{"title":"晚期胰腺癌患者总生存期与无进展生存期之间相关性的真实世界分析：NAPOLEON-1和2研究的结果。","authors":"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","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>PFS can be a surrogate marker of OS in first- and second-line therapies. Appropriate prognostic estimation might contribute to proper treatment selection.</p>","PeriodicalId":19497,"journal":{"name":"Oncology","volume":" ","pages":"1-11"},"PeriodicalIF":2.5000,"publicationDate":"2024-10-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Real-World Analysis of the Correlation between Overall Survival and Progression-Free Survival in Advanced Pancreatic Cancer: Results of NAPOLEON-1 and 2 Studies.\",\"authors\":\"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\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Introduction: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>PFS can be a surrogate marker of OS in first- and second-line therapies. Appropriate prognostic estimation might contribute to proper treatment selection.</p>\",\"PeriodicalId\":19497,\"journal\":{\"name\":\"Oncology\",\"volume\":\" \",\"pages\":\"1-11\"},\"PeriodicalIF\":2.5000,\"publicationDate\":\"2024-10-19\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Oncology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1159/000542137\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"ONCOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Oncology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1159/000542137","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"ONCOLOGY","Score":null,"Total":0}
引用次数: 0
摘要
简介：与吉西他滨（GEM）相比，氟尿嘧啶、亮菌素、伊立替康和奥沙利铂（FOLFIRINOX）可提高胰腺癌患者的总生存期（OS）和无进展生存期（PFS）。然而，在以 FOLFIRINOX 或吉西他滨加纳布紫杉醇为主的胰腺癌化疗中，PFS 是否是 OS 的替代指标仍是未知数。我们的目的是验证在预后预测中，PFS是否可以作为OS的替代指标：这是一项对 NAPOLEON 研究和 NAPOLEON-2 研究（一项在日本进行的多中心观察性研究）的回顾性队列进行的综合分析，使用的是真实世界的数据。主要和次要终点分别为OS和PFS。采用矩估计法评估了一线和二线治疗中OS和PFS之间的相关性。对随访结束时确认有OS的患者进行了分析。NAPOLEON-2队列仅包括接受5-氟尿嘧啶、亮菌素和纳米脂质体伊立替康（NFF）作为二线治疗的患者：在479例患者中，分别计算了310例和225例患者一线和二线化疗的PFS和OS之间的相关性。一线和二线化疗的 PFS 和 OS 相关性的 R 平方值分别为 0.74 和 0.76。FOLFIRINOX组和吉西他滨加纳布紫杉醇组的一线治疗差异无统计学意义（P=0.92）。因此，FOLFIRINOX组可能不会比NFF组显示出更强的相关性：结论：在一线和二线疗法中，PFS可以作为OS的替代指标。结论：在一线和二线疗法中，PFS 可以作为 OS 的替代指标，适当的预后评估有助于正确选择治疗方案。
Real-World Analysis of the Correlation between Overall Survival and Progression-Free Survival in Advanced Pancreatic Cancer: Results of NAPOLEON-1 and 2 Studies.
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.
期刊介绍：
Although laboratory and clinical cancer research need to be closely linked, observations at the basic level often remain removed from medical applications. This journal works to accelerate the translation of experimental results into the clinic, and back again into the laboratory for further investigation. The fundamental purpose of this effort is to advance clinically-relevant knowledge of cancer, and improve the outcome of prevention, diagnosis and treatment of malignant disease. The journal publishes significant clinical studies from cancer programs around the world, along with important translational laboratory findings, mini-reviews (invited and submitted) and in-depth discussions of evolving and controversial topics in the oncology arena. A unique feature of the journal is a new section which focuses on rapid peer-review and subsequent publication of short reports of phase 1 and phase 2 clinical cancer trials, with a goal of insuring that high-quality clinical cancer research quickly enters the public domain, regardless of the trial’s ultimate conclusions regarding efficacy or toxicity.
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