Positron emission tomography response evaluation from a randomized phase III trial of weekly nab -paclitaxel plus gemcitabine versus gemcitabine alone for patients with metastatic adenocarcinoma of the pancreas

In a phase III pancreatic cancer study, tumor response by positron emission tomography (PET) (exploratory end point) predicted treatment efficacy, including longer overall survival. nab -Paclitaxel/gemcitabine had a significantly higher rate of metabolic response versus gemcitabine. Overall, 5× more...

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Autores: Ramanathan, R. K., Goldstein, D., Korn, R. L., Arena, F. P, Moore, M., Siena, S., Teixeira, L., Tabernero, Josep|||0000-0002-2495-8139, Van Laethem, J.-L., Liu, H., McGovern, D., Lu, B., Von Hoff, D. D.
Formato: artículo
Fecha de publicación:2016
País:España
Recursos:Universitat Autònoma de Barcelona
Repositorio:Dipòsit Digital de Documents de la UAB
Idioma:inglés
OAI Identifier:oai:ddd.uab.cat:185773
Acesso em linha:https://ddd.uab.cat/record/185773
https://dx.doi.org/urn:doi:10.1093/annonc/mdw020
Access Level:acceso abierto
Palavra-chave:Pancreatic cancer
Positron emission tomography
Nab -paclitaxel
Gemcitabine
Metabolic response
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spelling Positron emission tomography response evaluation from a randomized phase III trial of weekly nab -paclitaxel plus gemcitabine versus gemcitabine alone for patients with metastatic adenocarcinoma of the pancreasRamanathan, R. K.Goldstein, D.Korn, R. L.Arena, F. PMoore, M.Siena, S.Teixeira, L.Tabernero, Josep|||0000-0002-2495-8139Van Laethem, J.-L.Liu, H.McGovern, D.Lu, B.Von Hoff, D. D.Pancreatic cancerPositron emission tomographyNab -paclitaxelGemcitabineMetabolic responseIn a phase III pancreatic cancer study, tumor response by positron emission tomography (PET) (exploratory end point) predicted treatment efficacy, including longer overall survival. nab -Paclitaxel/gemcitabine had a significantly higher rate of metabolic response versus gemcitabine. Overall, 5× more patients had a metabolic response by PET compared with RECIST. PET may be a more sensitive measure of response than radiographic modalities. In the phase III MPACT trial, nab -paclitaxel plus gemcitabine (nab -P + Gem) demonstrated superior efficacy versus Gem alone for patients with metastatic pancreatic cancer. We sought to examine the feasibility of positron emission tomography (PET) and to compare metabolic response rates and associated correlations with efficacy in the MPACT trial. Patients with previously untreated metastatic adenocarcinoma of the pancreas were randomized 1:1 to receive nab -P + Gem or Gem alone. Treatment continued until disease progression by RECIST or unacceptable toxicity. PET scans were carried out on the first 257 patients enrolled at PET-equipped centers (PET cohort). Most patients (252 of 257) had ≥2 PET-avid lesions, and median maximum standardized uptake values at baseline were 4.6 and 4.5 in the nab -P + Gem and Gem-alone arms, respectively. In a pooled treatment arm analysis, a metabolic response by PET (best response at any time during study) was associated with longer overall survival (OS) (median 11.3 versus 6.9 months; HR, 0.56; P < 0.001). Efficacy results within each treatment arm appeared better for patients with a metabolic response. The metabolic response rate (best response and week 8 response) was higher for nab -P + Gem (best response: 72% versus 53%, P = 0.002; week 8: 67% versus 51%; P = 0.014). Efficacy in the PET cohort was greater for nab -P + Gem versus Gem alone, including for OS (median 10.5 versus 8.4 months; hazard ratio [HR], 0.71; P = 0.009) and ORR by RECIST (31% versus 11%; P < 0.001). Pancreatic lesions were PET avid at baseline, and the rate of metabolic response was significantly higher for nab -P + Gem versus Gem alone at week 8 and for best response during study. Having a metabolic response was associated with longer survival, and more patients experienced a metabolic response than a RECIST-defined response. NCT00844649.Universitat Autònoma de Barcelona 22016-01-0120162016-01-01Articlehttp://purl.org/coar/resource_type/c_6501VoRhttp://purl.org/coar/version/c_970fb48d4fbd8a85info:eu-repo/semantics/articleapplication/pdfhttps://ddd.uab.cat/record/185773https://dx.doi.org/urn:doi:10.1093/annonc/mdw020reponame:Dipòsit Digital de Documents de la UABinstname:Universitat Autònoma de BarcelonaInglésengopen accesshttp://purl.org/coar/access_right/c_abf2Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original.https://creativecommons.org/licenses/by-nc/4.0/info:eu-repo/semantics/openAccessoai:ddd.uab.cat:1857732026-06-06T12:50:31Z
dc.title.none.fl_str_mv Positron emission tomography response evaluation from a randomized phase III trial of weekly nab -paclitaxel plus gemcitabine versus gemcitabine alone for patients with metastatic adenocarcinoma of the pancreas
title Positron emission tomography response evaluation from a randomized phase III trial of weekly nab -paclitaxel plus gemcitabine versus gemcitabine alone for patients with metastatic adenocarcinoma of the pancreas
spellingShingle Positron emission tomography response evaluation from a randomized phase III trial of weekly nab -paclitaxel plus gemcitabine versus gemcitabine alone for patients with metastatic adenocarcinoma of the pancreas
Ramanathan, R. K.
Pancreatic cancer
Positron emission tomography
Nab -paclitaxel
Gemcitabine
Metabolic response
title_short Positron emission tomography response evaluation from a randomized phase III trial of weekly nab -paclitaxel plus gemcitabine versus gemcitabine alone for patients with metastatic adenocarcinoma of the pancreas
title_full Positron emission tomography response evaluation from a randomized phase III trial of weekly nab -paclitaxel plus gemcitabine versus gemcitabine alone for patients with metastatic adenocarcinoma of the pancreas
title_fullStr Positron emission tomography response evaluation from a randomized phase III trial of weekly nab -paclitaxel plus gemcitabine versus gemcitabine alone for patients with metastatic adenocarcinoma of the pancreas
title_full_unstemmed Positron emission tomography response evaluation from a randomized phase III trial of weekly nab -paclitaxel plus gemcitabine versus gemcitabine alone for patients with metastatic adenocarcinoma of the pancreas
title_sort Positron emission tomography response evaluation from a randomized phase III trial of weekly nab -paclitaxel plus gemcitabine versus gemcitabine alone for patients with metastatic adenocarcinoma of the pancreas
dc.creator.none.fl_str_mv Ramanathan, R. K.
Goldstein, D.
Korn, R. L.
Arena, F. P
Moore, M.
Siena, S.
Teixeira, L.
Tabernero, Josep|||0000-0002-2495-8139
Van Laethem, J.-L.
Liu, H.
McGovern, D.
Lu, B.
Von Hoff, D. D.
author Ramanathan, R. K.
author_facet Ramanathan, R. K.
Goldstein, D.
Korn, R. L.
Arena, F. P
Moore, M.
Siena, S.
Teixeira, L.
Tabernero, Josep|||0000-0002-2495-8139
Van Laethem, J.-L.
Liu, H.
McGovern, D.
Lu, B.
Von Hoff, D. D.
author_role author
author2 Goldstein, D.
Korn, R. L.
Arena, F. P
Moore, M.
Siena, S.
Teixeira, L.
Tabernero, Josep|||0000-0002-2495-8139
Van Laethem, J.-L.
Liu, H.
McGovern, D.
Lu, B.
Von Hoff, D. D.
author2_role author
author
author
author
author
author
author
author
author
author
author
author
dc.contributor.none.fl_str_mv Universitat Autònoma de Barcelona
dc.subject.none.fl_str_mv Pancreatic cancer
Positron emission tomography
Nab -paclitaxel
Gemcitabine
Metabolic response
topic Pancreatic cancer
Positron emission tomography
Nab -paclitaxel
Gemcitabine
Metabolic response
description In a phase III pancreatic cancer study, tumor response by positron emission tomography (PET) (exploratory end point) predicted treatment efficacy, including longer overall survival. nab -Paclitaxel/gemcitabine had a significantly higher rate of metabolic response versus gemcitabine. Overall, 5× more patients had a metabolic response by PET compared with RECIST. PET may be a more sensitive measure of response than radiographic modalities. In the phase III MPACT trial, nab -paclitaxel plus gemcitabine (nab -P + Gem) demonstrated superior efficacy versus Gem alone for patients with metastatic pancreatic cancer. We sought to examine the feasibility of positron emission tomography (PET) and to compare metabolic response rates and associated correlations with efficacy in the MPACT trial. Patients with previously untreated metastatic adenocarcinoma of the pancreas were randomized 1:1 to receive nab -P + Gem or Gem alone. Treatment continued until disease progression by RECIST or unacceptable toxicity. PET scans were carried out on the first 257 patients enrolled at PET-equipped centers (PET cohort). Most patients (252 of 257) had ≥2 PET-avid lesions, and median maximum standardized uptake values at baseline were 4.6 and 4.5 in the nab -P + Gem and Gem-alone arms, respectively. In a pooled treatment arm analysis, a metabolic response by PET (best response at any time during study) was associated with longer overall survival (OS) (median 11.3 versus 6.9 months; HR, 0.56; P < 0.001). Efficacy results within each treatment arm appeared better for patients with a metabolic response. The metabolic response rate (best response and week 8 response) was higher for nab -P + Gem (best response: 72% versus 53%, P = 0.002; week 8: 67% versus 51%; P = 0.014). Efficacy in the PET cohort was greater for nab -P + Gem versus Gem alone, including for OS (median 10.5 versus 8.4 months; hazard ratio [HR], 0.71; P = 0.009) and ORR by RECIST (31% versus 11%; P < 0.001). Pancreatic lesions were PET avid at baseline, and the rate of metabolic response was significantly higher for nab -P + Gem versus Gem alone at week 8 and for best response during study. Having a metabolic response was associated with longer survival, and more patients experienced a metabolic response than a RECIST-defined response. NCT00844649.
publishDate 2016
dc.date.none.fl_str_mv 2
2016-01-01
2016
2016-01-01
dc.type.none.fl_str_mv Article
http://purl.org/coar/resource_type/c_6501
VoR
http://purl.org/coar/version/c_970fb48d4fbd8a85
dc.type.openaire.fl_str_mv info:eu-repo/semantics/article
format article
dc.identifier.none.fl_str_mv https://ddd.uab.cat/record/185773
https://dx.doi.org/urn:doi:10.1093/annonc/mdw020
url https://ddd.uab.cat/record/185773
https://dx.doi.org/urn:doi:10.1093/annonc/mdw020
dc.language.none.fl_str_mv Inglés
eng
language_invalid_str_mv Inglés
language eng
dc.rights.none.fl_str_mv open access
http://purl.org/coar/access_right/c_abf2
https://creativecommons.org/licenses/by-nc/4.0/
dc.rights.openaire.fl_str_mv info:eu-repo/semantics/openAccess
rights_invalid_str_mv open access
http://purl.org/coar/access_right/c_abf2
https://creativecommons.org/licenses/by-nc/4.0/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.source.none.fl_str_mv reponame:Dipòsit Digital de Documents de la UAB
instname:Universitat Autònoma de Barcelona
instname_str Universitat Autònoma de Barcelona
reponame_str Dipòsit Digital de Documents de la UAB
collection Dipòsit Digital de Documents de la UAB
repository.name.fl_str_mv
repository.mail.fl_str_mv
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