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 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.
Second Department of Surgery, Wakayama Medical University, Wakayama, Japan.
Ken-Ichi
KI
Okada
Second Department of Surgery, Wakayama Medical University, Wakayama, Japan.
Seiko
S
Hirono
Second Department of Surgery, Wakayama Medical University, Wakayama, Japan.
Manabu
M
Kawai
Second Department of Surgery, Wakayama Medical University, Wakayama, Japan.
Motoki
M
Miyazawa
Second Department of Surgery, Wakayama Medical University, Wakayama, Japan.
Atsushi
A
Shimizu
Second Department of Surgery, Wakayama Medical University, Wakayama, Japan.
Yuji
Y
Kitahata
Second Department of Surgery, Wakayama Medical University, Wakayama, Japan.
Masaki
M
Ueno
Second Department of Surgery, Wakayama Medical University, Wakayama, Japan.
Shinya
S
Hayami
Second Department of Surgery, Wakayama Medical University, Wakayama, Japan yamaue-h@wakayama-med.ac.jp.
Hiroki
H
Yamaue
D000368:Aged; D000418:Albumins / Q000008:administration & dosage / Q000009:adverse effects; D000505:Alopecia / Q000139:chemically induced; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D007970:Leukopenia / Q000139:chemically induced; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D009503:Neutropenia / Q000139:chemically induced; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D011446:Prospective Studies; D016896:Treatment Outcome; D000093542:Gemcitabine
C520255:130-nm albumin-bound paclitaxel; D000418:Albumins; D003841:Deoxycytidine; D017239:Paclitaxel; D000093542:Gemcitabine
Neoadjuvant chemotherapy; borderline resectable; pancreatic cancer