Evidence map›Paper›PMID 28632730›Full record

Trial reportBritish journal of cancer2017

Phase 2 study of combination SPI-1620 with docetaxel as second-line advanced biliary tract cancer treatment.

Richard Kim, E Gabriela Chiorean, Manik Amin, Caio Max S Rocha-Lima, Jitendra Gandhi, William P Harris, Tao Song, David Portnoy

Open access · hybridAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in British journal of cancer, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
2.5field-weighted citation impact, top 11% 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

8 citing papers in PubMed, 16 citations in OpenAlex.

  1. Trial
  2. Endothelin and the tumor microenvironment: a finger in every pie.Clinical science (London, England : 1979) · 2024
    Review
  3. Review
  4. Combination Therapies for Advanced Biliary Tract Cancer.Journal of clinical and translational hepatology · 2023
    Review
  5. Cholangiocarcinoma: State of the Art.Journal of gastrointestinal cancer · 2020
    Review
  6. Review
  7. Article
  8. Crystal structures of human ETNature communications · 2018
    Article
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

8 authors at 6 institutions in 1 country.

Richard KimDepartment of Gastrointestinal Oncology, H. Lee Moffitt Cancer Center &Research Institute, 12902 Magnolia Drive FOB-2, Tampa, FL 33612, USA.
E Gabriela ChioreanDivision of Oncology, Department of Medicine, University of Washington, 825 Eastlake Avenue E, G4-833, Seattle, WA 98109-1023, USA.
Manik AminDivision of Medical Oncology, Department of Medicine, Washington University School of Medicine, 5225 Midamerica Plaza, St Louis, MO 63129, USA.
Caio Max S Rocha-LimaAssociate Cancer Center Director for Translational Research, Gibbs Cancer Center &Research Institute, 380 Serpentine Drive, Suite 200, Spartanburg, SC 29303, USA.
Jitendra GandhiAssociates in Oncology &Hematology, 2205 McCallie Avenue, Suite 502, Chattanooga, TN 37404, USA.
William P HarrisDivision of Oncology, Department of Medicine, University of Washington, 825 Eastlake Avenue E, G4-833, Seattle, WA 98109-1023, USA.
Tao SongAssociate Director of Biostatistics, Spectrum Pharmaceuticals Inc., 157 Technology Drive, Irvine, CA 92618, USA.
David PortnoyWest Cancer Center, 7945 Wolf River Boulevard, Memphis, TN 38138, USA.
University of Washington · USHematology Oncology Associates · USMoffitt Cancer Center · USSpectrum Pharmaceuticals (United States) · USWashington University in St. Louis · USWest Cancer Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis multicentre, open-label study evaluated the efficacy and safety of SPI-1620, an analogue of endothelin-1, administered in combination with docetaxel as second-line treatment for patients with advanced biliary tract cancer (ABTC).

methodsEligible patients received continuous cycles of combination therapy with SPI-1620 (11 μg m

resultsOf the 30 enrolled patients, 25 patients had qualifying events (PD or death), 1 patient was nonevaluable, and 4 patients were censored at the time of their last tumour assessment. Our primary end point of PFS ⩾5 months was not reached. Median PFS was 2.6 months (95% confidence interval (CI): 1.4-2.8), ranging from 0.7 to 8.4 months. The ORR was 10.3% (95% CI: 0.02-0.27). Eleven additional patients achieved stable disease. The OS was 4.87 months. The most common grade 3-4 toxicities were febrile neutropenia and neutropenia.

conclusionsThe addition of docetaxel to SPI-1620 in second-line ABTC did not meet the pre-specified primary end point of PFS ⩾5 months in unselected patient population.

Indexed as

AdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsBiliary Tract NeoplasmsDisease-Free SurvivalDocetaxelDrug-Related Side Effects and Adverse ReactionsEndothelinsFemaleHumansMaleMiddle AgedNeoplasm Recurrence, LocalPeptide FragmentsTaxoidsDocetaxelEndothelinsPeptide FragmentssovateltideTaxoids

Identifiers

PMID28632730
PMCPMC5520510
OpenAlexW2649565258

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.