BackgroundMerkel cell carcinoma (MCC) is a rare, aggressive, cutaneous neuroendocrine neoplasm with annual incidence rates of 0.13–1.6 cases/100,000/year worldwide as of 2018. Chemotherapy for metastatic MCC (mMCC) has high objective response rates (ORRs), but responses are not durable and overall survival (OS) is poor. Avelumab (anti-programmed death-ligand 1) has demonstrated meaningful survival benefit and durable responses in clinical trials for mMCC. This study investigated real-world clinical outcomes in avelumab-treated patients with advanced (stage IIIB/IV) MCC in US academic medical centers.MethodsWe conducted a retrospective chart review of patients with advanced MCC who initiated avelumab between March 1, 2017, and July 31, 2019, at six US academic centers. Data were requested for eligible patients from index date through December 31, 2020. Descriptive analyses were conducted to assess demographic and clinical characteristics, real-world ORR (rwORR), real-world duration of response, real-world progression-free survival (rwPFS), and OS.ResultsNinety patients with advanced MCC (82%, stage IV; 18%, stage IIIB) received avelumab. Median follow-up was 20.8 months (95% CI: 19.1 to 24.2). Median age was 68 years (range, 48–83), and the majority of patients were men (58%) and white (93%). The primary tumor was most commonly located on the lower limb (38%), with metastases mostly located in lymph nodes (68%), lung (52%), and viscera (52%). Approximately 42% and 26% of patients had an Eastern Cooperative Oncology Group performance status of 2 and 3, respectively. Seventy-three patients (81%) received avelumab as first-line treatment of advanced MCC, while 17 (19%) received avelumab as second-line or later treatment. The median duration of avelumab treatment was 13.5 months (95% CI: 6.4 to 30.6), with 42% of patients still receiving avelumab by the end of follow-up. Patients with avelumab treatment had an rwORR of 73% (95% CI: 64 to 83), median rwPFS of 24.4 months (95% CI: 8.31 to not estimable (NE)), and median OS of 30.7 months (95% CI: 11.2 to NE).ConclusionsThis real-world study of patients with advanced MCC demonstrated that avelumab treatment resulted in a high response rate with durable responses and prolonged survival. The study findings validate the results demonstrated in prospective clinical trials and other observational studies.
Background Adherence to antipsychotic medication is critical for bipolar disorder (BPD), major depression (MDD) and schizophrenia (SCZ) patients. Digital tools have emerged to monitor medication adherence along with tracking general health. Evidence on physician or patient preferences for such tools exists but is limited among caregivers. The study objective was to assess preferences and willingness-to-pay (WTP) for medication adherence monitoring tools among caregivers of SMI patients. Methods A web-based survey was administered to caregivers of adult SMI patients. Twelve discrete choice questions comparing adherence monitoring tools that varied across two attribute bundles: (1) tool attributes including source of medication adherence information, frequency of information updates, access to adherence information, and physical activity, mood, and rest tracking, and (2) caregiver monthly out-of-pocket cost attribute were administered to caregiver respondents. Attributes were parameterized for both digital and non-digital tools. Random utility models were used to estimate caregivers’ preferences and WTP. Results Among 184 study-eligible caregivers, 57, 61 and 66 participants cared for BPD, MDD, and SCZ patients, respectively. Caregivers highly preferred (odds ratio (OR): 7.34, 95% confidence interval (CI): 5.00–10.79) a tool that tracked medication ingestion using a pill embedded with an ingestible event market (IEM) sensor and tracked patients’ physical activity, mood, and rest than a non-digital pill organizer. Additionally, caregivers were willing to pay $255 per month (95% CI: $123–$387) more for this tool compared to a pill organizer. Conclusion Caregivers of SMI patients highly preferred and were willing to pay more for digital tools that not only measures medication ingestion but also tracks general health.
BackgroundMerkel cell carcinoma (MCC) is a rare, aggressive cutaneous neuroendocrine neoplasm with annual incidence rates ranging from 0.13 to 1.6 cases per 100,000 per year.1 Chemotherapy for metastatic MCC (mMCC) has high objective response rates (ORRs), but responses are not durable and overall survival (OS) is poor. In March 2017, avelumab (anti–PD-L1) was approved for the treatment of mMCC and has demonstrated meaningful survival benefit and durable response.2 This study sought to investigate real-world clinical outcomes of avelumab-treated patients with advanced (stage IIIB/IV) MCC in academic medical centers in the United States (US).MethodsA retrospective chart review study of patients with advanced MCC who initiated avelumab between March 1, 2017, and July 31, 2019 was conducted at 6 US academic medical centers across the 4 US census regions. Eligible patients were followed through December 30, 2020. Descriptive analyses were conducted to assess demographics, clinical characteristics, and outcomes. Kaplan-Meier curves were constructed to illustrate real-world duration of response (rwDOR), real-world progression free survival (rwPFS), OS, and time-to-treatment discontinuation.ResultsNinety patients with advanced MCC were treated with avelumab, with a median follow-up of 15.0 months (95% CI, 13.1–17.8). Median age was 68 years; the majority were male (58%) and White (93%). During the time of avelumab initiation, 74 patients had stage IV MCC and 16 patients had stage IIIB MCC. Primary tumor was located most commonly on the lower limb (38%), with metastasis primarily to lymph nodes (67%) and lung (52%); 52% of patients had visceral metastases. Approximately 42% and 26% of patients had an Eastern Cooperative Oncology Group (ECOG) performance status of 2 and 3, respectively. Seventy-three patients (81%) received avelumab as first-line treatment of advanced MCC, whereas 17 (19%) received avelumab as second-line or later. Median duration of avelumab treatment was 13.5 months (95% CI, 6.4–30.6); 58% discontinued by the end of follow-up. Patients with avelumab treatment (n=90) had a rwORR of 73% (95% CI, 64–83), median rwPFS of 24.4 months (95% CI, 8.3-not reached [NR]), and median OS of 30.7 months (95% CI, 11.2-NR). Other clinical outcomes by line of avelumab treatment and stage at avelumab initiation are reported in table 1.ConclusionsThis real-world study of patients with advanced MCC treated with avelumab demonstrates high response rate with durable responses and prolonged survival. The study findings are consistent with the efficacy results demonstrated in pivotal clinical trials2 and other recent observational studies.3 4AcknowledgementsThe authors would like to acknowledge all physicians at the respective sites who participated in the data collection process for the study.ReferencesMüller-Richter UDA, Gesierich A, Kübler AC, Hartmann S, Brands RC. Merkel cell carcinoma of the head and neck: recommendations for diagnostics and treatment. Ann Surg Oncol 2017;24:3430–3437.D'Angelo SP, Bhatia S, Brohl AS, et al. Avelumab in patients with previously treated metastatic Merkel cell carcinoma: long-term data and biomarker analyses from the single-arm phase 2 JAVELIN Merkel 200 trial. J Immunother Cancer 2020;8:e000674.Cowey CL, Liu FX, Kim R, et al. Real-world clinical outcomes with first-line avelumab in locally advanced/metastatic Merkel cell carcinoma in the USA: SPEAR-Merkel. Future Oncol 2021;17:2339–2350.Levy S, Aarts MJB, Eskens FALM, et al. Avelumab for advanced Merkel cell carcinoma in the Netherlands: a real-world cohort. J Immunother Cancer 2020;8:e001076.Ethics ApprovalThe study was approved by New England Institutional Review Board.Abstract 628 Table 1Clinical outcomes among avelumab-treated patients with advanced MCC by line-of-treatment and stage at avelumab initiation
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
hi@scite.ai
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.