Evidence map›Paper›PMID 31464635›Full record

ArticleJournal of translational medicine2019

Second line therapy with axitinib after only prior sunitinib in metastatic renal cell cancer: Italian multicenter real world SAX study final results.

Gaetano Facchini, Sabrina Rossetti, Massimiliano Berretta, Carla Cavaliere, Sarah Scagliarini, Maria Giuseppa Vitale, Chiara Ciccarese, Giuseppe Di Lorenzo, Erica Palesandro, Vincenza Conteduca and 28 more

Abstract readMulticenter Study
In one paragraph

Article in Journal of translational medicine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
–field-weighted citation impact
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

12 citing papers in PubMed.

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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

38 authors.

Gaetano FacchiniDepartmental Unit of Clinical and Experimental Uro-Andrologic Oncology, Istituto Nazionale Tumori-IRCCS-Fondazione G. Pascale, Via M. Semmola, 80131, Napoli, Italy. g.facchini@istitutotumori.na.it.ORCID 0000-0002-7430-001X
Sabrina RossettiDepartmental Unit of Clinical and Experimental Uro-Andrologic Oncology, Istituto Nazionale Tumori-IRCCS-Fondazione G. Pascale, Via M. Semmola, 80131, Napoli, Italy.
Massimiliano BerrettaDepartment of Medical Oncology, Centro di Riferimento Oncologico, Istituto Nazionale Tumori CRO, Aviano, PN, Italy.
Carla CavaliereUOC of Medical Oncology ASL NA 3 SUD Ospedali Riuniti Area Nolana, Naples, Italy.
Sarah ScagliariniDivision of Oncology, Azienda Ospedaliera di Rilievo Nazionale A. Cardarelli, Naples, Italy.
Maria Giuseppa VitaleDivision of Medical Oncology, Azienda Ospedaliera Universitaria Policlinico di Modena, Modena, Italy.
Chiara CiccareseMedical Oncology, Azienda Ospedaliera Universitaria Integrata, University of Verona, Verona, Italy.
Giuseppe Di LorenzoDepartment of Clinical Medicine and Surgery, Università degli Studi di Napoli Federico II, Naples, Italy.
Erica PalesandroDivision of Medical Oncology, Candiolo Cancer Institute-FPO, IRCCS, Candiolo, Italy.
Vincenza ConteducaDepartment of Oncology, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.), Meldola, Italy.
Umberto BassoMedical Oncology Unit 1, Istituto Oncologico Veneto IOV IRCCS, Padua, Italy.
Emanuele NaglieriDivision of Medical Oncology, Istituto Oncologico Giovanni Paolo II, Bari, Italy.
Azzurra FarnesiUniversity Hospital of Pisa, Oncology Unit 2, Pisa, Pisa, Italy.
Michele AietaMedical Oncology Department, National Institute of Cancer, Rionero in Vulture, Italy.
Nicolò BorsellinoMedical Oncology Unit, "Buccheri-La Ferla" Hospital, Palermo, Italy.
Leonardo La TorreMedical Oncology Department, "Santa Maria della Scaletta" Hospital AUSL, Imola, Italy.
Gelsomina IovaneDepartmental Unit of Clinical and Experimental Uro-Andrologic Oncology, Istituto Nazionale Tumori-IRCCS-Fondazione G. Pascale, Via M. Semmola, 80131, Napoli, Italy.
Lucia BonomiOncology Department, Ospedale Papa Giovanni XXIII, Bergamo, Italy.
Donatello GasparroCivil Hospital, Parma, Italy.
Enrico RicevutoS. Salvatore Hospital, ASL1 Abruzzo, University of L'Aquila, L'Aquila, Italy.
Michele De TursiOncology and Experimental Medicine, "G. D'Annunzio" University, Chieti, Italy.
Rocco De VivoOspedale San Bortolo di Vicenza, Vincenza, Italy.
Giovanni Lo ReNCI Aviano, Oncology Pordenone-S.Vito, Pordenone, Italy.
Francesco GrilloneMedical Oncology Unit Azienda Ospedaliera "Mater Domini", Catanzaro, Italy.
Paolo MarchettiOspedale Sant' Andrea Oncology, Roma, Italy.
Ferdinando De VitaDivision of Medical Oncology, University of Campania "L. Vanvitelli", Napoli, Italy.
Claudio ScavelliMedical Oncology Unit, "S. Cuore di Gesù" Hospital, Gallipoli, Italy.
Claudio SiniOncologia Medica ASL 2, Olbia, Italy.
Salvatore PiscontiMedical Oncology Unit, POC SS Annunziata, Taranto, Italy.
Anna CrispoDepartmental Unit of Clinical and Experimental Uro-Andrologic Oncology, Istituto Nazionale Tumori-IRCCS-Fondazione G. Pascale, Via M. Semmola, 80131, Napoli, Italy.
Vittorio GebbiaMedical Oncology Unit, La Maddalena Clinic for Cancer, University of Palermo, Palermo, Italy.
Antonio MaestriMedical Oncology Department, "Santa Maria della Scaletta" Hospital AUSL, Imola, Italy.
Luca GalliUniversity Hospital of Pisa, Oncology Unit 2, Pisa, Pisa, Italy.
Ugo De GiorgiDepartment of Oncology, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.), Meldola, Italy.
Roberto IacovelliMedical Oncology, Azienda Ospedaliera Universitaria Integrata, University of Verona, Verona, Italy.
Carlo BuonerbaDepartment of Clinical Medicine and Surgery, Università degli Studi di Napoli Federico II, Naples, Italy.
Giacomo CartenìDivision of Oncology, Azienda Ospedaliera di Rilievo Nazionale A. Cardarelli, Naples, Italy.
Carmine D'AnielloDivision of Medical Oncology, AORN Dei Colli "Ospedali Monaldi-Cotugno-CTO", Napoli, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis multi-institutional retrospective real life study was conducted in 22 Italian Oncology Centers and evaluated the role of Axitinib in second line treatment in not selected mRCC patients.

methods148 mRCC patients were evaluated. According to Heng score 15.5%, 60.1% and 24.4% of patients were at poor risk, intermediate and favorable risk, respectively.

resultsPFS, OS, DCR and ORR were 7.14 months, 15.5 months, 70.6% and 16.6%, respectively. The duration of prior sunitinib treatment correlated with a longer significant mPFS, 8.8 vs 6.3 months, respectively. Axitinib therapy was safe, without grade 4 adverse events. The most frequent toxicities of all grades were: fatigue (50%), hypertension (26%), and hypothyroidism (18%). G3 blood pressure elevation significantly correlated with longer mPFS and mOS compared to G1-G2 or no toxicity. Dose titration (DT) to 7 mg and 10 mg bid was feasible in 24% with no statistically significant differences in mPFS and mOS. The sunitinib-axitinib sequence was safe and effective, the mOS was 41.15 months. At multivariate analysis, gender, DCR to axitinib and to previous sunitinib correlated significantly with PFS; whereas DCR to axitinib, nephrectomy and Heng score independently affected overall survival.

conclusionsAxitinib was effective and safe in a not selected real life mRCC population. Trial registration INT - Napoli - 11/16 oss. Registered 20 April 2016. http://www.istitutotumori.na.it.

Indexed as

AdultAgedAged, 80 and overAxitinibCarcinoma, Renal CellDisease-Free SurvivalFemaleHumansKaplan-Meier EstimateKidney NeoplasmsMaleMiddle AgedMultivariate AnalysisNeoplasm MetastasisSunitinibAxitinibSunitinibAxitinibMetastaticRenal cancerSunitinibTreatment

Identifiers

PMID31464635
PMCPMC6716812

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