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Tolerability of Nab-Paclitaxel Plus Gemcitabine as Adjuvant Setting in Japanese Patients With Resected Pancreatic Cancer: Phase I Study

OBJECTIVE: The combination of gemcitabine plus nab-paclitaxel (GnP) has not been studied in Japanese patients with resectable pancreatic cancer (PC). This study aimed to assess the tolerability of adjuvant GnP in Japanese patients with resected PC. METHODS: This was a Phase I, open-label, multicente...

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Autores principales: Ueno, Makoto, Morinaga, Soichiro, Hashimoto, Yusuke, Umemoto, Kumiko, Sasahira, Naoki, Saiura, Akio, Seyama, Yasuji, Honda, Goro, Ioka, Tatsuya, Takahashi, Hidenori, Miyamoto, Atsushi, Nakamori, Shoji, Unno, Michiaki, Takadate, Tatsuyuki, Mizuno, Nobumasa, Shimizu, Yasuhiro, Ueno, Hideki, Sugiyama, Masanori, Fukutomi, Akira, Shimizu, Satoshi, Okusaka, Takuji, Furuse, Junji
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Lippincott Williams & Wilkins 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7748052/
https://www.ncbi.nlm.nih.gov/pubmed/33370027
http://dx.doi.org/10.1097/MPA.0000000000001702
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author Ueno, Makoto
Morinaga, Soichiro
Hashimoto, Yusuke
Umemoto, Kumiko
Sasahira, Naoki
Saiura, Akio
Seyama, Yasuji
Honda, Goro
Ioka, Tatsuya
Takahashi, Hidenori
Miyamoto, Atsushi
Nakamori, Shoji
Unno, Michiaki
Takadate, Tatsuyuki
Mizuno, Nobumasa
Shimizu, Yasuhiro
Ueno, Hideki
Sugiyama, Masanori
Fukutomi, Akira
Shimizu, Satoshi
Okusaka, Takuji
Furuse, Junji
author_facet Ueno, Makoto
Morinaga, Soichiro
Hashimoto, Yusuke
Umemoto, Kumiko
Sasahira, Naoki
Saiura, Akio
Seyama, Yasuji
Honda, Goro
Ioka, Tatsuya
Takahashi, Hidenori
Miyamoto, Atsushi
Nakamori, Shoji
Unno, Michiaki
Takadate, Tatsuyuki
Mizuno, Nobumasa
Shimizu, Yasuhiro
Ueno, Hideki
Sugiyama, Masanori
Fukutomi, Akira
Shimizu, Satoshi
Okusaka, Takuji
Furuse, Junji
author_sort Ueno, Makoto
collection PubMed
description OBJECTIVE: The combination of gemcitabine plus nab-paclitaxel (GnP) has not been studied in Japanese patients with resectable pancreatic cancer (PC). This study aimed to assess the tolerability of adjuvant GnP in Japanese patients with resected PC. METHODS: This was a Phase I, open-label, multicenter, single-arm study of patients with resected PC in Japan. Patients received 125 mg/m(2) of nab-paclitaxel and 1000 mg/m(2) of gemcitabine on days 1, 8, and 15 of a 28-day cycle for a total of 6 cycles. The primary end point was tolerability, defined as the absence of specific grade 3 or higher treatment-related adverse events by the end of cycle 2. Secondary end points included safety, disease-free survival, and overall survival. RESULTS: Forty-one patients were enrolled between June 2016 and February 2017 (median age, 68 years; 51% male; stage II, 95%). Gemcitabine plus nab-paclitaxel met the tolerability criteria in 39 of the 40 patients included in the tolerability analysis set (97.5%). The most common treatment-related adverse events were leukopenia, neutropenia, alopecia, and peripheral sensory neuropathy. After a follow-up of 30.1 months, median disease-free survival was 17.0 months and median overall survival was not reached. CONCLUSIONS: These results show that adjuvant GnP is tolerable in Japanese patients with resected PC. Clinical Trial Registration No.: JapicCTI-163179
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spelling pubmed-77480522020-12-22 Tolerability of Nab-Paclitaxel Plus Gemcitabine as Adjuvant Setting in Japanese Patients With Resected Pancreatic Cancer: Phase I Study Ueno, Makoto Morinaga, Soichiro Hashimoto, Yusuke Umemoto, Kumiko Sasahira, Naoki Saiura, Akio Seyama, Yasuji Honda, Goro Ioka, Tatsuya Takahashi, Hidenori Miyamoto, Atsushi Nakamori, Shoji Unno, Michiaki Takadate, Tatsuyuki Mizuno, Nobumasa Shimizu, Yasuhiro Ueno, Hideki Sugiyama, Masanori Fukutomi, Akira Shimizu, Satoshi Okusaka, Takuji Furuse, Junji Pancreas Original Articles OBJECTIVE: The combination of gemcitabine plus nab-paclitaxel (GnP) has not been studied in Japanese patients with resectable pancreatic cancer (PC). This study aimed to assess the tolerability of adjuvant GnP in Japanese patients with resected PC. METHODS: This was a Phase I, open-label, multicenter, single-arm study of patients with resected PC in Japan. Patients received 125 mg/m(2) of nab-paclitaxel and 1000 mg/m(2) of gemcitabine on days 1, 8, and 15 of a 28-day cycle for a total of 6 cycles. The primary end point was tolerability, defined as the absence of specific grade 3 or higher treatment-related adverse events by the end of cycle 2. Secondary end points included safety, disease-free survival, and overall survival. RESULTS: Forty-one patients were enrolled between June 2016 and February 2017 (median age, 68 years; 51% male; stage II, 95%). Gemcitabine plus nab-paclitaxel met the tolerability criteria in 39 of the 40 patients included in the tolerability analysis set (97.5%). The most common treatment-related adverse events were leukopenia, neutropenia, alopecia, and peripheral sensory neuropathy. After a follow-up of 30.1 months, median disease-free survival was 17.0 months and median overall survival was not reached. CONCLUSIONS: These results show that adjuvant GnP is tolerable in Japanese patients with resected PC. Clinical Trial Registration No.: JapicCTI-163179 Lippincott Williams & Wilkins 2021-01 2020-12-09 /pmc/articles/PMC7748052/ /pubmed/33370027 http://dx.doi.org/10.1097/MPA.0000000000001702 Text en Copyright © 2020 The Author(s). Published by Wolters Kluwer Health, Inc. This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND) (http://creativecommons.org/licenses/by-nc-nd/4.0/) , where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.
spellingShingle Original Articles
Ueno, Makoto
Morinaga, Soichiro
Hashimoto, Yusuke
Umemoto, Kumiko
Sasahira, Naoki
Saiura, Akio
Seyama, Yasuji
Honda, Goro
Ioka, Tatsuya
Takahashi, Hidenori
Miyamoto, Atsushi
Nakamori, Shoji
Unno, Michiaki
Takadate, Tatsuyuki
Mizuno, Nobumasa
Shimizu, Yasuhiro
Ueno, Hideki
Sugiyama, Masanori
Fukutomi, Akira
Shimizu, Satoshi
Okusaka, Takuji
Furuse, Junji
Tolerability of Nab-Paclitaxel Plus Gemcitabine as Adjuvant Setting in Japanese Patients With Resected Pancreatic Cancer: Phase I Study
title Tolerability of Nab-Paclitaxel Plus Gemcitabine as Adjuvant Setting in Japanese Patients With Resected Pancreatic Cancer: Phase I Study
title_full Tolerability of Nab-Paclitaxel Plus Gemcitabine as Adjuvant Setting in Japanese Patients With Resected Pancreatic Cancer: Phase I Study
title_fullStr Tolerability of Nab-Paclitaxel Plus Gemcitabine as Adjuvant Setting in Japanese Patients With Resected Pancreatic Cancer: Phase I Study
title_full_unstemmed Tolerability of Nab-Paclitaxel Plus Gemcitabine as Adjuvant Setting in Japanese Patients With Resected Pancreatic Cancer: Phase I Study
title_short Tolerability of Nab-Paclitaxel Plus Gemcitabine as Adjuvant Setting in Japanese Patients With Resected Pancreatic Cancer: Phase I Study
title_sort tolerability of nab-paclitaxel plus gemcitabine as adjuvant setting in japanese patients with resected pancreatic cancer: phase i study
topic Original Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7748052/
https://www.ncbi.nlm.nih.gov/pubmed/33370027
http://dx.doi.org/10.1097/MPA.0000000000001702
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