Selective Personalized RadioImmunotherapy for Locally Advanced Non-Small-Cell Lung Cancer Trial (SPRINT).

PURPOSE: Standard therapy for locally advanced non-small-cell lung cancer (LA-NSCLC) is concurrent chemoradiotherapy followed by adjuvant durvalumab. For biomarker-selected patients with LA-NSCLC, we hypothesized that sequential pembrolizumab and risk-adapted radiotherapy, without chemotherapy, would be well-tolerated and effective. METHODS: Patients with stage III NSCLC or unresectable stage II NSCLC and an Eastern Cooperative Oncology Group performance status of 0-1 were eligible for this trial. Patients with a PD-L1 tumor proportion score (TPS) of ≥50% received three cycles of induction pembrolizumab (200 mg, once every 21 days), followed by a 20-fraction course of risk-adapted thoracic radiotherapy (55 Gy delivered to tumors or lymph nodes with metabolic volume exceeding 20 cc, 48 Gy delivered to smaller lesions), followed by consolidation pembrolizumab to complete a 1-year treatment course. The primary study end point was 1-year progression-free survival (PFS). Secondary end points included response rates after induction pembrolizumab, overall survival (OS), and adverse events. RESULTS: Twenty-five patients with a PD-L1 TPS of ≥50% were enrolled. The median age was 71, most patients (88%) had stage IIIA or IIIB disease, and the median PD-L1 TPS was 75%. Two patients developed disease progression during induction pembrolizumab, and two patients discontinued pembrolizumab after one infusion because of immune-related adverse events. Using RECIST criteria, 12 patients (48%) exhibited a partial or complete response after induction pembrolizumab. Twenty-four patients (96%) received definitive thoracic radiotherapy. The 1-year PFS rate is 76%, satisfying our efficacy objective. One- and 2-year OS rates are 92% and 76%, respectively. The most common grade 3 adverse events were colitis (n = 2, 8%) and esophagitis (n = 2, 8%), and no higher-grade treatment-related adverse events have occurred. CONCLUSION: Pembrolizumab and risk-adapted radiotherapy, without chemotherapy, are a promising treatment approach for patients with LA-NSCLC with a PD-L1 TPS of ≥50%.

Impact of Primary Care Access on Mortality of Lung Cancer Patients in an Underserved Community.

BACKGROUND: Lack of access to primary care physicians (PCPs) may be an important contributor to mortality differences attributed to race/ethnicity. This study examined the effects of primary care access on mortality of lung cancer patients in an underserved community. METHODS: Medical records of all newly diagnosed patients with primary lung cancer from 2012 to 2016 at a National Cancer Institute (NCI)-designated center in Bronx, New York were reviewed. Demographic data, PCP status, and residence in primary care shortage areas (PCSAs) were collected. Survival data from time of first imaging to death or the end of follow-up on January 1, 2018 were recorded. Survival analysis was performed using Kaplan-Meier and Cox hazards modeling. RESULTS: Among 1062 patients, 874 (82%) were PCSA residents, 314 (30%) were Hispanic, and 445 (42%) were African American. PCSA residents were likely Hispanics (P<0.001), African Americans (P<0.001), of lower income (P<0.001), and had advanced disease at diagnosis (P=0.01). Patients without established PCPs had more comorbidities (P=0.04), more advanced disease (P<0.001), and less in-network cancer treatment (P<0.001). PCSA residence (P=0.03, hazard ratio [HR]=1.27) and no established PCP (P<0.001, HR=1.50) were associated with increased mortality. In multivariable modeling, lack of established PCP remained a predictor of increased mortality (P=0.02, HR=1.25). DISCUSSION: Among newly diagnosed lung cancer patients, lack of established PCP is associated with increased mortality. Hispanics and African Americans increasingly resided in PCSAs, suggesting race/ethnicity mortality differences may be mediated by primary care shortage. Patients without PCPs had worse health outcomes. Effective health policy efforts to reduce mortality in lung cancer patients must include approaches to improve primary care access.

Screening Patterns and Mortality Differences in Patients With Lung Cancer at an Urban Underserved Community.

BACKGROUND: The landmark National Lung Screening Trial demonstrated significant reduction in lung cancer-related mortality. However, European lung cancer screening (LCS) trials have not confirmed such benefit. We examined LCS patterns and determined the impact of LCS-led diagnosis on the mortality of newly diagnosed patients with lung cancer in an underserved community. PATIENTS AND METHODS: Medical records of patients diagnosed with primary lung cancer in 2013 through 2016 (n = 855) were reviewed for primary care provider (PCP) status and LCS eligibility and completion, determined using United States Preventative Services Task Force guidelines. Univariate analyses of patient characteristics were conducted between LCS-eligible patients based on screening completion. Survival analyses were conducted using Kaplan-Meier and multivariate Cox regression. RESULTS: In 2013 through 2016, 175 patients with primary lung cancer had an established PCP and were eligible for LCS. Among them, 19% (33/175) completed screening prior to diagnosis. LCS completion was associated with younger age (P = .02), active smoking status (P < .01), earlier stage at time of diagnosis (P < .01), follow-up in-network cancer treatment (P = .03), and surgical management (P < .01). LCS-eligible patients who underwent screening had improved all-cause mortality compared with those not screened (P < .01). Multivariate regression showed surgery (hazard ratio, 0.31; P = .04) significantly affected mortality. CONCLUSION: To our knowledge, this is the first study to assess LCS patterns and mortality differences on patients with screen-detected lung cancer in an urban underserved setting since the inception of United States Preventative Services Task Force guidelines. Patients with a LCS-led diagnosis had improved mortality, likely owing to cancer detection at earlier stages with curative treatment, which echoes the finding of prospective trials.