Evidence map›Paper›PMID 25290090›Full record

ArticleBritish journal of cancer2014

Bosutinib plus capecitabine for selected advanced solid tumours: results of a phase 1 dose-escalation study.

S J Isakoff, D Wang, M Campone, A Calles, E Leip, K Turnbull, N Bardy-Bouxin, L Duvillié, E Calvo

Abstract readClinical Trial, Phase IMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in British journal of cancer, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers.

0numbers the graph read from it
0cells of the map it votes in
20citing 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

20 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

9 authors.

S J IsakoffDivision of Hematology and Oncology, Massachusetts General Hospital Cancer Center, and Harvard Medical School, 55 Fruit Street, Boston, MA 02114, USA.
D WangPhase I Clinical Trials Program, Henry Ford Hospital, 2799 West Grand Boulevard, Detroit, MI 48202, USA.
M CamponeInstitut de Cancerologie de l'Quest-Rene Gauducheau, Saint Herblain, Nantes Cedex 44805, France.
A CallesSTART Madrid, Centro Integral Oncológico Clara Campal, Hospital Madrid Norte-Sanchinarro, C/Oña n°10, 28050 Madrid, Spain.
E LeipOncology Clinical Statistics, Pfizer Inc, 10 Fawcett Street, Suite 2013, Cambridge, MA 02138, USA.
K TurnbullOncology Clinical Development, Pfizer Inc, 10 Fawcett Street, Suite 2013, Cambridge, MA 02138, USA.
N Bardy-BouxinOncology Late Phase Strategy Development, Pfizer Global Research and Development, 23-25 av du Dr Lannelongue, Paris 75668, France.
L DuvilliéOncology Clinical Development, Pfizer Global Research and Development, 23-25 av du Dr Lannelongue, Paris 75668, France.
E CalvoSTART Madrid, Centro Integral Oncológico Clara Campal, Hospital Madrid Norte-Sanchinarro, C/Oña n°10, 28050 Madrid, Spain.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis phase 1 study evaluated the maximum tolerated dose (MTD), safety, and efficacy of bosutinib (competitive Src/Abl tyrosine kinase inhibitor) plus capecitabine.

methodsPatients with locally advanced/metastatic breast, pancreatic, or colorectal cancers; cholangiocarcinoma; or glioblastoma received bosutinib plus capecitabine at eight of nine possible dose combinations using an 'up-down' design to determine the toxicity contour of the combination.

resultsAmong 32 enrolled patients, none of the 9 patients receiving MTD (bosutinib 300 mg once daily plus capecitabine 1000 mg m(-2) twice daily) experienced dose-limiting toxicities (DLTs). Overall, 2 out of 31 (6%) evaluable patients experienced DLTs (grade 3 neurologic pain (n=1); grade 3 pruritus/rash and increased alanine aminotransferase (n=1)). Most common treatment-related adverse events (AEs) were diarrhoea, nausea, vomiting, palmar-plantar erythrodysesthesia (PPE), fatigue; most frequent grade 3/4 AEs: PPE, fatigue, and increased alanine/aspartate aminotransferase. Although diarrhoea was common, 91% of affected patients experienced maximum grade 1/2 events that resolved. Best overall confirmed partial response or stable disease >24 weeks (all tumour types) was observed in 6 and 13% of patients.

conclusionsIn this population of patients with advanced solid tumours, bosutinib plus capecitabine demonstrated a safety profile similar to that previously reported for bosutinib or capecitabine monotherapy; limited efficacy was observed.

Indexed as

AdultAgedAged, 80 and overAniline CompoundsAntineoplastic Combined Chemotherapy ProtocolsCapecitabineDeoxycytidineFemaleFluorouracilHumansMaleMaximum Tolerated DoseMiddle AgedNeoplasmsNeoplasm StagingNitrilesAniline CompoundsbosutinibCapecitabineDeoxycytidineFluorouracilNitrilesQuinolines

Identifiers

PMID25290090
PMCPMC4260032

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Registered trials

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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.