Evidence map›Paper›PMID 32663379›Full record

Trial reportCancer medicine2020

Rivaroxaban thromboprophylaxis in ambulatory patients with pancreatic cancer: Results from a pre-specified subgroup analysis of the randomized CASSINI study.

Saroj Vadhan-Raj, Mairéad G McNamara, Marino Venerito, Hanno Riess, Eileen M O'Reilly, Michael J Overman, Xiao Zhou, Ujjwala Vijapurkar, Simrati Kaul, Peter Wildgoose and 1 more

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Cancer medicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02555878 (Efficacy and Safety of Rivaroxaban Prophylaxis Compared With Placebo in Ambulatory Cancer Patients Initiating Systemic Cancer Therapy and at High Risk for Venous Thromboembolism), which is not on this map. Cited by 26 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 3 pooled it
2.6field-weighted citation impact, top 6% 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.

NCT02555878 phase3completednot on this map

Efficacy and Safety of Rivaroxaban Prophylaxis Compared With Placebo in Ambulatory Cancer Patients Initiating Systemic Cancer Therapy and at High Risk for Venous Thromboembolism

TypeinterventionalSponsorJanssen Research & Development, LLCRan2015 to 2018Enrolled841ConditionsNeoplasmsArmsRivaroxaban, Placebo
3 · Its place in the literature

Who cites it

26 citing papers in PubMed, 3 syntheses or guidelines pooled it, 37 citations in OpenAlex.

  1. Guideline
  2. SEOM clinical guidelines on venous thromboembolism (VTE) and cancer (2023).Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2024
    Guideline
  3. Guideline
  4. Trial
  5. Review
  6. Review
  7. Review
  8. Implementation failure: thromboprophylaxis in ambulatory patients with cancer.Hematology. American Society of Hematology. Education Program · 2025
    Review
  9. Article
  10. Pancreatic Cancer and Venous Thromboembolism.International journal of molecular sciences · 2024
    Review
  11. Article
  12. Article
  13. Review
  14. Review
  15. Primary ambulatory thromboprophylaxis in patients with pancreatic cancer receiving chemotherapy: hope or hype?Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2022
    Review
  16. Article
  17. Review
  18. Review
  19. Review
  20. 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

11 authors at 7 institutions in 3 countries.

Saroj Vadhan-RajThe UT MD Anderson Cancer Center, Department of Sarcoma Medical Oncology, Section of Cytokines and Supportive Oncology, Houston, TX, USA.ORCID 0000-0002-6790-8457
Mairéad G McNamaraDepartment of Medical Oncology, The Christie NHS Foundation Trust & Division of Cancer Sciences, University of Manchester, Manchester, United Kingdom.
Marino VeneritoKlinik für Gastroenterologie, Hepatologie und Infektiologie Universitätsklinikum, Magdeburg, Germany.
Hanno RiessCharité Universitätsmedizin Berlin, Berlin, Germany.
Eileen M O'ReillyMemorial Sloan Kettering Cancer Center, Weill Cornell Medical College, New York, NY, USA.ORCID 0000-0002-8076-9199
Michael J OvermanThe UT MD Anderson Cancer Center, Houston, TX, USA.
Xiao ZhouThe UT MD Anderson Cancer Center, Department of Sarcoma Medical Oncology, Section of Cytokines and Supportive Oncology, Houston, TX, USA.
Ujjwala VijapurkarJanssen Research & Development, LLC, Raritan, NJ, USA.
Simrati KaulJanssen Scientific Affairs, LLC, Titusville, NJ, USA.
Peter WildgooseJanssen Scientific Affairs, LLC, Titusville, NJ, USA.
Alok A KhoranaDepartment of Hematology and Medical Oncology, Cleveland Clinic, Cleveland, OH, USA.
Janssen (United States) · USThe University of Texas MD Anderson Cancer Center · USCharité - Universitätsmedizin Berlin · DECleveland Clinic · USKlinikum Magdeburg · DEMemorial Sloan Kettering Cancer Center · USUniversity of Manchester · GB

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
Novel approaches to improve prediction of cancer-associated thrombosisU01HL143402 · NHLBI · CLEVELAND CLINIC LERNER COM-CWRU · PI KHORANA, ALOK A, MCCRAE, KEITH R. · 2018 to 2022
$4.7M
Risk-adapted thromboprophylaxis of hospitalized cancer patientsR34HL127156 · NHLBI · BETH ISRAEL DEACONESS MEDICAL CENTER · PI KHORANA, ALOK A, ZWICKER, JEFFREY · 2016 to 2018
$810k
NCI NIH HHS P30 CA008748NHLBI NIH HHS R34 HL127156NHLBI NIH HHS U01 HL143402
6 · The paper itself

Abstract

backgroundPancreatic cancer patients are at risk for venous thromboembolism (VTE); the value of thromboprophylaxis has not been definitively established.

methodsThis trial randomized cancer patients initiating a new regimen and at high risk for VTE (Khorana score ≥2) to rivaroxaban 10 mg or placebo up to day 180. This analysis examined the subset of pancreatic cancer patients. The primary efficacy endpoint was the composite of symptomatic deep-vein thrombosis (DVT), asymptomatic proximal DVT, any pulmonary embolism, and VTE-related death. The primary safety endpoint was International Society on Thrombosis and Haemostasis-defined major bleeding.

resultsIn total, 49/1080 (4.5%) patients enrolled had baseline VTE on screening, with higher rates (24/362 [6.6%]) in pancreatic cancer and they were not randomized. Of 841 randomized patients, 273 (32.5%) had pancreatic cancer; 155/273 (57% in each arm) completed the double-blind period. The primary endpoint occurred in 13/135 (9.6%) patients in the rivaroxaban group and in 18/138 (13.0%) in the placebo group (hazard ratio [HR] = 0.70; 95% CI, 0.34-1.43; P = .328) in up-to-day-180 period and 5/135 (3.7%) patients receiving rivaroxaban and 14/138 (10.1%) receiving placebo in the intervention period (HR = 0.35; 95% CI, 0.13-0.97; P = .034). Major bleeding was similar (2 [1.5%] receiving rivaroxaban and 3 [2.3%] receiving placebo). Correlative biomarker studies demonstrated significant decline in D-dimer (weeks 8 and 16) in patients randomized to rivaroxaban compared to placebo (P < .01).

conclusionsIn ambulatory pancreatic cancer patients, rivaroxaban did not result in significantly lower incidence of VTE or VTE-related death in the 180-day period. During the intervention period, however, rivaroxaban substantially reduced VTE without increasing major bleeding, suggesting benefit of rivaroxaban prophylaxis in this setting.

trial registrationClinicalTrials.gov identifier, NCT02555878.

Indexed as

OutpatientsAdultAgedAged, 80 and overAnticoagulantsDouble-Blind MethodFemaleFibrin Fibrinogen Degradation ProductsHemorrhageHumansIncidenceMaleMiddle AgedPancreatic NeoplasmsPlacebosPulmonary EmbolismAnticoagulantsFibrin Fibrinogen Degradation Productsfibrin fragment DPlacebosRivaroxabanmajor bleedingpancreatic cancerrivaroxabanthromboprophylaxisvenous thromboembolism

Identifiers

PMID32663379
PMCPMC7476843
OpenAlexW2947995092

What OpenQuestion holds

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LicenceCC BY
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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.