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; Machiko Kawahira; Mototsugu Shimokawa; Taiga Otsuka; Kohei Hayashi; Yuki Sonoda; Takuya Honda; Kazuhiko Nakao; Taro Shibuki; Junichi Nakazawa; Shiho Arima; Masaru Fukahori; Keisuke Miwa; Futa Koga; Yujiro Ueda; Yoshihito Kubotsu; Akitaka Makiyama; Hozumi Shimokawa; Shigeyuki Takeshita; Kazuo Nishikawa; Azusa Komori; Satoshi Otsu; Ayumu Hosokawa; Tatsunori Sakai; Hisanobu Oda; Shuji Arita; Hiroki Taguchi; Kengo Tsuneyoshi; Yasunori Kawaguchi; Toshihiro Fujita; Takahiro Sakae; Kenta Nio; Yasushi Ide; Norio Ureshino; Tsuyoshi Shirakawa; Toshihiko Mizuta; Kenji Mitsugi

doi:10.1159/000542137

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

Oncology. 2024 Oct 19:1-11. doi: 10.1159/000542137. Online ahead of print.

Authors

Tomonori Araki¹, Machiko Kawahira², Mototsugu Shimokawa^{3

4}, Taiga Otsuka^{5

6}, Kohei Hayashi⁷, Yuki Sonoda⁷, Takuya Honda⁷, Kazuhiko Nakao⁷, Taro Shibuki⁸, Junichi Nakazawa⁹, Shiho Arima¹⁰, Masaru Fukahori¹¹, Keisuke Miwa¹², Futa Koga¹³, Yujiro Ueda¹⁴, Yoshihito Kubotsu¹⁵, Akitaka Makiyama¹⁶, Hozumi Shimokawa¹⁶, Shigeyuki Takeshita¹⁷, Kazuo Nishikawa¹⁸, Azusa Komori¹⁸, Satoshi Otsu¹⁸, Ayumu Hosokawa¹⁹, Tatsunori Sakai²⁰, Hisanobu Oda²¹, Shuji Arita²², Hiroki Taguchi²³, Kengo Tsuneyoshi²⁴, Yasunori Kawaguchi²⁵, Toshihiro Fujita²³, Takahiro Sakae²³, Kenta Nio²⁶, Yasushi Ide¹⁵, Norio Ureshino⁵, Tsuyoshi Shirakawa^{27

28}, Toshihiko Mizuta²⁹, Kenji Mitsugi^{26

30}

Affiliations

¹ Department of Gastroenterology and Hepatology, Graduate School of Biomedical Sciences, Nagasaki University, Nagasaki, Japan, toaraki@nagasaki-u.ac.jp.
² Department of Gastroenterology, Kagoshima Kouseiren Hospital, Kagoshima, Japan.
³ Clinical Research Institute, National Kyushu Cancer Center, Fukuoka, Japan.
⁴ Department of Biostatistics, Yamaguchi University Graduate School of Medicine, Yamaguchi, Japan.
⁵ Department of Medical Oncology, Saga-Ken Medical Center Koseikan, Saga, Japan.
⁶ Department of Internal Medicine, Minato Medical Clinic, Fukuoka, Japan.
⁷ Department of Gastroenterology and Hepatology, Graduate School of Biomedical Sciences, Nagasaki University, Nagasaki, Japan.
⁸ Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, Chiba, Japan.
⁹ Department of Medical Oncology, Kagoshima City Hospital, Kagoshima, Japan.
¹⁰ Digestive and Lifestyle Diseases, Kagoshima University Graduate School of Medical and Dental Sciences, Kagoshima, Japan.
¹¹ Division of Gastroenterology, Department of Medicine, Kurume University School of Medicine, Fukuoka, Japan.
¹² Multidisciplinary Treatment Cancer Center, Kurume University Hospital, Fukuoka, Japan.
¹³ Department of Hepatobiliary and Pancreatology, Saga Medical Center Koseikan, Saga, Japan.
¹⁴ Department of Hematology and Oncology, Japanese Red Cross Kumamoto Hospital, Kumamoto, Japan.
¹⁵ Department of Internal Medicine, Karatsu Red Cross Hospital, Saga, Japan.
¹⁶ Department of Hematology Oncology, Japan Community Healthcare Organization Kyushu Hospital, Fukuoka, Japan.
¹⁷ Department of Gastroenterology, Japanese Red Cross Nagasaki Genbaku Hospital, Nagasaki, Japan.
¹⁸ Department of Medical Oncology and Hematology, Oita University Faculty of Medicine, Oita, Japan.
¹⁹ Department of Clinical Oncology, University of Miyazaki Hospital, Miyazaki, Japan.
²⁰ Department of Medical Oncology, National Hospital Organization Kumamoto Medical Center, Kumamoto, Japan.
²¹ Division of Integrative Medical Oncology, Saiseikai Kumamoto Hospital, Kumamoto, Japan.
²² Department of Chemotherapy, Miyazaki Prefectural Miyazaki Hospital, Miyazaki, Japan.
²³ Department of Gastroenterology, Saiseikai Sendai Hospital, Kagoshima, Japan.
²⁴ Department of Gastroenterology, Izumi General Medical Center, Kagoshima, Japan.
²⁵ Department of Gastroenterology, Asakura Medical Association Hospital, Fukuoka, Japan.
²⁶ Department of Medical Oncology, Sasebo Kyosai Hospital, Nagasaki, Japan.
²⁷ Clinical Hematology Oncology Treatment Study Group, Fukuoka, Japan.
²⁸ Eikoh Hospital, Fukuoka, Japan.
²⁹ Department of Internal Medicine, Imari Arita Kyoritsu Hospital, Saga, Japan.
³⁰ Department of Medical Oncology, Hamanomachi Hospital, Fukuoka, Japan.

PMID: 39427640
DOI: 10.1159/000542137

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.