Evidence map›Paper›PMID 26554651›Full record

ArticleBritish journal of cancer2015

A phase I combination dose-escalation study of eribulin mesylate and gemcitabine in patients with advanced solid tumours: a study of the Princess Margaret Consortium.

S Lheureux, A M Oza, S A Laurie, R Halford, D Jonker, E Chen, D Keller, V Bourade, L Wang, L Doyle and 2 more

Open access · hybridAbstract readClinical Trial, Phase I
PubMed Full text at PMC Publisher
In one paragraph

Article in British journal of cancer, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.9field-weighted citation impact, top 24% 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.

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

3 citing papers in PubMed, 15 citations in OpenAlex.

  1. Efficacy of Eribulin Plus Gemcitabine Combination in L-Sarcomas.International journal of molecular sciences · 2022
    Article
  2. Review
  3. 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

12 authors at 2 institutions in 2 countries.

S LheureuxDepartment of Medical Oncology, Princess Margaret Cancer Centre, Toronto, ON, Canada M5G2M9.
A M OzaDepartment of Medical Oncology, Princess Margaret Cancer Centre, Toronto, ON, Canada M5G2M9.
S A LaurieDepartment of Medical Oncology, The Ottawa Hospital Cancer Centre, Ottawa, ON, Canada K1H8M5.
R HalfordDepartment of Medical Oncology, Princess Margaret Cancer Centre, Toronto, ON, Canada M5G2M9.
D JonkerDepartment of Medical Oncology, The Ottawa Hospital Cancer Centre, Ottawa, ON, Canada K1H8M5.
E ChenDepartment of Medical Oncology, Princess Margaret Cancer Centre, Toronto, ON, Canada M5G2M9.
D KellerDepartment of Medical Oncology, The Ottawa Hospital Cancer Centre, Ottawa, ON, Canada K1H8M5.
V BouradeDepartment of Medical Oncology, The Ottawa Hospital Cancer Centre, Ottawa, ON, Canada K1H8M5.
L WangDepartment of Medical Oncology, Princess Margaret Cancer Centre, Toronto, ON, Canada M5G2M9.
L DoyleCTEP, National Cancer Institute, Bethesda, MD 20892, USA.
L L SiuDepartment of Medical Oncology, Princess Margaret Cancer Centre, Toronto, ON, Canada M5G2M9.
R GoelDepartment of Medical Oncology, The Ottawa Hospital Cancer Centre, Ottawa, ON, Canada K1H8M5.
Ottawa Hospital · CANational Cancer Institute · US

Funding

NCI NIH HHS HHSN261201100032C
6 · The paper itself

Abstract

backgroundEribulin mesylate is a synthetic microtubule inhibitor that showed cytotoxic synergy in combination with gemcitabine preclinically. This combination was assessed in a Phase I dose-finding trial in patients diagnosed with advanced solid tumours who had received up to two prior chemotherapy regimens for metastatic disease (CP cohort).

methodsDose escalation was performed in a 3+3 design to identify the recommended phase II dose (RP2D). Two additional expansion cohorts in women with gynaecologic cancers at the RP2D (G), and further dose escalation of metastatic chemotherapy-naive patients (CN), were evaluated.

results45 patients were treated: 21 (CP), 10 (G) and 14 (CN). The initial combination of eribulin and gemcitabine was administered on days 1, 8, and 15 of a 28-day cycle; however, due to 2 out of 6 dose-limiting haematological toxicities at the first dose level, a reduced dose-intense schedule was assessed. The RP2D was defined at 1.0 mg m(-2) eribulin and 1000 mg m(-2) gemcitabine day 1 and 8 q3 weeks. No other significant toxicities were observed in the G expansion cohort. Neutropenia prevented further dose escalation in the CN cohort. Objective responses were seen in all three cohorts - 2/21 (CP), 1/10 (G) and 2/14 (CN).

conclusionsThe combination of eribulin and gemcitabine was well tolerated at the RP2D.

Indexed as

AdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsDeoxycytidineDisease-Free SurvivalEndometrial NeoplasmsFemaleFuransGemcitabineHumansKetonesMaleMiddle AgedNeoplasm MetastasisNeoplasmsDeoxycytidineeribulinFuransGemcitabineKetonesPolyether Polyketides

Identifiers

PMID26554651
PMCPMC4705880
OpenAlexW2131784126

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-SA
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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.