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Observational Study
. 2025;103(7):569-579.
doi: 10.1159/000542137. Epub 2024 Oct 19.

Real-World Analysis of the Correlation between Overall Survival and Progression-Free Survival in Advanced Pancreatic Cancer: Results of NAPOLEON-1 and 2 Studies

Tomonori Araki  1 , Machiko Kawahira  2 , Mototsugu Shimokawa  3   4 , Taiga Otsuka  5   6 , Kohei Hayashi  7 , Yuki Sonoda  7 , Takuya Honda  7 , Kazuhiko Nakao  7 , Taro Shibuki  8 , Junichi Nakazawa  9 , Shiho Arima  10 , Masaru Fukahori  11 , Keisuke Miwa  12 , Futa Koga  13 , Yujiro Ueda  14 , Yoshihito Kubotsu  15 , Akitaka Makiyama  16 , Hozumi Shimokawa  16 , Shigeyuki Takeshita  17 , Kazuo Nishikawa  18 , Azusa Komori  18 , Satoshi Otsu  18 , Ayumu Hosokawa  19 , Tatsunori Sakai  20 , Hisanobu Oda  21 , Shuji Arita  22 , Hiroki Taguchi  23 , Kengo Tsuneyoshi  24 , Yasunori Kawaguchi  25 , Toshihiro Fujita  23 , Takahiro Sakae  23 , Kenta Nio  26 , Yasushi Ide  15 , Norio Ureshino  5 , Tsuyoshi Shirakawa  27   28 , Toshihiko Mizuta  29 , Kenji Mitsugi  26   30
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Free article
Observational Study

Real-World Analysis of the Correlation between Overall Survival and Progression-Free Survival in Advanced Pancreatic Cancer: Results of NAPOLEON-1 and 2 Studies

Tomonori Araki et al. Oncology. 2025.
Free article

Abstract

Introduction: Fluorouracil, leucovorin, irinotecan, and oxaliplatin (FOLFIRINOX) improve overall survival (OS) and progression-free survival (PFS) in patients with pancreatic cancer, compared with gemcitabine (GEM). However, whether PFS is a surrogate marker of OS in pancreatic cancer chemotherapy focusing on FOLFIRINOX or GEM plus nab-paclitaxel remains unknown. We aimed to verify whether PFS can be a surrogate marker of OS in prognosis prediction.

Methods: This was an integrated analysis of the NAPOLEON study and retrospective cohort of the NAPOLEON-2 study - a multicenter observational study conducted in Japan, using real-world data. The primary and secondary endpoints were OS and PFS, respectively. The correlation between OS and PFS in first- and second-line treatments was assessed using Method of Moments estimation. An analysis was performed in patients with confirmed OS at the end of follow-up. The NAPOLEON-2 cohort included only patients who received 5-fluorouracil, leucovorin, and nanoliposomal irinotecan (NFF) as second-line treatment.

Results: Among 479 patients, the correlation between PFS and OS from first- and second-line chemotherapies was calculated in 310 and 225 patients, respectively. The R-squared values for the correlation between PFS and OS from first- and second-line chemotherapies were 0.74 and 0.76, respectively. There was no statistically significant difference in first-line treatment between the FOLFIRINOX and GEM plus nab-paclitaxel groups (p = 0.92). Therefore, the FOLFIRINOX group may not have shown a stronger correlation than the NFF group.

Conclusion: PFS can be a surrogate marker of OS in first- and second-line therapies. Appropriate prognostic estimation might contribute to proper treatment selection.

Keywords: Correlation of data; Pancreatic cancer; Progression-free survival; Retrospective studies; Survival analysis.

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