Abstract
Background
Disparities in prostate cancer-specific mortality (PCSM) between African American and non-Hispanic White (White) patients have been attributed to biological and systemic factors. ...We evaluated drivers of these disparities in the Surveillance, Epidemiology, and End Results (SEER) national registry and an equal-access system, the Veterans Health Administration (VHA).
Methods
We identified African American and White patients diagnosed with prostate cancer between 2004 and 2015 in SEER (n = 311 691) and the VHA (n = 90 749). We analyzed the association between race and metastatic disease at presentation using multivariable logistic regression adjusting for sociodemographic factors and PCSM using sequential competing-risks regression adjusting for disease and sociodemographic factors.
Results
The median follow-up was 5.3 years in SEER and 4.7 years in the VHA. African American men were more likely than White men to present with metastatic disease in SEER (adjusted odds ratio = 1.23, 95% confidence interval CI = 1.17 to 1.30) but not in the VHA (adjusted odds ratio = 1.07, 95% CI = 0.98 to 1.17). African American vs White race was associated with an increased risk of PCSM in SEER (subdistribution hazard ratio SHR = 1.32, 95% CI = 1.10 to 1.60) but not in the VHA (SHR = 1.00, 95% CI = 0.93 to 1.08). Adjusting for disease extent, prostate-specific antigen, and Gleason score eliminated the association between race and PCSM in SEER (aSHR = 1.04, 95% CI = 0.93 to 1.16).
Conclusions
Racial disparities in PCSM were present in a nationally representative registry but not in an equal-access health-care system, because of differences in advanced disease at presentation. Strategies to increase health-care access may bridge the racial disparity in outcomes. Longer follow-up is needed to fully assess mortality outcomes.
Stereotactic body radiation therapy (SBRT) has demonstrated encouraging local tumor control rates in the treatment of pancreatic cancer, yet we lack prospective clinical trials evaluating ...dose-escalation strategies among patients treated with 5-fraction SBRT. This phase 1 dose-escalation trial was conducted to determine the maximum tolerated dose of SBRT in patients with pancreatic cancer.
Thirty patients with pancreatic cancer were enrolled and treated with 40, 45, or 50 Gy SBRT in 5 fractions with doses determined using a time-to-event continual reassessment method trial design. Systemic therapy was permitted before and after SBRT, but not mandated by the study protocol. Toxicity was the primary study endpoint, and any grade ≥3 acute or late toxicity potentially attributable to SBRT was considered a dose-limiting toxicity. Secondary endpoints included local progression, distant progression, and overall survival.
The median follow up from SBRT was 8.9 months (range, 1.7-62.6 months). Nineteen patients (63%) had locally advanced disease, 3 patients (10%) had metastatic disease, and 8 patients (27%) had medically unresectable disease. Three patients (10%) received 40 Gy, 16 patients (53%) received 45 Gy, and 11 patients (37%) received 50 Gy. Seven patients (23%) experienced grade ≤2 acute toxicity, and 2 patients (6.7%) experienced grade 4 to 5 late toxicity, both of which occurred in the 45 Gy group. Median survival time was 17.1 months from the time of diagnosis and 9.8 months from SBRT. The 1-year cumulative incidence of local progression was 14.2% (95% confidence interval, 4.2%-30%).
This dose-escalation trial evaluated high-dose SBRT delivered in 5 fractions, and overall demonstrated favorable local control and survival, but was associated with nontrivial rates of severe late gastrointestinal toxicity potentially attributable to radiation. Further prospective studies are needed to define the safety and efficacy of high-dose SBRT in patients with pancreatic cancer.
Background
Pay‐for‐performance reimbursement ties hospital payments to standardized quality‐of‐care metrics. To the authors' knowledge, the impact of pay‐for‐performance reimbursement models on ...hospitals caring primarily for uninsured or underinsured patients remains poorly defined. The objective of the current study was to evaluate how standardized quality‐of‐care metrics vary by a hospital's propensity to care for uninsured or underinsured patients and demonstrate the potential impact that pay‐for‐performance reimbursement could have on hospitals caring for the underserved.
Methods
The authors identified 1,703,865 patients with cancer who were diagnosed between 2004 and 2015 and treated at 1344 hospitals. Hospital safety‐net burden was defined as the percentage of uninsured or Medicaid patients cared for by that hospital, categorizing hospitals into low‐burden, medium‐burden, and high‐burden hospitals. The authors evaluated the impact of safety‐net burden on concordance with 20 standardized quality‐of‐care measures, adjusting for differences in patient age, sex, stage of disease at diagnosis, and comorbidity.
Results
Patients who were treated at high‐burden hospitals were more likely to be young, male, Black and/or Hispanic, and to reside in a low‐income and low‐educated region. High‐burden hospitals had lower adherence to 13 of 20 quality measures compared with low‐burden hospitals (all P < .05). Among the 350 high‐burden hospitals, concordance with quality measures was found to be lowest for those caring for the highest percentage of uninsured or Medicaid patients, minority patients, and less educated patients (all P < .001).
Conclusions
Hospitals caring for uninsured or underinsured individuals have decreased quality‐of‐care measures. Under pay‐for‐performance reimbursement models, these lower quality‐of‐care scores could decrease hospital payments, potentially increasing health disparities for at‐risk patients with cancer.
Safety‐net hospitals have decreased quality‐of‐cancer‐care measures. Under pay‐for‐performance reimbursement models, these lower quality‐of‐care scores could decrease hospital payments, potentially increasing health disparities for at‐risk patients with cancer.
Objectives
Most transoral robotic surgery (TORS) literature for HPV‐positive oropharyngeal squamous cell carcinoma (HPV‐OPC) derives from high‐volume tertiary‐care centers. This study aims to ...describe long‐term recurrence and survival outcomes among Veterans Health Administration patients.
Materials and Methods
Using the US Veterans Affairs database, we identified patients with HPV‐OPC treated with TORS between January 2010 and December 2016. Patients were stratified in risk categories: low (0–1 metastatic nodes, negative margins), intermediate (close margins, 2–4 metastatic nodes, lymphovascular or perineural invasion, pT3‐pT4 tumor), or high (positive margins, extranodal extension (ENE), and/or ≥5 metastatic nodes). Primary outcomes included overall survival (OS), disease‐specific survival (DSS), and recurrence‐free survival (RFS).
Results
The cohort included 161 patients of which 29 (18%) were low‐risk, 45 (28%) intermediate‐risk, and 87 (54%) high‐risk. ENE was present in 41% of node‐positive cases and 24% had positive margins. Median follow‐up was 5.6 years (95% CI, 3.0–9.3). The 5‐year DSS for low, intermediate, and high‐risk groups were: 100%, 90.0% (95% CI, 75.4–96.1%), and 88.7% (95% CI, 78.3–94.2%). Pathologic features associated with poor DSS on univariable analysis included pT3‐T4 tumors (HR 3.81, 95% CI, 1.31–11; p = 0.01), ≥5 metastatic nodes (HR 3.41, 95% CI, 1.20–11; p = 0.02), and ENE (HR 3.53, 95% CI, 1.06–12; p = 0.04). Higher 5‐year cumulative incidences of recurrence were observed in more advanced tumors (pT3‐T4, 33% 95% CI, 14–54% versus pT1‐T2, 13% 95% CI, 8–19%; p = 0.01).
Conclusions
In this nationwide study, patients with HPV‐OPC treated with TORS followed by adjuvant therapy at Veterans Affairs Medical Centers demonstrated favorable survival outcomes comparable to those reported in high‐volume academic centers and clinical trials.
Level of Evidence
4 Laryngoscope, 134:207–214, 2024
Using the US Veterans Affairs database, we identified 161 patients with HPV‐positive oropharyngeal carcinoma treated with TORS of which 29 (18%) were low‐risk, 45 (28%) intermediate‐risk, and 87 (54%) high‐risk. TORS followed by adjuvant treatment revealed 5‐year DSS of 100%, 90%, and 89% for low, intermediate, and high‐risk patients. ENE, pT3/T4 tumor, and >5 pathologic lymph nodes were associated with poor DSS. Cumulative incidence of first recurrence was 17%, 18%, and 13% and of distant metastasis was 0%, 12%, and 8%.
IMPORTANCE: There is concern that African American men with low-risk prostate cancer may harbor more aggressive disease than non-Hispanic White men. Therefore, it is unclear whether active ...surveillance is a safe option for African American men. OBJECTIVE: To compare clinical outcomes of African American and non-Hispanic White men with low-risk prostate cancer managed with active surveillance. DESIGN, SETTING, AND PARTICIPANTS: Retrospective cohort study in the US Veterans Health Administration Health Care System of African American and non-Hispanic White men diagnosed with low-risk prostate cancer between January 1, 2001, and December 31, 2015, and managed with active surveillance. The date of final follow-up was March 31, 2020. EXPOSURES: Active surveillance was defined as no definitive treatment within the first year of diagnosis and at least 1 additional surveillance biopsy. MAIN OUTCOMES AND MEASURES: Progression to at least intermediate-risk, definitive treatment, metastasis, prostate cancer–specific mortality, and all-cause mortality. RESULTS: The cohort included 8726 men, including 2280 African American men (26.1%) (median age, 63.2 years) and 6446 non-Hispanic White men (73.9%) (median age, 65.5 years), and the median follow-up was 7.6 years (interquartile range, 5.7-9.9; range, 0.2-19.2). Among African American men and non-Hispanic White men, respectively, the 10-year cumulative incidence of disease progression was 59.9% vs 48.3% (difference, 11.6% 95% CI, 9.2% to 13.9%); P < .001); of receipt of definitive treatment, 54.8% vs 41.4% (difference, 13.4% 95% CI, 11.0% to 15.7%; P < .001); of metastasis, 1.5% vs 1.4% (difference, 0.1% 95% CI, –0.4% to 0.6%; P = .49); of prostate cancer–specific mortality, 1.1% vs 1.0% (difference, 0.1% 95% CI, –0.4% to 0.6%; P = .82); and of all-cause mortality, 22.4% vs 23.5% (difference, 1.1% 95% CI, –0.9% to 3.1%; P = 0.09). CONCLUSIONS AND RELEVANCE: In this retrospective cohort study of men with low-risk prostate cancer followed up for a median of 7.6 years, African American men, compared with non-Hispanic White men, had a statistically significant increased 10-year cumulative incidence of disease progression and definitive treatment, but not metastasis or prostate cancer–specific mortality. Longer-term follow-up is needed to better assess the mortality risk.
MRI-guided radiation therapy (MRgRT) is an emerging, innovative technology that provides opportunities to transform and improve the current clinical care process in radiation oncology. As with many ...new technologies in radiation oncology, careful evaluation from a healthcare economic and policy perspective is required for its successful implementation. In this review article, we describe the current evidence surrounding MRgRT, framing it within the context of value within the healthcare system. Additionally, we highlight areas in which MRgRT may disrupt the current process of care, and discuss the evidence thresholds and timeline required for the widespread adoption of this promising technology.
Background
The safety of active surveillance (AS) for African American men compared with non‐Hispanic White (White) men with intermediate‐risk prostate cancer is unclear.
Methods
The authors ...identified patients with modified National Comprehensive Cancer Network favorable (“low‐intermediate”) and unfavorable (“high‐intermediate”) intermediate‐risk prostate cancer diagnosed between 2001 and 2015 and initially managed with AS in the Veterans Health Administration database. They analyzed definitive treatment, disease progression, metastases, prostate cancer–specific mortality (PCSM), and all‐cause mortality by using cumulative incidences and multivariable competing‐risks (disease progression, metastasis, and PCSM) or Cox (all‐cause mortality) regression.
Results
The cohort included 1007 men (African Americans, 330 32.8%; Whites, 677 67.2%) followed for a median of 7.7 years; 773 (76.8%) had low‐intermediate‐risk disease, and 234 (23.2%) had high‐intermediate‐risk disease. The 10‐year cumulative incidences of definitive treatment were not significantly different (African Americans, 83.5%; 95% confidence interval CI, 78.5%‐88.7%; Whites, 80.6%; 95% CI, 76.6%‐84.4%; P = .17). Among those with low‐intermediate‐risk disease, there were no significant differences in the 10‐year cumulative incidences of disease progression (African Americans, 46.8%; 95% CI, 40.0%‐53.3%; Whites, 46.9%; 95% CI, 42.1%‐51.5%; P = .91), metastasis (African Americans, 7.1%; 95% CI, 3.7%‐11.8%; Whites, 10.8%; 95% CI, 7.6%‐14.6%; P = .17), or PCSM (African Americans, 3.8%; 95% CI, 1.6%‐7.5%; Whites, 3.8%; 95% CI, 2.0%‐6.3%; P = .69). In a multivariable regression including the entire cohort, African American race was not associated with increased risks of definitive treatment, disease progression, metastasis, PCSM, or all‐cause mortality (all P > .30).
Conclusions
Outcomes in the Veterans Affairs Health System were similar for African American and White men treated for low‐intermediate‐risk prostate cancer with AS.
The safety of active surveillance for African American men with intermediate‐risk prostate cancer is unclear. This study has measured similar clinical outcomes for African American men and non‐Hispanic White men treated for either modified National Comprehensive Cancer Network (NCCN) favorable (“low‐intermediate”) or unfavorable (“high‐intermediate”) intermediate‐risk prostate cancer with active surveillance, and it suggests that active surveillance may be an appropriate option for both African American men and non‐Hispanic White men with modified NCCN favorable (“low‐intermediate”) intermediate‐risk prostate cancer.
Active surveillance (AS) is a safe treatment option for men with low-risk, localized prostate cancer. However, the safety of AS for patients with intermediate-risk prostate cancer remains unclear.
We ...identified men with NCCN-classified low-risk and favorable and unfavorable intermediate-risk prostate cancer diagnosed between 2001 and 2015 and initially managed with AS in the Veterans Health Administration. We analyzed progression to definitive treatment, metastasis, prostate cancer-specific mortality (PCSM), and all-cause mortality using cumulative incidences and multivariable competing-risks regression.
The cohort included 9,733 men, of whom 1,007 (10.3%) had intermediate-risk disease (773 76.8% favorable, 234 23.2% unfavorable), followed for a median of 7.6 years. The 10-year cumulative incidence of metastasis was significantly higher for patients with favorable (9.6%; 95% CI, 7.1%-12.5%; P<.001) and unfavorable intermediate-risk disease (19.2%; 95% CI, 13.4%-25.9%; P<.001) than for those with low-risk disease (1.5%; 95% CI, 1.2%-1.9%). The 10-year cumulative incidence of PCSM was also significantly higher for patients with favorable (3.7%; 95% CI, 2.3%-5.7%; P<.001) and unfavorable intermediate-risk disease (11.8%; 95% CI, 6.8%-18.4%; P<.001) than for those with low-risk disease (1.1%; 95% CI, 0.8%-1.4%). In multivariable competing-risks regression, favorable and unfavorable intermediate-risk patients had significantly increased risks of metastasis and PCSM compared with low-risk patients (all P<.001).
Compared with low-risk patients, those with favorable and unfavorable intermediate-risk prostate cancer managed with AS are at increased risk of metastasis and PCSM. AS may be an appropriate option for carefully selected patients with favorable intermediate-risk prostate cancer, though identification of appropriate candidates and AS protocols should be tested in future prospective studies.
Treatment with nivolumab-ipilimumab combination therapy was found to improve overall survival compared with chemotherapy among patients with advanced non-small cell lung cancer (NSCLC) in the ...CheckMate 227 clinical trial. However, these drugs are substantially more expensive than chemotherapy and, given the high incidence of advanced NSCLC, the incorporation of dual immune checkpoint inhibitors into the standard of care could have substantial economic consequences.
To assess whether nivolumab-ipilimumab combination therapy is a cost-effective first-line treatment for patients with advanced NSCLC.
This economic evaluation designed a Markov model to compare the cost-effectiveness of nivolumab-ipilimumab combination therapy with platinum-doublet chemotherapy as first-line treatment for patients with advanced NSCLC. The Markov model was created to simulate patients with advanced NSCLC who were receiving either nivolumab-ipilimumab combination therapy or platinum-doublet chemotherapy. Transition probabilities, including disease progression, survival, and treatment toxic effects, were derived using data from the CheckMate 227 clinical trial. Costs and health utilities were obtained from published literature. Data analyses were conducted from November 2019 to September 2020.
Nivolumab-ipilimumab combination therapy.
The primary study outcomes were quality-adjusted life-years (QALYs) and cost in 2020 US dollars. Cost-effectiveness was measured using an incremental cost-effectiveness ratio (ICER), with an ICER less than $100 000 per QALY considered cost-effective. Model uncertainty was assessed with 1-way and probabilistic sensitivity analyses.
Treatment with nivolumab-ipilimumab combination therapy was associated with an increase in overall cost of $201 900 and improved effectiveness of 0.50 QALYs compared with chemotherapy, yielding an ICER of $401 700 per QALY. The study model was sensitive to the cost and duration of immunotherapy. Treatment with nivolumab-ipilimumab combination therapy became cost-effective when monthly treatment costs were reduced from $26 425 to $5058 (80.9% reduction) or when the maximum duration of immunotherapy was reduced from 24.0 months to 1.4 months. The model was not sensitive to assumptions about survival or programmed cell death 1 ligand 1 status. A probabilistic sensitivity analysis indicated that, at a willingness-to-pay threshold of $100 000 per QALY, nivolumab-ipilimumab combination therapy was less cost-effective than chemotherapy 99.9% of the time.
In this study, first-line treatment with nivolumab-ipilimumab combination therapy was not found to be cost-effective at current prices despite clinical trial data indicating that this regimen increases overall survival among patients with advanced NSCLC.
The association of prostate-specific antigen velocity (PSAV) with clinical progression in patients with localized prostate cancer managed with active surveillance remains unclear and, to our ...knowledge, has not been studied in African American patients.
To test the hypothesis that PSAV is associated with clinical progression in patients with low-risk prostate cancer treated with active surveillance and to identify differences between African American and non-Hispanic White patients.
This was a retrospective population-based cohort study using patient records from the Veterans Heath Administration Informatics and Computing Infrastructure on 5296 patients with a diagnosis of localized prostate cancer from January 1, 2001, to December 31, 2015, who were managed with active surveillance. Follow-up extended through March 31, 2020. Low-risk prostate cancer was defined as International Society of Urologic Pathology grade group (GG) 1 clinical tumor stage 2A or lower, PSA level of 10 ng/dL or lower, active surveillance, and no definitive treatment within the first year after diagnosis with at least 1 additional staging biopsy after diagnostic biopsy.
Prostate-specific antigen testing.
The primary outcome was GG progression detected after repeated biopsy or prostatectomy, defined as GG2 or higher or GG3 or higher. The secondary outcome was incident metastases. Cumulative incidence functions and multivariable Cox proportional hazards regression models were used to test associations between PSAV and outcomes.
The final cohort (n = 5296) included 3919 non-Hispanic White men (74.0%; mean SD age, 65.7 5.8 years) and 1377 African American men (26.0%; mean SD age, 62.8 6.6 years). Compared with African American patients, non-Hispanic White patients were older (mean SD age, 65.7 5.8 years vs 62.8 6.6 years; P < .001), presented with higher cT stage (stage T2, 608 15.5% vs 111 8.1%; P < .001), had a higher Charlson Comorbidity Index score (1 and ≥2, 912 23.3% vs 273 19.8%; P = .002), had higher median income ($60 000 to ≥$100 000, 1223 31.2% vs 282 20.5%; P < .001), and had a higher median level of education (20% to ≥30% with college degree, 1192 30.4% vs 333 24.2%; P < .001). Progression to GG2 or higher occurred in 2062 patients (38.9%), with a cumulative incidence of 43.2%, and progression to GG3 or higher occurred in 728 patients (13.7%). Fifty-four patients (1.0%) developed metastases. On multivariable analysis, PSAV was significantly associated with progression to GG2 (hazard ratio, 1.32 95% CI, 1.26-1.39), GG3 (hazard ratio, 1.51 95% CI, 1.41-1.62), and metastases (hazard ratio, 1.38 95% CI, 1.10-1.74). Optimal PSAV thresholds that were associated with progression were significantly lower for African American patients (0.44 ng/mL/y) compared with non-Hispanic White patients (1.18 ng/mL/y).
This study suggests that PSAV is significantly associated with grade progression among patients with low-risk prostate cancer managed with active surveillance, but at lower values for African American patients compared with non-Hispanic White patients. These data suggest that serial PSA measures may potentially substitute for multiple prostate biopsies and that African American patients may merit increased frequency of PSA testing.
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