Evidence map›Paper›PMID 30374686›Full record

Trial reportInternational journal of clinical oncology2019

The combination of bevacizumab/temsirolimus after first-line anti-VEGF therapy in advanced renal-cell carcinoma: a clinical and biomarker study.

Aristotelis Bamias, Vasilios Karavasilis, Nikolaos Gavalas, Kimon Tzannis, Epaminontas Samantas, Gerasimos Aravantinos, Angelos Koutras, Ioannis Gkerzelis, Euthymios Kostouros, Konstantinos Koutsoukos and 3 more

Registry-linked trialAbstract readClinical Trial, Phase II
PubMed Publisher
In one paragraph

Trial report in International journal of clinical oncology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01264341 (Phase II Study of Efficacy and Safety of Bevacizumab in Combination With Temsirolimus, After 1st Line Anti-VEGF Treatment in Patients With Advanced Renal Cancer), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.4field-weighted citation impact, top 33% 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.

NCT01264341 phase2terminatednot on this map

Phase II Study of Efficacy and Safety of Bevacizumab in Combination With Temsirolimus, After 1st Line Anti-VEGF Treatment in Patients With Advanced Renal Cancer

TypeinterventionalSponsorHellenic Cooperative Oncology GroupRan2010 to 2015Enrolled39ConditionsKidney CancerArmsBevacizumab, Temsirolimus
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 6 citations in OpenAlex.

  1. Article
  2. Review
  3. Review
  4. 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

13 authors at 7 institutions in 1 country.

Aristotelis BamiasDepartment of Clinical Therapeutics, Alexandra Hospital, National and Kapodistrian University of Athens, 80 Vas. Sofias Ave, 115 28, Athens, Greece. abamias@med.uoa.gr.
Vasilios KaravasilisDepartment of Medical Oncology, Papageorgiou Hospital, School of Health Sciences, Faculty of Medicine, Aristotle University of Thessaloniki, Thessaloníki, Greece.
Nikolaos GavalasDepartment of Clinical Therapeutics, Alexandra Hospital, National and Kapodistrian University of Athens, 80 Vas. Sofias Ave, 115 28, Athens, Greece. ngavalas@med.uoa.gr.
Kimon TzannisDepartment of Clinical Therapeutics, Alexandra Hospital, National and Kapodistrian University of Athens, 80 Vas. Sofias Ave, 115 28, Athens, Greece.
Epaminontas SamantasThird Department of Medical Oncology, Agii Anargiri Cancer Hospital, Athens, Greece.
Gerasimos AravantinosDepartment of Medical Oncology, Agii Anargiri Cancer Hospital, Athens, Greece.
Angelos KoutrasDivision of Oncology, Department of Medicine, University Hospital, University of Patras Medical School, Patras, Greece.
Ioannis GkerzelisDepartment of Urology, General Hospital Konstantopouleio Agia Olga, Athens, Greece.
Euthymios KostourosDepartment of Clinical Therapeutics, Alexandra Hospital, National and Kapodistrian University of Athens, 80 Vas. Sofias Ave, 115 28, Athens, Greece.
Konstantinos KoutsoukosDepartment of Clinical Therapeutics, Alexandra Hospital, National and Kapodistrian University of Athens, 80 Vas. Sofias Ave, 115 28, Athens, Greece.
Flora ZagouriDepartment of Clinical Therapeutics, Alexandra Hospital, National and Kapodistrian University of Athens, 80 Vas. Sofias Ave, 115 28, Athens, Greece.
George FountzilasLaboratory of Molecular Oncology, Hellenic Foundation for Cancer Research/Aristotle University of Thessaloniki, Thessaloníki, Greece.
Meletios-Athanasios DimopoulosDepartment of Clinical Therapeutics, Alexandra Hospital, National and Kapodistrian University of Athens, 80 Vas. Sofias Ave, 115 28, Athens, Greece.
National and Kapodistrian University of Athens · GRAlexandra Hospital · GRHospital Agioi Anargyroi · GRAgia Olga Hospital · GRAristotle University of Thessaloniki · GRPapageorgiou General Hospital · GRUniversity of Patras · GR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundVascular endothelial growth factor (VEGF) targeting represents the standard first-line therapy for metastatic renal-cell carcinoma (mRCC), while blocking the mammalian target of rapamycin (mTOR) is effective in relapsed disease. Since continuing blockade of VEGF may be of value, we studied the combination of bevacizumab with temsirolimus in mRCC patients relapsing after first-line treatment.

methodsA prospective, phase II study of the combination of bevacizumab (10 mg/kg, every 2 weeks) with temsirolimus (25 mg weekly) in patients with mRCC who failed first-line anti-VEGF treatment. 6-month progression-free survival (PFS) rate was the primary end point. The association of VEGFa, VEGFR2, fibroblast growth factor (FGF) b, platelet-derived growth factor receptor (PDGFR) a and PDGFRb with prognostic factors and outcomes were also studied.

results39 patients were enrolled. First-line therapy included: sunitinib (n = 16), bevacizumab/interferon (n = 12), pazopanib (n = 10), sorafenib (n = 1). After a median follow-up of 37 months, 6-month PFS rate was 50.9% [95% confidence interval (CI) 33.8-65.7], median time to progression 6.8 months (95% CI 5.5-9.2) and median overall survival (OS) 18.2 months (95% CI 12.9-27.2). Objective response rate was 27%. The most common AEs were metabolic (33%), renal (8%) and gastrointestinal (GI) (7%). The most common grade 3-5 AEs were GI (18%), infections (14%) and metabolic (25%). Toxicity was the most frequent cause of treatment discontinuation (40%). FGFb levels were associated with OS.

conclusionsIn concert with recent data, our study confirms the efficacy of anti-VEGF/anti-mTOR combination in mRCC relapsing after anti-VEGF therapy. Toxicity was considerable leading to high rate of treatment discontinuations.

trial registrationClinicalTrials.gov: NCT01264341.

Indexed as

AdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsBevacizumabBiomarkers, TumorCarcinoma, Renal CellHumansIndazolesKidney NeoplasmsMiddle AgedNeoplasm Recurrence, LocalProspective StudiesPyrimidinesSirolimusSorafenibBevacizumabBiomarkers, TumorIndazolesMTOR protein, humanpazopanibPyrimidinesSirolimusSorafenibSulfonamidesSunitinibtemsirolimusTOR Serine-Threonine KinasesVascular Endothelial Growth Factor AVEGFA protein, humanBevacizumabFGFMetastaticRenal cancerSecond-line, temsirolimus

Identifiers

PMID30374686
OpenAlexW2898702642

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.