Phase I Study of Nab-Paclitaxel plus Gemcitabine as Neoadjuvant Therapy for Borderline Resectable Pancreatic Cancer

The aim of this study was to investigate the safety and feasibility of neoadjuvant nab-paclitaxel plus gemcitabine therapy for patients with borderline resectable pancreatic carcinoma (BRPC). The study was a prospective single-center phase I trial for patients with BRPC. The primary endpoint was the...

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Bibliographic Details
Published in:Anticancer research 2017-02, Vol.37 (2), p.853-858
Main Authors: Okada, Ken-Ichi, Hirono, Seiko, Kawai, Manabu, Miyazawa, Motoki, Shimizu, Atsushi, Kitahata, Yuji, Ueno, Masaki, Hayami, Shinya, Yamaue, Hiroki
Format: Article
Language:English
Subjects:
Aged
Albumins - administration & dosage
Albumins - adverse effects
Alopecia - chemically induced
Antineoplastic Combined Chemotherapy Protocols - adverse effects
Antineoplastic Combined Chemotherapy Protocols - therapeutic use
Combined Modality Therapy
Deoxycytidine - administration & dosage
Deoxycytidine - adverse effects
Deoxycytidine - analogs & derivatives
Feasibility Studies
Female
Humans
Leukopenia - chemically induced
Male
Middle Aged
Neoadjuvant Therapy
Neutropenia - chemically induced
Paclitaxel - administration & dosage
Paclitaxel - adverse effects
Pancreatic Neoplasms - drug therapy
Pancreatic Neoplasms - pathology
Pancreatic Neoplasms - surgery
Prospective Studies
Treatment Outcome
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Summary:The aim of this study was to investigate the safety and feasibility of neoadjuvant nab-paclitaxel plus gemcitabine therapy for patients with borderline resectable pancreatic carcinoma (BRPC). The study was a prospective single-center phase I trial for patients with BRPC. The primary endpoint was the toxicity, and secondary endpoints were the resection rate, the R0 resection rate and quality of life (QOL) regarding the peripheral sensory neuropathy (PSN). This trial was registered on the UMIN Clinical Trials Registry (UMIN000018382) and on ClinicalTrials.gov (NCT02506803). The overall rate of any grade and grade 3-4 events (CTCAE ver. 4.0 criteria) were 100% and 90%. The majority of these adverse events represented expected neutropenia. The resection and R0 resection rates were 80% and 70%, respectively. We found that neoadjuvant nab-paclitaxel plus gemcitabine therapy was safe and feasible without stringent selection of patients with BRPC.
ISSN:0250-7005
1791-7530
DOI:10.21873/anticanres.11389