Treatment approaches for stages I–III NSCLC are rapidly evolving due to recent regulatory approvals of EGFR-targeted therapy and immunotherapy, increasing the importance of understanding real-world treatment patterns in US community practices. This observational study aimed to describe patient characteristics and primary treatments pre-2020 and from 2020–2022. The Syapse Learning Health Network of patients with cancer who receive care in US community health systems was queried for adults with stage I-III NSCLC with no historical primary cancer within 5 years, and minimum 10 months potential follow-up from NSCLC diagnosis. Two cohorts were compared descriptively by time period of initial NSCLC diagnosis: 2015–2019 (cohort 1) and 2020–2022 (cohort 2), overall and by NSCLC stage. In both cohort 1 (N=5503) and cohort 2 (N=2963), median age was 70 years; 52% were women; 82–83% were White; and 92% were current/former smokers. NSCLC stages in cohorts 1/2 were 45%/47% at stage I; 16%/16% at stage II; and 39%/38% at stage III. Overall, 40%/43% of patients had surgical primary treatment (Table), most commonly for stage I (54%/59%) or stage II NSCLC (53%/51%) vs. stage III (20%/20%). Among those with surgery, neoadjuvant (± adjuvant) therapy use was only 6%/5% overall; surgery + adjuvant therapy use was 23%/24% overall (Table) and increased with NSCLC stage (6%/6% at stage I; 51%/58% at stage II; 53%/64% at stage III). Of stage III patients, 59%/61% received nonsurgical treatments, most commonly with chemoradiation (67%/68%). Table: 112PPrimary treatments for stages I-III NSCLC by time periodCohort 1, N=5503 (2015–2019 diagnosis)Cohort 2, N=2963 (2020–2022 diagnosis)Surgical primary treatment, n (%)2216 (40)1270 (43)Surgery only1567 (71)901 (71)Neoadjuvant ± adjuvant therapy138 (6)60 (5)Surgery + adjuvant therapy511 (23)309 (24)Nonsurgical primary treatment, n (%)2207 (40)1191 (40)Definitive chemoradiation only992 (45)542 (46)Definitive radiotherapy only823 (37)470 (39)Systemic therapy only392 (18)179 (15)No treatment identified, n (%)1080 (20)500 (17) Open table in a new tab No major changes in primary treatments were evident in community practice for patients with stage I–III NSCLC from pre-2020 to the 2020–2022 period. Among surgical approaches, neoadjuvant and adjuvant therapy use was low, although adjuvant therapy rates were greater for stages II and III NSCLC. Nonsurgical approaches remained most common for stage III NSCLC, particularly chemoradiation.
Background and purpose: The treatment landscape for patients with advanced non-small cell lung cancer (NSCLC) has evolved significantly since the introduction of immunotherapies. We here describe PD-L1 testing rates, treatment patterns, and real-world outcomes for PD-(L)1 inhibitors in Sweden. Materials and methods: Data were obtained from the Swedish National Lung Cancer Registry for patients with advanced NSCLC and Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0–2 who initiated first-line systemic treatment from 01 April 2017 to 30 June 2020. PD-L1 testing was available in the registry from 01 January 2018. Kaplan-Meier was used for overall survival (OS) by type treatment and histology. Results: A total of 2,204 patients with pathologically confirmed unresectable stage IIIB/C or IV NSCLC initiated first-line treatment, 1,807 (82%) with nonsquamous (NSQ) and 397 (18%) with SQ. Eighty-six per cent (NSQ) or 85% (SQ) had been tested for PD-L1 expression, a proportion that increased over time. The use of platinum-based therapy as first-line treatment decreased substantially over time while there was an upward trend for PD-(L)1-based therapy. Among patients with PS 0–1 initiating a first-line PD-(L)1 inhibitor monotherapy, the median OS was 18.6 and 13.3 months for NSQ and SQ NSCLC patients, respectively, while for the PD-(L)1 inhibitor and chemotherapy combination regimen, the median OS was 24.0 months for NSQ and not evaluable for SQ patients. Interpretation: The majority of advanced NSCLCs in Sweden were tested for PD-L1 expression. Real-world OS in patients with PS 0–1 receiving first-line PD-(L)1 inhibitor-based regimens was similar to what has been reported in pivotal clinical trials on PD-(L)1 inhibitors.
Background Given a lack of standard of care treatment for patients with recurrent/metastatic nasopharyngeal carcinoma (R/M NPC), the objectives were to assess treatment utilization and overall survival (OS) outcomes for R/M NPC in the real-world setting. Methods A retrospective chart review was conducted in South Korea (SK) and Taiwan (TW) to identify patients who initiated first-line systemic therapy for R/M NPC between January 1, 2012 and June 30, 2013. Patients were followed through December 31, 2015. Stratification of study outcomes was performed per location of metastases for patients with distant metastatic disease vs. metastatic disease in distant lymph nodes only. Results Among 154 R/M NPC patients enrolled across 12 sites, median age was 52 years (interquartile range 45-59), 78% were male, and 87% had ECOG 0-1. In TW (N = 104), all patients had distant metastatic disease either as newly diagnosed metastatic (stage IVc) disease (32%) or disease recurrence with distant metastases (68%). In SK (N = 50), 42% of patients had distant metastatic disease, and 58% presented with distant lymph nodes only. Among patients with distant metastatic disease, patients mainly received systemic therapy only as first-line treatment in both TW (72%) and SK (67%), among which platinum + 5-FU was most common (34%). Remaining patients with distant metastatic disease received systemic therapy + radiation (28% TW; 33% SK). In contrast, patients with distant lymph nodes only in SK primarily received systemic therapy + radiation (83%). Median OS for patients with distant metastatic disease who received systemic therapy only was 23 months (95% confidence interval [CI] 18-32), compared with 32 months (95% CI: 22-Not Determined) for patients who received systemic therapy + radiation. Median OS was not reached for patients with distant lymph nodes only who received systemic therapy + radiation. Conclusions Differences in the location of metastases for patients with R/M NPC led to variation in treatment approaches across TW and SK. Prognosis in patients with distant metastatic disease remains poor with limited therapeutic options, underscoring the need for newer, more efficacious treatments. Legal entity responsible for the study Merck and Co., Inc. Funding Merck and Co., Inc. Disclosure M-J. Ahn: Honoraria (self): Merck Sharpe and Dohme; Honoraria (self): Astra-Zeneca; Honoraria (self): Bristol Myers Squibb; Honoraria (self): Merck ; Honoraria (self): Roche; Honoraria (self): Alphas Pharmaceutical. D.R. Chirovsky: Shareholder / Stockholder / Stock options, Full / Part-time employment: Merck and Co. Inc. H. Kuyas: Research grant / Funding (institution), Full / Part-time employment: Kantar Health Division. V. Auclair: Research grant / Funding (institution), Full / Part-time employment: Kantar Health Division. S. Abounit: Research grant / Funding (institution), Full / Part-time employment: Kantar Health Division. S. Joo: Shareholder / Stockholder / Stock options, Full / Part-time employment: Merck and Co, Inc. R. Shah: Full / Part-time employment: Merck and Co, Inc. All other authors have declared no conflicts of interest.
Background: PD-L1 expression in malignancies contributes to an immunosuppressive microenvironment and disruption of anti-tumoral immune responses. Data are limited on the association between PD-L1 expression and survival in OSCC, overall and by HPV p16 status. We explored the prognostic effect of PD-L1 and p16 in localized or locally advanced OSCC treated with primary RT. Methods: Patients (pts) diagnosed with OSCC from 2000-12 were identified from the Danish Head and Neck Cancer database (DAHANCA). PD-L1 expression was measured in tumor tissue using Agilent’s investigational PD-L1 imunohistochemistry (IHC) PharmDx Assay (clone 22C3). PDL1+ expression was defined as a score >1 using Tumor Proportion Score (TPS) as % of neoplastic cells expressing PDL1 at any intensity, Mononuclear Inflammatory Density Score (MIDS) as the estimate of PDL1 expressing mononuclear inflammatory cells associated with neoplastic cells, and Combined Positive Score (CPS) calculated using both TPS and MIDS. HPV oncogene expression was assessed using a > 70% cut-point for p16 IHC (clone E6H4). Data were analyzed using Cox proportional hazard model. Results: 303 OSCC pts with full clinical data, and PD-L1 and p16 staining were evaluated. Median follow up was 55 months (2-184). Median age (range) was 59 years (34-85), 72% were male, 91% had WHO 0-1 performance status, 55% were current smokers. All had primary RT, 66-68Gy, 2Gy/fx, 6 fx/wk, and 3% had concomitant cisplatin. 81% were UICC 7 stage 3-4 tumors. 55% were p16+. 76% were PD-L1+ by CPS, 35% by TPS, and 31% by MIDS. TPS was significantly associated with MIDS (Chi square p = 0.003). p16 was a strong prognostic factor for loco-regional control [crude hazard ratio (HR) of 0.31 (95% CI: 0.21-0.49)], disease-specific survival [0.39 (0.26-0.57)] and overall survival [0.34 (0.25-0.46)]. PD-L1 expressed as CPS, TPS or MIDS, was not prognostic of the clinical endpoints, overall or by p16 status. Adjustment for other covariates did not change the results. Conclusions: PD-L1 expression is not prognostic in localized or locally advanced OSCC, including p16 positive disease. p16 is affirmed the strongest biological prognostic factor in OSCC. Legal entity responsible for the study: The Danish Head and Neck Cancer Group (DAHANCA). Funding: Merck & Co, Inc. Disclosure: T. Steiniche: Research funding: Merck & Co, Inc. P-T. Vo, D.R. Chirovsky: Employement, stock ownership, research funding, travel and accommodations expenses: Merck & Co, Inc. J. Cheng: Employment, stock ownership: Merck & Co. D. Aurora-Garg, R. Swaby: Employment Merck & Co. All other authors have declared no conflicts of interest.