Evidence map›Paper›PMID 24983373›Full record

ArticleBritish journal of cancer2014

Phase I study of capecitabine combined with radioembolization using yttrium-90 resin microspheres (SIR-Spheres) in patients with advanced cancer.

S J Cohen, A A Konski, S Putnam, D S Ball, J E Meyer, J Q Yu, I Astsaturov, C Marlow, A Dickens, D N Cade and 1 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase I
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. It is linked to trial NCT04339036 (UPCC 04219 Phase 2 Study of Capecitabine-Temozolomide), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.0field-weighted citation impact, top 23% 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.

NCT04339036 phase2recruitingnot on this mapstarted 2021, after this paper: background citation

UPCC 04219 Phase 2 Study of Capecitabine-Temozolomide(CapTem) With Yttrium-90 Radioembolization in the Treatment of Patients With Unresectable Metastatic Grade 2/3 Neuroendocrine Tumors

TypeinterventionalSponsorAbramson Cancer Center at Penn MedicineRan2021 to 2028Enrolled70ConditionsNeuroendocrine Tumor Grade 2, Neuroendocrine TumorsArmsCapecitabine Oral Product, Temozolomide Oral Product, transarterial radioembolization
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 22 citations in OpenAlex.

  1. Article
  2. Article
  3. Radioembolization in the Setting of Systemic Therapies.Seminars in interventional radiology · 2021
    Review
  4. Review
  5. 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

11 authors at 4 institutions in 2 countries.

S J CohenDepartment of Medical Oncology, Fox Chase Cancer Center, Philadelphia, Pennsylvania, USA.
A A KonskiDepartment of Radiation Oncology, Karmanos Cancer Center, Wayne State University School of Medicine, Detroit, Michigan, USA.
S PutnamDepartment of Radiology, Fox Chase Cancer Center, Philadelphia, Pennsylvania, USA.
D S BallDepartment of Radiology, Fox Chase Cancer Center, Philadelphia, Pennsylvania, USA.
J E MeyerDepartment of Radiation Oncology, Fox Chase Cancer Center, Philadelphia, Pennsylvania, USA.
J Q YuDepartment of Radiology, Fox Chase Cancer Center, Philadelphia, Pennsylvania, USA.
I AstsaturovDepartment of Medical Oncology, Fox Chase Cancer Center, Philadelphia, Pennsylvania, USA.
C MarlowClinical Trials Office, Fox Chase Cancer Center, Philadelphia, Pennsylvania, USA.
A DickensClinical Trials Office, Fox Chase Cancer Center, Philadelphia, Pennsylvania, USA.
D N CadeSirtex Medical Ltd, Sydney, New South Wales, Australia.
N J MeropolDivision of Hematology and Oncology, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center, Case Western Reserve University, Cleveland, Ohio, USA.
Fox Chase Cancer Center · USCase Western Reserve University · USSirtex (Australia) · AUThe Barbara Ann Karmanos Cancer Institute · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis was a prospective single-centre, phase I study to document the maximum tolerated dose (MTD), dose-limiting toxicity (DLT), and the recommended phase II dose for future study of capecitabine in combination with radioembolization.

methodsPatients with advanced unresectable liver-dominant cancer were enrolled in a 3+3 design with escalating doses of capecitabine (375-1000 mg/m(2) b.i.d.) for 14 days every 21 days. Radioembolization with (90)Y-resin microspheres was administered using a sequential lobar approach with two cycles of capecitabine.

resultsTwenty-four patients (17 colorectal) were enrolled. The MTD was not reached. Haematologic events were generally mild. Common grade 1/2 non-haematologic toxicities included transient transaminitis/alkaline phosphatase elevation (9 (37.5%) patients), nausea (9 (37.5%)), abdominal pain (7 (29.0%)), fatigue (7 (29.0%)), and hand-foot syndrome or rash/desquamation (7 (29.0%)). One patient experienced a partial gastric antral perforation with a capecitabine dose of 750 mg/m(2). The best response was partial response in four (16.7%) patients, stable disease in 17 (70.8%) and progression in three (12.5%). Median time to progression and overall survival of the metastatic colorectal cancer cohort was 6.4 and 8.1 months, respectively.

conclusionsThis combined modality treatment was generally well tolerated with encouraging clinical activity. Capecitabine 1000 mg/m(2) b.i.d. is recommended for phase II study with sequential lobar radioembolization.

Indexed as

AgedAged, 80 and overAntimetabolites, AntineoplasticCapecitabineCohort StudiesDeoxycytidineEmbolization, TherapeuticFemaleFluorouracilHumansMaleMaximum Tolerated DoseMicrospheresMiddle AgedNeoplasmsProspective StudiesAntimetabolites, AntineoplasticCapecitabineDeoxycytidineFluorouracilYttrium Radioisotopes

Identifiers

PMID24983373
PMCPMC4102951
OpenAlexW2054625427

What OpenQuestion holds

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LicenceCC BY-NC-SA
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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.