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

Aged Albumins / adverse effects Antineoplastic Combined Chemotherapy Protocols / adverse effects Carcinoma, Pancreatic Ductal / mortality Chemotherapy, Adjuvant Deoxycytidine / adverse effects Disease Progression Disease-Free Survival Female Humans Japan Male Middle Aged Paclitaxel / adverse effects Pancreatectomy / adverse effects Pancreatic Neoplasms / mortality Time Factors Gemcitabine

Journal

Pancreas

ISSN: 1536-4828

Titre abrégé: Pancreas

Pays: United States

ID NLM: 8608542

Informations de publication

Date de publication:
01 01 2021

Historique:

entrez: 28 12 2020

pubmed: 29 12 2020

medline: 15 12 2021

Statut: ppublish

Résumé

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. 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. 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. These results show that adjuvant GnP is tolerable in Japanese patients with resected PC.Clinical Trial Registration No.: JapicCTI-163179.

Identifiants

DOI: 10.1097/MPA.0000000000001702 PMID: 33370027 PMC: PMC7748052

pubmed: 33370027

doi: 10.1097/MPA.0000000000001702

pii: 00006676-202101000-00012

pmc: PMC7748052

doi:

Substances chimiques

130-nm albumin-bound paclitaxel 0

Albumins 0

Deoxycytidine 0W860991D6

Paclitaxel P88XT4IS4D

Gemcitabine 0

Banques de données

JapicCTI

['JapicCTI-163179']

Types de publication

Clinical Trial, Phase I Journal Article Multicenter Study Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

Pagination

83-88

Informations de copyright

Déclaration de conflit d'intérêts

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, 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.

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