Evidence map›Paper›PMID 25230695›Full record

Trial reportTargeted oncology2015

Dose-finding/phase II trial: bevacizumab, immunotherapy, and chemotherapy (BIC) in metastatic renal cell cancer (mRCC). Antitumor effects and variations of circulating T regulatory cells (Treg).

M Donini, S Buti, S Lazzarelli, R Bozzetti, L Rivoltini, C Camisaschi, C Castelli, A Bearz, C Simonelli, G Lo Re and 4 more

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

Trial report in Targeted oncology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04462445 (Prospective Translational Study Investigating Possible Molecular prEdictors of Resistance to First-Line pazopanIb in Metastatic reNal Cell Carcinoma), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.0field-weighted citation impact, top 22% 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.

NCT04462445 phase2completednot on this map

Prospective Translational Study Investigating Possible Molecular prEdictors of Resistance to First-Line pazopanIb in Metastatic reNal Cell Carcinoma

TypeinterventionalSponsorFondazione IRCCS Istituto Nazionale dei Tumori, MilanoRan2015 to 2017Enrolled25ConditionsMetastatic Renal Cell CarcinomaArmsPazopanib
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 9 citations in OpenAlex.

  1. Review
  2. Article
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  5. Article
  6. Review
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

14 authors at 5 institutions in 1 country.

M DoniniOncology Division, Azienda Istituti Ospitalieri di Cremona, Viale Concordia 1, 26100, Cremona, Italy, maddalenadonini@gmail.com.
S Buti
S Lazzarelli
R Bozzetti
L Rivoltini
C Camisaschi
C Castelli
A Bearz
C Simonelli
G Lo Re
R Mattioli
C Caminiti
R Passalacqua
GOIRC (Italian Oncology Group for Clinical Research)
Istituti Ospitalieri di Cremona · ITCentro di Riferimento Oncologico · ITFondazione IRCCS Istituto Nazionale dei Tumori · ITOspedale di Parma · ITAzienda Ospedaliera Santa Maria Degli Angeli · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The aim of this study was to explore the efficacy and toxicities of a combined regimen of bevacizumab plus immunotherapy and chemotherapy (BIC) and the circulating T regulatory cells (Treg) in metastatic renal cell cancer (mRCC). Nephrectomized mRCC patients were enrolled into a multicenter single-arm dose-finding study with five escalated dose levels of chemotherapy with intravenous gemcitabine and 5-fluorouracil associated with fixed intravenous doses of bevacizumab, subcutaneous low doses of interleukin-2, and interferon-α-2a. An expanded cohort (phase II study) was treated at the recommended dose for additional safety and efficacy information according to minimax Simon two-stage design. Blood samples for Treg were collected and evaluated by fluorescence-activated cell sorting (FACS) analysis on cycle 1. Fifty-one patients were entered to receive one of five dose levels. Median age was 58 years (male 67 %, pretreated 49 %): 15 patients were low risk according to Memorial Sloan-Kettering Cancer Center (MSKCC) criteria, while 27 and nine were respectively intermediate- and high-risk patients. More frequent grade 3 and 4 toxicities included nonfebrile neutropenia, thrombocytopenia, and fever. Among patients evaluable for response (49), 29.5 % had partial response and 37 % stable disease. Overall median time to progression and median overall survival were 8.8 and 22.67 months, respectively. We observed a rapid increase in the percentage of Treg after immunotherapy and a reduction after bevacizumab only in patient who obtained a partial response or stable disease. The BIC was feasible, well tolerated, and shown interesting activity. Further studies are needed to explore if Treg could have a role in clinical response in mRCC treated with bevacizumab.

Indexed as

Administration, IntravenousAdultAgedAged, 80 and overAngiogenesis InhibitorsAntimetabolites, AntineoplasticAntineoplastic Combined Chemotherapy ProtocolsBevacizumabCarcinoma, Renal CellCell SeparationChemotherapy, AdjuvantDeoxycytidineDisease-Free SurvivalDisease ProgressionFemaleFlow CytometryAngiogenesis InhibitorsAntimetabolites, AntineoplasticBevacizumabDeoxycytidineFluorouracilGemcitabineInterferon-alphaInterferon alpha-2Interleukin-2Recombinant Proteins

Identifiers

PMID25230695
OpenAlexW2084214039

What OpenQuestion holds

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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.