Background Real-world evidence is limited regarding the relationship between race and use of durvalumab, an immunotherapy approved for use in adults with unresectable stage III non-small cell lung cancer (NSCLC) post-chemoradiotherapy (CRT). This study aimed to evaluate if durvalumab treatment patterns differed by race in patients with unresectable stage III NSCLC in a Veterans Health Administration (VHA) population. Materials and Methods This was a retrospective analysis of White and Black adults with unresectable stage III NSCLC treated with durvalumab presenting to any VHA facility in the US from January 1, 2017, to June 30, 2020. Data captured included baseline characteristics and durvalumab treatment patterns, including treatment initiation delay (TID), interruption (TI), and discontinuation (TD); defined as CRT completion to durvalumab initiation greater than 42 days, greater than 28 days between durvalumab infusions, and more than 28 days from the last durvalumab dose with no new durvalumab restarts, respectively. The number of doses, duration of therapy, and adverse events were also collected. Results A total of 924 patients were included in this study (White = 726; Black = 198). Race was not a significant factor in a multivariate logistic regression model for TID (OR, 1.39; 95% CI, 0.81-2.37), TI (OR, 1.58; 95% CI, 0.90-2.76), or TD (OR, 0.84; 95% CI, 0.50-1.38). There were also no significant differences in median (interquartile range [IQR]) number of doses (White: 15 [7-24], Black: 18 [7-25]; P = .25) or median (IQR) duration of therapy (White: 8.7 months [2.9-11.8], Black: 9.8 months [3.6-12.0]; P = .08), although Black patients were less likely to experience an immune-related adverse event (28% vs. 36%, P = .03) and less likely to experience pneumonitis (7% vs. 14%, P < .01). Conclusion Race was not found to be linked with TID, TI, or TD in this real-world study of patients with unresectable stage III NSCLC treated with durvalumab at the VHA.
8556 Background: Durvalumab is an FDA-approved immunotherapy for the treatment of adults with UnResectable stage III non-small cell lung cancer (UR-NSCLC) without disease progression following concurrent chemoradiotherapy (CRT). There are limited real-world data regarding Durvalumab treatment initiation delays (TIDs) and reasons for them in the UR-NSCLC population. Methods: Patients with stage III UR-NSCLC receiving consolidation Durvalumab at the Veterans Health Administration (VHA) between January 1, 2017 and June 30, 2020 were selected from the VHA database using ICD-10, HCPCS, and J codes. All had the opportunity to be treated for 12 months and were followed from Durvalumab initiation through the earliest of their last VHA visit, loss to follow up, death, or the study’s end (and excluded if Durvalumab therapy was ongoing at the study’s end). Trained data abstractors determined the occurrence and reasons for TIDs (> 6 weeks from end of CRT to initiation of Durvalumab as in the PACIFIC trial) by chart review. Results: 935 patients were eligible for analysis (median age = 69 years; 95% males; 16% with ECOG performance status >1). TIDs occurred in 39% of the patients (Table). Durvalumab was initiated 61 days (median) from the end of CRT in TID patients vs. 31 days for those without TIDs. There were no significant (α<0.05) differences in age, race, smoking status, histology, or ECOG performance status and no comorbidity differences (except in patients with a history of cerebrovascular accident, for whom TIDs were more likely) between the TID/No-TID patients. Patients without timely post-CRT scans were more likely to have a TID. Of the 367 patients who experienced TIDs, 200 had documented reasons for the delay, consisting of other (not categorized) (28.5%), physician preference (20%), toxicity (11%), patient preference (10.5%), decline in performance status (10%), system issues (9.5%), social reasons (9%), and progression (0.5%). Conclusions: This is one of the largest retrospective cohort studies reporting real-world data in patients with UR-NSCLC receiving Durvalumab. TIDs were associated with increased time to post-CRT scans. This potential issue can be improved with care coordination and involvement of cancer navigators. Additional studies are needed to assess the impact of TIDs on survival outcomes.[Table: see text]
e19568 Background: Primary mediastinal B-cell lymphoma (PMBCL) is considered a rare distinct clinicopathological and molecular subtype of diffuse large B-cell lymphoma (DLBCL), mainly affecting females in their 4th and 5th decades [1,2,3]. Since the 1960s, there has been a significant increase in the number of immigrants to the US; and the states of Florida (FL) and Texas (TX) are well known for their Hispanic (HI) enriched population. Since there is scarce data of PMBCL in HI; we researched demographics, treatment patterns and outcomes in H compared to Non-Hispanics (NH) from FL and TX. Methods: This is a retrospective study of patients diagnosed with PMBCL from the Texas Cancer Registry (TCR) and the Florida Cancer Data System (FCDS), with years of analysis 2006-2017. Patients were identified by the International Classification of Diseases for Oncology Third Edition (ICD-O-3). Key variables collected included gender, race, ethnicity, dates at diagnosis and death, primary payer at diagnosis, stage, type of treatment, poverty index, and vitality status. The significance of variation in the distribution of categorical outcomes with ethnicity (H, NH) was assessed with Fisher’s Exact tests or Pearson’s Chi-square tests as appropriate. Survival distributions were described with Kaplan-Meier curves, and the significance of variation in median survival with ethnicity was assessed with log-rank testing. All statistical testing was two-sided with a significance level of 5%. Results: We had 2 cohorts; cohort A (A) includes 19 H vs. 89 NH from TX, cohort B (B), 27 H vs. 121 NH from FL. The median age at diagnosis in A was 33 years (y) in H vs 40 y in NH ( p-value = 0.091); while median age in B was 36 y in H vs 46 y in NH ( p-value = 0.005). Regarding poverty index; in A, most of H were in the 10-20% bracket, and most NH were in the 5-10% bracket. On the contrary, in B, most of H were in the 5-10%, and most NH were in the 10-20% bracket. Lack of insurance was more prevalent in H in A vs. NH, 42% vs. 12%, respectively, where it was less prevalent in H vs. NH in B, 8% vs. 5%. Multiple agents of chemotherapy were delivered to 74% of H, 70% of NH vs. 82% of H and 65% of NH with p-value = 0.292 and 0.635 in A and B, respectively. In A, the NH had better median survival (m) than H, not reached vs. 10.3 y, respectively. In B, H had better m than the NH, 10.7 y vs. not reached, respectively. The 5 y survival probability in A was even among H and NH; 0.702 [95% CI 0.49-1] and 0.732 [95% CI 0.578 - 0.9280], respectively. While 5 y survival probability in B was higher in H compared to NH, 0.923 [95% CI 0.675 -0.869] and 0.766 [95% CI 0.434 - 0.615], respectively. The overall survival (OS) difference in A and B, H vs. NH was not statistically significant. Conclusions: Despite some identified demographic differences in patients diagnosed with PMBCL, comparing H vs. NH on each cohort, there was no statistically significant difference in the overall survival probability.
8554 Background: The PD-1/PD-L1 pathway is a mechanism of immune evasion and disruption of this pathway with immune checkpoint inhibitors (ICIs) has shown clinical benefit in multiple malignancies. Based on results from the PACIFIC trial, durvalumab is approved as consolidation therapy in patients (pts) with stage III unresectable non-small cell lung cancer (UR-NSCLC) without progression following concurrent chemoradiotherapy (cCRT). Durvalumab has been used extensively in Veterans Health Administration (VHA) facilities, providing an opportunity to evaluate durvalumab treatment interruptions (TI), treatment discontinuations (TD), and the reasons for these on a national scale. Methods: Patients with stage III UR-NSCLC receiving durvalumab consolidation immunotherapy at the VHA between January 1, 2017 and June 30, 2020 with a minimum follow up for 12 months were included using ICD-10, HCPCS, and J codes and followed from their durvalumab start date through the earliest of last VHA visit, loss to follow up, death, or end of study (excluded if durvalumab therapy was ongoing at the end of the study, because the full treatment course could not be determined). TI were defined as durvalumab infusions separated by >28 days. Reasons for TI and TD are presented descriptively. Durations are reported using medians and interquartile ranges (IQR). Results: 935 pts were included (median age = 69 years; 95% males; 96% current or former smokers; 70% with COPD; histologies [squamous (50%), non-squamous (43%), other/missing (7%)]; and 77% with carboplatin-paclitaxel as their platinum-based CRT). Durvalumab TI were experienced by 19% of pts (median [IQR] number of TI = 1 [1-1], median [IQR] TI duration = 53 days [39-90]). The main reasons for TI were toxicity (8%) and social reasons (3%) (Table). The median duration of treatment (DoT) with durvalumab (TI included) was 9.0 months (IQR 2.9-11.8). Durvalumab TD occurred in 59% of pts. Top reasons for discontinuation across all 935 pts included disease progression (24%) and toxicity (18%) (Table). Conclusions: In this real world analysis of national VHA data, durvalumab DoT was similar to PACIFIC despite having a patient population with worse prognostic factors (e.g. more males, squamous, COPD) with 8% of VHA pts experiencing TI and 18% TD due to toxicity. Patients could benefit from additional efforts to prevent, identify, and manage toxicities in the UR-NSCLC population [Table: see text]
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