Evidence map›Paper›PMID 30488350›Full record

Trial reportTargeted oncology2018

Gemcitabine Combined with the mTOR Inhibitor Temsirolimus in Patients with Locally Advanced or Metastatic Pancreatic Cancer. A Hellenic Cooperative Oncology Group Phase I/II Study.

Vasilios Karavasilis, Epaminontas Samantas, Georgia-Angeliki Koliou, Anna Kalogera-Fountzila, George Pentheroudakis, Ioannis Varthalitis, Helena Linardou, Grigorios Rallis, Maria Skondra, Georgios Papadopoulos and 7 more

Abstract readClinical Trial, Phase IClinical Trial, Phase IIMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Targeted oncology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 1 pooled it
1.0field-weighted citation impact, top 19% 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

16 citing papers in PubMed, 1 synthesis or guideline pooled it, 27 citations in OpenAlex.

  1. Pooled it
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  3. Review
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  6. Article
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  10. Article
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  12. Review
  13. KRAS mutation in pancreatic cancer.Seminars in oncology · 2021
    Review
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  15. Article
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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

17 authors at 9 institutions in 1 country.

Vasilios KaravasilisDepartment of Medical Oncology, Papageorgiou Hospital, School of Health Sciences, Faculty of Medicine, Aristotle University of Thessaloniki, Thessaloniki, Greece. karavasv@auth.gr.
Epaminontas SamantasThird Department of Medical Oncology, Agii Anargiri Cancer Hospital, Athens, Greece.
Georgia-Angeliki KoliouSection of Biostatistics, Hellenic Cooperative Oncology Group, Athens, Greece.
Anna Kalogera-FountzilaDepartment of Radiology, AHEPA Hospital, School of Health Sciences, Faculty of Medicine, Aristotle University of Thessaloniki, Thessaloniki, Greece.
George PentheroudakisDepartment of Medical Oncology, Ioannina University Hospital, Ioannina, Greece.
Ioannis VarthalitisOncology Department, General Hospital of Chania, Crete, Greece.
Helena LinardouFirst Department of Medical Oncology, Metropolitan Hospital, Piraeus, Greece.
Grigorios RallisDepartment of Medical Oncology, Papageorgiou Hospital, School of Health Sciences, Faculty of Medicine, Aristotle University of Thessaloniki, Thessaloniki, Greece.
Maria SkondraOncology Section, Second Department of Internal Medicine, Hippokration Hospital, Athens, Greece.
Georgios PapadopoulosDepartment of Radiology, AHEPA Hospital, School of Health Sciences, Faculty of Medicine, Aristotle University of Thessaloniki, Thessaloniki, Greece.
George PapatsibasOncology Department, University General Hospital of Larissa, Larissa, Greece.
Joseph SgourosThird Department of Medical Oncology, Agii Anargiri Cancer Hospital, Athens, Greece.
Athina GoudopoulouDepartment of Pharmacovigilance, Hellenic Cooperative Oncology Group, Athens, Greece.
Konstantine T KalogerasTranslational Research Section, Hellenic Cooperative Oncology Group, Athens, Greece.
Christos DervenisFirst Department of Surgery, General Hospital Konstantopouleio Agia Olga, Athens, Greece.
Dimitrios PectasidesOncology Section, Second Department of Internal Medicine, Hippokration Hospital, Athens, Greece.
George FountzilasLaboratory of Molecular Oncology, Hellenic Foundation for Cancer Research/Aristotle University of Thessaloniki, Thessaloniki, Greece.
Aristotle University of Thessaloniki · GRHellenic Cooperative Oncology Group · GRHippocration General Hospital · GRHospital Agioi Anargyroi · GRAgia Olga Hospital · GRChania General Hospital ”St. George” · GRMetropolitan Hospital · GRUniversity Hospital of Ioannina · GRUniversity Hospital of Larissa · GR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe prognosis of patients with advanced pancreatic cancer is dismal, and there is a need for novel and effective treatments.

objectivesTο determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of a novel gemcitabine (G) and temsirolimus (T) combination (phase I) and estimate the 6-month progression-free survival (PFS) in patients treated with the T + G combination (phase II). PATIENTS AND

methodsEligible patients with histologically confirmed inoperable or metastatic pancreatic carcinoma (MPC) were entered into the trial. G was given bi-weekly and T weekly in a 4-week cycle. The first dose level was set at G 800 mg/m

resultsThirty patients were enrolled in the phase I component at the pre-planned six dose levels; one bilirubin DLT of grade III occurred at the first dose level. The MTD was established as the approved doses of both drugs. Fifty-five patients were entered into the phase II component. Median relative dose intensities administered in the first cycle were 0.75 for T and 0.99 for G. Grade 3-4 hematological toxicities were recorded in 87.3% of patients. The most common non-hematological adverse events were metabolic disorders (81.8%) followed by gastrointestinal disorders (63.6%). Median PFS was 2.69 months (95% CI 1.74-4.95) and median OS was 4.95 months (95% CI 3.54-6.85), while the 6-month PFS rate was 30.9%.

conclusionsCombination of G and T is feasible in patients with locally advanced or MPC with manageable side effects, but lacks clinical efficacy. The study was registered in the Australian New Zealand Clinical Trials Registry (ACTRN12611000643976).

Indexed as

AdultAgedAged, 80 and overAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsDeoxycytidineFemaleGemcitabineHumansMaleMiddle AgedNeoplasm MetastasisPancreatic NeoplasmsSirolimusAntineoplastic AgentsDeoxycytidineGemcitabineSirolimustemsirolimus

Identifiers

PMID30488350
OpenAlexW2902345163

What OpenQuestion holds

Textmetadata
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.