Treatment of initially unresectable local advanced pancreatic adenocarcinoma with FOLFIRINOX: A prospective study YCOG1403 (C-FLAP study)

Version 1 : Received: 8 January 2024 / Approved: 11 January 2024 / Online: 11 January 2024 (07:41:17 CET)
Version 2 : Received: 8 February 2024 / Approved: 9 February 2024 / Online: 9 February 2024 (11:16:19 CET)

How to cite: Kobayashi, N.; Yabushita, Y.; Mori, R.; Takahashi, T.; Miyake, K.; Sawada, Y.; Homma, Y.; Matsuyama, R.; Okubo, N.; Katsuta, E.; Kubota, K.; Yamanaka, S.; Ichikawa, Y.; Endo, I. Treatment of initially unresectable local advanced pancreatic adenocarcinoma with FOLFIRINOX: A prospective study YCOG1403 (C-FLAP study). Preprints 2024, 2024010886. https://doi.org/10.20944/preprints202401.0886.v2 Kobayashi, N.; Yabushita, Y.; Mori, R.; Takahashi, T.; Miyake, K.; Sawada, Y.; Homma, Y.; Matsuyama, R.; Okubo, N.; Katsuta, E.; Kubota, K.; Yamanaka, S.; Ichikawa, Y.; Endo, I. Treatment of initially unresectable local advanced pancreatic adenocarcinoma with FOLFIRINOX: A prospective study YCOG1403 (C-FLAP study). Preprints 2024, 2024010886. https://doi.org/10.20944/preprints202401.0886.v2

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MDPI and ACS Style

Kobayashi, N.; Yabushita, Y.; Mori, R.; Takahashi, T.; Miyake, K.; Sawada, Y.; Homma, Y.; Matsuyama, R.; Okubo, N.; Katsuta, E.; Kubota, K.; Yamanaka, S.; Ichikawa, Y.; Endo, I. Treatment of initially unresectable local advanced pancreatic adenocarcinoma with FOLFIRINOX: A prospective study YCOG1403 (C-FLAP study). Preprints 2024, 2024010886. https://doi.org/10.20944/preprints202401.0886.v2

APA Style

Kobayashi, N., Yabushita, Y., Mori, R., Takahashi, T., Miyake, K., Sawada, Y., Homma, Y., Matsuyama, R., Okubo, N., Katsuta, E., Kubota, K., Yamanaka, S., Ichikawa, Y., & Endo, I. (2024). Treatment of initially unresectable local advanced pancreatic adenocarcinoma with FOLFIRINOX: A prospective study YCOG1403 (C-FLAP study). Preprints. https://doi.org/10.20944/preprints202401.0886.v2

Chicago/Turabian Style

Kobayashi, N., Yasushi Ichikawa and Itaru Endo. 2024 "Treatment of initially unresectable local advanced pancreatic adenocarcinoma with FOLFIRINOX: A prospective study YCOG1403 (C-FLAP study)" Preprints. https://doi.org/10.20944/preprints202401.0886.v2

Abstract

Background: A challenge in locally advanced, unresectable pancreatic cancer treatment is to achieve both survival benefits and a safe margin-negative resection. There is no robust evidence regarding the treatment of patients with unresectable pancreatic cancer. Methods: We conducted a prospective, single-arm, phase II trial in patients with unresectable pancreatic cancer using the FOLFIRINOX regimen. After completing 4–8 cycles, patients underwent surgical resection when feasible. The primary endpoint was the R0 resection rate. Results: Fifteen patients were enrolled in this study. This study was terminated without reaching the prespecified accrual target due to low accrual rate. A median of six courses of FOLFIRINOX chemotherapy was administered, and a partial response or R0 resection was achieved in 26.7% or 33% of the patients, respectively. Se-vere adverse events due to chemotherapy and major surgical complications were observed in 33.3% and 6.7% of patients, respectively. The median overall survival rate of patients who un-derwent R0 resection or with R1 or unresectable disease was 47.8 months (95% CI, 22.5–73.1) or 14.5 months (95% CI, 11.8–17.2), respectively (P=0.031). Conclusions: Well-selected patients with URLA-PC treated with FOLFIRINOX achieved a relatively high rate of R0 resection and had pro-longed survival. Therefore, induction FOLFIRINOX is feasible and well-tolerated for locally ad-vanced, initially unresectable pancreatic cancer, and may be effective in facilitating R0 resection and prolonging survival. This should be further assessed in future randomized multicenter trials.

Keywords

unresectable locally advanced pancreatic cancer; FOLFIRINOX; R0 resection

Subject

Medicine and Pharmacology, Oncology and Oncogenics

Copyright: This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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