, Zurich, CH, Switzerland.
Thomas WinderDepartment of Medical Oncology, University Hospital Zurich, Rämistrasse 100, 8091, Zurich, CH, Switzerland.
Jonas FeilchenfeldtNational Center for Cancer Care and Research, Doha, Qatar.
Stefan BreitensteinDepartment of Surgery, Cantonal Hospital of Winterthur, Brauerstrasse 15, 8401, Winterthur, Switzerland.
Pierre-Alain ClavienSwiss HBP Center, University Hospital Zurich, Rämistrasse 100, 8091, Zurich, CH, Switzerland.
Roger StuppDepartment of Medical Oncology, University Hospital Zurich, Rämistrasse 100, 8091, Zurich, CH, Switzerland.
Alexander KnuthNational Center for Cancer Care and Research, Doha, Qatar.
Bernhard PestalozziDepartment of Medical Oncology, University Hospital Zurich, Rämistrasse 100, 8091, Zurich, CH, Switzerland.
Panagiotis SamarasDepartment of Medical Oncology, University Hospital Zurich, Rämistrasse 100, 8091, Zurich, CH, Switzerland.
University Hospital of Zurich · CHNational Center for Cancer Care and Research · QAKantonsspital Winterthur · CHUniversity of Zurich · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundBiliary tract cancer (BTC) is a dismal disease, even after curative intent surgery. We conducted this prospective, non-randomized phase II study to evaluate the feasibility and efficacy of cisplatin and gemcitabine as adjuvant treatment in patients with resected BTC.

methodsPatients initially received gemcitabine 1000 mg/m

resultsOverall 30 patients were enrolled in the study from August 2008 and last patient was enrolled at 2nd December 2014. The follow-up of the patients ended at 31st December 2016. The first 9 patients received single-agent gemcitabine. The interim analysis met the predefined feasibility criteria and, from September 2010 on, the second group of 21 patients received the combination of cisplatin plus gemcitabine. In the single-agent cohort with gemcitabine the median relative dose intensity (RDI) was 100% (IQR 88.3-100). Patients treated with the combination cisplatin-gemcitabine received an overall median RDI of 100% (IQR 50-100) for cisplatin and 100% (IQR 75-100) for gemcitabine respectively. The most significant non-hematological adverse events (grade 3 or 4) were fatigue (20%), infections during neutropenia (10%), and two cases of biliary sepsis (7%). Abnormal liver function was seen in 10% of the patients. One patient died due to infectious complications during treatment with cisplatin and gemcitabine. The median disease-free survival (DFS) was 14.9 months (95% CI 0-33.8) with a corresponding 3-year DFS of 43.1 ± 9.1%. The median overall survival (OS) was 40.6 months (95% CI 18.8-62.3) with a 3-year OS of 55.7 ± 9.2%. No statistically significant differences in survival were seen between the two treatment cohorts.

conclusionAdjuvant chemotherapy with gemcitabine with or without cisplatin was well tolerated and resulted in promising survival of the patients.

trial registrationThe study was retrospectively registered on 25th June 2009 at clinicaltrials.gov ( NCT01073839 ).

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsBiliary Tract NeoplasmsChemotherapy, AdjuvantCholangiocarcinomaCisplatinDeoxycytidineDisease-Free SurvivalDrug-Related Side Effects and Adverse ReactionsFemaleGemcitabineHumansMaleMiddle AgedTreatment OutcomeCisplatinDeoxycytidineGemcitabineAdjuvant chemotherapyBiliary tract cancerCholangiocellular carcinomaCisplatin and gemcitabineFeasibilityGallbladder cancer

Identifiers

PMID29325521
PMCPMC5765636
OpenAlexW2782763130

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.