Results of a Phase II Study on the Use of Neoadjuvant Chemotherapy (FOLFIRINOX or GEM/nab-PTX) for Borderline-resectable Pancreatic Cancer (NUPAT-01).

Abstract

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.

• Authors: Junpei Yamaguchi, Yukihiro Yokoyama, Tsutomu Fujii, Suguru Yamada, Hideki Takami, Hiroki Kawashima, Eizaburo Ohno, Takuya Ishikawa, Osamu Maeda, Hiroshi Ogawa, Yasuhiro Kodera, Masato Nagino, Tomoki Ebata
• Journal: Annals of surgery (Ann Surg) Vol. 275 Issue 6 Pg. 1043-1049 (06 01 2022) ISSN: 1528-1140 [Electronic] United States
• PMID: 35258510 (Publication Type: Clinical Trial, Phase II, Journal Article, Randomized Controlled Trial)
• Copyright: Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.

Chemical References

• Albumins
• folfirinox
• Oxaliplatin
• Deoxycytidine
• Irinotecan
• Paclitaxel
• Leucovorin
• Fluorouracil

Topics

• Albumins (therapeutic use)
• Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
• Deoxycytidine (therapeutic use)
• Fluorouracil
• Humans
• Irinotecan
• Leucovorin
• Neoadjuvant Therapy (methods)
• Oxaliplatin
• Paclitaxel (therapeutic use)
• Pancreatic Neoplasms (drug therapy, surgery)
• Pancreatic Neoplasms