Abstract

BackgroundNo reliable nomogram has been developed until date for predicting the survival in patients with unresectable pancreatic cancer undergoing treatment with gemcitabine plus nab–paclitaxel (GnP) or FOLFIRINOX.MethodsThis analysis was conducted using clinical data of Japanese patients with unresectable pancreatic cancer undergoing GnP or FOLFIRINOX treatment obtained from a multicenter study (NAPOLEON study). A Cox proportional hazards model was used to identify the independent prognostic factors. A nomogram to predict 6–, 12–, and 18–month survival probabilities was generated, validated by using the concordance index (C–index), and calibrated by the bootstrapping method. And then, we attempted risk stratification for survival by classifying the patients according to the sum of the scores on the nomogram (total nomogram points).ResultsA total of 318 patients were enrolled. A prognostic nomogram was generated using data on the Eastern Cooperative Oncology Group performance status, liver metastasis, serum LDH, serum CRP, and serum CA19–9. The C–indexes of the nomogram were 0.77, 0.72 and 0.70 for 6–, 12–, and 18–month survival, respectively. The calibration plot showed optimal agreement at all points. Risk stratification based on tertiles of the total nomogram points yielded clear separations of the survival curves. The median survival times in the low–, moderate–, and high–risk groups were 15.8, 12.8 and 7.8 months (P<0.05), respectively.ConclusionsOur nomogram might be a convenient and inexpensive tool to accurately predict survival in Japanese patients with unresectable pancreatic cancer undergoing treatment with GnP or FOLFIRINOX, and will help clinicians in selecting appropriate therapeutic strategies for individualized management.

Highlights

  • No reliable nomogram has been developed until date for predicting the survival in patients with unresectable pancreatic cancer undergoing treatment with gemcitabine plus nab–paclitaxel (GnP) or FOLFIRINOX

  • Assessments The goal of this study was to identify factors influencing the prognosis in pancreatic cancer patients, and to develop and validate a prognostic nomogram in a relatively large real–world cohort derived from the NAPOLEON study

  • The univariate analyses identified higher ECOG Eastern Cooperative Oncology Group performance status (PS) scores, presence of liver metastasis, more than two sites of metastatic disease, presence of ascites, serum albumin level less than 3.0 g/dL, elevated serum lactate dehydrogenase (LDH), elevated serum C–reactive protein (CRP), serum carbohydrate antigen 19–9 (CA19–9) level greater than 370 U/mL, and American Joint Committee on Cancer (AJCC) TNM stage IV as being significantly associated with shorter overall survival times

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Summary

Introduction

No reliable nomogram has been developed until date for predicting the survival in patients with unresectable pancreatic cancer undergoing treatment with gemcitabine plus nab–paclitaxel (GnP) or FOLFIRINOX. Palliative chemotherapy is used for patients diagnosed as having unresectable pancreatic cancer. Great strides have been made in palliative chemotherapy for patients with metastatic pancreatic cancer due to development of the gemcitabine plus nab–paclitaxel (GnP) and FOLFIRINOX (fluorouracil, leucovorin, irinotecan, and oxaliplatin) regimens [4, 5]. One of the reasons for the high mortality rate of pancreatic cancer patients may be the absence of a reliable method for prognosis determination and risk stratification. If the prognosis of pancreatic cancer patients could be evaluated more accurately, we could offer better therapeutic strategies and individualized treatments

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