Role of cytoreductive nephrectomy (CN) in metastatic renal cell carcinoma (mRCC).

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 4582-4582
Author(s):  
Pooja Ghatalia ◽  
Elizabeth A. Handorf ◽  
Mengying Deng ◽  
Matthew R. Zibelman ◽  
Philip Abbosh ◽  
...  
Keyword(s):  
Propensity Score ◽  
Systemic Therapy ◽  
Proportional Hazards ◽  
Statistical Significance ◽  
Patient Characteristics ◽  
Cox Proportional Hazards ◽  
Time Varying ◽  
Health Database ◽  
Time Varying Covariates

4582 Background: The role of CN in mRCC was challenged by the results of the CARMENA trial in the targeted therapy (TT) era. We sought to evaluate the role of both upfront and deferred CN in pts receiving modern IO-based and TT regimens. Methods: Pts with synchronous mRCC who received systemic therapy (tx) for mRCC after 2011 were included from the de-identified nationwide Flatiron Health database. We evaluated 3 groups: systemic tx alone, systemic-> CN, and CN-> systemic tx. Overall survival (OS) was calculated from the time of initiation of first therapy – systemic or CN. Patient characteristics were compared using chi-squared tests or t-test. Weighted Kaplan-Meier curves, log-rank tests, and Cox proportional hazards regressions with time-varying covariates were used to assess the effect of tx on survival. Adjustment was conducted via inverse probability of treatment weighing based on the generalized propensity score, estimated via Bayesian Additive Regression Trees. Covariates in the model were age, gender, race, insurance at mRCC diagnosis, and IMDC risk group. Results: Of 1719 pts with mRCC, 972 (56.5%) received systemic tx alone, 605 (35.1%) received CN-> systemic tx, and 142 (8.2%) received systemic->CN. 310 pts received IO or IO/IO, 123 pts received IO+TT and 1152 pts received only TT. The median follow-up was 37.1 months. In adjusted analyses using propensity score weighting and time-varying covariates, CN-> systemic was significantly associated with improved OS compared with systemic tx alone (Table). When stratifying groups by type of systemic treatment (IO and TT), there was improvement of OS in the CN groups compared to systemic tx alone, although we lacked power to reach statistical significance. Among CN-treated patients, the order of systemic tx relative to CN did not change OS (hazard ratio [HR] = 1.00, 95% CI 0.76-1.32, p=0.96). Conclusions: Using a national, EHR-based cohort, which includes a large number of IO treated pts, our findings support an oncologic role for CN in select mRCC pts. The timing of CN, for pts who were able to receive both systemic therapy and CN, may not affect overall outcome. The associated improvement in survival of CN is seen in pts receiving IO and TKI based systemic tx.[Table: see text]

scholarly journals Risk Evaluation of Denosumab And Zoledronic Acid For Medication-Related Osteonecrosis of The Jaw In Patients With Bone Metastases: A Propensity Score-Matched Analysis

2021 ◽  
Author(s):  
Hiroaki Ikesue ◽  
Kohei Doi ◽  
Mayu Morimoto ◽  
Masaki Hirabatake ◽  
Nobuyuki Muroi ◽  
...  
Keyword(s):  
Zoledronic Acid ◽  
Bone Metastasis ◽  
Propensity Score ◽  
Proportional Hazards ◽  
Significant Risk ◽  
Patient Characteristics ◽  
Osteonecrosis Of The Jaw ◽  
Cox Proportional Hazards ◽  
Close Monitoring ◽  
Patients With Cancer

Abstract Purpose: This study evaluated the risk of medication-related osteonecrosis of the jaw (MRONJ) in patients with cancer who received denosumab or zoledronic acid (ZA) for treating bone metastasis.Methods: The medical records of patients were retrospectively reviewed. Patients who did not undergo a dental examination at baseline were excluded. The primary endpoint was a comparison of the risk of developing MRONJ between the denosumab and ZA groups. Propensity score matching was used to control for baseline differences between patient characteristics and compare outcomes for both groups.Results: Among the 799 patients enrolled, 58 (7.3%) developed MRONJ. The incidence of MRONJ was significantly higher in the denosumab group than in the ZA group (9.6% [39/406] vs. 4.8% [19/393], p = 0.009). Multivariate Cox proportional hazards regression analysis revealed that denosumab treatment (hazard ratio [HR], 2.89; 95% confidence interval [CI], 1.65–5.25; p < 0.001) and tooth extraction after starting ZA or denosumab (HR, 4.26; 95% CI, 2.38–7.44; p < 0.001) were significant risk factors for MRONJ. Propensity score-matched analysis confirmed that the risk of developing MRONJ was significantly higher in the denosumab group than in the ZA group (HR, 2.34; 95% CI, 1.17–5.01; p = 0.016). Conclusion: The results of this study suggest that denosumab poses a significant risk for developing MRONJ in patients treated for bone metastasis, and thus these patients require close monitoring.

The role of perioperative systemic therapy in localized pancreatic neuroendocrine tumor.

2019 ◽  
Vol 37 (4_suppl) ◽  
pp. 322-322
Author(s):  
Hao Xie ◽  
Siddhartha Yadav ◽  
Xavier Keutgen ◽  
Timothy J. Hobday ◽  
Jonathan R. Strosberg ◽  
...  
Keyword(s):  
Surgical Resection ◽  
Systemic Therapy ◽  
Proportional Hazards ◽  
Pancreatic Neuroendocrine Tumor ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Regression ◽  
Proportional Hazards Regression ◽  
Grade 3 ◽  
Head Of Pancreas

322 Background: The role of perioperative systemic therapy (PST) is unclear in the management of localized pancreatic neuroendocrine tumor (pNET). We aim to evaluate the benefit of PST compared to surgical resection alone in localized pNET. Methods: We identified patients with stage I–III pNET who underwent curative-intent surgical resection in National Cancer Database from 2006 to 2014. Patients who underwent PST and surgical resection were matched with patients who received surgery alone by propensity score at 1:1 ratio with nearest neighbor method. Factors predicting the use of PST were identified from logistic regression. Survival was estimated with Kaplan-Meier method and compared with Cox proportional hazards regression. Results: 4919 patients were included in this study with median age of 60 years. 1397 (28%) patients had pNET at the head of pancreas. 2708 (55%) patients had pNET at pancreas body and tail. 334 (6.8%) patients received PST. Factors associated with significant more use of PST compared to surgery alone were age < 65 years, low income, community medical facilities, grade 3/4 tumor, tumor at the head of pancreas, T3-4 tumor and N1 tumor. 310 patients in PST group were matched with 310 patients in surgery alone group, with no significant difference for all covariates after match. For those in PST group, 64 (21%) patients received neoadjuvant systemic therapy, 173 (56%) patients received adjuvant systemic therapy, 7 (2.3%) patients received both, and 66 (21%) patients received PST without clear sequence. In the matched cohort, PST group had significantly shorter overall survival (OS) compared to surgery alone group (median OS 91.1 months versus not reached, p = 0.04). This finding was confirmed by multivariable Cox proportional hazards regression in unmatched cohort with HR 1.5 (95% CI 1.2 – 1.9, p = 0.002). Subgroup analysis in patients with grade 3/4 tumor demonstrated PST group has a trend of shorter OS compared to surgery alone group (median OS 34.1 versus 54.4 months, p = 0.1). Conclusions: PST compared to surgery alone is associated with worse OS in patients with localized pNET. This finding suggests that we may use PST in localized pNET with caution in the absence of solid clinical trial data.

scholarly journals Generating Survival Times Using Cox Proportional Hazards Models with Cyclic and Piecewise Time-Varying Covariates

2020 ◽  
Vol 12 (3) ◽  
pp. 324-339 ◽  
Author(s):  
Yunda Huang ◽  
Yuanyuan Zhang ◽  
Zong Zhang ◽  
Peter B. Gilbert
Keyword(s):  
Survival Data ◽  
Dose Regimen ◽  
Hazard Function ◽  
Proportional Hazards ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Time Varying ◽  
Proportional Hazards Models ◽  
Cox Proportional Hazards Models ◽  
Time Varying Covariates

Abstract Time-to-event outcomes with cyclic time-varying covariates are frequently encountered in biomedical studies that involve multiple or repeated administrations of an intervention. In this paper, we propose approaches to generating event times for Cox proportional hazards models with both time-invariant covariates and a continuous cyclic and piecewise time-varying covariate. Values of the latter covariate change over time through cycles of interventions and its relationship with hazard differs before and after a threshold within each cycle. The simulations of data are based on inverting the cumulative hazard function and a log link function for relating the hazard function to the covariates. We consider closed-form derivations with the baseline hazard following the exponential, Weibull, or Gompertz distribution. We propose two simulation approaches: one based on simulating survival data under a single-dose regimen first before data are aggregated over multiple-dosing cycles and another based on simulating survival data directly under a multiple-dose regimen. We consider both fixed intervals and varying intervals of the drug administration schedule. The method’s validity is assessed in simulation experiments. The results indicate that the proposed procedures perform well in generating data that conform to their cyclic nature and assumptions of the Cox proportional hazards model.

Role of adjuvant radiation in patients with squamous cell carcinomas of the oral cavity.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 6042-6042
Author(s):  
Steven Brad Maron ◽  
Bonnie Gould Rothberg ◽  
Michael Otremba ◽  
Benjamin Judson ◽  
Daniel Morgensztern
Keyword(s):  
Oral Cavity ◽  
Squamous Cell ◽  
Proportional Hazards ◽  
Statistical Significance ◽  
Cox Proportional Hazards ◽  
Stage Iii ◽  
Multiple Primary Cancers ◽  
Adjuvant Radiation ◽  
Number Of Patients

6042 Background: Although surgery is the initial treatment of choice for patients with stage III squamous cell carcinoma (SCC) of the oral cavity (OC), the role of adjuvant radiotherapy (RT) remains undefined. We evaluated the differences in outcome according to stage subsets and use of adjuvant RT. Methods: The Surveillance Epidemiology and End Results (SEER) database was queried for patients with SCCOC, treated with surgery (S), RT, or both (SRT); older than 21 years; and diagnosed between 2004 and 2009. Patients with extracapsular lymph node extension or multiple primary cancers were excluded. Overall Survival (OS) rates were estimated by the Kaplan-Meier method and compared using log-rank testing as well as Cox proportional hazards. Results: Among the 1,051 patients meeting eligibility criteria, the most common treatment was SRT (49.1%), followed by S alone (28.9%), and RT alone (22.0%). The 5-year OS ranged from 33.3% in T3N1 to 52.8% in T1N1. Compared to S alone, the addition of RT improved 5-year OS in the entire cohort from 39.5% to 51.1% (HR 0.69, 95% CI 0.54-0.87, p = 0.002). This benefit, however, was significant only for stage T3N0 with a trend towards improvement in the T3N1 group. No significant benefit was observed in T1N1 or T2N1 disease (Table). Conclusions: Stage III SCC of the oral cavity is a heterogeneous disease with significant differences in survival according to its subsets. Adjuvant RT was associated with improved survival for patients with stage T3N0 disease but not T1N1 or T2N1. The benefit of RT in T3N1 cases did not reach statistical significance likely due to the small number of patients. If confirmed in prospective studies, further subdivision of stage III SCC of OC may be necessary, and the indication for RT may be restricted to patients with T3 disease. [Table: see text]

Abstract 13950: Predicted Heart Mass and BMI: Evaluating Undersized Heart Transplantation in Obese vs. Non-Obese Patients

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Samuel T Kim ◽  
Mark R Helmers ◽  
Peter Altshuler ◽  
Amit Iyengar ◽  
Jason Han ◽  
...  
Keyword(s):  
Propensity Score ◽  
Heart Transplantation ◽  
Propensity Score Matching ◽  
Proportional Hazards ◽  
Cox Proportional Hazards ◽  
Hazard Ratio ◽  
Obese Patients ◽  
Heart Transplants ◽  
Term Survival ◽  
Heart Mass

Introduction: Although guidelines for heart transplant currently recommend against donors weighing ≥ 30% less than the recipient, recent studies have shown that the detriment of under-sizing may not be as severe in obese recipients. Furthermore, predicted heart mass (PHM) has been shown to be more reliable for size matching compared to metrics such as weight and body surface area. In this study, we use PHM to characterize the effects of undersized heart transplantation (UHT) in obese vs. non-obese recipients. Methods: Retrospective analysis of the UNOS database was performed for heart transplants from Jan. 1995 to Sep. 2020. Recipients were stratified by obese (BMI ≥ 30) and non-obese (30 > BMI ≥ 18.5). Undersized donors were defined as PHM ≥ 20% less than recipient PHM. Obese and non-obese populations separately underwent propensity score matching, and Kaplan-Meier estimates were used to graph survival. Multivariable Cox proportional-hazards analyses were used to adjust for confounders and estimate the hazard ratio for death attributable to under-sizing. Results: Overall, 50,722 heart transplants were included in the analysis. Propensity-score matching resulted in 2,214, and 1,011 well-matched pairs, respectively, for non-obese and obese populations. UHT in non-obese recipients resulted in similar 30-day mortality (5.7% vs. 6.3%, p = 0.38), but worse 15-year survival (38% vs. 35%, P = 0.04). In contrast, obese recipients with UHT saw similar 30-day mortality (6.4% vs. 5.5%, p = 0.45) and slightly increased 15-year survival (31% vs. 35%, P = 0.04). Multivariate Cox analysis showed that UHT resulted in an adjusted hazard ratio of 1.08 (95% CI 1.01 - 1.16) in non-obese recipients, and 0.87 (95% CI 0.78 - 0.98) in obese recipients. Conclusions: Non-obese patients with UHT saw worse long-term survival, while obese patients with UHT saw slightly increased survival. These findings may warrant reevaluation of the current size criteria for obese patients awaiting a heart.

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