Comparative effectiveness of adjuvant chemotherapy (AC) versus observation in patients with ≥ pT3 and/or pN+ bladder cancer (BCa).

2015 ◽  
Vol 33 (7_suppl) ◽  
pp. 292-292 ◽  
Author(s):  
Matt D. Galsky ◽  
Kristian Stensland ◽  
Erin L. Moshier ◽  
John Sfakianos ◽  
Russell Bailey McBride ◽  
...  

292 Background: Though Level I evidence supports the use of neoadjuvant chemotherapy (NAC) in BCa, the data supporting AC has been mixed. Experience suggests an adequately powered trial to definitively assess the role of AC is unlikely to be completed. Alternative approaches to evidence development are necessary. Methods: Patients who underwent cystectomy for ≥pT3 and/or pN+ M0 BCa were identified from the National Cancer Database. Patients who received NAC and/or diagnosed after 2006 (most recent year with survival data) were excluded. Logistic regression was used to calculate propensity scores representing the predicted probabilities of assignment to AC versus observation based on: age, demographics, year of diagnosis, pT stage, margin status, lymph node density, distance to hospital, hospital cystectomy volume, and hospital type and location. A propensity score-matched cohort of AC versus observation (1:2) patients was created. Stratified Cox proportional hazards regression was used to estimate the hazard ratio (HR) for overall survival for the matched sample while propensity score adjusted and inverse probability of treatment weighted proportional hazards models were used to estimate adjusted HR for the full sample. A sensitivity analysis examined the impact of comorbidities. Results: 3,294 patients undergoing cystectomy alone and 937 patients undergoing cystectomy plus AC met inclusion criteria.Patients receiving AC were significantly more likely to: be younger, have more lymph nodes examined and involved, have higher pT stage, have positive margins, reside in the Northeast and closer to the hospital, and have private insurance. AC was associated with improved overall survival (Table). The results were robust to sensitivity analysis for comorbidities. Conclusions: AC was associated with improved survival in patients with ≥pT3 and/or pN+ BCa in this large comparative effectiveness analysis. [Table: see text]

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e19026-e19026
Author(s):  
Young soo Rho ◽  
Ian Pagano ◽  
Jared David Acoba

e19026 Background: Cancer surgeries performed at high case volume centers (hCVCs) are associated with improved surgical and clinical outcomes. Resectable hepatocellular carcinoma (rHCC) is not common in the US and the impact of surgery at hCVCs has not been well assessed. We analyzed the impact of surgery at hCVCs on survival, and the potential racial and socioeconomic disparities associated with obtaining care at hCVCs. Methods: We collected demographic, diagnostic, treatment, and survival data of 96,215 patients with stage I-III HCC diagnosed between 2004 – 2015 from the National Cancer Database. To estimate the average surgical volume/year, number of reported cases were divided by the number of years the facility was represented in the database. Logistic regression was used to determine the associations between case volume, facility type and the demographic and clinical variables. We assessed demographic and clinical predictors of overall survival (OS) using Cox proportional hazards regression. Results: In total, 10,419 resected HCC patients were included in the analysis. The median age was 64 (18 – 90), 68.4% were male and 69.5% were white. Facilities were divided into quartiles by average number of surgical CV/year: 1st quartile (1Q) 0.08-1.60, 2Q 1.61 – 3.91, 3Q 3.92 – 8.34, and 4Q 8.35 – 45.34. In a multivariate model, improved OS was seen with each increase in quartiles with the highest CVCs (i.e 4Q) HR 0.70 (95% CI 0.63 – 0.77). Treatment at academic centers did not show an OS advantage (HR 0.93; 95% CI 0.86 – 1.01). Factors including black race (OR 0.83; 95% CI 0.75-0.93), age 65+ (OR 0.91; 95% CI 0.82 – 1.00), and living in a metro area with a population of 250,000 – 1 million people (OR 0.68; 95% CI 0.62 – 0.74) were less likely to be associated with treatment at hCVCs. Conversely, Asians/Pacific Islanders (OR 2.28; 95% CI 2.04 – 2.55) and those with private insurance (OR 1.33; 95% CI 1.18– 1.40) or Medicare (OR 1.21; 95% CI 1.05 – 1.38) were more likely to be treated at hCVCs. Conclusions: rHCC is not common in the US and having surgery at hCVCs improves OS. However, racial and socioeconomic disparities exist in receiving care at these hCVCs.


2021 ◽  
Vol 8 (2) ◽  
pp. 27-33
Author(s):  
Jiping Zeng ◽  
Ken Batai ◽  
Benjamin Lee

In this study, we aimed to evaluate the impact of surgical wait time (SWT) on outcomes of patients with renal cell carcinoma (RCC), and to investigate risk factors associated with prolonged SWT. Using the National Cancer Database, we retrospectively reviewed the records of patients with pT3 RCC treated with radical or partial nephrectomy between 2004 and 2014. The cohort was divided based on SWT. The primary out-come was 5-year overall survival (OS). Logistic regression analysis was used to investigate the risk factors associated with delayed surgery. Cox proportional hazards models were fitted to assess relations between SWT and 5-year OS after adjusting for confounding factors. A total of 22,653 patients were included in the analysis. Patients with SWT > 10 weeks had higher occurrence of upstaging. Using logistic regression, we found that female patients, African-American or Spanish origin patients, treatment in academic or integrated network cancer center, lack of insurance, median household income of <$38,000, and the Charlson–Deyo score of ≥1 were more likely to have prolonged SWT. SWT > 10 weeks was associated with decreased 5-year OS (hazard ratio [HR], 1.24; 95% confidence interval [CI], 1.15–1.33). This risk was not markedly attenuated after adjusting for confounding variables, including age, gender, race, insurance status, Charlson–Deyo score, tumor size, and surgical margin status (adjusted HR, 1.13; 95% CI, 1.04–1.24). In conclusion, the vast majority of patients underwent surgery within 10 weeks. There is a statistically significant trend of increasing SWT over the study period. SWT > 10 weeks is associated with decreased 5-year OS.


2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e18143-e18143
Author(s):  
Elysia Marie Alvarez ◽  
Frances Maguire ◽  
Helen M. Parsons ◽  
Cyllene Morris ◽  
Arti Parikh-Patel ◽  
...  

e18143 Background: Studies have shown that having public or no insurance at sarcoma diagnosis is associated with higher stage disease and poor survival. However, previous studies have not differentiated sarcoma patients who enrolled in Medicaid at diagnosis from those previously insured, groups with differing access to care. Therefore, we examined the impact of insurance on stage at diagnosis and overall survival for AYAs with soft tissue sarcoma (STS), osteosarcoma (OS) and Ewing sarcoma (EWS). Methods: Using Medicaid enrollment data linked to the California Cancer Registry, we identified AYAs with STS (n = 1782), OS (n = 458), and EWS (n = 348), diagnosed during 2005-14. Insurance was classified as Medicaid [1. Continuous (≥5 months prior to diagnosis), 2. Discontinuous, 3. At diagnosis (no coverage prior to diagnosis)], private, and uninsured. Logistic and Cox proportional hazards regression determined the association of insurance with metastatic stage (vs localized) and overall survival, respectively adjusting for sociodemographic factors, baseline comorbidities, type of facility, treatment (survival) and stage (survival). Results: Only 17.5% of sarcoma patients had continuous Medicaid prior to diagnosis, with 11% of STS, 17% of EWS and 19% of OS patients obtaining Medicaid at diagnosis. AYAs with Medicaid at diagnosis [Odds Ratio (OR) 3.03, 95% Confidence Interval (CI) 2.27-4.03; vs private] and discontinuous Medicaid (OR 2.25, CI 1.48-3.41) had a higher likelihood of metastatic disease. STS patients with Medicaid at diagnosis [Hazard Ratio (HR) 1.83, CI 1.44-2.33; vs private) and discontinuous Medicaid (HR 1.45, CI 1.01-2.08) had worse survival. Medicaid at diagnosis (HR 1.68, CI 1.07-2.63) also was associated with worse survival in OS patients, but this association was not observed in EWS patients. Conclusions: Lacking insurance prior to diagnosis is associated with metastatic disease at presentation and worse survival in AYA patients with sarcoma. Health insurance remained associated with worse survival even after adjusting for stage, highlighting the importance of continuous health insurance to improve outcomes for this patient population.


2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 7049-7049
Author(s):  
Brian Christopher Baumann ◽  
Nandita Mitra ◽  
Joanna Harton ◽  
Ying Xiao ◽  
Andrzej Wojcieszynski ◽  
...  

7049 Background: Proton therapy may increase the tolerability/efficacy of concurrent chemoradiotherapy (CRT) but is controversial & generally not covered by private insurers. There is little data on the comparative effectiveness (CE) of proton vs photon CRT among private insurance pts to guide payers on proton coverage policies. Methods: We conducted a CE study of adult non-metastatic cancer pts with private insurance treated with curative-intent proton vs photon CRT from 2011-2016 at Penn. The choice of radiation modality was heavily influenced by the insurer’s proton coverage policy. Data on adverse events (AEs) & survival were gathered prospectively using standardized templates. Primary endpoint was 90-day AEs associated with unplanned hospitalizations (CTCAEv4 grade ≥3 AEs). Secondary endpoints included 90-day grade ≥2 AEs, decline in ECOG performance status (PS) during treatment, disease-free survival (DFS) & overall survival (OS). Modified Poisson regression models with inverse propensity score weighting were used for adverse event outcomes. Weighted Cox proportional hazards models were used for survival outcomes. Propensity scores were estimated using an ensemble machine-learning approach. P<0.01 was significant. Results: 920 pts were included (178 proton/742 photon), with H&N(25 proton/296 photon); CNS(44/128); lung(41/120); upper GI(34/78) & lower GI/GYN(34/120). Median age was 57. Race, comorbidity score, BMI, baseline AEs & baseline PS were similar (p>0.05 for all). 11.2% of proton pts had grade ≥3 AE’s vs 26.8% of photon pts. On propensity score weighted-analyses, proton CRT was associated with significantly lower relative risk (RR) of 90-day grade ≥3 AEs (RR 0.51, 95%CI 0.32-0.81, p<0.01). 90-day grade ≥2 AE’s (RR 0.91, 95%CI 0.83-0.99, p=0.03); decline in PS (RR 0.85, 95%CI 0.70-1.04, p=0.11); DFS (HR 0.64, 95%CI 0.27-1.52, p=0.31) & OS (HR 0.53, 95%CI 0.18-1.52, p=0.24) favored protons. Sensitivity analysis showed that a substantial imbalance in an unmeasured confounder would be needed to alter the significance of the primary outcome. Proton accepting insurance status was not associated with a difference in 90-day grade ≥3 AE’s (RR 1.02, 95%CI 0.95-1.10, p=0.54) for pts treated with photon CRT (608 with non-proton accepting insurance & 134 with proton-accepting insurance). Conclusions: In adults with private insurance, proton CRT was associated with significantly reduced acute grade ≥3 AE’s with similar DFS & OS. Proton-accepting insurance status was not associated with better health outcomes when adjusting for RT modality.


2020 ◽  
Author(s):  
Shilong Wu ◽  
Mengyang Liu ◽  
Weixue Cui ◽  
Guilin Peng ◽  
Jianxing He

Abstract Background Thymoma is an uncommon intrathoracic malignant tumor and has a long natural history. It is uncertain whether the survival of thymoma patient is affected by prior cancer history. Finding out the impact of a prior cancer history on thymoma survival has important implications for both decision making and research. Method The Surveillance, Epidemiology, and End Results (SEER) database was queried for thymoma patients diagnosed between 1975 and 2015. Kaplan-Meier methods and Cox proportional hazards model were used to analyze overall survival across a variety of stages, age, and treatment methods with a prior cancer history or not. Results A total of 3604 patients with thymoma were identified including 507 (14.1%) with a prior cancer history. The 10-year survival rate of patients with a prior cancer history (53.8%) was worse than those without a prior cancer history (40.32%, 95%CI 35.24-45.33, P < 0.0001). However, adjusted analyses showed that the impact of a prior cancer history was heterogenous across age and treatment methods. In subset analyses, prior cancer history was associated with worse survival among patients who were treated with chemoradiotherapy (HR: 2.80, 95% CI: 1.51-5.20, P = 0.001) and age ≤ 65 years (HR: 1.33, 95%CI: 1.02-1.73, P = 0.036). Conclusions Prior cancer history provides an inferior overall survival for patients with thymoma. But it does not worsen the survival in some subgroups and these thymoma patients should not be excluded from clinical trials.


2019 ◽  
Vol 17 (3) ◽  
pp. 211-219 ◽  
Author(s):  
Nikolai A. Podoltsev ◽  
Mengxin Zhu ◽  
Amer M. Zeidan ◽  
Rong Wang ◽  
Xiaoyi Wang ◽  
...  

ABSTRACTBackground: Current guidelines recommend hydroxyurea (HU) as frontline therapy for patients with high-risk essential thrombocythemia (ET) to prevent thrombosis. However, little is known about the impact of HU on thrombosis or survival among these patients in the real-world setting. Patients and Methods: A retrospective cohort study was conducted of older adults (aged ≥66 years) diagnosed with ET from 2007 through 2013 using the linked SEER-Medicare database. Multivariable Cox proportional hazards regression models were used to assess the effect of HU on overall survival, and multivariable competing risk models were used to assess the effect of HU on the occurrence of thrombotic events. Results: Of 1,010 patients, 745 (73.8%) received HU. Treatment with HU was associated with a significantly lower risk of death (hazard ratio [HR], 0.52; 95% CI, 0.43–0.64; P<.01). Every 10% increase in HU proportion of days covered was associated with a 12% decreased risk of death (HR, 0.88; 95% CI, 0.86–0.91; P<.01). Compared with nonusers, HU users also had a significantly lower risk of thrombotic events (HR, 0.51; 95% CI, 0.41–0.64; P<.01). Conclusions: Although underused in our study population, HU was associated with a reduced incidence of thrombotic events and improved overall survival in older patients with ET.


2014 ◽  
Vol 32 (3_suppl) ◽  
pp. 528-528
Author(s):  
David Mitchell Marcus ◽  
Dana Nickleach ◽  
Bassel F. El-Rayes ◽  
Jerome Carl Landry

528 Background: The standard treatment for locally advanced rectal cancer is neoadjuvant chemoradiation followed by surgery, but many physicians question the benefit of multimodality therapy in patients with stage T3N0M0 disease. We aimed to determine the impact of radiation therapy (RT) on overall survival (OS) in this group of patients. Methods: We used the Surveillance, Epidemiology, and End Results database to identify patients undergoing surgery for T3N0M0 adenocarcinoma of the rectum from 2004 to 2010. The Kaplan-Meier method was used to compare OS for patients receiving RT vs. no RT, along with for pre-op vs. post-op RT among patients that received RT. Multivariable analysis (MVA) using a Cox proportional hazards model was performed to assess the association of RT with OS after adjusting for patient age, gender, race, tumor grade, carcinoembryonic antigen, type of surgery, and circumferential margin status. The analysis was repeated separately on patients that underwent total colectomy (TC) vs. sphincter-sparing surgery. Results: The cohort included 8,679 patients, including 4,705 who received RT and 3,974 who did not. Median age was 66 years. Five year OS was 76.5% in patients who received RT, compared to 60.0% in patients who did not receive RT (p <0.001). Five year OS was 76.9% for patients receiving pre-op RT vs. 75.7% in patients receiving post-op RT (p = 0.247). In patients undergoing TC, five year OS was 74.7% for patients receiving RT, compared to 47.5% in patients not receiving RT (p <0.001). In patients undergoing sphincter-sparing surgery, five year OS was 77.7% in patients receiving RT, compared to 62.9% in patients not receiving RT (p <0.001). Use of RT was significantly associated with OS on MVA, both in the entire cohort (HR 0.70 [95% CI 0.60-0.81]; p<0.001) and in subsets of patients undergoing TC (HR 0.55 [95% CI 0.38-0.79]; p=0.001) and sphincter-sparing surgery (HR 0.70 [95% CI 0.59-0.84]; p<0.001). Conclusions: The use of RT is associated with superior OS in patients undergoing surgery for T3N0M0 adenocarcinoma of the rectum. This benefit is demonstrated in both the pre-op and post-op settings and applies to patients undergoing both TC and sphincter-sparing surgery.


2019 ◽  
Vol 37 (4_suppl) ◽  
pp. 417-417
Author(s):  
Johannes Uhlig ◽  
Cortlandt Sellers ◽  
Sajid A. Khan ◽  
Charles Cha ◽  
Hyun S. Kevin Kim

417 Background: To assess the impact of hospital volume and type on survival in patients with hepatocellular carcinoma (HCC). Methods: Patients with histopathological or imaging-based diagnosis of HCC were identified from the 2003-2015 National Cancer Database (NCDB). First-line treatment was stratified as liver transplant, surgical resection, interventional oncology (IO) and chemotherapy. Hospital volume was stratified as high (ranking among top 10% in case numbers) and low volume, separately for each treatment modality. Hospital type was categorized as academic and non-academic. Overall survival was assessed using multivariable Cox proportional hazards models. Results: A total of 63,877 patients were included (transplant n = 10,596, surgical resection n = 11,132, IO n = 12,286, chemotherapy n = 29,863). Of 1,261 hospitals systems which treated HCC, 226 (17.9%) were academic centers and 1,035 (82.1 %) were non-academic centers. Mean number of cases treated annually was higher in academic centers (55.2; 34.6; 40.7; 79.9) versus non-academic centers (10.7; 6.25; 6.6; 11.9 for transplant; surgical resection; IO and chemotherapy; p < 0.001, respectively). Young African American patients and those with private insurance, high income and education were more likely to receive treatment at academic centers. Geographical difference were evident among US regions, with highest proportion of HCC treated at academic centers in New England states (83.6%) and lowest in South Atlantic states (48.6%). Overall survival was superior for academic versus non-academic centers (HR = 0.89, 95% CI: 0.87-0.91, p < 0.001) and high versus low volume centers (HR = 0.79, 95% CI: 0.77-0.81, p < 0.001), after multivariable adjustment for potential confounders. These effects were evident among all HCC treatment modalities. Conclusions: HCC treatment in academic centers shows distinct patterns according to patient demographics and US geography. Among all treatment modalities, both academic setting and hospital volume independently affected HCC outcomes, with highest patient survival observed in high-volume academic centers.


2020 ◽  
Vol 38 (6_suppl) ◽  
pp. 473-473
Author(s):  
Catherine Curran ◽  
Gregory Russell Pond ◽  
Amin Nassar ◽  
Sarah Abou Alaiwi ◽  
Bradley Alexander McGregor ◽  
...  

473 Background: Many ICIs are approved to treat mUC following platinum-based chemo and as 1st-line therapy for selected patients (pts). While RECIST 1.1 responses are generally durable and associated with prolonged survival, the benefit of ICIs extends beyond this group of pts. Stable disease (SD) consists of a heterogeneous population of pts with both increase and decrease in tumor size and is confounded by the impact of pre-ICI disease pace. We hypothesized that in the setting of ICIs, any regression of tumor (ART) within 12 weeks may capture early benefit and correlate with survival more comprehensively than RECIST 1.1. Methods: mUC pts who received an ICI following platinum-based chemo at DFCI were eligible for analysis. Pts were required to have tumor size changes, RECIST 1.1 response by week 12 and survival data available. Demographics and prognostic factors were collected. Descriptive stats were calculated, and univariable Cox proportional hazards regression analysis was conducted to examine the prognostic effect of ART and RECIST 1.1 with overall survival (OS). Results: 104 pts were evaluable. The median age was 66 (range 34-89). 71% were male. The numbers of pts with ART and RECIST1.1 partial response (PR) were 45 (43.3%) and 32 (30.1%), respectively. Univariable analyses identified an association between ART and RECIST 1.1 response with OS (p<0.001). The 1-year OS (95% CI) for ART vs. no ART was 83.6 % (68.7, 91.8) and 35.9 % (23.1, 48.8), while the 1-year OS (95% CI) for RECIST 1.1 response vs. no response was 81.3% (62.9, 91.1) and 45.6% (32.9, 57.4), respectively. RECIST 1.1 category was not significantly associated with OS (p-value=0.68) after adjusting for ART; however, statistically, ART associated with OS (p=0.002) after adjusting for RECIST 1.1 category. The modest size of this cohort is a limitation. Conclusions: ART within 12 weeks is identified early and is robustly associated with OS in pts with mUC receiving post-platinum ICIs. ART may serve as a more optimal intermediate endpoint for survival compared to RECIST 1.1 in the setting of ICIs. Evaluating this endpoint in other malignancies is warranted.


2018 ◽  
Vol 55 (2) ◽  
pp. 273-279 ◽  
Author(s):  
Pier Luigi Filosso ◽  
Francesco Guerrera ◽  
Nicola Rosario Falco ◽  
Pascal Thomas ◽  
Mariano Garcia Yuste ◽  
...  

Abstract OBJECTIVES Typical carcinoids (TCs) are rare, slow-growing neoplasms, usually characterized by satisfactory surgical outcomes. Due to the rarity of TCs, international guidelines for the management of particular clinical presentations currently do not exist. In particular, non-anatomical resections (wedges) are sometimes advocated for Stage 1 TCs because of their indolent behaviour. The aim of this paper was to evaluate the most effective type of surgery for Stage 1 TCs, using the European Society of Thoracic Surgeons retrospective database of the Neuroendocrine Tumors of the Lung Working Group. METHODS We analysed the effect of surgical procedure on the survival of patients with Stage 1 TCs. Overall survival (OS) was calculated from the date of intervention. The cumulative incidence of cause-specific death (tumour- and non-tumour-related) was also estimated. The impact of the surgical procedure (i.e. lobectomy vs segmentectomy vs wedge resection) on survival was investigated using the Cox model with shared frailty (for OS, accounting for the within-centre correlation) and the Fine and Gray model (for cause-specific mortality) using the approach based on the multinomial propensity score. Effects were estimated including in the model the logit-transformed propensity scores of segmentectomy and wedge resection as covariates. RESULTS A total of 876 patients with Stage 1 TCs (569 women, 65%) were included in this study. The median age was 60 years (interquartile range 47–69). At the last follow-up, 66 patients had died: The 5-year OS rate was 94.3% [95% confidence interval (CI) 92.2–95.9]. The 5-year cumulative incidences of tumour- and non-tumour-related deaths were 2.4% (95% CI 1.4–3.9) and 3.9% (95% CI 2.5–5.6%), respectively. The analysis performed using the multinomial propensity score approach confirmed the significantly worse survival of patients treated with a wedge resection compared to those treated with a lobectomy (hazard ratio 2.01, 95% CI 1.09–3.69; P = 0.024). Similar effects of wedge resection are detectable for cause-specific deaths: tumour-related (hazard ratio 2.28, 95% CI 0.86–6.02; P = 0.096) and non-tumour-related (hazard ratio 1.74, 95% CI 0.89–3.40; P = 0.105). CONCLUSIONS In a large cohort of patients, we were able to demonstrate the superiority of anatomical surgical resection in Stage 1 TCs in terms of OS. This result should therefore be considered for future clinical guidelines for the management of TCs.


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