Abstract
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/m2 of nab-paclitaxel and 1000 mg/m2 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
Original language | English |
---|---|
Pages (from-to) | 83-88 |
Number of pages | 6 |
Journal | Pancreas |
Volume | 50 |
Issue number | 1 |
DOIs | |
Publication status | Published - 2021 |
Externally published | Yes |
Keywords
- ABI-007
- GnP
- PDAC
- albumin-bound paclitaxel
- pancreatic ductal adenocarcinoma
- resectable
ASJC Scopus subject areas
- Internal Medicine
- Endocrinology, Diabetes and Metabolism
- Hepatology
- Endocrinology
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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.
In: Pancreas, Vol. 50, No. 1, 2021, p. 83-88.Research output: Contribution to journal › Article › peer-review
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TY - JOUR
T1 - Tolerability of Nab-Paclitaxel plus Gemcitabine as Adjuvant Setting in Japanese Patients with Resected Pancreatic Cancer
T2 - Phase i Study
AU - Ueno, Makoto
AU - Morinaga, Soichiro
AU - Hashimoto, Yusuke
AU - Umemoto, Kumiko
AU - Sasahira, Naoki
AU - Saiura, Akio
AU - Seyama, Yasuji
AU - Honda, Goro
AU - Ioka, Tatsuya
AU - Takahashi, Hidenori
AU - Miyamoto, Atsushi
AU - Nakamori, Shoji
AU - Unno, Michiaki
AU - Takadate, Tatsuyuki
AU - Mizuno, Nobumasa
AU - Shimizu, Yasuhiro
AU - Ueno, Hideki
AU - Sugiyama, Masanori
AU - Fukutomi, Akira
AU - Shimizu, Satoshi
AU - Okusaka, Takuji
AU - Furuse, Junji
N1 - Funding Information: From the *Department of Gastroenterology, Hepatobiliary and Pancreatic Medical Oncology Division, Kanagawa Cancer Center; †Department of Gastrointestinal Surgery, Kanagawa Cancer Center, Yokohama; ‡Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, Kashiwa; §Department of Hepatobiliary and Pancreatic Medicine, Cancer Institute Hospital of Japanese Foundation for Cancer Research; ||Department of Hepatobiliary and Pancreatic Surgery, Cancer Institute Hospital of Japanese Foundation for Cancer Research; ¶Division of Hepato-Biliary-Pancreatic Surgery, Department of Surgery, and #Department of Surgery, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo; Departments of **Cancer Survey and Gastrointestinal Oncology and ††Gastroenterological Surgery, Osaka International Cancer Institute; ‡‡Department of Surgery, National Hospital Organization Osaka National Hospital, Osaka; §§Department of Surgery, Tohoku University Graduate School of Medicine, Miyagi; Departments of ||||Gastroenterology and ¶¶Gastroenterological Surgery, Aichi Cancer Center Hospital, Nagoya; ##Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Tokyo; ***Department of Surgery, Kyorin University, School of Medicine, Mitaka; †††Division of Gastrointestinal Oncology, Shizuoka Cancer Center, Shizuoka; ‡‡‡Department of Gastroenterology, Saitama Cancer Center, Saitama; and §§§Department of Medical Oncology, Kyorin University Faculty of Medicine, Mitaka, Japan. Received for publication May 28, 2020; accepted October 23, 2020. Address correspondence to: Makoto Ueno, MD, Department of Gastroenterology, Hepatobiliary and Pancreatic Medical Oncology Division, Kanagawa Cancer Center, 2-3-2 Nakao, Asahi-ku, Yokohama, Kanagawa 241-8515, Japan (e‐mail: uenom@kcch.jp). M.U. has received grants from NanoCarrier Co, Ltd, Dainippon Sumitomo Pharma Co, Ltd, and Yakult Honsha Co, Ltd, and honoraria or payment for lectures (including speakers bureaus) for Ono Pharmaceutical Co, Ltd, Merck Biopharma Co, Ltd, and AstraZeneca K.K., is currently receiving grant funding from Taiho Pharmaceutical Co, Ltd, Eisai Co, Ltd, AstraZeneca K.K., Ono Pharmaceutical Co, Ltd, MSD K.K., Merck Biopharma Co, Ltd, Incyte, and Astellas Pharma, Inc, and is currently receiving honoraria or payment for lectures fees from Taiho Pharmaceutical Co, Ltd, Yakult Honsha Co, Ltd, and AstraZeneca K.K. Y.H. has received grants, honoraria, and payment for lectures including service on speakers bureaus for Taiho Pharmaceutical Co, Ltd, and is currently receiving grant funding from Takara Bio, Inc, and IBM, honoraria or payment for lectures (including speakers bureaus) from Medico's Hirata, Inc, and Boston Scientific and consulting fees from Zeon Medical, Inc, and Medico's Hirata, Inc. N.S. has received grants from AstraZeneca K.K., Chugai Pharmaceutical Co, Ltd, Daiichi Sankyo Co, Ltd, Eisai Co, Ltd, Shionogi & Co, Ltd, Sumitomo Dainippon Pharma Co, Ltd, Taiho Pharmaceutical Co, Ltd, Teijin Pharma Limited, and Yakult Honsha Co, Ltd, and has received honoraria or payment for lectures (including speakers bureaus) from Boston Scientific, Cook Medical, EA Pharma Co, Ltd, Eisai Co, Ltd, Kawasumi Laboratories, Inc, and Taiho Pharmaceutical Co, Ltd A.S. has received and is currently receiving grants from Johnson & Johnson K.K., Senko Medical Instrument Mfg Co, Ltd, and Covidien Japan, Inc. G.H. has received honoraria or payments for lectures including service on speakers bureaus from Ethicon, Inc, Medtronic, Olympus Corporation, Taiho Pharmaceutical Co, Ltd, Intuitive Surgical, and Kaken Pharmaceutical Co, Ltd. T.I. has received grants from Nippon Zoki Pharmaceutical Co, Ltd, Eisai Co, Ltd, and Shire, honoraria or payment for lectures (including speakers bureaus) from Taiho Pharmaceutical Co, Ltd, Daiichi Sankyo Co, Ltd, Chugai Pharmaceutical Co, Ltd, Nippon Kayaku Co, Ltd, Yakult Honsha Co, Ltd, and Shire, consulting fees from Taiho Pharmaceutical Co, Ltd, and Otsuka Pharmaceutical Co, Ltd, and funding to meet travel and/or accommodation and other meeting expenses from Shire, and is currently receiving the following: grants from Sumitomo Dainippon Pharma Co, Ltd, Funding Information: Taiho Pharmaceutical Co, Ltd, AstraZeneca K.K., Astellas Pharma, Inc, Takara Bio, Inc, and Incyte; honoraria or payment for lectures (including speakers bureaus) from Taiho Pharmaceutical Co, Ltd, Chugai Pharmaceutical Co, Ltd, Nihon Servier, and Yakult Honsha Co, Ltd, consulting fees from Taiho Pharmaceutical Co, Ltd, and Otsuka Pharmaceutical Co, Ltd. M.U. has received and is currently receiving grants from Taiho Pharmaceutical Co, Ltd, Chugai Pharmaceutical Co, Ltd, Takeda Pharmaceutical Company Limited, and MSD K.K., and honoraria or payment for lectures (including speakers bureaus) from Taiho Pharmaceutical Co, Ltd. N.M. has received grants from Taiho Pharmaceutical Co, Ltd, AstraZeneca K.K., NanoCarrier Co, Ltd, Eisai Co, Ltd, ASLAN Pharmaceuticals, Pharma Valley Center, Yakult Honsha Co, Ltd, Novartis Pharma K.K., MSD K.K., Sumitomo Dainippon Pharma Co, Ltd, and Incyte, and honoraria or payment for lectures (including speakers bureaus) from Taiho Pharmaceutical Co, Ltd, Teijin Pharma Limited, Yakult Honsha Co, Ltd, MSD K.K., and Novartis Pharma K.K., and has received consulting fees from Teijin Pharma Ltd, and is currently receiving grants from MSD K.K., Sumitomo Dainippon Pharma Co, Ltd, and Incyte. A.F. has received grants from Taiho Pharmaceutical Co, Ltd, Teijin Pharma Ltd, and NanoCarrier Co, Ltd, and honoraria or payment for lectures (including speakers bureaus) from Taiho Pharmaceutical Co, Ltd, Yakult Honsha Co, Ltd, and Shire and is currently receiving grants from ASLAN Pharmaceuticals, Sumitomo Dainippon Pharma Co, Ltd, Yakult Honsha Co, Ltd, Incyte, Eisai Co, Ltd, and J-Pharma Co, Ltd. S.S. has received grants from Yakult Honsha Co, Ltd, and Sumitomo Dainippon Pharma Co, Ltd, and is currently receiving grants from AstraZeneca K.K. and Incyte. T.O. has received grants and is currently receiving grants from AstraZeneca K.K., Chugai Pharmaceutical Co, Ltd, Eisai Co, Ltd, Novartis Pharma K.K., and Bristol-Myers Squibb K.K. and has received consulting fees from Taiho Pharmaceutical Co, Ltd. J.F. has received grants from NanoCarrier Co, Ltd, and is currently receiving grants from Ono Pharmaceutical Co, Ltd, MSD K.K., Sumitomo Dainippon Pharma Co, Ltd, J-Pharma Co, Ltd, Yakult Honsha Co, Ltd, AstraZeneca K.K., Daiichi Sankyo Co, Ltd, Eisai Co, Ltd, Bayer Yakuhin, Ltd, Pfizer Japan, Inc, Kyowa Kirin Co, Ltd, Taiho Pharmaceutical Co, Ltd, Chugai Pharmaceutical Co, Ltd, Sanofi K.K., Takeda Pharmaceutical Company Limited, Mochida Pharmaceutical Co, Ltd, Astellas Pharma, Inc, and Eli Lilly Japan K.K. and has received honoraria or payment for lectures (including speakers bureaus) from Eisai Co, Ltd, Bayer Yakuhin, Ltd, Taiho Pharmaceutical Co, Ltd, Ono Pharmaceutical Co, Ltd, Novartis Pharma K.K., Yakult Honsha Co, Ltd, Teijin Pharma Ltd, Shionogi & Co, Ltd, EA Pharma Co, Ltd, Eli Lilly Japan K.K., Takeda Pharmaceutical Col, Ltd, Chugai Pharmaceutical Co, Ltd, Mochida Pharmaceutical Co, Ltd, Nihon Servier, Sanofi K.K., FUJIFILM Toyama Chemical Co, Ltd, Nobelpharma Co, Ltd, Pfizer Japan, Inc, Sawai Pharmaceutical Co, Ltd, Daiichi Sankyo Co, Ltd, Sumitomo Dainippon Pharma Co, Ltd, Merck Serono Co, Ltd, Nippon Kayaku Co, Ltd, MSD K.K., Shire, and Kyowa Hakko Kirin Co, Ltd, and is currently receiving consulting fees from Eisai Co, Ltd, FUJIFILM Corporation, Ono Pharmaceutical Co, Ltd, Yakult Honsha Co, Ltd, MSD K.K., Merck Biopharma Co, Ltd, J-Pharma Co, Ltd, MSD K.K., Chugai Pharmaceutical Co, Ltd, Taiho Pharmaceutical Co, Ltd, Nihon Servier, AstraZeneca K.K., Abbvie, Inc, and Astellas Pharma, Inc. The other authors declare no conflict of interest. Funding Information: Funding for this clinical trial was received from Taiho Pharmaceutical Co, Ltd, via grants provided to the institutions of each author. Funding Information: The authors thank all the patients, their families, the investigators who participated in this study, our medical adviser Atsushi Sato, and the data and safety monitoring committee composed of Kazuo Tamura, Keisuke Aiba, and Yusuke Tanigawara. The authors also thank Katsuhiko Murakami of Taiho Pharmaceutical Co, Ltd, for the support in completing this study, and Sheridan Henness, PhD, on behalf of inScience Communications, Springer Healthcare, who wrote the first draft of the manuscript under the direction of the authors. This medical writing assistance was funded by Taiho Pharmaceutical Co, Ltd. Publisher Copyright: © Wolters Kluwer Health, Inc. All rights reserved.
PY - 2021
Y1 - 2021
N2 - 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/m2 of nab-paclitaxel and 1000 mg/m2 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
AB - 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/m2 of nab-paclitaxel and 1000 mg/m2 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
KW - ABI-007
KW - GnP
KW - PDAC
KW - albumin-bound paclitaxel
KW - pancreatic ductal adenocarcinoma
KW - resectable
UR - http://www.scopus.com/inward/record.url?scp=85098112131&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85098112131&partnerID=8YFLogxK
U2 - 10.1097/MPA.0000000000001702
DO - 10.1097/MPA.0000000000001702
M3 - Article
C2 - 33370027
AN - SCOPUS:85098112131
VL - 50
SP - 83
EP - 88
JO - Pancreas
JF - Pancreas
SN - 0885-3177
IS - 1
ER -