Evidence map›Paper›PMID 30944458›Full record

Trial reportBritish journal of cancer2019

Sorafenib alone vs. sorafenib plus GEMOX as 1

Eric Assenat, Georges-Philippe Pageaux, Simon Thézenas, Jean-Marie Peron, Yves Bécouarn, Jean-François Seitz, Philippe Merle, Jean-Frédéric Blanc, Olivier Bouché, Mohamed Ramdani and 4 more

Abstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in British journal of cancer, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 36 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
36citing papers in PubMed, 6 pooled it
–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

36 citing papers in PubMed, 6 syntheses or guidelines pooled it.

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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

14 authors.

Eric AssenatInstitut du Cancer de Montpellier (ICM), Université de Montpellier, Montpellier, France. eric.assenat@icm.unicancer.fr.
Georges-Philippe PageauxCentre Hospitalier Universitaire de Montpellier, Université de Montpellier, Montpellier, France.
Simon ThézenasInstitut du Cancer de Montpellier (ICM), Université de Montpellier, Montpellier, France.
Jean-Marie PeronCentre Hospitalier Universitaire de Toulouse, Toulouse, France.
Yves BécouarnBergonié Institute, Bordeaux, France.
Jean-François SeitzCentre Hospitalier Universitaire de Marseille, Marseille, France.
Philippe MerleCentre Hospitalier Universitaire de Lyon, Lyon, France.
Jean-Frédéric BlancSaint-André Hospital, Bordeaux, France.
Olivier BouchéCentre Hospitalier Universitaire de Reims, Reims, France.
Mohamed RamdaniCentre Hospitalier Universitaire de Béziers, Béziers, France.
Sylvain PoujolInstitut du Cancer de Montpellier (ICM), Université de Montpellier, Montpellier, France.
Hélène de ForgesInstitut du Cancer de Montpellier (ICM), Université de Montpellier, Montpellier, France.
Marc YchouInstitut du Cancer de Montpellier (ICM), Université de Montpellier, Montpellier, France.
Valérie BoigeGustave Roussy, Villejuif, France.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSorafenib remains one major first-line therapeutic options for advanced hepatocellular carcinoma (aHCC), with modest efficacy. We investigated the addition of gemcitabine and oxaliplatin (GEMOX) to sorafenib in aHCC patients.

methodsOur multicentre phase II trial randomised aHCC first-line patients to sorafenib (400 mg BID) or sorafenib-GEMOX every 2 weeks (1000 mg/m

resultsNinety-four patients were randomised (sorafenib-GEMOX: n = 48; sorafenib: n = 46). Median age was 64 years, PS 0 (69%) or 1 (31%), 63% patients had cirrhosis, 29% portal vein thrombosis and 70% extra-hepatic disease. Median duration of sorafenib treatment was 4 months (1-51); median number of GEMOX cycles was 7 (1-16). The 4-month PFS rates were 64% and 61% in the sorafenib-GEMOX and sorafenib arms, respectively; median PFS and OS were 6.2 (95% CI: 3.8-6.8) and 13.5 (7.5-16.2) months, and 4.6 (3.9-6.2) months and 14.8 (12.2-22.2), respectively. The ORR/DCR were 9%/70% and 15%/77% in the sorafenib-GEMOX and sorafenib alone arms, respectively. Main toxicities were (sorafenib-GEMOX/sorafenib) neutropenia (23%/0), thrombocytopenia (33%/0), diarrhoea (18%/9), peripheral neuropathy (5%/0) and hand-foot syndrome (5%/18).

conclusionsAddition of GEMOX had an inpact on ORR and was well-tolerated as frontline systemic therapy. The benefit on PFS seems moderate; no subsequent study was planned.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, HepatocellularDeoxycytidineFemaleGemcitabineHumansLiver NeoplasmsMaleMiddle AgedOxaliplatinProtein Kinase InhibitorsSorafenibDeoxycytidineGemcitabineOxaliplatinProtein Kinase InhibitorsSorafenib

Identifiers

PMID30944458
PMCPMC6734663

What OpenQuestion holds

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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.