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Background: The ErbB family blocker, afatinib, is approved for patients with squamous cell carcinoma (SqCC) of the lung following platinum-doublet chemotherapy but has not been explored following immunochemotherapy. Here, we assessed the characteristics and outcomes of patients with SqCC of the lung who received second-line afatinib or chemotherapy after first-line pembrolizumab plus chemotherapy in a "real-world" setting., Methods: In this retrospective, multisite cohort study, community oncologists identified eligible patients and extracted data from electronic health records. Primary outcome measures were patient demographics and clinical characteristics, time on treatment, and incidence of severe immune-related adverse events (irAEs)., Results: Two hundred patients were included: 99 received second-line afatinib and 101 received second-line chemotherapy. Median age was 68 and 66 years, respectively; 35% and 3% of patients had mixed histology tumors, and 39% and 5% of tumors were epidermal growth factor receptor (EGFR) mutation-positive (EGFRm + ). Median time on treatment was 7.3 months with afatinib (mixed histology/SqCC tumors: 8.1/5.8 months; EGFRm + /EGFRm - tumors: 7.4/5.9 months) and 4.2 months with chemotherapy. Grade 3/4 irAEs were observed in 6 patients in the afatinib cohort (all had a prior grade 3/4 irAE during first-line therapy) and no patients in the chemotherapy cohort. The most common adverse drug reactions with afatinib were diarrhea (26%), rash (6%), stomatitis, fatigue, and nausea (5% each)., Conclusion: Encouraging time on treatment, and absence of newly diagnosed irAEs, indicate that afatinib is a treatment option following immunochemotherapy in patients with SqCC of the lung, and is currently the only approved oral agent in this setting., (Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.)

Objectives: Real-world evidence (RWE) has gained increased attention in recent years as a complement to traditional clinical trials. The use of RWE to establish the efficacy of oncology drugs for Food and Drug Administration (FDA) approval has not been described. In this paper, we review 5 recent examples where RWE was submitted in support of the FDA approvals of original or supplementary indications for oncology drugs., Methods: To identify cases where RWE was used, we reviewed drug approval packages available at Drugs@FDA for oncology drugs approved between 2017 and 2019. Five cases were selected to present a broad overview of different types of RWE, different circumstances under which RWE has been used for regulatory approvals, and how FDA evaluated the data in each case. The type of RWE submitted, the indication, limitations identified by FDA reviewers, and the outcome of the submission are discussed., Results: RWE, particularly historical controls for rare or orphan indications, has been used to support both original and supplementary oncology drug approvals. Types of RWE included data from electronic health records, claims, post-marketing safety reports, retrospective medical record reviews, and expanded access studies. Small sample sizes, data quality, and methodological issues were among concerns cited by FDA reviewers., Conclusion: By bridging the gap between the constraints of the trial setting and the realities of clinical practice, RWE can add value to a regulatory submission. These early examples provide insight into how regulators evaluated RWE submitted as evidence of efficacy for oncology drugs., (Copyright © 2020 ISPOR–The Professional Society for Health Economics and Outcomes Research. Published by Elsevier Inc. All rights reserved.)

Background: Health communication increasingly has been recognized as an important part of public health practice that can help raise awareness of potential health risks, influence attitudes and beliefs, and motivate individuals to change unhealthy behaviors. Yet, few health communication messages exist that target people with disabilities. An evaluation was conducted to assess the relevance and usefulness of health communication materials developed by or disseminated in, or both, three state disability and health programs., Methods: Health care providers and people with a variety of physical and sensory disabilities participated in the evaluation. Qualitative and quantitative data were collected in each of the three states using key informant interviews, focus groups, and a Web-based provider survey., Results: State program staff reported that health communication strategies and messages should be developed to improve access and remove barriers to health care, provide access to facilities, empower consumers, and educate health care providers about the needs of people with disabilities. Several of these needs are consistent with the needs identified by consumers in the focus groups. Consumers indicated that improvements to the overall content and design of the state-developed health communication materials are needed, yet health care and human service providers who participated in the Web-based survey were generally satisfied with the materials. Nearly all providers reported being aware of the materials; however, consumers were not familiar with the state-developed materials reviewed by the focus groups., Conclusions: Improvements in the content and dissemination of health promotion materials designed by states are indicated. Implications for public health practice, including recommendations for improving future health communication materials, are addressed in this article., (Copyright © 2010 Elsevier Inc. All rights reserved.)