Outcome measures in multimodal rectal cancer trials

There is a large variability regarding the definition and choice of primary endpoints in phase 2 and phase 3 multimodal rectal cancer trials, resulting in inconsistency and difficulty of data interpretation. Also, surrogate properties of early and intermediate endpoints have not been systematically...

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Veröffentlicht in:The lancet oncology Jg. 21; H. 5; S. e252 - e264
Hauptverfasser: Fokas, Emmanouil, Glynne-Jones, Robert, Appelt, Ane, Beets-Tan, Regina, Beets, Geerard, Haustermans, Karin, Marijnen, Corrie, Minsky, Bruce D, Ludmir, Ethan, Quirke, Phil, Sebag-Montefiore, David, Garcia-Aguilar, Julio, Gambacorta, Maria Antonietta, Valentini, Vincenzo, Buyse, Marc, Rödel, Claus
Format: Journal Article
Sprache:Englisch
Veröffentlicht: England Elsevier Ltd 01.05.2020
Elsevier Limited
Schlagworte:
Cancer
Cancer therapies
Chemotherapy
Clinical decision making
Clinical trials
Colorectal cancer
Decision making
Hematology, Oncology, and Palliative Medicine
Lymphatic system
Medical prognosis
Metastases
Metastasis
Patients
Preservation
Radiation therapy
Rectum
Response rates
Surgery
ISSN:1470-2045, 1474-5488, 1474-5488
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Abstract There is a large variability regarding the definition and choice of primary endpoints in phase 2 and phase 3 multimodal rectal cancer trials, resulting in inconsistency and difficulty of data interpretation. Also, surrogate properties of early and intermediate endpoints have not been systematically assessed. We provide a comprehensive review of clinical and surrogate endpoints used in trials for non-metastatic rectal cancer. The applicability, advantages, and disadvantages of these endpoints are summarised, with recommendations on clinical endpoints for the different phase trials, including limited surgery or non-operative management for organ preservation. We discuss how early and intermediate endpoints, including patient-reported outcomes and involvement of patients in decision making, can be used to guide trial design and facilitate consistency in reporting trial results in rectal cancer.
AbstractList There is a large variability regarding the definition and choice of primary endpoints in phase 2 and phase 3 multimodal rectal cancer trials, resulting in inconsistency and difficulty of data interpretation. Also, surrogate properties of early and intermediate endpoints have not been systematically assessed. We provide a comprehensive review of clinical and surrogate endpoints used in trials for non-metastatic rectal cancer. The applicability, advantages, and disadvantages of these endpoints are summarised, with recommendations on clinical endpoints for the different phase trials, including limited surgery or non-operative management for organ preservation. We discuss how early and intermediate endpoints, including patient-reported outcomes and involvement of patients in decision making, can be used to guide trial design and facilitate consistency in reporting trial results in rectal cancer.There is a large variability regarding the definition and choice of primary endpoints in phase 2 and phase 3 multimodal rectal cancer trials, resulting in inconsistency and difficulty of data interpretation. Also, surrogate properties of early and intermediate endpoints have not been systematically assessed. We provide a comprehensive review of clinical and surrogate endpoints used in trials for non-metastatic rectal cancer. The applicability, advantages, and disadvantages of these endpoints are summarised, with recommendations on clinical endpoints for the different phase trials, including limited surgery or non-operative management for organ preservation. We discuss how early and intermediate endpoints, including patient-reported outcomes and involvement of patients in decision making, can be used to guide trial design and facilitate consistency in reporting trial results in rectal cancer.
There is a large variability regarding the definition and choice of primary endpoints in phase 2 and phase 3 multimodal rectal cancer trials, resulting in inconsistency and difficulty of data interpretation. Also, surrogate properties of early and intermediate endpoints have not been systematically assessed. We provide a comprehensive review of clinical and surrogate endpoints used in trials for non-metastatic rectal cancer. The applicability, advantages, and disadvantages of these endpoints are summarised, with recommendations on clinical endpoints for the different phase trials, including limited surgery or non-operative management for organ preservation. We discuss how early and intermediate endpoints, including patient-reported outcomes and involvement of patients in decision making, can be used to guide trial design and facilitate consistency in reporting trial results in rectal cancer.
SummaryThere is a large variability regarding the definition and choice of primary endpoints in phase 2 and phase 3 multimodal rectal cancer trials, resulting in inconsistency and difficulty of data interpretation. Also, surrogate properties of early and intermediate endpoints have not been systematically assessed. We provide a comprehensive review of clinical and surrogate endpoints used in trials for non-metastatic rectal cancer. The applicability, advantages, and disadvantages of these endpoints are summarised, with recommendations on clinical endpoints for the different phase trials, including limited surgery or non-operative management for organ preservation. We discuss how early and intermediate endpoints, including patient-reported outcomes and involvement of patients in decision making, can be used to guide trial design and facilitate consistency in reporting trial results in rectal cancer.
Summary There is a large variability regarding the definition and choice of primary endpoints in phase 2 and phase 3 multimodal rectal cancer trials, resulting in inconsistency and difficulty of data interpretation. Also, surrogate properties of early and intermediate endpoints have not been systematically assessed. We provide a comprehensive review of clinical and surrogate endpoints used in trials for non-metastatic rectal cancer. The applicability, advantages, and disadvantages of these endpoints are summarised, with recommendations on clinical endpoints for the different phase trials, including limited surgery or non-operative management for organ preservation. We discuss how early and intermediate endpoints, including patient-reported outcomes and involvement of patients in decision making, can be used to guide trial design and facilitate consistency in reporting trial results in rectal cancer.
Author Haustermans, Karin
Minsky, Bruce D
Beets, Geerard
Sebag-Montefiore, David
Buyse, Marc
Garcia-Aguilar, Julio
Valentini, Vincenzo
Marijnen, Corrie
Ludmir, Ethan
Appelt, Ane
Rödel, Claus
Quirke, Phil
Glynne-Jones, Robert
Fokas, Emmanouil
Gambacorta, Maria Antonietta
Beets-Tan, Regina
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  organization: Department of Radiotherapy and Oncology, University of Frankfurt, Frankfurt, Germany
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  surname: Glynne-Jones
  fullname: Glynne-Jones, Robert
  organization: Department of Radiotherapy, Mount Vernon Cancer Centre, Northwood, UK
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  surname: Appelt
  fullname: Appelt, Ane
  organization: Institute of Medical Research at St James's, University of Leeds, Leeds, UK
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  givenname: Regina
  surname: Beets-Tan
  fullname: Beets-Tan, Regina
  organization: Department of Radiology, The Netherlands Cancer Institute, Amsterdam, Netherlands
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  fullname: Beets, Geerard
  organization: Department of Surgery, The Netherlands Cancer Institute, Amsterdam, Netherlands
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  surname: Haustermans
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  organization: Department of Radiation Oncology, University Hospital Leuven, Leuven, Belgium
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  organization: Department of Radiation Oncology, The Netherlands Cancer Institute, Amsterdam, Netherlands
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  organization: Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA
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  surname: Ludmir
  fullname: Ludmir, Ethan
  organization: Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA
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  organization: Division of Pathology and Data Analytics, School of Medicine, Leeds University, Leeds, UK
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  givenname: Maria Antonietta
  surname: Gambacorta
  fullname: Gambacorta, Maria Antonietta
  organization: Department of Radiation Oncology, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy
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  givenname: Vincenzo
  surname: Valentini
  fullname: Valentini, Vincenzo
  organization: Department of Radiation Oncology, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy
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  surname: Buyse
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  organization: Interuniversity Institute for Biostatistics and Statistical Bioinformatics, Hasselt University, Diepenbeek, Belgium
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  givenname: Claus
  surname: Rödel
  fullname: Rödel, Claus
  organization: Department of Radiotherapy and Oncology, University of Frankfurt, Frankfurt, Germany
BackLink https://www.ncbi.nlm.nih.gov/pubmed/32359501$$D View this record in MEDLINE/PubMed
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crossref_citationtrail_10_1016_S1470_2045_20_30024_3
crossref_primary_10_1016_S1470_2045_20_30024_3
elsevier_sciencedirect_doi_10_1016_S1470_2045_20_30024_3
elsevier_clinicalkeyesjournals_1_s2_0_S1470204520300243
elsevier_clinicalkey_doi_10_1016_S1470_2045_20_30024_3
PublicationCentury 2000
PublicationDate 2020-05-01
PublicationDateYYYYMMDD 2020-05-01
PublicationDate_xml – month: 05
  year: 2020
  text: 2020-05-01
  day: 01
PublicationDecade 2020
PublicationPlace England
PublicationPlace_xml – name: England
– name: London
PublicationTitle The lancet oncology
PublicationTitleAlternate Lancet Oncol
PublicationYear 2020
Publisher Elsevier Ltd
Elsevier Limited
Publisher_xml – name: Elsevier Ltd
– name: Elsevier Limited
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Snippet There is a large variability regarding the definition and choice of primary endpoints in phase 2 and phase 3 multimodal rectal cancer trials, resulting in...
SummaryThere is a large variability regarding the definition and choice of primary endpoints in phase 2 and phase 3 multimodal rectal cancer trials, resulting...
Summary There is a large variability regarding the definition and choice of primary endpoints in phase 2 and phase 3 multimodal rectal cancer trials, resulting...
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SubjectTerms Cancer
Cancer therapies
Chemotherapy
Clinical decision making
Clinical trials
Colorectal cancer
Decision making
Hematology, Oncology, and Palliative Medicine
Lymphatic system
Medical prognosis
Metastases
Metastasis
Patients
Preservation
Radiation therapy
Rectum
Response rates
Surgery
Title Outcome measures in multimodal rectal cancer trials
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https://www.clinicalkey.es/playcontent/1-s2.0-S1470204520300243
https://dx.doi.org/10.1016/S1470-2045(20)30024-3
https://www.ncbi.nlm.nih.gov/pubmed/32359501
https://www.proquest.com/docview/2425645398
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Volume 21
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