Real-World Data Validation of NAPOLI-1 Nomogram for the Prediction of Overall Survival in Metastatic Pancreatic Cancer

被引：5

作者：

Su, Yung-Yeh ^{[1
,2
,3
,4
]}

Chiang, Nai-Jung ^{[1
,5
,6
]}

Yang, Yi-Hsin ^{[1
]}

Yen, Chia-Jui ^{[2
]}

Bai, Li-Yuan ^{[7
,8
]}

Chiu, Chang-Fang ^{[7
,8
,9
]}

Chuang, Shih-Chang ^{[10
,11
]}

Yang, Shih-Hung ^{[12
]}

Chou, Wen-Chi ^{[13
,14
]}

Chen, Jen-Shi ^{[13
,14
]}

Chiu, Tai-Jan ^{[14
,15
]}

Chen, Yen-Yang ^{[14
,15
]}

Chan, De-Chuan ^{[16
]}

Peng, Cheng-Ming ^{[17
]}

Chiu, Sz-Chi ^{[18
]}

Li, Chung-Pin ^{[6
,19
,20
]}

Shan, Yan-Shen ^{[3
,21
]}

Chen, Li-Tzong ^{[1
,2
,4
,22
]}

机构：

[1] Natl Hlth Res Inst, Natl Inst Canc Res, Tainan 704016, Taiwan

[2] Natl Cheng Kung Univ, Natl Cheng Kung Univ Hosp, Coll Med, Dept Oncol, Tainan 704302, Taiwan

[3] Natl Cheng Kung Univ, Inst Clin Med, Coll Med, Tainan 704017, Taiwan

[4] Kaohsiung Med Univ, Ctr Canc Res, Kaohsiung 807377, Taiwan

[5] Taipei Vet Gen Hosp, Dept Oncol, Taipei 112201, Taiwan

[6] Natl Yang Ming Chiao Tung Univ, Coll Med, Sch Med, Taipei 112304, Taiwan

[7] China Med Univ, China Med Univ Hosp, Dept Internal Med, Div Hematol & Oncol, Taichung 404327, Taiwan

[8] China Med Univ, Coll Med, Sch Med, Taichung 404328, Taiwan

[9] China Med Univ, China Med Univ Hosp, Canc Ctr, Taichung 404327, Taiwan

[10] Kaohsiung Med Univ Hosp, Dept Surg, Div Gen & Digest Surg, Kaohsiung 807377, Taiwan

[11] Kaohsiung Med Univ, Fac Med, Dept Surg, Kaohsiung 807378, Taiwan

[12] Natl Taiwan Univ Hosp, Dept Oncol, Taipei 100229, Taiwan

[13] Linkou Chang Gung Mem Hosp, Dept Internal Med, Div Hematol Oncol, Taoyuan 333423, Taiwan

[14] Chang Gung Univ, Coll Med, Taoyuan 33302, Taiwan

[15] Kaohsiung Chang Gung Mem Hosp, Dept Internal Med, Div Hematol Oncol, Kaohsiung 833401, Taiwan

[16] Natl Def Med Ctr, Triserv Gen Hosp, Dept Surg, Div Gen Surg, Taipei 114202, Taiwan

[17] Chung Shan Med Univ, Chung Shan Med Univ Hosp, Dept Surg, Taichung 402306, Taiwan

[18] PharmaEngine Inc, Taipei 104511, Taiwan

[19] Taipei Vet Gen Hosp, Dept Med Educ, Div Clin Skills Training, Taipei 112201, Taiwan

[20] Taipei Vet Gen Hosp, Dept Med, Div Gastroenterol & Hepatol, Taipei 112201, Taiwan

[21] Natl Cheng Kung Univ, Natl Cheng Kung Univ Hosp, Coll Med, Dept Surg,Div Gen Surg, Tainan 704302, Taiwan

[22] Kaohsiung Med Univ, Kaohsiung Med Univ Hosp, Dept Internal Med, Kaohsiung 807377, Taiwan

来源：

CANCERS | 2023年 / 15卷 / 04期

关键词：

pancreatic cancer; nal-IRI; nomogram; real-world; GEMCITABINE-BASED THERAPY; LIPOSOMAL IRINOTECAN; NANOLIPOSOMAL IRINOTECAN; FOLINIC ACID; 5-FLUOROURACIL; IMPUTATION;

D O I：

10.3390/cancers15041008

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Simple Summary The nomogram derived from the pivotal phase III NAPOLI-1 study could predict the overall survival in gemcitabine-refractory metastatic pancreatic cancer treated with liposomal irinotecan plus fluorouracil and leucovorin. However, the NAPOLI-1 nomogram has not been validated in a real-world setting and therefore the applicability of the NAPOLI-1 nomogram in daily practice remains unknown. In the current study, we validated the NAPOLI-1 nomogram in a multicenter real-world cohort and confirmed that the NAPOLI-1 nomogram could predict the prognosis of gemcitabine-refractory metastatic pancreatic cancer in daily practice and may help clinical decision making. We further found that the relative dose intensity at 6 weeks was an independent prognostic factor beyond the NAPOLI-1 nomogram, which highlighted the importance of optimal dose delivery regardless of the baseline condition. Background: The nomogram derived from the pivotal phase III NAPOLI-1 study demonstrated a significant ability to predict median overall survival (OS) in gemcitabine-refractory metastatic pancreatic ductal adenocarcinoma (PDAC) treated with liposomal irinotecan plus fluorouracil and leucovorin (nal-IRI+5-FU/LV). However, the NAPOLI-1 nomogram has not been validated in a real-world setting and therefore the applicability of the NAPOLI-1 nomogram in daily practice remains unknown. This study aims to evaluate the NAPOLI-1 nomogram in a multicenter real-world cohort. Methods: The NAPOLI-1 nomogram was applied to a previously established cohort of metastatic PDAC patients treated with nal-IRI+5-FU/LV in nine participating centers in Taiwan. Patients were divided into three risk groups according to the NAPOLI-1 nomogram. The survival impact of relative dose intensity at 6 weeks (RDI at 6 weeks) in different risk groups was also investigated. Results: Of the 473 included patients, the median OSs of patients classified as low (n = 156), medium (n = 186), and high (n = 131) risk were 10.9, 6.3, and 4.3 months, respectively (p < 0.0001). The survival impact of RDI at 6 weeks remained significant after stratification by risk groups, adjustment with Cox regression, inverse probability weighting, or propensity score matching. Conclusions: Our results support the usefulness of the NAPOLI-1 nomogram for risk stratification in gemcitabine-refractory metastatic PDAC treated with nal-IRI+5-FU/LV in daily practice. We further showed that the RDI at 6 weeks is an independent prognostic factor beyond the NAPOLI-1 nomogram.

引用

页数：13

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