Influence of risk factors for renal cell carcinoma (RCC) on outcome of patients (pts) with metastatic disease treated with sunitinib.

2012 ◽  
Vol 30 (5_suppl) ◽  
pp. 437-437 ◽  
Author(s):  
Daniel Keizman ◽  
Maya Ish-Shalom ◽  
Jason David Taksey ◽  
Roberto Pili ◽  
Hans J. Hammers ◽  
...  
Keyword(s):  
Risk Factors ◽  
Cox Regression ◽  
Clear Cell ◽  
Performance Status ◽  
Independent Effect ◽  
Active Smoking ◽  
Ecog Performance Status ◽  
Elevated Alkaline Phosphatase ◽  
Factors Associated ◽  
Never Smokers

437 Background: Obesity, smoking, hypertension (HTN) and diabetes (DM) are risk factors for RCC development. Their presence has been associated with a worse outcome of therapy (tx) in various metastatic cancers. We sought to determine their influence on the progression free survival (PFS) and overall survival (OS) of Su tx in mRCC. Methods: We performed a multicentre retrospective study of pts with mRCC, who were treated with Su. We analyzed the pre-tx status of smoking (active vs past vs never), BMI (obese=BMI≥30 vs overweight=BMI 25-29.9 vs normal weight=BMI <25), HTN, DM, and known prognostic factors including past nephrectomy, clear cell/non clear cell histology, time from initial diagnosis to Su tx, > 2 metastasis (mets) sites, lung/liver/bone mets, ECOG performance status, anemia, calcium level > 10 mg/dL, elevated alkaline phosphatase (AP), platelets count, pre-tx neutrophil to lymphocyte ratio (NLR) >3, Su induced HTN, use of angiotensin system inhibitors (ASIs), past cytokines/targeted tx, and mean Su dose/cycle. PFS and OS were determined by the Kaplan-Meier method. Multivariate analyses using Cox Regression model were performed to determine their independent effect. Results: Between 2004-2011, 209 pts with mRCC were treated with Su. 40 pts were active smoker, 51 obese, 55 diabetic, and 122 had pre-tx HTN. In the entire pt cohort, median PFS was 8 months (mos) and OS 15 mos. Factors associated with PFS were active smoking (HR 2.5, p= 0.005, median PFS 4 vs 10 mos in past smokers vs 10 mos in never smokers), non clear cell histology (HR 1.8, p=0.023), pre-tx NLR >3 (HR 0.2, p<0.0001) and the use of ASIs (HR 1.66, p=0.028). Factors associated with OS were were active smoking (HR 2.1, p= 0.03, median OS 8.5 vs 18 mos in past smokers vs 18 mos in never smokers), AP (HR 1.76, p=0.049), pre-tx NLR >3 (HR 0.294, p<0.0001), and liver mets (HR 0.553, p=0.04). BMI, DM, and pre-tx HTN were not associated with PFS or OS. Conclusions: Active smoking may decrease the PFS and OS of pts with mRCC that are treated with Su. BMI, DM, and pre-tx HTN were not found to be associated with outcome. These results should be investigated prospectively, and if validated applied in clinical practice and clinical trials.

Influence of risk factors for renal cell carcinoma (RCC) on outcome of patients (pts) with metastatic disease (mRCC) treated with sunitinib (Su).

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e15058-e15058 ◽  
Author(s):  
Raanan Berger ◽  
Daniel Keizman ◽  
Maya Ish-Shalom ◽  
Hans J. Hammers ◽  
Mario A. Eisenberger ◽  
...  
Keyword(s):  
Risk Factors ◽  
Cox Regression ◽  
Clear Cell ◽  
Performance Status ◽  
Independent Effect ◽  
Active Smoking ◽  
Ecog Performance Status ◽  
Elevated Alkaline Phosphatase ◽  
Factors Associated ◽  
Never Smokers

e15058 Background: Obesity, smoking, hypertension (HTN) and diabetes (DM) are risk factors for RCC development. Their presence has been associated with a worse outcome of therapy (tx) in various metastatic cancers. We sought to determine their influence on the progression free survival (PFS) and overall survival (OS) of Su tx in mRCC. Methods: We performed an international multicenter retrospective study of pts with mRCC, who were treated with Su. We analyzed the pre-tx status of smoking (active vs past vs never), BMI (obese= BMI≥30 vs overweight=BMI 25-29.9 vs normal weight= BMI <25), HTN, DM, and known prognostic factors including past nephrectomy, clear cell vs non clear cell histology, initial diagnosis to Su tx initiation time, ≥ 2 metastasis (mets) sites, lung/liver/bone mets, ECOG performance status, anemia, calcium level > 10, elevated alkaline phosphatase (AP), pre-tx neutrophil to lymphocyte ratio (NLR) >3, Su induced HTN, use of angiotensin system inhibitors (ASIs), past cytokines/targeted tx, and median Su dose/cycle. PFS and OS were determined by the Kaplan-Meier method. Multivariate analyses using Cox Regression model were performed to determine their independent effect. Results: Between 2004-2011, 244 pts with mRCC were treated with Su. 51 pts were active smokers, 58 obese, 62 diabetic, and 145 had pre-tx HTN. In the entire pt cohort, median PFS was 9 months (mos) and OS 21 mos. Factors associated with PFS were active smoking (HR 2.29, p= 0.003, median PFS 4 vs 10 mos in past smokers vs 12 mos in never smokers), non clear cell histology (HR 1.7, p=0.042), pre-tx NLR >3 (HR 1.92, p<0.0001) and the use of ASIs (HR 0.58, p=0.03). Factors associated with OS were were active smoking (HR 1.85, p= 0.018, median OS 11 vs 25 mos in past smokers vs 27 mos in never smokers), AP (HR 1.9, p=0.017), pre-tx NLR >3 (HR 2.5, p<0.0001), and liver mets (HR 1.86, p=0.021). BMI, DM, and pre-tx HTN were not associated with PFS or OS. Conclusions: Active smoking may decrease the PFS and OS of pts with mRCC that are treated with Su. BMI, DM, and pre-tx HTN were not found to be associated with outcome. These results should be investigated prospectively, and if validated applied in clinical practice and clinical trials.

Use of bisphosphonates (Bis) combined with sunitinib (Su) to improve the response rate (RR), progression-free survival (PFS), and overall survival (OS) of patients (pts) with bone metastases (mets) from renal cell carcinoma (RCC).

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 4619-4619
Author(s):  
Avivit Peer ◽  
Maya Ish-Shalom ◽  
Hans J. Hammers ◽  
Mario A. Eisenberger ◽  
Victoria J. Sinibaldi ◽  
...  
Keyword(s):  
Prognostic Factors ◽  
Cox Regression ◽  
Clear Cell ◽  
Performance Status ◽  
Objective Response ◽  
Partial Likelihood ◽  
Elevated Alkaline Phosphatase ◽  
Factors Associated ◽  
Group 2 ◽  
Group 1

4619 Background: Bis are used to prevent skeletal events of bone mets, and may exhibit anti tumor effects. We aimed to evaluate whether Bis can bring a RR, PFS, and OS benefit to pts with bone mets from RCC that are treated with Su. Methods: We performed an international multicenter retrospective study of pts with bone mets from RCC who were treated with Su. Pts were divided into Bis users (group 1) and nonusers (group 2). The effect of Bis on RR, PFS and OS, was tested with adjustment for known prognostic factors using a chisquare test from contingency table and partial likelihood test from Cox regression model. Results: Between 2004-2011, 244 pts with metastatic RCC were treated with Su. 92 pts had bone mets, 41 group 1 and 51 group 2. The groups were balanced regarding the following known prognostic factors: past nephrectomy, clear cell vs non clear cell histology, initial diagnosis to sunitinib treatment (tx) time, presence of ≥ 2 mets sites, presence of lung/liver mets, ECOG performance status, anemia, calcium level > 10 mg/dL, elevated alkaline phosphatase (AP), pre-tx neutrophil to lymphocyte ratio (NLR) >3, sunitinib induced HTN, and the use of angiotensin system inhibitors. They were also balanced with regard to past cytokines/targeted tx, and mean sunitinib dose/cycle. Objective response was partial response/stable disease 85% (n=35) vs 71% (n=36), and progressive disease 15% (n=6) vs 29% (n=15) (OR 3.287, p=0.07) in group 1 vs 2 respectively. Median PFS was 15 vs 5 months (HR 0.433, p=0.035), and median OS not reached with a median folloup time of 43 mos vs 12 months (HR 0.398, p=0.003), in favor of group 1. In multivariate analysis of the entire pt cohort (n=92), factors associated with PFS were Bis use (HR 0.433, p=0.035), pre-tx NLR ≤3 (HR 0.405, p=0.016), and elevated AP (HR=3.63, p=0.012). Factors associated with OS were Bis use (HR 0.32, p=0.003), elevated AP (HR 3.18, p=0.002), and Su induced HTN (HR 0.193, p< 0.001). Conclusions: Bis may improve the outcome of Su tx in RCC with bone mets. This should be investigated prospectively, and if validated applied in clinical practice and clinical trials.

Pretreatment (pre-tx) neutrophil to lymphocyte ratio (NLR) in metastatic castration-resistant prostate cancer (mCRPC) patients (pts) treated with ketoconazole (keto): Association with outcome and predictive model.

2012 ◽  
Vol 30 (5_suppl) ◽  
pp. 37-37 ◽  
Author(s):  
Daniel Keizman ◽  
Maya Ish-Shalom ◽  
Natalie Maimon ◽  
Maya Gottfried ◽  
Michael Anthony Carducci ◽  
...  
Keyword(s):  
Risk Factors ◽  
Predictive Model ◽  
Cox Regression ◽  
Progression Free Survival ◽  
Risk Groups ◽  
Axial Skeleton ◽  
Independent Effect ◽  
Appendicular Skeleton ◽  
Castration Resistant Prostate Cancer ◽  
Factors Associated

37 Background: The CYP17 inhibitor Keto is active in mCRPC. The NLR, an index of systemic inflammation, is associated with prognosis in several types of cancer. We assessed the association between pre-tx NLR and outcome of mCRPC pts treated with keto. Methods: We performed a multicenter retrospective study of pts with mCRPC, who were treated with keto. We analyzed the pre-tx NLR and previously described factors associated with keto tx outcome as prior response to hormonal tx, pre-tx PSADT, and extent of metastatic disease (limited-axial skeleton/nodal vs extensive- appendicular skeleton/visceral). Progression free survival (PFS) was determined by the Kaplan-Meier method. Multivariate analyses using Cox regression model were performed to determine their independent effect, and to form a predictive model. A survival tree analysis was used to find the best NLR cut-off value. Results: From 1999-2011, 135 mCRPR pts were treated with keto. 67/135 (50%) had ≥ 50% PSA decline. Overall median PFS was 8 months (mos) (range 1-134 ). Excluded from the analysis were pts without available data on pre-tx NLR (n=8), and those with recent (≤1 mos) health event (surgery, n=1) or tx (steroids, n=3 or radiation, n=3) known to be associated with a change of blood counts. 120 pts were included in the analysis. 57 (48%) had an elevated pre-tx NLR >3. Risk factors associated with PFS (table) were pre-tx NLR >3, prior response to GnRH-a <24 mos and to AA <6 mos, and pre-tx PSADT <3 mos. The number of risk factors was used to categorize patients into three risk groups (table): favorable (0-1 factors), intermediate (2 factors), and poor (3-4 factors). Conclusions: In mCRPC pts treated with keto, pre-tx NLR, prior response to hormonal tx, and pre-tx PSADT are associated with PFS, and may be used to categorize pts into risk groups. [Table: see text]

Heterogeneity of intermediate prognosis patients (pts) with metastatic renal cell cancer (mRCC) treated with sunitinib.

2014 ◽  
Vol 32 (4_suppl) ◽  
pp. 446-446
Author(s):  
Avishay Sella ◽  
M. Dror Michaelson ◽  
Ewa M. Matczak ◽  
Ronit Simantov ◽  
Mariajose Lechuga ◽  
...  
Keyword(s):  
Risk Factors ◽  
Kinase Inhibitors ◽  
Risk Model ◽  
Cox Regression ◽  
Performance Status ◽  
Cell Cancer ◽  
Objective Response ◽  
Progression Free Survival ◽  
Cancer Center ◽  
Ecog Performance Status

446 Background: The Memorial Sloan Kettering Cancer Center risk model (MSKCC) stratifies pts with mRCC into 3 prognostic groups based on 5 risk factors. The Intermediate Prognosis (INTMP) risk group is characterized by the presence of 1 or 2 factors, equivalent to 15 possible distinct entities. This heterogeneity suggests that the efficacy of tyrosine kinase inhibitors may be less predictable in the INTMP than in the other groups. Methods: We identified 548 patients with INTMP mRCC from a pooled analysis of patients treated with sunitinib in 6 prospective phase II and III clinical trials. Statistical analysis was performed using Cox regression and Kaplan-Meier methods and Pearson chi-square tests. Results: Most INTMP pts were male (69%), with clear cell carcinoma (93%), good ECOG performance status (PS) (60.5% PS 0; 38% PS 1; 1.5% PS 2) and median age 60. There were 325 pts (56%) with 1risk factor, and the most common were <1 year from diagnosis (38%); low hemoglobin (Hg) (29%), or both (16%). Objective response rate (RR) was 35.4%, progression free survival (PFS) was 8.4 months (m) and overall survival (OS) was 20.5 m. The 325 (59.3%) pts with one risk factor fared better than the 223 (40.7%) patients with two: PFS 10.7 vs 6.5 m, HR 0.684(95% CI 0.563-0.832, p<0.001); OS 26.3 vs 14.1 m, HR 0.522 (95% CI 0.420-0.648, p<0.001). RR was similar (38.5% vs 30.9%, p=0.071). Sunitinib was more effective in pts with PS 0: PFS 9.7 vs 7.8 m, HR 0.797 (95% CI 0.654-0.972, p=0.0242); OS 24.7 vs 14.0 m, HR 0.529 (95% CI 0.426-0.657, p<0.001), RR 38.9% vs 30.1%, (p=0.036). The most common grade 3/4 adverse events (AE) were fatigue (17%), hypertension (10%), hand foot skin reaction (9%), and nausea (4%). Overall, 17% of patients discontinued due to AE, and the overall pattern of AEs did not vary among the subgroups. Conclusions: MSKCC INTMP is a heterogeneous group comprised mostly of pts with low Hg and/or < 1 year from diagnosis. PFS and OS are superior in pts with 1 vs. 2 risk factors, and PS is also an important factor in the INTMP group. Sunitinib is active and well-tolerated in INTMP pts. Clinical trial information: NCT00077974, NCT00083889, NCT00137423, NCT00267748, NCT00338884, NCT00054886.

Effect of bisphosphonates (Bis) combined with sunitinib (Su) on the response rate (RR), progression-free survival (PFS), and overall survival (OS) of patients (pts) with bone metastases (mets) from renal cell carcinoma (RCC).

2012 ◽  
Vol 30 (5_suppl) ◽  
pp. 379-379
Author(s):  
Daniel Keizman ◽  
Maya Ish-Shalom ◽  
Jason David Taksey ◽  
Roberto Pili ◽  
Hans J. Hammers ◽  
...  
Keyword(s):  
Alkaline Phosphatase ◽  
Prognostic Factors ◽  
Cox Regression ◽  
Clear Cell ◽  
Objective Response ◽  
Partial Likelihood ◽  
Elevated Alkaline Phosphatase ◽  
Factors Associated ◽  
Group 2 ◽  
Group 1

379 Background: Bis are used to prevent skeletal events of bone mets, and may exhibit anti tumor effects. We aimed to evaluate whether Bis can bring a RR, PFS, and OS benefit to pts with bone mets from RCC that are treated with Su. Methods: We performed a multicentre retrospective study of pts with bone mets from RCC who were treated with Su. Pts were divided into Bis users (group 1) and nonusers (group 2). The effect of Bis on RR, PFS and OS, was tested with adjustment for known prognostic factors using a chisquare test from contingency table and partial likelihood test from Cox regression model. Results: Between 2004–2011, 209 pts with metastatic RCC were treated with Su. 76 pts had bone mets, 35 group 1 and 41 group 2. The groups were balanced regarding the following known prognostic factors: past nephrectomy, clear cell/non clear cell histology, time from initial diagnosis to sunitinib treatment (tx), the presence of > 2 mets sites, the presence of lung/liver mets, ECOG performance status, anemia, calcium level >10 mg/dL, elevated alkaline phosphatase, platelets count, pre-tx neutrophil to lymphocyte ratio (NLR) >3, sunitinib induced HTN, and the use of angiotensin system inhibitors. They were also balanced with regard to past cytokines/targeted tx, and mean sunitinib dose/cycle. Objective response was partial response/stable disease 86% (n=30) vs 71% (n=29), and progressive disease 14% (n=5) vs 29% (n=12) (p=0.125, OR 2.48) in group 1 vs 2 respectively. Median PFS was 15 vs 5 months (HR 2.6, p < 0.0001), and median OS 21 vs 13 months (HR 2.1, p=0.029), in favor of group 1. In multivariate analysis of the entire pt cohort (n=76), factors associated with PFS were Bis use (HR 2.2, p=0.035) and pre-tx NLR >3 (HR 0.38, p=0.009). Factors associated with OS were Bis use (HR 2.8, p=0.008), elevated alkaline phosphatase level (HR 0.287, p=0.0003), and Su induced HTN (HR 5.57, p < 0.0001). Conclusions: Bis may improve the outcome of Su tx in RCC with bone mets. Whether this is generalizable to other TKIs is not known. This should be investigated prospectively, and if validated applied in clinical practice and clinical trials.

Patients with metastatic papillary renal cell carcinoma (RCC) who may benefit from sunitinib therapy (tx): Results from an international metastatic RCC database.

2014 ◽  
Vol 32 (4_suppl) ◽  
pp. 486-486 ◽  
Author(s):  
Daniel Kejzman ◽  
Maya Gottfried ◽  
Natalie Maimon ◽  
Hans J. Hammers ◽  
Mario A. Eisenberger ◽  
...  
Keyword(s):  
Cox Regression ◽  
Clear Cell ◽  
Progression Free Survival ◽  
Papillary Renal Cell Carcinoma ◽  
Active Smoking ◽  
Factors Associated ◽  
Clinicopathologic Factors ◽  
Papillary Rcc ◽  
Clear Cell Rcc ◽  
Pre Treatment

486 Background: The VEGFR inhibitor sunitinib is a standard tx for metastatic clear cell RCC. Data on the activity of sunitinib in metastatic non clear cell RCC, is limited by small or heterogeneous (mixed histology or targeted therapies) studies, that revealed a lower antitumor activity than in patients with clear cell histology. We aimed to analyze the activity of sunitinib in a large international cohort of patients with metastatic papillary RCC, and to characterize patients who may benefit for this therapy. Methods: Records from metastatic papillary RCC patients treated with sunitinib in 10 centers across 3 countries were retrospectively reviewed. Univariate and multivariate analyses of association between clinicopathologic factors and clinical outcome were performed using Cox regression. Results: Between 2004-2013, 74 patients (median age 60, 68% male) with metastatic papillary RCC were treated with sunitinib. 78% had a prior nephrectomy. HENG risk was good 11%, intermediate 56%, and poor 33%. 21% were active smokers, and 31% users of angiotensin system inhibitors. 24% and 41% had liver and bone metastases, respectively. 55% had a pre-treatment neutrophil to lymphocyte ratio (NLR) >3. 40% had dose reduction/treatment interruption. Sunitinib induced hypothyroidism and hypertension (HTN) occurred in 30% and 43%, respectively. 70% achieved a clinical benefit (partial response + stable disease), while 30% had disease progression within the first 3 months of therapy. Median progression free survival (PFS) and overall survival (OS) were 5 and 12 months, respectively. 27% had a PFS ≥ 1 year, and 26% survived ≥ 2 years. Factors associated with PFS were sunitinib induced HTN (HR 0.31, p=0.002), pre-treatment NLR >3 (HR 5.3, p=0.001), and active smoking (HR 2.5, p=0.01). Factors associated with OS were sunitinib induced hypothyroidism (HR 0.4, p=0.024), past nephrectomy (HR 0.41, p=0.02), pre-treatment NLR >3 (HR 2.25, p=0.036), and active smoking (HR 2.3, p=0.027). Conclusions: Clinicopathologic factors may be used to identify patients with metastatic papillary RCC who may benefit from sunitinib tx. A prolonged PFS and OS were noted in 26-27% of patients.

Pretreatment (pre-tx) neutrophil to lymphocyte ratio (NLR) in metastatic castration-resistant prostate cancer (mCRPC) patients (pts) treated with ketoconazole (keto): Association with outcome and predictive model.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 4564-4564 ◽  
Author(s):  
Avishay Sella ◽  
Maya Ish-Shalom ◽  
Natalie Maimon ◽  
Maya Gottfried ◽  
Avivit Neumann ◽  
...  
Keyword(s):  
Risk Factors ◽  
Predictive Model ◽  
Cox Regression ◽  
Progression Free Survival ◽  
Risk Groups ◽  
Independent Effect ◽  
Castration Resistant Prostate Cancer ◽  
Factors Associated ◽  
Kaplan Meier ◽  
Health Event

4564 Background: The CYP17 inhibitor keto is active in mCRPC. The NLR, an index of systemic inflammation, is associated with prognosis in several types of cancer. We assessed the association between pre-tx NLR and outcome of mCRPC pts treated with keto. Methods: We performed an international multicenter retrospective study of pts with mCRPC, who were treated with keto. We analyzed the pre-tx NLR and previously described factors associated with keto tx outcome as prior response to hormonal tx, pre-tx PSADT, and extent of metastatic disease (limited vs extensive). Progression free survival (PFS) was determined by the Kaplan-Meier method. Multivariate analyses using Cox regression model were performed to determine their independent effect, and to form a predictive model. A survival tree analysis was used to find the best NLR cut-off value. Results: From 1999-2011, 156 mCRPR pts (median age 69) were treated with keto. 78/156 (50%) had ≥ 50% PSA decline. Overall median PFS was 8 months (mos) (range 1-144). Excluded from the analysis were 23 pts without available data on pre-tx NLR, and those with recent (≤1 mos) health event or tx (surgery, steroids, radiation) associated with a change of blood counts. 133 pts were included in the analysis. 62 (47%) had an elevated pre-tx NLR >3. Risk factors associated with PFS (table) were pre-tx NLR >3, prior response to GnRH-a <24 mos and to antiandrogen (AA) <6 mos, and pre-tx PSADT <3 mos. The number of risk factors was used to categorize patients into three risk groups (table): favorable (0-1 factors), intermediate (2 factors), and poor (3-4 factors). Conclusions: In mCRPC pts treated with keto, pre-tx NLR, prior response to hormonal tx, and pre-tx PSADT are associated with PFS, and may be used to categorize pts into risk groups. [Table: see text]

scholarly journals Liver Metastases in Newly Diagnosed Pancreatic Ductal Adenocarcinoma: A Population Based Analysis

2020 ◽  
Author(s):  
Guoyi Wu ◽  
Xiaoben Pan ◽  
Baohua Wang ◽  
Xiaolei Zhu ◽  
Jing Wu ◽  
...  
Keyword(s):  
Risk Factors ◽  
Liver Metastases ◽  
Pancreatic Ductal Adenocarcinoma ◽  
Tumor Size ◽  
Cox Regression ◽  
Population Based ◽  
The Body ◽  
Ductal Adenocarcinoma ◽  
Rank Test ◽  
Factors Associated

Abstract Background Estimates of the incidence and prognosis of developing liver metastases at the pancreatic ductal adenocarcinoma (PDAC) diagnosis are lacking.Methods In this study, we analyzed the association of liver metastases and the PDAC patients outcome. The risk factors associated with liver metastases in PDAC patients were analyzed using multivariable logistic regression analysis. The overall survival (OS) was estimated using Kaplan-Meier curves and log-rank test. Cox regression was performed to identify factors associated with OS.Results Patients with primary PDAC in the tail of the pancreas had a higher incidence of liver metastases (62.2%) than those with PDAC in the head (28.6%). Female gender, younger age, primary PDAC in the body or tail of the pancreas, and larger primary PDAC tumor size were positively associated with the occurrence of liver metastases. The median survival of patients with liver metastases was significantly shorter than that of patients without liver metastases. Older age, unmarried status, primary PDAC in the tail of the pancreas, and tumor size ≥4 cm were risk factors for OS in the liver metastases cohort.Conclusions Population-based estimates of the incidence and prognosis of PDAC with liver metastases may help decide whether diffusion-weighted magnetic resonance imaging should be performed in patients with primary PDAC in the tail or body of the pancreas. The location of primary PDAC should be considered during the diagnosis and treatment of primary PDAC.

scholarly journals Abandoning resectional intent in patients initially deemed suitable for esophagectomy: a nationwide study of risk factors and outcomes

2020 ◽  
Author(s):  
David Edholm ◽  
Mats Lindblad ◽  
Gustav Linder
Keyword(s):  
Risk Factors ◽  
Cox Regression ◽  
Advanced Disease ◽  
Gastroesophageal Junction ◽  
Neoadjuvant Treatment ◽  
Multivariable Logistic Regression Analysis ◽  
Factors Associated ◽  
Gastroesophageal Junction Cancer ◽  
Increased Risk ◽  
Impact On Survival

Summary The main curative treatment modality for esophageal cancer is resection. Patients initially deemed suitable for resection may become unsuitable, most commonly due to signs of generalized disease or having become unfit for surgery. The aim was to assess risk factors for abandoning esophagectomy and its impact on survival. All patients diagnosed with an esophageal or gastroesophageal junction cancer in the Swedish National Register for Esophageal and Gastric Cancer from 2006–2016 were included and risk factors associated with becoming ineligible for resection were analyzed in multivariable logistic regression analysis. Overall survival was explored by multivariable Cox regression models. Among 1,792 patients planned for resection, 189 (11%) became unsuitable for resection before surgery and 114 (6%) had exploratory surgery without resection. Intermediate and high educational levels were associated with an increased probability of resection (odds ratio (OR) 1.46, 95% CI 1.05–2.05, OR 1.92, 95% CI 1.28–2.87, respectively) as was marital status (married: OR 1.37, 95% CI 1.01–1.85). Clinically advanced disease (cT4: OR 0.38, 95% CI 0.16–0.87; cN3: OR 0.27, 95% CI 0.09–0.81) and neoadjuvant treatment were associated with a decreased probability of resection (OR 0.62, 95% CI 0.46–0.88). Five-year survival for non-resected patients was only 4.5% although neoadjuvant treatment was associated with improved survival (HR 0.75, 95% CI 0.56–0.99). Non-resected patients with squamous cell carcinoma had comparatively reduced survival (HR 1.64, 95% CI 1.10–2.43). High socioeconomic status was associated with an increased probability of completing the plan to resect whereas clinically advanced disease and neoadjuvant treatment were independent factors associated with increased risk of abandoning resectional intent.

Induction Therapy with Fludarabine, ara-C and G-CSF Results in Improved Event Free Survival in Core Binding Factor Leukemia.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 2004-2004
Author(s):  
Gautam Borthakur ◽  
Hagop Kantarjian ◽  
Xuemei Wang ◽  
Francis Giles ◽  
Jorge E. Cortes ◽  
...  
Keyword(s):  
Posterior Probability ◽  
Cox Regression ◽  
Cox Model ◽  
Performance Status ◽  
Period Effect ◽  
Event Free Survival ◽  
Ecog Performance Status ◽  
Bayesian Approaches ◽  
Free Survival ◽  
Hematologic Disorder

Abstract Previously (Blood2001;98:3575–3583) we reported that pts with inv (16) or t(8;21) (CBF) seemed to benefit from receiving fludarabine + ara-C (FA) rather than idarubicin + ara-C (IA), although other groups did not. Ara-C doses were 2g/m2 daily X 4–5 with FA and 1.5g/m2 daily X 2–4 by continuous infusion with IA. Because this observation was based on only 14 CBF pts given FA we proceeded, from 2000-present, to give all CBF pts FA either with (2000–2002; 22 pts) or without G-CSF (2003-present; 45 pts) on the days when FA was administered. Idarubicin(12 mg/m2 daily X 3) was given only if pts presented with WBC > 50,000, forcing start of treatment before cytogenetic results were known; once CR was achieved and CBF status was known, pts received 6 courses of post-remission therapy with FA (or FA +GCSF, FLAG) as described above. Median age was 41.5 years (range 16–83), 61 were male, 16 patients had antecedent hematologic disorder (AHD), 96 patients had ECOG performance status (PS) ≤ 1. One hundred and six patients (93%) achieved complete remission (CR). Events were defined as death, failure or relapse. Median time to event was 91 weeks and estimated EFS at 10 years was approximately 40%. Event-free survival (EFS) was compared in the 67 pts treated with FA or FLAG with EFS in 47 pts treated with IA +/− GCSF (IA/IAG). Because IA/IAG was given to CBF pts from 1991–2000 and FA or FLAG from 2000-present, we compared covariate-adjusted EFS in 436 pts with cytogenetics other than CBF according to whether they received IA before or after 2000 to estimate “period-effect”.EFS was superior in the earlier period, and this difference, seeming to inherently favor IA/IAG rather than FA or FLAG, was accounted for in the comparisons of these treatments in the CBF group. Preliminary analyses suggested that EFS in CBF pts was similar between IA and IAG (these groups were considered together for subsequent analyses) and longer with FLAG than with FA or IA/IAG (p= 0.06). After adjustments for covariates (age, WBC,platelets, marrow blasts etc) we compared EFS with FA, FLAG ,and IA/IAG, using both standard (Cox regression) and Bayesian approaches. The Bayesian model indicated that the posterior probability that FLAG was superior to IA/IAG was 0.98, and that, among pts given FA, the posterior probability that FLAG was superior to FA was 0.91. The Cox model indicated that the risk of an event with FLAG relative to IA/IAG was 0.84 (p = 0.07). A possible explanation for the seeming superiority of FLAG is the ability of G to increase accumulation of fludarabine-triphosphate in blasts during therapy (Clin Cancer Res1995; 1:169–178). Figure Figure Figure Figure

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