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Gemcitabine plus Nab-paclitaxel as a second-line treatment following FOLFIRINOX failure in advanced pancreatic cancer: a multicenter, single-arm, open-label, phase 2 trial

BACKGROUND: The aim of this study was to evaluate the efficacy and safety of gemcitabine plus nab-paclitaxel (GnP) as second-line chemotherapy following first-line FOLFIRINOX treatment failure in advanced pancreatic cancer. METHODS: This was a multicenter, single-arm, open-label, phase 2 trial done...

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Autores principales: Huh, Gunn, Lee, Hee Seung, Choi, Jin Ho, Lee, Sang Hyub, Paik, Woo Hyun, Ryu, Ji Kon, Kim, Yong-Tae, Bang, Seungmin, Lee, Eaum Seok
Formato: Online Artículo Texto
Lenguaje:English
Publicado: SAGE Publications 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8591648/
https://www.ncbi.nlm.nih.gov/pubmed/34790261
http://dx.doi.org/10.1177/17588359211056179
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author Huh, Gunn
Lee, Hee Seung
Choi, Jin Ho
Lee, Sang Hyub
Paik, Woo Hyun
Ryu, Ji Kon
Kim, Yong-Tae
Bang, Seungmin
Lee, Eaum Seok
author_facet Huh, Gunn
Lee, Hee Seung
Choi, Jin Ho
Lee, Sang Hyub
Paik, Woo Hyun
Ryu, Ji Kon
Kim, Yong-Tae
Bang, Seungmin
Lee, Eaum Seok
author_sort Huh, Gunn
collection PubMed
description BACKGROUND: The aim of this study was to evaluate the efficacy and safety of gemcitabine plus nab-paclitaxel (GnP) as second-line chemotherapy following first-line FOLFIRINOX treatment failure in advanced pancreatic cancer. METHODS: This was a multicenter, single-arm, open-label, phase 2 trial done at three tertiary centers in South Korea from May 2018 to December 2019. Eligible patients were aged 20 years or older, had histologically confirmed advanced pancreatic ductal adenocarcinoma, and disease progression after receiving first-line FOLFIRINOX. Patients received a second-line GnP regimen as intravenous nab-paclitaxel at a dose of 125 mg/m(2) and gemcitabine at a dose of 1000 mg/m(2), on days 1, 8, and 15 every 4 weeks until disease progression or unacceptable toxicity. The primary outcome was survival rate at 6 months and the secondary outcomes were median progression-free survival (PFS), overall survival (OS), disease control rate (DCR), and adverse events. This study is registered with Clinicaltrials.gov. (NCT03401827) RESULTS: Forty patients were enrolled in the study. The survival rate at 6 months was 72.5% [95% confidence interval (CI), 59.9–87.7], achieving superiority over prespecified assumed 6-month OS rate of 20% for best supportive care only (p < 0.001). The median PFS and OS were 5.8 months (95% CI, 4.3–8.7) and 9.9 months (95% CI, 7.5–12.4), respectively. DCR was 87.5% with six partial responses and 29 stable diseases. Grade 3 or higher treatment-related adverse events occurred in 25 (62.5%) patients with the most common being thrombocytopenia, anemia, neutropenia, peripheral neuropathy, and peripheral edema. CONCLUSION: GnP demonstrated favorable efficacy with acceptable toxicity in patients with advanced pancreatic ductal adenocarcinoma after FOLFIRINOX failure.
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spelling pubmed-85916482021-11-16 Gemcitabine plus Nab-paclitaxel as a second-line treatment following FOLFIRINOX failure in advanced pancreatic cancer: a multicenter, single-arm, open-label, phase 2 trial Huh, Gunn Lee, Hee Seung Choi, Jin Ho Lee, Sang Hyub Paik, Woo Hyun Ryu, Ji Kon Kim, Yong-Tae Bang, Seungmin Lee, Eaum Seok Ther Adv Med Oncol Original Research BACKGROUND: The aim of this study was to evaluate the efficacy and safety of gemcitabine plus nab-paclitaxel (GnP) as second-line chemotherapy following first-line FOLFIRINOX treatment failure in advanced pancreatic cancer. METHODS: This was a multicenter, single-arm, open-label, phase 2 trial done at three tertiary centers in South Korea from May 2018 to December 2019. Eligible patients were aged 20 years or older, had histologically confirmed advanced pancreatic ductal adenocarcinoma, and disease progression after receiving first-line FOLFIRINOX. Patients received a second-line GnP regimen as intravenous nab-paclitaxel at a dose of 125 mg/m(2) and gemcitabine at a dose of 1000 mg/m(2), on days 1, 8, and 15 every 4 weeks until disease progression or unacceptable toxicity. The primary outcome was survival rate at 6 months and the secondary outcomes were median progression-free survival (PFS), overall survival (OS), disease control rate (DCR), and adverse events. This study is registered with Clinicaltrials.gov. (NCT03401827) RESULTS: Forty patients were enrolled in the study. The survival rate at 6 months was 72.5% [95% confidence interval (CI), 59.9–87.7], achieving superiority over prespecified assumed 6-month OS rate of 20% for best supportive care only (p < 0.001). The median PFS and OS were 5.8 months (95% CI, 4.3–8.7) and 9.9 months (95% CI, 7.5–12.4), respectively. DCR was 87.5% with six partial responses and 29 stable diseases. Grade 3 or higher treatment-related adverse events occurred in 25 (62.5%) patients with the most common being thrombocytopenia, anemia, neutropenia, peripheral neuropathy, and peripheral edema. CONCLUSION: GnP demonstrated favorable efficacy with acceptable toxicity in patients with advanced pancreatic ductal adenocarcinoma after FOLFIRINOX failure. SAGE Publications 2021-11-10 /pmc/articles/PMC8591648/ /pubmed/34790261 http://dx.doi.org/10.1177/17588359211056179 Text en © The Author(s), 2021 https://creativecommons.org/licenses/by-nc/4.0/This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License (https://creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages (https://us.sagepub.com/en-us/nam/open-access-at-sage).
spellingShingle Original Research
Huh, Gunn
Lee, Hee Seung
Choi, Jin Ho
Lee, Sang Hyub
Paik, Woo Hyun
Ryu, Ji Kon
Kim, Yong-Tae
Bang, Seungmin
Lee, Eaum Seok
Gemcitabine plus Nab-paclitaxel as a second-line treatment following FOLFIRINOX failure in advanced pancreatic cancer: a multicenter, single-arm, open-label, phase 2 trial
title Gemcitabine plus Nab-paclitaxel as a second-line treatment following FOLFIRINOX failure in advanced pancreatic cancer: a multicenter, single-arm, open-label, phase 2 trial
title_full Gemcitabine plus Nab-paclitaxel as a second-line treatment following FOLFIRINOX failure in advanced pancreatic cancer: a multicenter, single-arm, open-label, phase 2 trial
title_fullStr Gemcitabine plus Nab-paclitaxel as a second-line treatment following FOLFIRINOX failure in advanced pancreatic cancer: a multicenter, single-arm, open-label, phase 2 trial
title_full_unstemmed Gemcitabine plus Nab-paclitaxel as a second-line treatment following FOLFIRINOX failure in advanced pancreatic cancer: a multicenter, single-arm, open-label, phase 2 trial
title_short Gemcitabine plus Nab-paclitaxel as a second-line treatment following FOLFIRINOX failure in advanced pancreatic cancer: a multicenter, single-arm, open-label, phase 2 trial
title_sort gemcitabine plus nab-paclitaxel as a second-line treatment following folfirinox failure in advanced pancreatic cancer: a multicenter, single-arm, open-label, phase 2 trial
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8591648/
https://www.ncbi.nlm.nih.gov/pubmed/34790261
http://dx.doi.org/10.1177/17588359211056179
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