Prognostic factors for survival with nab-paclitaxel plus gemcitabine in metastatic pancreatic cancer in real-life practice: the ANICE-PaC study

BackgroundTreatment with nab-paclitaxel plus gemcitabine increases survival in patients with metastatic pancreatic cancer. However, the assessment of treatment efficacy and safety in non-selected patients in a real-life setting may provide useful information to support decision-making processes in r...

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Autores: Fernández A, Salgado M, García A, Buxo, Elvira, Vera, Ruth, Adeva, Jorge, Jimenez-Fonseca, Paula, Quintero, Guillermo, Llorca, Cristina, Canabate, Mamen, Jesus Lopez, Luis, Munoz, Andres, Ramirez, Patricia, Gonzalez, Paula, Lopez, Carlos, Reboredo, Margarita, Gallardo, Elena, Sanchez-Canovas, Manuel, Gallego, Javier, Guillen, Carmen, Ruiz-Miravet, Nuria, Navarro-Perez, Victor, De la Camara, Juan, Ales-Diaz, Inmaculada, Antonio Pazo-Cid, Roberto, Carmona-Bayonas, Alberto
Formato: artículo
Estado:Versión publicada
Fecha de publicación:2018
País:España
Recursos:Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO)
Repositorio:r-FISABIO. Repositorio Institucional de Producción Científica
OAI Identifier:oai:fisabio.fundanetsuite.com:p2909
Acesso em linha:https://fisabio.portalinvestigacion.com/publicaciones/2909
Access Level:acceso abierto
Palavra-chave:Metastatic pancreatic adenocarcinoma
Gemcitabine
Nab-paclitaxel
Real-life
First-line chemotherapy
Survival
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spelling Prognostic factors for survival with nab-paclitaxel plus gemcitabine in metastatic pancreatic cancer in real-life practice: the ANICE-PaC studyFernández ASalgado MGarcía ABuxo, ElviraVera, RuthAdeva, JorgeJimenez-Fonseca, PaulaQuintero, GuillermoLlorca, CristinaCanabate, MamenJesus Lopez, LuisMunoz, AndresRamirez, PatriciaGonzalez, PaulaLopez, CarlosReboredo, MargaritaGallardo, ElenaSanchez-Canovas, ManuelGallego, JavierGuillen, CarmenRuiz-Miravet, NuriaNavarro-Perez, VictorDe la Camara, JuanAles-Diaz, InmaculadaAntonio Pazo-Cid, RobertoCarmona-Bayonas, AlbertoMetastatic pancreatic adenocarcinomaGemcitabineNab-paclitaxelReal-lifeFirst-line chemotherapySurvivalBackgroundTreatment with nab-paclitaxel plus gemcitabine increases survival in patients with metastatic pancreatic cancer. However, the assessment of treatment efficacy and safety in non-selected patients in a real-life setting may provide useful information to support decision-making processes in routine practice.MethodsRetrospective, multicenter study including patients with metastatic pancreatic cancer, who started first-line treatment with nab-paclitaxel plus gemcitabine between December 2013 and June 2015 according to routine clinical practice. In addition to describing the treatment pattern, overall survival (OS) and progression-free survival (PFS) were assessed for the total sample and the exploratory subgroups based on the treatment and patients' clinical characteristics.ResultsAll 210 eligible patients had a median age of 65.0years (range 37-81). Metastatic pancreatic adenocarcinoma was recurrent in 46 (21.9%) patients and de novo in 164 (78.1%); 38 (18%) patients had a biliary stent. At baseline, 33 (18.1%) patients had an ECOG performance status 2. Patients received a median of four cycles of treatment (range 1-21), with a median duration of 3.5months; 137 (65.2%) patients had a dose reduction of nab-paclitaxel and/or gemcitabine during treatment, and 33 (17.2%) discontinued treatment due to toxicity. Relative dose intensity (RDI) for nab-paclitaxel, gemcitabine, and the combined treatment was 66.7%. Median OS was 7.2months (95% CI 6.0-8.5), and median PFS was 5.0months (95% CI 4.3-5.9); 50 patients achieved either a partial or complete response (ORR 24.6%). OS was influenced by baseline ECOG PS, NLR and CA 19.9, but not by age70years and/or the presence of hepatobiliary stent or RDI <85%. All included variables, computed as dichotomous, showed a significant contribution to the Cox regression model to build a nomogram for predicting survival in these patients: baseline ECOG 0-1 vs. 2-3 (p=0.030), baseline NLR >3 vs. 3 (p=0.043), and baseline CA 19.9>37U/mL vs. 37U/mL (p=0.004).ConclusionsNab-Paclitaxel plus gemcitabine remain effective in a real-life setting, despite the high burden of dose reductions and poorer performance of these patients. A nomogram to predict survival using baseline ECOG performance status, NLR and CA 19.9 is proposed.BMC2018info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttps://fisabio.portalinvestigacion.com/publicaciones/2909BMC CANCERISSN: 14712407reponame:r-FISABIO. Repositorio Institucional de Producción Científicainstname:Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO)Inglésinfo:eu-repo/semantics/openAccessoai:fisabio.fundanetsuite.com:p29092026-06-11T12:45:17Z
dc.title.none.fl_str_mv Prognostic factors for survival with nab-paclitaxel plus gemcitabine in metastatic pancreatic cancer in real-life practice: the ANICE-PaC study
title Prognostic factors for survival with nab-paclitaxel plus gemcitabine in metastatic pancreatic cancer in real-life practice: the ANICE-PaC study
spellingShingle Prognostic factors for survival with nab-paclitaxel plus gemcitabine in metastatic pancreatic cancer in real-life practice: the ANICE-PaC study
Fernández A
Metastatic pancreatic adenocarcinoma
Gemcitabine
Nab-paclitaxel
Real-life
First-line chemotherapy
Survival
title_short Prognostic factors for survival with nab-paclitaxel plus gemcitabine in metastatic pancreatic cancer in real-life practice: the ANICE-PaC study
title_full Prognostic factors for survival with nab-paclitaxel plus gemcitabine in metastatic pancreatic cancer in real-life practice: the ANICE-PaC study
title_fullStr Prognostic factors for survival with nab-paclitaxel plus gemcitabine in metastatic pancreatic cancer in real-life practice: the ANICE-PaC study
title_full_unstemmed Prognostic factors for survival with nab-paclitaxel plus gemcitabine in metastatic pancreatic cancer in real-life practice: the ANICE-PaC study
title_sort Prognostic factors for survival with nab-paclitaxel plus gemcitabine in metastatic pancreatic cancer in real-life practice: the ANICE-PaC study
dc.creator.none.fl_str_mv Fernández A
Salgado M
García A
Buxo, Elvira
Vera, Ruth
Adeva, Jorge
Jimenez-Fonseca, Paula
Quintero, Guillermo
Llorca, Cristina
Canabate, Mamen
Jesus Lopez, Luis
Munoz, Andres
Ramirez, Patricia
Gonzalez, Paula
Lopez, Carlos
Reboredo, Margarita
Gallardo, Elena
Sanchez-Canovas, Manuel
Gallego, Javier
Guillen, Carmen
Ruiz-Miravet, Nuria
Navarro-Perez, Victor
De la Camara, Juan
Ales-Diaz, Inmaculada
Antonio Pazo-Cid, Roberto
Carmona-Bayonas, Alberto
author Fernández A
author_facet Fernández A
Salgado M
García A
Buxo, Elvira
Vera, Ruth
Adeva, Jorge
Jimenez-Fonseca, Paula
Quintero, Guillermo
Llorca, Cristina
Canabate, Mamen
Jesus Lopez, Luis
Munoz, Andres
Ramirez, Patricia
Gonzalez, Paula
Lopez, Carlos
Reboredo, Margarita
Gallardo, Elena
Sanchez-Canovas, Manuel
Gallego, Javier
Guillen, Carmen
Ruiz-Miravet, Nuria
Navarro-Perez, Victor
De la Camara, Juan
Ales-Diaz, Inmaculada
Antonio Pazo-Cid, Roberto
Carmona-Bayonas, Alberto
author_role author
author2 Salgado M
García A
Buxo, Elvira
Vera, Ruth
Adeva, Jorge
Jimenez-Fonseca, Paula
Quintero, Guillermo
Llorca, Cristina
Canabate, Mamen
Jesus Lopez, Luis
Munoz, Andres
Ramirez, Patricia
Gonzalez, Paula
Lopez, Carlos
Reboredo, Margarita
Gallardo, Elena
Sanchez-Canovas, Manuel
Gallego, Javier
Guillen, Carmen
Ruiz-Miravet, Nuria
Navarro-Perez, Victor
De la Camara, Juan
Ales-Diaz, Inmaculada
Antonio Pazo-Cid, Roberto
Carmona-Bayonas, Alberto
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv Metastatic pancreatic adenocarcinoma
Gemcitabine
Nab-paclitaxel
Real-life
First-line chemotherapy
Survival
topic Metastatic pancreatic adenocarcinoma
Gemcitabine
Nab-paclitaxel
Real-life
First-line chemotherapy
Survival
description BackgroundTreatment with nab-paclitaxel plus gemcitabine increases survival in patients with metastatic pancreatic cancer. However, the assessment of treatment efficacy and safety in non-selected patients in a real-life setting may provide useful information to support decision-making processes in routine practice.MethodsRetrospective, multicenter study including patients with metastatic pancreatic cancer, who started first-line treatment with nab-paclitaxel plus gemcitabine between December 2013 and June 2015 according to routine clinical practice. In addition to describing the treatment pattern, overall survival (OS) and progression-free survival (PFS) were assessed for the total sample and the exploratory subgroups based on the treatment and patients' clinical characteristics.ResultsAll 210 eligible patients had a median age of 65.0years (range 37-81). Metastatic pancreatic adenocarcinoma was recurrent in 46 (21.9%) patients and de novo in 164 (78.1%); 38 (18%) patients had a biliary stent. At baseline, 33 (18.1%) patients had an ECOG performance status 2. Patients received a median of four cycles of treatment (range 1-21), with a median duration of 3.5months; 137 (65.2%) patients had a dose reduction of nab-paclitaxel and/or gemcitabine during treatment, and 33 (17.2%) discontinued treatment due to toxicity. Relative dose intensity (RDI) for nab-paclitaxel, gemcitabine, and the combined treatment was 66.7%. Median OS was 7.2months (95% CI 6.0-8.5), and median PFS was 5.0months (95% CI 4.3-5.9); 50 patients achieved either a partial or complete response (ORR 24.6%). OS was influenced by baseline ECOG PS, NLR and CA 19.9, but not by age70years and/or the presence of hepatobiliary stent or RDI <85%. All included variables, computed as dichotomous, showed a significant contribution to the Cox regression model to build a nomogram for predicting survival in these patients: baseline ECOG 0-1 vs. 2-3 (p=0.030), baseline NLR >3 vs. 3 (p=0.043), and baseline CA 19.9>37U/mL vs. 37U/mL (p=0.004).ConclusionsNab-Paclitaxel plus gemcitabine remain effective in a real-life setting, despite the high burden of dose reductions and poorer performance of these patients. A nomogram to predict survival using baseline ECOG performance status, NLR and CA 19.9 is proposed.
publishDate 2018
dc.date.none.fl_str_mv 2018
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://fisabio.portalinvestigacion.com/publicaciones/2909
url https://fisabio.portalinvestigacion.com/publicaciones/2909
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv BMC
publisher.none.fl_str_mv BMC
dc.source.none.fl_str_mv BMC CANCER
ISSN: 14712407
reponame:r-FISABIO. Repositorio Institucional de Producción Científica
instname:Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO)
instname_str Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO)
reponame_str r-FISABIO. Repositorio Institucional de Producción Científica
collection r-FISABIO. Repositorio Institucional de Producción Científica
repository.name.fl_str_mv
repository.mail.fl_str_mv
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