Background: The landscape of non-small cell lung cancer (NSCLC) therapy is rapidly changing. This analysis aimed to understand patient characteristics, diagnosis and treatment patterns in patients with metastatic NSCLC (mNSCLC) without EGFR and ALK mutations across five European countries. Methods: Data were drawn from the Adelphi NSCLC Disease Specific Programme™, a point-in-time survey of oncologists/pulmonologists and their consulting patients in France, Germany, Italy, Spain and UK. Physicians completed record forms (RFs) for the next six consecutive consulting patients with advanced NSCLC, who then voluntarily completed questionnaires. As an oversample, physicians provided a further ten RFs specifically for patients with EGFR-wild-type mNSCLC: five patients diagnosed before March 2020 (pre-SARS-CoV-2 [COVID-19]) and five patients diagnosed from March 2020 (during COVID-19). Only EGFR-wild-type/ALK-wild-type patients were included for analysis. Results: Mean (standard deviation [SD]) age for 1073 patients with EGFR-wild-type/ALK-wild-type mNSCLC was 66.2 (8.9) years, 65.2% were male and 63.7% had adenocarcinoma. Level of PD-L1 expression at advanced diagnosis was < 1% for 23.1% of patients, 1–49% for 40.9% and ≥ 50% for 36.0%. Most common first-line (1L) advanced treatment was chemotherapy only (36.9%), immunotherapy monotherapy (30.5%) or immunotherapy + chemotherapy (27.6%). Of 158 patients who had progressed beyond 1L therapy, the mean (SD) time-to-treatment discontinuation was 5.1 (4.3) months; 75.9% of whom completed their 1L treatment as intended. A complete response was achieved by 6.7% and a partial response by 69.2% of patients. Of 38 patients who discontinued 1L treatment early, disease progression was reported for 73.7%. Quality of life (QoL) reported by patients was generally lower than normative reference values. Of 2373 oversample patients, physicians reported management changes for 34.7% due to COVID-19, ranging from 19.6% in Germany to 79.7% in the UK. Immunotherapy was prescribed as 1L NSCLC treatment during COVID-19 for 64.2% (n = 786) of patients and pre-COVID-19, for 47.8% (n = 549). Conclusions: Real-world treatment patterns suggest that chemotherapy use remains high despite guidelines recommending immunotherapy-based 1L treatment for mNSCLC. QoL reported by patients was generally lower than population reference values. Not implying causality, 1L immunotherapy use was higher during COVID-19 than pre-COVID-19, and the UK saw the biggest impact to patient management due to COVID-19.
The advent of immunotherapies (I-O) and targeted therapies has transformed the treatment landscape in advanced non-small cell lung cancer (NSCLC). However, adoption of new treatment guidelines and evolving treatment patterns in clinical practice are largely unknown. The aim of this systematic literature review (SLR) was to capture real-world first-line treatment patterns in advanced (staged IIIB-IV) or recurrent NSCLC patients in the US. Electronic databases were systematically searched for observational studies published 2012-2020 that reported on adult patients receiving first-line therapy for advanced NSCLC. Included studies were reviewed and treatment patterns were summarized descriptively. Eighteen studies were included. Platinum-doublet (PD) chemotherapy and unspecified chemotherapy regimens were the most commonly used first-line treatments (up to 71% and 96%, respectively). Chemotherapy as monotherapy was mainly utilized in patients ≥65 years. While chemotherapy use was continuously high, I-O became the preferred front-line treatment in 2018 (32.9%). I-O monotherapy was more prevalent among patients with PD-L1 ≥50%, compared to patients with lower levels. First-line use of tyrosine kinase inhibitors and bevacizumab-based therapies was common in 2010 (33.4% and 21.7%, respectively), but gradually declined to <1% in 2018. Consistent with the evolving first-line NSCLC treatment landscape in the US, this SLR captures the increasing use of I-O in recent years. While the brief lag in I-O use from the time of authorization may be attributable to an initial resistance to treatment adoption or publication delays, continued use of chemotherapy regimens may reflect an unmet treatment need, which warrants further research.
In this 5-year follow-up from the CheckMate 743 study in patients with unresectable pleural mesothelioma (PM), we evaluated updated efficacy and safety outcomes and biomarkers and performed treatment-switching analyses with first-line nivolumab plus ipilimumab versus chemotherapy. With a median follow-up of 66.8 months, nivolumab plus ipilimumab demonstrated continued overall survival (OS) benefit versus chemotherapy in all randomly assigned patients (5-year OS rates, 14% v 6%; hazard ratio [HR], 0.74 [95% CI, 0.62 to 0.88]); similar benefit was observed regardless of tumor histology. Of biomarker-evaluable patients treated with nivolumab plus ipilimumab (n = 242), high baseline monocytic myeloid-derived suppressor cell (M-MDSC) levels correlated with worse OS versus low M-MDSC levels (HR, 1.25 [95% CI, 1.09 to 1.43]). After adjusting for 24% of patients in the chemotherapy arm who received subsequent immunotherapy, nivolumab plus ipilimumab demonstrated continued OS benefit versus chemotherapy (HR, 0.64 [95% CI, 0.53 to 0.78]). No new safety signals were observed. These results demonstrate long-term, durable clinical benefit with nivolumab plus ipilimumab versus chemotherapy, which continued to be preserved even after treatment-switching adjustment in the chemotherapy arm. Exploratory analyses suggested greater benefit with nivolumab plus ipilimumab in the low M-MDSC subgroup. These results further support first-line nivolumab plus ipilimumab as standard of care for unresectable PM.
We evaluated the cost-effectiveness of nivolumab in combination with ipilimumab (NIVO + IPI) versus platinum-doublet chemotherapy (PDC) for the first-line treatment of stage IV or recurrent non-sma...
Objectives: The Medical Monitoring Project (MMP) is a public health surveillance system that provides representative estimates of the experiences and behaviors of adults with diagnosed HIV in the United States. In 2015, the sample design and frame of MMP changed from a system that only included HIV patients to one that captures the experiences of persons receiving and not receiving HIV care. We describe methods investigated for calculating survey weights, the approach chosen, and the benefits of using a dynamic surveillance registry as a sampling frame. Methods: MMP samples adults with diagnosed HIV from the National HIV Surveillance System, the HIV case surveillance registry for the United States. In the methodological study presented in this manuscript, we compared methods that account for sample design and nonresponse, including weighting class adjustment vs. propensity weighting and a single-stage nonresponse adjustment vs. sequential adjustments for noncontact and nonresponse. We investigated how best to adjust for non-coverage using surveillance data to post-stratify estimates. Results: After assessing these methods, we chose as our preferred procedure weighting class adjustments and a single-stage nonresponse adjustment. Classes were constructed using variables associated with respondents’ characteristics and important survey outcomes, chief among them laboratory results available from surveillance that served as a proxy for medical care. Conclusions: MMPs weighting procedures reduced sample bias by leveraging auxiliary information on medical care available from the surveillance registry sampling frame. Expanding MMPs population of focus provides important information on characteristics of persons with diagnosed HIV that complement the information provided by the surveillance registry. MMP methods can be applied to other disease registries or population-monitoring systems when more detailed information is needed for a population, with the detailed information obtained efficiently from a representative sample of the population covered by the registry.