Cargando…
Utility of (18)fluoro-deoxyglucose positron emission tomography for prognosis and response assessments in a phase 2 study of romidepsin in patients with relapsed or refractory peripheral T-cell lymphoma
BACKGROUND: For patients with peripheral T-cell lymphoma (PTCL), the value of (18)fluoro-deoxyglucose positron emission tomography (FDG-PET) scans for assessing prognosis and response to treatment remains unclear. The utility of FDG-PET, in addition to conventional radiology, was examined as a plann...
Autores principales: | , , , , , , , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Oxford University Press
2015
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4374388/ https://www.ncbi.nlm.nih.gov/pubmed/25605745 http://dx.doi.org/10.1093/annonc/mdv010 |
_version_ | 1782363482194182144 |
---|---|
author | Horwitz, S. Coiffier, B. Foss, F. Prince, H. M. Sokol, L. Greenwood, M. Caballero, D. Morschhauser, F. Pinter-Brown, L. Iyer, S. P. Shustov, A. Nichols, J. Balser, J. Balser, B. Pro, B. |
author_facet | Horwitz, S. Coiffier, B. Foss, F. Prince, H. M. Sokol, L. Greenwood, M. Caballero, D. Morschhauser, F. Pinter-Brown, L. Iyer, S. P. Shustov, A. Nichols, J. Balser, J. Balser, B. Pro, B. |
author_sort | Horwitz, S. |
collection | PubMed |
description | BACKGROUND: For patients with peripheral T-cell lymphoma (PTCL), the value of (18)fluoro-deoxyglucose positron emission tomography (FDG-PET) scans for assessing prognosis and response to treatment remains unclear. The utility of FDG-PET, in addition to conventional radiology, was examined as a planned exploratory end point in the pivotal phase 2 trial of romidepsin for the treatment of relapsed/refractory PTCL. PATIENTS AND METHODS: Patients received romidepsin at a dose of 14 mg/m(2) on days 1, 8, and 15 of 28-day cycles. The primary end point was the rate of confirmed/unconfirmed complete response (CR/CRu) as assessed by International Workshop Criteria (IWC) using conventional radiology. For the exploratory PET end point, patients with at least baseline FDG-PET scans were assessed by IWC + PET criteria. RESULTS: Of 130 patients, 110 had baseline FDG-PET scans, and 105 were PET positive at baseline. The use of IWC + PET criteria increased the objective response rate to 30% compared with 26% by conventional radiology. Durations of response were well differentiated by both conventional radiology response criteria [CR/CRu versus partial response (PR), P = 0.0001] and PET status (negative versus positive, P < 0.0001). Patients who achieved CR/CRu had prolonged progression-free survival (PFS, median 25.9 months) compared with other response groups (P = 0.0007). Patients who achieved PR or stable disease (SD) had similar PFS (median 7.2 and 6.3 months, respectively, P = 0.6427). When grouping PR and SD patients by PET status, patients with PET-negative versus PET-positive disease had a median PFS of 18.2 versus 7.1 months (P = 0.0923). CONCLUSION(S): Routine use of FDG-PET does not obviate conventional staging, but may aid in determining prognosis and refine response assessments for patients with PTCL, particularly for those who do not achieve CR/CRu by conventional staging. The optimal way to incorporate FDG-PET scans for patients with PTCL remains to be determined. TRIAL REGISTRATION: NCT00426764. |
format | Online Article Text |
id | pubmed-4374388 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2015 |
publisher | Oxford University Press |
record_format | MEDLINE/PubMed |
spelling | pubmed-43743882015-03-30 Utility of (18)fluoro-deoxyglucose positron emission tomography for prognosis and response assessments in a phase 2 study of romidepsin in patients with relapsed or refractory peripheral T-cell lymphoma Horwitz, S. Coiffier, B. Foss, F. Prince, H. M. Sokol, L. Greenwood, M. Caballero, D. Morschhauser, F. Pinter-Brown, L. Iyer, S. P. Shustov, A. Nichols, J. Balser, J. Balser, B. Pro, B. Ann Oncol Original Articles BACKGROUND: For patients with peripheral T-cell lymphoma (PTCL), the value of (18)fluoro-deoxyglucose positron emission tomography (FDG-PET) scans for assessing prognosis and response to treatment remains unclear. The utility of FDG-PET, in addition to conventional radiology, was examined as a planned exploratory end point in the pivotal phase 2 trial of romidepsin for the treatment of relapsed/refractory PTCL. PATIENTS AND METHODS: Patients received romidepsin at a dose of 14 mg/m(2) on days 1, 8, and 15 of 28-day cycles. The primary end point was the rate of confirmed/unconfirmed complete response (CR/CRu) as assessed by International Workshop Criteria (IWC) using conventional radiology. For the exploratory PET end point, patients with at least baseline FDG-PET scans were assessed by IWC + PET criteria. RESULTS: Of 130 patients, 110 had baseline FDG-PET scans, and 105 were PET positive at baseline. The use of IWC + PET criteria increased the objective response rate to 30% compared with 26% by conventional radiology. Durations of response were well differentiated by both conventional radiology response criteria [CR/CRu versus partial response (PR), P = 0.0001] and PET status (negative versus positive, P < 0.0001). Patients who achieved CR/CRu had prolonged progression-free survival (PFS, median 25.9 months) compared with other response groups (P = 0.0007). Patients who achieved PR or stable disease (SD) had similar PFS (median 7.2 and 6.3 months, respectively, P = 0.6427). When grouping PR and SD patients by PET status, patients with PET-negative versus PET-positive disease had a median PFS of 18.2 versus 7.1 months (P = 0.0923). CONCLUSION(S): Routine use of FDG-PET does not obviate conventional staging, but may aid in determining prognosis and refine response assessments for patients with PTCL, particularly for those who do not achieve CR/CRu by conventional staging. The optimal way to incorporate FDG-PET scans for patients with PTCL remains to be determined. TRIAL REGISTRATION: NCT00426764. Oxford University Press 2015-04 2015-01-20 /pmc/articles/PMC4374388/ /pubmed/25605745 http://dx.doi.org/10.1093/annonc/mdv010 Text en © The Author 2015. Published by Oxford University Press on behalf of the European Society for Medical Oncology. http://creativecommons.org/licenses/by-nc/4.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com |
spellingShingle | Original Articles Horwitz, S. Coiffier, B. Foss, F. Prince, H. M. Sokol, L. Greenwood, M. Caballero, D. Morschhauser, F. Pinter-Brown, L. Iyer, S. P. Shustov, A. Nichols, J. Balser, J. Balser, B. Pro, B. Utility of (18)fluoro-deoxyglucose positron emission tomography for prognosis and response assessments in a phase 2 study of romidepsin in patients with relapsed or refractory peripheral T-cell lymphoma |
title | Utility of (18)fluoro-deoxyglucose positron emission tomography for prognosis and response assessments in a phase 2 study of romidepsin in patients with relapsed or refractory peripheral T-cell lymphoma |
title_full | Utility of (18)fluoro-deoxyglucose positron emission tomography for prognosis and response assessments in a phase 2 study of romidepsin in patients with relapsed or refractory peripheral T-cell lymphoma |
title_fullStr | Utility of (18)fluoro-deoxyglucose positron emission tomography for prognosis and response assessments in a phase 2 study of romidepsin in patients with relapsed or refractory peripheral T-cell lymphoma |
title_full_unstemmed | Utility of (18)fluoro-deoxyglucose positron emission tomography for prognosis and response assessments in a phase 2 study of romidepsin in patients with relapsed or refractory peripheral T-cell lymphoma |
title_short | Utility of (18)fluoro-deoxyglucose positron emission tomography for prognosis and response assessments in a phase 2 study of romidepsin in patients with relapsed or refractory peripheral T-cell lymphoma |
title_sort | utility of (18)fluoro-deoxyglucose positron emission tomography for prognosis and response assessments in a phase 2 study of romidepsin in patients with relapsed or refractory peripheral t-cell lymphoma |
topic | Original Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4374388/ https://www.ncbi.nlm.nih.gov/pubmed/25605745 http://dx.doi.org/10.1093/annonc/mdv010 |
work_keys_str_mv | AT horwitzs utilityof18fluorodeoxyglucosepositronemissiontomographyforprognosisandresponseassessmentsinaphase2studyofromidepsininpatientswithrelapsedorrefractoryperipheraltcelllymphoma AT coiffierb utilityof18fluorodeoxyglucosepositronemissiontomographyforprognosisandresponseassessmentsinaphase2studyofromidepsininpatientswithrelapsedorrefractoryperipheraltcelllymphoma AT fossf utilityof18fluorodeoxyglucosepositronemissiontomographyforprognosisandresponseassessmentsinaphase2studyofromidepsininpatientswithrelapsedorrefractoryperipheraltcelllymphoma AT princehm utilityof18fluorodeoxyglucosepositronemissiontomographyforprognosisandresponseassessmentsinaphase2studyofromidepsininpatientswithrelapsedorrefractoryperipheraltcelllymphoma AT sokoll utilityof18fluorodeoxyglucosepositronemissiontomographyforprognosisandresponseassessmentsinaphase2studyofromidepsininpatientswithrelapsedorrefractoryperipheraltcelllymphoma AT greenwoodm utilityof18fluorodeoxyglucosepositronemissiontomographyforprognosisandresponseassessmentsinaphase2studyofromidepsininpatientswithrelapsedorrefractoryperipheraltcelllymphoma AT caballerod utilityof18fluorodeoxyglucosepositronemissiontomographyforprognosisandresponseassessmentsinaphase2studyofromidepsininpatientswithrelapsedorrefractoryperipheraltcelllymphoma AT morschhauserf utilityof18fluorodeoxyglucosepositronemissiontomographyforprognosisandresponseassessmentsinaphase2studyofromidepsininpatientswithrelapsedorrefractoryperipheraltcelllymphoma AT pinterbrownl utilityof18fluorodeoxyglucosepositronemissiontomographyforprognosisandresponseassessmentsinaphase2studyofromidepsininpatientswithrelapsedorrefractoryperipheraltcelllymphoma AT iyersp utilityof18fluorodeoxyglucosepositronemissiontomographyforprognosisandresponseassessmentsinaphase2studyofromidepsininpatientswithrelapsedorrefractoryperipheraltcelllymphoma AT shustova utilityof18fluorodeoxyglucosepositronemissiontomographyforprognosisandresponseassessmentsinaphase2studyofromidepsininpatientswithrelapsedorrefractoryperipheraltcelllymphoma AT nicholsj utilityof18fluorodeoxyglucosepositronemissiontomographyforprognosisandresponseassessmentsinaphase2studyofromidepsininpatientswithrelapsedorrefractoryperipheraltcelllymphoma AT balserj utilityof18fluorodeoxyglucosepositronemissiontomographyforprognosisandresponseassessmentsinaphase2studyofromidepsininpatientswithrelapsedorrefractoryperipheraltcelllymphoma AT balserb utilityof18fluorodeoxyglucosepositronemissiontomographyforprognosisandresponseassessmentsinaphase2studyofromidepsininpatientswithrelapsedorrefractoryperipheraltcelllymphoma AT prob utilityof18fluorodeoxyglucosepositronemissiontomographyforprognosisandresponseassessmentsinaphase2studyofromidepsininpatientswithrelapsedorrefractoryperipheraltcelllymphoma |