Population-based, real-world prognostic factors related to survival among patients with metastatic pancreatic ductal adenocarcinoma (mPDAC).

2021 ◽  
Vol 39 (3_suppl) ◽  
pp. 389-389
Author(s):  
Kenneth H. Yu ◽  
Paul Cockrum ◽  
Andy Surinach ◽  
Shu Wang ◽  
Bong Chul Chu
Keyword(s):  
Prognostic Factors ◽  
Serum Albumin ◽  
Real World ◽  
Predictive Models ◽  
Serum Bilirubin ◽  
Predictive Accuracy ◽  
Population Based ◽  
Ductal Adenocarcinoma ◽  
C Statistic ◽  
Liposomal Irinotecan

389 Background: Pancreatic cancer is expected to be the third deadliest cancer in the US in 2020. Many real-world studies of pts with mPDAC are restricted to single centers, limiting the generalizability of the insights they generate. There is a need to understand prognostic factors of survival in a broader setting to aid in tailoring treatment strategies for pts. This study aimed to identify important population-based predictors related to survival among pts diagnosed with mPDAC. Methods: Data were extracted for pts diagnosed with mPDAC between Jan 2017 and Dec 2019 from the Flatiron Health database. Predictive models for overall survival from the start of each treatment were developed using multivariable Cox proportional hazards regression. Treatment specific predictive models were generated for pts treated with first line (1L) gemcitabine + nab-paclitaxel (GNP), 1L FOLFIRINOX, 1L gemcitabine monotherapy (gem-mono), and 2L liposomal irinotecan-based regimens. The holdout method was used for cross-validation, splitting the data into 70% training / 30% validation. Age at diagnosis, sex, body mass index, smoking status, and ECOG performance score (PS) were included in all models due to clinical importance. Demographic, clinical characteristics, hematological labs, liver function tests (LFTs), and serum bilirubin levels were assessed for inclusion into the models. Uno’s concordance statistic (c-statistic) was used to assess the predictive accuracy of the models. Results: Of the 3,572 pts included in the study, 44% (n = 1,557) received 1L GNP, 27% (n = 954) received 1L FOLFIRINOX, 7% (n = 265) received gem-mono, and 22% (n = 796) received other regimens. 38% (n = 1,345) pts received 2L and of those, 17% (n = 222) received liposomal irinotecan-based regimens. Among all 1L pts, the following were included in the final model: prior surgery, white blood cell (WBC) counts, serum albumin, LFTs (ALP and ALT), serum bilirubin, and ascites (c-statistic: 0.65). The model for pts treated with GNP differed from the overall model via the addition of neutrophil counts and removal of serum bilirubin and ascites (c-statistic: 0.67). Stage at initial diagnosis was included in the model only for pts treated with 1L FOLFIRINOX (c-statistic: 0.68). Among pts treated with gem-mono the LFTs were not included in the model (c-statistic: 0.78). ALP, serum albumin, and WBC counts were important predictors of survival among pts treated with 2L liposomal irinotecan-based regimens (c-statistic: 0.70). Across all regimens the strongest predictors of survival were ECOG PS, serum albumin, and ALP. Conclusions: In one of the largest contemporary real-world studies of patients with mPDAC to date, important population predictors of survival in pts receiving systemic treatment were identified. Further validation studies are needed to understand the generalizability of these results.

A nomogram for predicting overall survival in patients with uterine leiomyosarcoma: a SEER population-based study

2020 ◽  
Vol 16 (10) ◽  
pp. 573-584
Author(s):  
Yu-Jie Lu ◽  
Han Wang ◽  
Lin-Yan Fang ◽  
Wen-Jie Wang ◽  
Wei Song ◽  
...  
Keyword(s):  
Overall Survival ◽  
Prognostic Factors ◽  
Marital Status ◽  
Tumor Size ◽  
Multivariate Analyses ◽  
Predictive Accuracy ◽  
Population Based ◽  
Uterine Leiomyosarcoma ◽  
Population Based Study ◽  
End Results

Aim: To establish and validate a nomogram for the estimation of overall survival of patients with uterine leiomyosarcoma (uLMS). Methods: Information on patients diagnosed as uLMS was retrospectively retrieved from the Surveillance, Epidemiology, and End Results database. The patients were randomly assigned into the training and the validation cohorts. Univariate and multivariate analyses were used to determine the independent prognostic factors for building a nomogram for predicting overall survival. The predictive accuracy was evaluated based on the concordance indices and the calibration plots. Results: A nomogram that combined age, marital status, tumor size, Surveillance, Epidemiology, and End Result stage, surgery and radiation was established. The internal and external concordance indices were 0.748 and 0.745, respectively. The calibration plots approached 45 degrees. Conclusion: The nomogram might be an effective tool for predicting the survival of patients with uLMS.

Real-world safety data and differentiation of second-line (2L) 5-fluorouracil (5-FU) based regimens among patients with metastatic pancreatic ductal adenocarcinoma (mPDAC).

2021 ◽  
Vol 39 (3_suppl) ◽  
pp. 390-390
Author(s):  
George P. Kim ◽  
Paul Cockrum ◽  
Aleksander Chudnovsky ◽  
Andy Surinach ◽  
Zev A. Wainberg ◽  
...  
Keyword(s):  
Adverse Events ◽  
Real World ◽  
Safety Data ◽  
Ductal Adenocarcinoma ◽  
Icd 10 ◽  
Health Database ◽  
Liposomal Irinotecan ◽  
Grade 3 ◽  
Cost Implications

390 Background: Chemotherapy related adverse events (AEs) can impact the treatment of patients, reducing quality of life and leading to dose delays and treatment discontinuation. This study examined the proportion of patients (pts) with mPDAC treated with 5-FU-based regimens in the 2L setting who experienced AEs during treatment. Methods: Data were extracted for pts diagnosed with mPDAC who initiated 2L treatment between January 2016 and July 2020 from the Flatiron Health electronic health database. Pts included in the study were treated with FOLFIRINOX (FFX), FOLFOX, FOLFIRI, or a regimen containing liposomal irinotecan. The occurrence of grade 3 (G3) and grade 4 (G4) neutropenia, G3/G4 elevated alanine transaminase (ALT) and anemia where transfusion was indicated were determined using lab results and the grading criteria from the Common Terminology Criteria for Adverse Events v4.03. The occurrence of diarrhea, fatigue, nausea and vomiting (N/V), and neuropathy were identified from structured diagnosis records through ICD-10-CM codes. Duration of therapy (DOT) was assessed for each regimen. Descriptive statistics for AEs and DOT were reported. Results: Of the 804 pts included in the study, 28.4% (n=228) received FFX, 39.8% (n=320) received regimens containing liposomal irinotecan, 24.8% (n=199) received FOLFOX, and 7.1% (n=57) received FOLFIRI. The median DOT (IQR) was 86 days (d) (43 – 206), 79d (41 – 169), 72d (43 – 166), and 84d (46 – 148) for pts who received FFX, liposomal irinotecan, FOLFOX, and FOLFIRI, respectively. G3/G4 neutropenia (<1000/mm3) presented in 28.1% (n=64) of pts treated with FFX, 11.9% (n=38) of pts treated with liposomal irinotecan, 17.1% (n=34) of pts treated with FOLFOX, and 36.8% (n=21) of pts treated with FOLFIRI. NV occurred in 14.9% (n=34), 13.1% (n=42), 12.6% (n=25), and 10.5% (n=6), respectively. The full AE results are summarized in the table. Conclusions: In this assessment of often dose-limiting AEs among pts with mPDAC treated in 2L, pts who received liposomal irinotecan had the lowest proportion of neutropenia. No clear pattern was noted for N/V, neuropathy, fatigue, anemia, and elevated ALT. Further research is necessary to determine the real-world cost implications of AEs in this patient population. [Table: see text]

scholarly journals Liposomal irinotecan pre-emptive dose reduction in patients with pancreatic ductal adenocarcinoma: 667 patients’ experience within a population-based study

2021 ◽  
Vol 13 ◽  
pp. 175883592110582
Author(s):  
Tai-Jan Chiu ◽  
Yung-Yeh Su ◽  
Shih-Hung Yang ◽  
Chung-Pin Li ◽  
Li-Yuan Bai ◽  
...  
Keyword(s):  
Pancreatic Ductal Adenocarcinoma ◽  
Large Population ◽  
Population Based ◽  
Ductal Adenocarcinoma ◽  
Efficacy And Safety ◽  
Population Based Study ◽  
Standard Clinical Practice ◽  
Negative Prognostic Factor ◽  
Liposomal Irinotecan ◽  
Patients Experience

Background: Liposomal irinotecan (nal-IRI) plus 5-fluorouracil and leucovorin (5-FU/LV) is currently the standard second-line treatment for patients with pancreatic ductal adenocarcinoma (PDAC) after previous failed gemcitabine-based therapy. This population-based study aimed to evaluate the efficacy and safety of nal-IRI + 5-FU/LV and the association of pre-emptive nal-IRI dosing with treatment outcomes in patients with PDAC. Methods: We retrospectively enrolled a total of 667 consecutive patients with PDAC who received nal-IRI plus 5-FU/LV treatment between August 2018 and November 2020 at 9 medical centers in Taiwan. Patients were allocated into groups according to pre-emptive nal-IRI dosing (⩾75%, 50–74%, <50%) for comparison of treatment efficacy and safety. Results: The median overall survival (OS) and time to treatment failure (TTF) were 5.9 months [95% confidence interval (CI), 5.3–6.5] and 2.8 months (95% CI, 2.6–3.0), respectively. The median OS was 6.5 months (95% CI, 5.7–6.7), 5.0 months (95% CI, 3.4–6.5), and 4.1 months (95% CI, 2.7–5.6), respectively, among the ⩾75%, 50–74%, and <50% pre-emptive nal-IRI dosing groups, whereas the median TTF of the three groups was 3.0 months (95% CI, 2.6–3.4), 2.6 months (95% CI, 2.3–2.9), and 1.9 months (95% CI, 1.6–2.2), respectively. Pre-emptive nal-IRI dosing <50% was an independent negative prognostic factor for OS and TTF in multivariate analyses. The most common severe adverse events were neutropenia (22.9%), anemia (21.1%), and hypokalemia (15.4%). Patients in the <50% pre-emptive nal-IRI dosing group had a significantly lower incidence of neutropenia and non-neutropenic infection than those in the other groups. Conclusion: Our results support the use of nal-IRI + 5-FU/LV as standard clinical practice for treating patients with PDAC based on this large population-based study. Our findings encourage physicians to provide adequate doses of nal-IRI in order to achieve better outcomes without compromising safety profiles.

scholarly journals First- and Second-Line Palliative Systemic Treatment Outcomes in a Real-World Metastatic Pancreatic Cancer Cohort

2021 ◽  
pp. 1-8
Author(s):  
Esther N. Pijnappel ◽  
Willemieke P.M. Dijksterhuis ◽  
Lydia G. van der Geest ◽  
Judith de Vos-Geelen ◽  
Jan Willem B. de Groot ◽  
...  
Keyword(s):  
Real World ◽  
Systemic Treatment ◽  
Population Based ◽  
Ductal Adenocarcinoma ◽  
Rank Test ◽  
Time To Failure ◽  
Second Line ◽  
First Line ◽  
Kaplan Meier ◽  
Netherlands Cancer Registry

Background: Metastatic pancreatic ductal adenocarcinoma (PDAC) is characterized by a poor survival rate, which can be improved by systemic treatment. Consensus on the most optimal first- and second-line palliative systemic treatment is lacking. The aim of this study was to describe the use of first- and second-line systemic treatment, overall survival (OS), and time to failure (TTF) of first- and second-line treatment in metastatic PDAC in a real-world setting. Patients and Methods: Patients with synchronous metastatic PDAC diagnosed between 2015 and 2018 who received systemic treatment were selected from the nationwide Netherlands Cancer Registry. OS and TTF were evaluated using Kaplan-Meier curves with log-rank test and multivariable Cox proportional hazard analyses. Results: The majority of 1,586 included patients received FOLFIRINOX (65%), followed by gemcitabine (18%), and gemcitabine + nab-paclitaxel (13%) in the first line. Median OS for first-line FOLFIRINOX, gemcitabine + nab-paclitaxel, and gemcitabine monotherapy was 6.6, 4.7, and 2.9 months, respectively. Compared to FOLFIRINOX, gemcitabine + nab-paclitaxel showed significantly inferior OS after adjustment for confounders (hazard ratio [HR], 1.20; 95% CI, 1.02–1.41), and gemcitabine monotherapy was independently associated with a shorter OS and TTF (HR, 1.98; 95% CI, 1.71–2.30 and HR, 2.31; 95% CI, 1.88–2.83, respectively). Of the 121 patients who received second-line systemic treatment, 33% received gemcitabine + nab-paclitaxel, followed by gemcitabine (31%) and FOLFIRINOX (10%). Conclusions: Based on population-based data in patients with metastatic PDAC, treatment predominantly consists of FOLFIRINOX in the first line and gemcitabine with or without nab-paclitaxel in the second line. FOLFIRINOX in the first line shows superior OS compared with gemcitabine with or without nab-paclitaxel.

scholarly journals Predictive Models for Neonatal Follow-Up Serum Bilirubin: Model Development and Validation (Preprint)

2020 ◽  
Author(s):  
Joseph H Chou
Keyword(s):  
Neural Network ◽  
Predictive Models ◽  
Serum Bilirubin ◽  
Predictive Accuracy ◽  
Characteristic Curve ◽  
Receiver Operator Characteristic Curve ◽  
Total Serum Bilirubin ◽  
Total Serum ◽  
Test Set

BACKGROUND Hyperbilirubinemia affects many newborn infants and, if not treated appropriately, can lead to irreversible brain injury. OBJECTIVE This study aims to develop predictive models of follow-up total serum bilirubin measurement and to compare their accuracy with that of clinician predictions. METHODS Subjects were patients born between June 2015 and June 2019 at 4 hospitals in Massachusetts. The prediction target was a follow-up total serum bilirubin measurement obtained &lt;72 hours after a previous measurement. Birth before versus after February 2019 was used to generate a training set (27,428 target measurements) and a held-out test set (3320 measurements), respectively. Multiple supervised learning models were trained. To further assess model performance, predictions on the held-out test set were also compared with corresponding predictions from clinicians. RESULTS The best predictive accuracy on the held-out test set was obtained with the multilayer perceptron (ie, neural network, mean absolute error [MAE] 1.05 mg/dL) and Xgboost (MAE 1.04 mg/dL) models. A limited number of predictors were sufficient for constructing models with the best performance and avoiding overfitting: current bilirubin measurement, last rate of rise, proportion of time under phototherapy, time to next measurement, gestational age at birth, current age, and fractional weight change from birth. Clinicians made a total of 210 prospective predictions. The neural network model accuracy on this subset of predictions had an MAE of 1.06 mg/dL compared with clinician predictions with an MAE of 1.38 mg/dL (<i>P</i>&lt;.0001). In babies born at 35 weeks of gestation or later, this approach was also applied to predict the binary outcome of subsequently exceeding consensus guidelines for phototherapy initiation and achieved an area under the receiver operator characteristic curve of 0.94 (95% CI 0.91 to 0.97). CONCLUSIONS This study developed predictive models for neonatal follow-up total serum bilirubin measurements that outperform clinicians. This may be the first report of models that predict specific bilirubin values, are not limited to near-term patients without risk factors, and take into account the effect of phototherapy. CLINICALTRIAL

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