2023
DOI: 10.3390/cancers15041008
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Real-World Data Validation of NAPOLI-1 Nomogram for the Prediction of Overall Survival in Metastatic Pancreatic Cancer

Abstract: 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 … Show more

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Cited by 5 publications
(4 citation statements)
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“…Consequently, the inclusion criteria in the trial closely resembled those of our standard approach in daily patient care, which was reflected by the lack of a significant difference in survival between patients enrolled and not enrolled in the clinical trial. Both the GOFL and SLOG regimens were incorporated into daily practice in our hospitals prior to the reimbursement of nab-paclitaxel and FOLFORINOX [ 58 62 ]. Patients treated with gemcitabine monotherapy (n = 21), usually prescribed for fragile patients as recommended in the majority of treatment guidelines, were excluded in the present study to prevent selection bias when comparing survival between patients treated with platinum-based and platinum-free chemotherapy.…”
Section: Discussionmentioning
confidence: 99%
“…Consequently, the inclusion criteria in the trial closely resembled those of our standard approach in daily patient care, which was reflected by the lack of a significant difference in survival between patients enrolled and not enrolled in the clinical trial. Both the GOFL and SLOG regimens were incorporated into daily practice in our hospitals prior to the reimbursement of nab-paclitaxel and FOLFORINOX [ 58 62 ]. Patients treated with gemcitabine monotherapy (n = 21), usually prescribed for fragile patients as recommended in the majority of treatment guidelines, were excluded in the present study to prevent selection bias when comparing survival between patients treated with platinum-based and platinum-free chemotherapy.…”
Section: Discussionmentioning
confidence: 99%
“…There are many reports on predictors of treatment-response by nal-IRI-based therapy. In particular, CAR, NLR, GPS, total bilirubin, carcinomatosis, and previous treatment with irinotecan have been significantly associated with overall survival (3)(4)(5)(6)(7)(8). However, no study has reported the risk factors for the adverse events during nal-IRI/FL treatment based on the analysis of factors other than the UGT1A1 polymorphism in clinical settings.…”
Section: Discussionmentioning
confidence: 99%
“…Based on this trial result, the regulatory agency in Japan has approved the nal-IRI plus 5-FU and L-leucovorin (nal-IRI/FL) combination therapy. Particularly interesting studies focused on predictors of treatment-response by nal-IRI-based therapy in patients with pancreatic cancer have indicated that C-reactive protein/albumin ratio (CAR), neutrophil/lymphocyte ratio (NLR), Glasgow prognostic score (GPS), total bilirubin, carcinomatosis, and previous irinotecan treatment are significantly associated with overall survival (3)(4)(5)(6)(7)(8).…”
mentioning
confidence: 99%
“…To keep up with the rising demand for Brain-Computer Interface (BCI) systems, it will be necessary to implement strategies that reduce user anxiety and make the necessary adjustments to BCI systems [26]. The current concept places an emphasis on using data collected in real-world settings to verify the efficiency of detection mechanisms.…”
Section: Literature Reviewmentioning
confidence: 99%