Differences among age groups just reached statistical significance (log-rank mutation status (log-rank mutation status
Differences among age groups just reached statistical significance (log-rank mutation status (log-rank mutation status. 18C84); most patients were male (66%) and white (94%). Of those with available data, 38% had .0014, log-rank test) was evident for patients with ECOG performance status (PS) of 0 to 1 1 (vs? 1), normal (vs elevated) LDH level, and no (vs yes) corticosteroid prescription 3 months before. No difference was recorded in OS by brain metastases (log-rank mutation status (log-rank mutation status, at oncology practices in the United States (US).[7] Pembrolizumab was the first PD-1 inhibitor approved by the US Food and Drug Administration (FDA; in September 2014) for Arhalofenate treating advanced melanoma. Clinical trial findings have demonstrated the efficacy of pembrolizumab[4,8] and established it as standard of care for advanced melanoma.[9] Recently published long-term results of advanced melanoma trials report estimated 4-year OS rate of 42% with pembrolizumab as first- or second-line therapy[10] and estimated 5-year OS rate of 41% with pembrolizumab as first-line therapy.[11] These findings can be contrasted with historical 1-year OS rates Arhalofenate of 25% for advanced melanoma in the pre-immunotherapy era.[12] In real-world clinical practice, however, both patient population and the setting of care are different from those in clinical trials.[13,14] Pivotal melanoma clinical trials, including the KEYNOTE trials for pembrolizumab, typically exclude patients with Eastern Cooperative Oncology Group performance status (ECOG PS) of 1, as well as patients with active or untreated brain metastases or active autoimmune disease.[6,8,15,16] A recent study of patients included in a Danish metastatic melanoma registry determined that 55% of patients would not have been eligible for a clinical trial, most commonly because of ECOG PS? 1?and/or active/untreated brain metastases.[17] In addition, Arhalofenate while no upper age limit is imposed for these clinical trials, SIGLEC6 older patients may be under-represented in the trials.[18] A strong need exists therefore to understand characteristics and outcomes of patients treated for advanced melanoma with PD-1 inhibitors such as pembrolizumab outside of clinical trials. In a prior observational study of 168 patients with advanced melanoma, Cowey et al[19] identified ECOG PS? 1, elevated lactate dehydrogenase (LDH) level, the presence of brain metastases, and third-line/later (vs first-line) pembrolizumab therapy, but not mutation status, as significant predictors of decreased survival. Overall, the results of their study and of 2 other small observational studies suggested real-world effectiveness of PD-1 inhibitors for advanced melanoma[19C21]; however, larger studies with longer follow-up are needed to evaluate patient characteristics and the outcomes of PD-1 inhibitor therapy for advanced melanoma outside of the clinical trial setting. The aims of this retrospective observational study were to examine the real-world utilization pattern of pembrolizumab, patient characteristics, and associated outcomes for patients with melanoma treated at US oncology clinical practices, including OS, time on treatment, and time to next line of treatment. We paid particular focus on the final results and features of sufferers not really qualified to receive or under-represented in clinical studies. 2.?Strategies 2.1. Databases We utilized de-identified data within the Flatiron Wellness cloud-based longitudinal data source containing electronic wellness record (EHR) data from cancers clinics and chosen educational centers.[22] Flatiron Health’s data source is a longitudinal, demographically and geographically different database which includes data from over 265 cancer clinics (800 sites of care) through the entire US. The Flatiron Wellness EHR data consist of both organised data and unstructured data, such as for example physician’s records, captured using technology-enabled abstraction, as described previously.[23] The EHR data in the Flatiron Health dataset are refreshed regular; as well as the scholarly research dataset was.