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Background Talazoparib is a poly (adenosine diphosphate-ribose) polymerase inhibitor approved for the treatment of adult patients with deleterious or suspected deleterious germline BRCA -mutated (g BRCA m), HER2-negative, locally advanced or metastatic breast cancer (LA/mBC), with approval based on the EMBRACA trial. To date, there are no published data on talazoparib use in the real-world United States (USA) setting. Patients and Methods Characteristics, treatment patterns, and clinical outcomes of real-world US patients with g BRCA m HER2-negative LA/mBC treated with talazoparib monotherapy were collected via retrospective chart review and summarized using descriptive statistics. Results Among 84 eligible patients, 35.7% had hormone receptor-positive tumors and 64.3% had triple-negative LA/mBC (TNBC). At talazoparib initiation, 29.8% had ECOG PS of ≥2 and 19.0% had brain metastasis. Mutations in g BRCA1 or 2 were detected among 64.3% and 35.7% of patients, respectively. Talazoparib was given as 1st-line therapy in 14.3% of patients, 2nd-line in 40.5%, and 3rd- or 4th-line in 45.2%. Median time to talazoparib treatment failure was 8.5 months (95% CI, 8.0-9.7), median progression-free survival was 8.7 months (95% CI, 8.0-9.9), the median time from initiation to chemotherapy was 12.2 months (95% CI, 10.5-20.1), and the overall response rate was 63.1%. No differences in clinical outcomes were observed between patients with HR-positive/HER2-negative LA/mBC and patients with TNBC by using unadjusted statistical comparisons. Brain metastasis and ECOG PS ≥2 at talazoparib initiation were associated with treatment failure and progression or mortality. Conclusion Overall, talazoparib clinical outcomes in this real-world population are consistent with findings from EMBRACA. [ABSTRACT FROM AUTHOR]

Ruxolitinib is an FDA-approved treatment of intermediate- and high-risk myelofibrosis. In the phase 3 COMFORT studies, ruxolitinib reduced spleen volume in patients with myelofibrosis, with a median time to response of 3 months. However, nearly 20% of patients discontinued by month 4 with few treatment options available following discontinuation of ruxolitinib treatment. In this study, 2 independent patient care data sources were queried (Cardinal Health Oncology Provider Extended Network [OPEN] and HealthCore Integrated Research Environment [HIRE®]), and a retrospective review of medical charts was conducted. Patients aged ≥18 years with a diagnosis of myelofibrosis (primary or secondary), use of ruxolitinib for myelofibrosis, and documented physician-directed ruxolitinib interruption were included. Among 26 included patients, pre-interruption median (interquartile range [IQR]) ruxolitinib treatment duration was 123 (57–391, OPEN) and 110 (37–148, HIRE) days. Half the patients interrupted treatment within 3 months, commonly for adverse events (42% and 71%, respectively). After restarting ruxolitinib, median (IQR) re-treatment duration was 196 (54–553) and 166 (108–262) days, respectively. Consistent with previous reports, symptoms and spleen size improved in (OPEN/HIRE) 45%/43% and 40%/33% of evaluable patients, respectively. Further studies investigating the management of dose modifications and interruptions are needed to optimize benefit from ruxolitinib therapy. [ABSTRACT FROM AUTHOR]

Myelofibrosis (MF) is a chronic myeloproliferative neoplasm with a prevalence of 4 to 6 per 100,000 people in the USA. Treatment recommendations are risk-adapted. This study was conducted to evaluate how physicians risk-stratify patients at the time of MF diagnosis, the accuracy of the risk stratification, and its effect on treatment selection. Medical charts were reviewed at US community hematology/oncology practices in the Cardinal Health Oncology Provider Extended Network; patient clinical characteristics, risk stratification, and treatment data were collected. Physician-assigned risk categorizations were compared with data-derived risk categorizations based on the International Prognostic Scoring System, the system recommended at diagnosis. A total of 491 patients diagnosed with MF between 2012 and 2016 (mean [SD] age at diagnosis, 65.4 [11.8] years; 54.8% male, 69.2% with primary MF) were included. Risk categorization was not assigned for 30.1% of patients. Of the patients with a physician-assigned risk categorization (n = 343), a scoring system was used in 49.9%. Compared with data-derived risk categorizations, 42.9% of physician-assigned risk categorizations were incorrect; 85.0% of incorrect physician-assigned risk categorizations were underestimations. Notably, 38.5% of patients with data-derived intermediate- or high-risk categorizations did not initiate treatment within 120 days of diagnosis. Among patients with data-derived intermediate risk, those with an underestimated physician-assigned risk categorization were significantly less likely to receive treatment within 120 days of diagnosis (51.6% with correct physician-assigned categorization vs 18.5% with underestimated risk categorization; P = 0.0023). These results highlight the gap in risk assessment and the importance of accurate risk stratification at diagnosis. [ABSTRACT FROM AUTHOR]

Introduction: Lenvatinib has become the most commonly prescribed first-line (1L) agent for the treatment of radioactive iodine-refractory differentiated thyroid cancer (RAI-r DTC) since its approval in 2015. With no real-world studies describing clinical outcomes of 1L lenvatinib and subsequent therapy, the current study aimed to assess treatment sequencing and related clinical outcomes in patients treated with 1L lenvatinib in the USA METHODS: We conducted a multisite, retrospective chart review of US patients with a diagnosis of RAI-r DTC who had initiated 1L therapy with lenvatinib from January 1, 2016 through May 31, 2017 with follow-up through October 17, 2018. Physicians completed electronic case report forms for two patient cohorts: patients still receiving 1L lenvatinib (cohort 1) and those who had initiated second-line (2L) therapy prior to data cutoff (cohort 2). Real-world objective response rate (ORR) was assessed for both cohorts. Progression-free survival (PFS) and overall survival (OS) were assessed for cohort 2.Results: A total of 252 patients met the study criteria with 71 in cohort 1 and 181 in cohort 2. Patients were predominantly female, had papillary DTC, and had lung metastases. The ORR was 64.8% for cohort 1 and 53.6% for cohort 2. In cohort 2, median PFS from 1L lenvatinib initiation was 14.0 months (95% CI 12.7-15.0). Second-line treatments included sorafenib (49.7%), cabozantinib (19.3%), and other targeted/chemotherapy/immuno-oncology agents. The ORR in 2L therapy was 15.5%. For cohort 2, the 12-, 18-, and 24-month OS from initiation of 1L lenvatinib was 92.8%, 81.5%, and 66.9%, respectively.Conclusions: In this first real-world examination of clinical effectiveness of 1L lenvatinib and subsequent therapy among patients in the US, the results demonstrated that treatment with 1L lenvatinib followed by another 2L therapy may deliver a clinical benefit, thus allowing a number of potential 2L options following 1L lenvatinib for patients with RAI-r DTC. [ABSTRACT FROM AUTHOR]

Background: In the absence of randomized controlled trials, real‐world evidence may aid practitioners in optimizing the selection of therapy for patients with cancer. The study's aim was to determine real‐word use, as well as compare effectiveness, of single‐agent and combination chemotherapy as palliative treatment for female patients with metastatic breast cancer (mBC). Materials and Methods: Using administrative claims data from the Symphony Health's Integrated Oncology Dataverse, female patients with mBC treated with at least one chemotherapy‐only treatment (COT) between January 1, 2013, and December 31, 2017 were selected. The frequency of use of single‐agent versus combination chemotherapy overall and by line of therapy (LOT) was calculated whereas effectiveness was measured using time to next treatment (TNT). Results: A total of 12,381 patients with mBC were identified, and 3,777 (31%) received at least one line of COT. Of the 5,586 observed LOTs among the 3,777 patients, 66.5% were single‐agent and 33.5% combination chemotherapy. Combination chemotherapy was most frequently used in first‐line (45%) and least frequently in fifth‐line (16%). Across all LOTs, median TNT was significantly longer for single‐agent versus combination chemotherapy (5.3 months vs. 4.1 months, p <.0001). Comparison of median TNT by LOT showed significance in third‐line and greater but not in first‐line or second‐line. Among single agents, the median TNT for patients receiving capecitabine was longest in comparison to all other single agents. Conclusions: The frequency of combination COT use, particularly in first‐line, warrants further research given published guideline recommendations. The observed TNT difference favoring single‐agent treatment in later lines supports guideline recommendations. Variance between single‐agent preference and observed TNT was noteworthy. Implications for Practice: Although published data from evidence‐ and consensus‐based guidelines recommend single‐agent over combination chemotherapy, the extensive list of agents available for use and a gap in the comparative effectiveness research of these agents have resulted in significant variances in patterns of care. The aim of this study was to assess real‐world treatment patterns and their effectiveness during palliative therapy of metastatic breast cancer. The objective was to understand when and how chemotherapy‐only treatment is used in metastatic breast cancer and whether comparative effectiveness analysis supports the observed patterns of care. This article analyzes the use of palliative chemotherapy in metastatic breast cancer, in aggregate and by cancer subtype, to better understand the effectiveness of single‐agent versus combination chemotherapy among patients in the real‐world setting. [ABSTRACT FROM AUTHOR]

Treatment options for patients with acute myeloid leukemia (AML), who are unfit for induction chemotherapy are unsatisfactory. Overall survival (OS) superiority has not been demonstrated in randomized controlled trials (RCT) in this population, challenging the value of available therapies. We sought to assess the relative value of approved therapies using value-assessment tools. Clinical, safety, quality-of-life (QOL), supportive care, and resource utilization outcomes data were abstracted from RCTs and examined using value-assessment frameworks. Three RCTs, one each of azacitidine, decitabine, and low-dose cytarabine were identified. OS was not statistically significant and secondary outcomes including response rates, rates of transfusion independence, the frequency of hospitalizations and changes in QOL were reported differently across trials. Value-assessment tools considered OS as the primary efficacy endpoint without consideration to response rates. The NCCN Evidence BlocksTM were most successful in considering secondary endpoints. With the move toward value-based care, understanding how these value tools apply to AML patients is critical. [ABSTRACT FROM AUTHOR]