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Perspective

Time to Next Treatment as a Meaningful Endpoint for Trials of Primary Cutaneous Lymphoma

1
Department of Radiation Oncology, Peter MacCallum Cancer Centre, Melbourne, VIC 3000, Australia
2
Department of Clinical Pathology, The University of Melbourne, Parkville, VIC 3010, Australia
3
Department of Dermatology, University Hospital Birmingham, Birmingham B15 2TH, UK
4
Department of Dermatology, Stanford Cancer Institute, Stanford, CA 94305, USA
5
Division of Hematology and Medical Oncology, Department of Internal Medicine, University of Michigan Rogel Cancer Center, Ann Arbor, MI 48109, USA
6
Department of Surgical Oncology, Peter MacCallum Cancer Centre, Melbourne, VIC 3000, Australia
7
Department of Dermatology, St Vincent’s Hospital Melbourne, Fitzroy, VIC 3065, Australia
8
Department of Clinical Haematology, Peter MacCallum Cancer Centre and Royal Melbourne Hospital, Melbourne, VIC 3000, Australia
9
Sir Peter MacCallum Department of Oncology, The University of Melbourne, Parkville, VIC 3010, Australia
*
Author to whom correspondence should be addressed.
Cancers 2020, 12(8), 2311; https://doi.org/10.3390/cancers12082311
Received: 1 July 2020 / Revised: 9 August 2020 / Accepted: 11 August 2020 / Published: 17 August 2020
(This article belongs to the Section Clinical Trials of Cancer)
Time to next treatment (TTNT) is an emerging endpoint in clinical studies of primary cutaneous T-cell lymphomas (CTCL), with utility as a surrogate marker for the “duration of clinical benefit”. TTNT provides a highly clinically meaningful endpoint that uniquely reflects not only the duration of treatment efficacy on disease and symptom control, but also incorporates the patient experience by accounting for patient compliance and tolerance to the studied therapy(s). Given the distinct challenges of pin-pointing the exact date of progression in patients with multi-compartmental CTCL, TTNT overcomes many of the shortcomings of conventional, disease-focused, clinical endpoints in primary CTCL research. Although widely accepted in clinical research for numerous other incurable malignancies, TTNT currently lacks a standardised definition. In this paper, we describe the value of TTNT as a clinical endpoint, review the applications of TTNT in primary CTCL research, and propose a standardised definition of TTNT to be applied in future clinical research of primary CTCL therapies. View Full-Text
Keywords: time to next treatment; primary cutaneous lymphomas; clinical trials; clinical endpoint; study design time to next treatment; primary cutaneous lymphomas; clinical trials; clinical endpoint; study design
MDPI and ACS Style

Campbell, B.A.; Scarisbrick, J.J.; Kim, Y.H.; Wilcox, R.A.; McCormack, C.; Prince, H.M. Time to Next Treatment as a Meaningful Endpoint for Trials of Primary Cutaneous Lymphoma. Cancers 2020, 12, 2311. https://doi.org/10.3390/cancers12082311

AMA Style

Campbell BA, Scarisbrick JJ, Kim YH, Wilcox RA, McCormack C, Prince HM. Time to Next Treatment as a Meaningful Endpoint for Trials of Primary Cutaneous Lymphoma. Cancers. 2020; 12(8):2311. https://doi.org/10.3390/cancers12082311

Chicago/Turabian Style

Campbell, Belinda A., Julia J. Scarisbrick, Youn H. Kim, Ryan A. Wilcox, Christopher McCormack, and H. Miles Prince. 2020. "Time to Next Treatment as a Meaningful Endpoint for Trials of Primary Cutaneous Lymphoma" Cancers 12, no. 8: 2311. https://doi.org/10.3390/cancers12082311

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