2024-03-29T08:06:48Z
https://nagoya.repo.nii.ac.jp/oai
oai:nagoya.repo.nii.ac.jp:02003930
2023-06-05T04:24:26Z
499:500:501
Results of a Phase II Study on the Use of Neoadjuvant Chemotherapy (FOLFIRINOX or GEM/nab-PTX) for Borderline-resectable Pancreatic Cancer (NUPAT-01)
Yamaguchi, Junpei
Yokoyama, Yukihiro
Fujii, Tsutomu
Yamada, Suguru
Takami, Hideki
Kawashima, Hiroki
Ohno, Eizaburo
Ishikawa, Takuya
Maeda, Osamu
Ogawa, Hiroshi
Kodera, Yasuhiro
Nagino, Masato
Ebata, Tomoki
Objective: Given the frequent adverse events with multidrug chemotherapy, not only the survival benefit but also the feasibility of using neoadjuvant chemotherapy to treat pancreatic cancer need to be clarified. Summary of Background Data: Although the development of multidrug chemotherapy regimens has improved the survival outcomes of patients with unresectable pancreatic cancer, the benefits of these treatments in the neo-adjuvant setting remain controversial. Methods: Patients with borderline-resectable pancreatic cancer were enrolled and randomly assigned to receive neoadjuvant chemotherapy with either FOLFIRINOX or gemcitabine with nab-paclitaxel (GEM/nab-PTX). After the completion of chemotherapy, patients underwent surgical resection when feasible. This study (NUPAT-01) was a randomized phase II trial, and the primary endpoint was the R0 resection rate. Results: Fifty-one patients were enrolled in this study [FOLFIRINOX (n = 26) and GEM/nab-PTX (n = 25)]. A total of 84.3% (n = 43/51) of the patients eventually underwent surgery, and R0 resection was achieved in 67.4% (n = 33/ 51) of the patients. Adverse events (grade >3) due to neoadjuvant treatment were observed in 45.1% of the patients (n = 23/51), and major surgical complications occurred in 30.0% (n = 13/43), with no mortality noted. The intention-to-treat analysis showed that the 3-year overall survival rate was 54.7%, with a median survival time of 39.4 months, and a significant difference in overall survival was not observed between the FOLFIRINOX and GEM/nab-PTX groups. Conclusions: These results indicate that neoadjuvant chemotherapy with FOLFIRINOX or GEM/nab-PTX is feasible and well tolerated, achieving an R0 resection rate of 67.4%. The survival of patients was even found to be favorable in the intention-to-treat analysis.
journal article
Wolters Kluwer Health
2022-06
application/pdf
Annals of Surgery
6
275
1043
1049
0003-4932
https://nagoya.repo.nii.ac.jp/record/2003930/files/NUPAT01.pdf
eng
https://doi.org/10.1097/SLA.0000000000005430
"This is a non-final version of an article published in final form in (Yamaguchi, Junpei; Yokoyama, Yukihiro; Fujii, Tsutomu; Yamada, Suguru; Takami, Hideki; Kawashima, Hiroki; Ohno, Eizaburo; Ishikawa, Takuya; Maeda, Osamu; Ogawa, Hiroshi; Kodera, Yasuhiro; Nagino, Masato; Ebata, Tomoki. Results of a Phase II Study on the Use of Neoadjuvant Chemotherapy (FOLFIRINOX or GEM/nab-PTX) for Borderline-resectable Pancreatic Cancer (NUPAT-01). Annals of Surgery: June 2022 - Volume 275 - Issue 6 - p 1043-1049 doi: 10.1097/SLA.0000000000005430)."