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Add-aspirin trial: a phase III, double blind, placebo-controlled, randomized trial assessing the effects of aspirin on disease recurrence and survival after primary therapy in common nonmetastatic solid tumors

Add-aspirin trial: a phase III, double blind, placebo-controlled, randomized trial assessing the effects of aspirin on disease recurrence and survival after primary therapy in common nonmetastatic solid tumors
Add-aspirin trial: a phase III, double blind, placebo-controlled, randomized trial assessing the effects of aspirin on disease recurrence and survival after primary therapy in common nonmetastatic solid tumors
Background: Pre-clinical data demonstrate that aspirin inhibits tumour growth and prevents metastases. Meta-analyses of individual patient data from randomized trials evaluating cardiovascular (CV) effects of aspirin show reduced metastases and cancer deaths for those on aspirin. Toxicity concerns have limited aspirin use as a primary anti-cancer prevention agent. In the adjuvant setting, the risk:benefit ratio differs, with higher morbidity and mortality from recurrence potentially outweighing risks. Aspirin, an inexpensive drug with a potential therapeutic role in several common cancers, could have a large impact on the global cancer burden. The Add-Aspirin trial investigates if aspirin use after curative treatment for non-metastatic solid tumours prevents recurrence and prolongs survival.

Methods: Add-Aspirin is a double blind, placebo-controlled, multicentre, international trial. Eligible participants (n=9,920) from the UK and India will have had potentially curative treatment for non-metastatic cancer. There are 4 separate tumour cohorts – breast (BC), colorectal (CRC), gastro-oesophageal (GOC) and prostate cancer (PC). Following an 8 week active run-in period of aspirin 100mg daily to assess adherence and tolerability, participants are randomised to aspirin 100mg, 300mg or placebo daily for > 5 years. Each tumour specific cohort is individually powered and has a separate disease-specific primary outcome measure: BC (n = 3,100) invasive disease-free survival (DFS); CRC (n = 2,600) DFS; GOC (n = 2,100) overall survival (OS); and PC (n = 2,120) biochemical recurrence-free survival. Secondary outcome measures include adherence, toxicity and CV events. OS across the 4 cohorts is a co-primary outcome measure. Sub-studies include assessment of thromboxane B2 for compliance and methodological work to assess the utility of long-term passive follow up. Blood/tissue specimens collected at enrolment will allow tumour-specific mutations to be used as stratification factors. Funder CRUK; Sponsor University College UK. Clinical trial information: 2013-004398-28.
1527-7755
TPS1617
Langley, Ruth E.
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Wilson, Richard H.
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Ring, Alistair E.
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Kynaston, Howard Gordon
cc327bde-bf3b-4e32-9bdb-da36c76aa4f9
Cameron, David A.
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Coyle, Christopher
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Gilbert, Duncan Charles
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Patrono, Carlo
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Rowley, Sam
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Murphy, Claire
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Adlam, David
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Hubner, Richard
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Iveson, Tim
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Steele, Robert J.
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Thomas, Anne L.
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Underwood, Timothy J.
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Jankowski, Janusz
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Gupta, Sudeep
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Pramesh, Conjeevaram S.
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Parmar, Mahesh
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Langley, Ruth E.
bf82e2b5-a6bf-4d8a-8ac4-cb5596fc3114
Wilson, Richard H.
d9c481a6-7960-45c7-ba93-8f9542bdcecc
Ring, Alistair E.
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Kynaston, Howard Gordon
cc327bde-bf3b-4e32-9bdb-da36c76aa4f9
Cameron, David A.
9709006c-ed70-4864-acdd-2468bc8b2744
Coyle, Christopher
0ef863d5-9dd4-464e-b504-ad554fc070cc
Gilbert, Duncan Charles
511f00af-552f-4f6c-870a-6f6b753b3111
Patrono, Carlo
b5975584-3e97-4f6d-ad0f-5ba45748f20b
Rowley, Sam
447b37ca-35c2-402a-b804-0bd8bff44da9
Murphy, Claire
109775dd-eb4f-4948-a049-a5d75669a0e3
Adlam, David
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Hubner, Richard
23340894-eabf-4cb5-a41e-ae4d23a2419e
Iveson, Tim
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Steele, Robert J.
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Thomas, Anne L.
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Underwood, Timothy J.
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Jankowski, Janusz
41ac6a28-b60e-4eed-bcae-b65d6d76beda
Gupta, Sudeep
39527356-4e6a-45c5-8d80-cb60dc2b9a4c
Pramesh, Conjeevaram S.
872903ef-0b23-46db-8d52-1654635e6f73
Parmar, Mahesh
87d142fa-23e7-4e5e-988a-9292aa410732

Langley, Ruth E., Wilson, Richard H., Ring, Alistair E., Kynaston, Howard Gordon, Cameron, David A., Coyle, Christopher, Gilbert, Duncan Charles, Patrono, Carlo, Rowley, Sam, Murphy, Claire, Adlam, David, Hubner, Richard, Iveson, Tim, Steele, Robert J., Thomas, Anne L., Underwood, Timothy J., Jankowski, Janusz, Gupta, Sudeep, Pramesh, Conjeevaram S. and Parmar, Mahesh (2014) Add-aspirin trial: a phase III, double blind, placebo-controlled, randomized trial assessing the effects of aspirin on disease recurrence and survival after primary therapy in common nonmetastatic solid tumors. Journal of Clinical Oncology, 32 (15), supplement 2014 ASCO Annual Meeting Abstracts, TPS1617.

Record type: Article

Abstract

Background: Pre-clinical data demonstrate that aspirin inhibits tumour growth and prevents metastases. Meta-analyses of individual patient data from randomized trials evaluating cardiovascular (CV) effects of aspirin show reduced metastases and cancer deaths for those on aspirin. Toxicity concerns have limited aspirin use as a primary anti-cancer prevention agent. In the adjuvant setting, the risk:benefit ratio differs, with higher morbidity and mortality from recurrence potentially outweighing risks. Aspirin, an inexpensive drug with a potential therapeutic role in several common cancers, could have a large impact on the global cancer burden. The Add-Aspirin trial investigates if aspirin use after curative treatment for non-metastatic solid tumours prevents recurrence and prolongs survival.

Methods: Add-Aspirin is a double blind, placebo-controlled, multicentre, international trial. Eligible participants (n=9,920) from the UK and India will have had potentially curative treatment for non-metastatic cancer. There are 4 separate tumour cohorts – breast (BC), colorectal (CRC), gastro-oesophageal (GOC) and prostate cancer (PC). Following an 8 week active run-in period of aspirin 100mg daily to assess adherence and tolerability, participants are randomised to aspirin 100mg, 300mg or placebo daily for > 5 years. Each tumour specific cohort is individually powered and has a separate disease-specific primary outcome measure: BC (n = 3,100) invasive disease-free survival (DFS); CRC (n = 2,600) DFS; GOC (n = 2,100) overall survival (OS); and PC (n = 2,120) biochemical recurrence-free survival. Secondary outcome measures include adherence, toxicity and CV events. OS across the 4 cohorts is a co-primary outcome measure. Sub-studies include assessment of thromboxane B2 for compliance and methodological work to assess the utility of long-term passive follow up. Blood/tissue specimens collected at enrolment will allow tumour-specific mutations to be used as stratification factors. Funder CRUK; Sponsor University College UK. Clinical trial information: 2013-004398-28.

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More information

Published date: 20 May 2014
Organisations: Cancer Sciences

Identifiers

Local EPrints ID: 370717
URI: http://eprints.soton.ac.uk/id/eprint/370717
ISSN: 1527-7755
PURE UUID: 7cb7c1ae-dbb3-46ad-9fd0-e4199b800159
ORCID for Tim Iveson: ORCID iD orcid.org/0000-0002-4681-2712
ORCID for Timothy J. Underwood: ORCID iD orcid.org/0000-0001-9455-2188

Catalogue record

Date deposited: 05 Nov 2014 11:17
Last modified: 23 Jul 2022 01:51

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Contributors

Author: Ruth E. Langley
Author: Richard H. Wilson
Author: Alistair E. Ring
Author: Howard Gordon Kynaston
Author: David A. Cameron
Author: Christopher Coyle
Author: Duncan Charles Gilbert
Author: Carlo Patrono
Author: Sam Rowley
Author: Claire Murphy
Author: David Adlam
Author: Richard Hubner
Author: Tim Iveson ORCID iD
Author: Robert J. Steele
Author: Anne L. Thomas
Author: Janusz Jankowski
Author: Sudeep Gupta
Author: Conjeevaram S. Pramesh
Author: Mahesh Parmar

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