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Introduction: There is a need to understand the current treatment landscape for LA HNSCC in the real-world setting. Methods: This retrospective study assessed real-world outcomes and treatment patterns of 1,158 adult patients diagnosed with locally advanced (stage III-IVB) HNSCC initiating chemoradiotherapy (CRT) within the period January 2015 to December 2017 in a large network of US community oncology practices. Structured data were abstracted from electronic health records. Demographic, clinical and treatment characteristics were analyzed descriptively overall and stratified by index treatment (cisplatin + radiotherapy [RT], cisplatin + other chemotherapy + RT, or cetuximab + RT). Time to next treatment (TTNT) and overall survival (OS) were measured using the Kaplan-Meier method, and median duration of treatment was assessed. OS was compared across treatment cohorts using multinomial logistic regression with inverse probability treatment weighting. To identify covariates associated with OS, a multivariable adjusted Cox proportional hazard model was used. Results: This study examined 22,782 records, of which 2124 had stage III to stage IVB and no other cancers, and 1158 met all eligibility criteria. Among the treatment cohorts analyzed (cisplatin + RT, cisplatin + other chemotherapy + RT, or cetuximab + RT), cisplatin + RT was the most common concurrent chemotherapy (65.8%). Among 1158 patients, 838 (72.4%) did not initiate subsequent treatment and 139 (12.0%) died. The median TTNT and median OS were only reached by the cetuximab + RT cohort. Among patients with oropharynx primary tumor location, patients with human papilloma virus (HPV) positive status had the longest time on treatment and highest survival at 60 months. Covariates associated with improved survival were never/former tobacco use, HPV positive status, and overweight or obese body mass index. Covariates associated with poorer survival were age of 60+ years, primary tumor location of hypopharynx or oral cavity and Eastern Cooperative Oncology Group performance status score of 2+. Conclusion: These data describe real-world treatment patterns in locally advanced head and neck squamous cell cancer and sets the baseline to assess outcomes for future studies on the community oncology population. [ABSTRACT FROM AUTHOR]

Background: Limited data are available regarding second‐line (2 L) treatment for advanced or metastatic biliary tract cancers (BTC) in the US real‐world setting. This study explores the rapidly evolving and growing treatment landscape in the 2 L setting for advanced or metastatic BTC with a large cohort of patients treated in a community oncology setting. Methods: Adult patients with BTC initiating 2 L treatment after a platinum‐containing first‐line between 1/1/10‐ and 6/30/19 were identified from the US Oncology Network electronic healthcare record database and followed through 12/31/19. Baseline patient and treatment characteristics were analyzed descriptively, including overall response rate (ORR) in the real‐world clinical setting. Kaplan–Meier methods were used to measure duration of response, progression‐free survival (PFS), and overall survival (OS). Results: The overall population (N = 160) included 74 patients (46.3%) with intrahepatic cholangiocarcinoma, 41 (25.6%) with extrahepatic cholangiocarcinoma, and 45 (28.1%) with gallbladder cancer. Thirty unique 2 L regimens were recorded for the study population, with folinic acid, fluorouracil and oxaliplatin (FOLFOX, 34.4%) and capecitabine monotherapy (20.0%) being the most common. ORR was 7.5% (95% CI, 3.9%–12.7%). From 2 L initiation, median PFS was 2.8 months (95% CI, 2.4–3.3 months), and median OS was 5.2 months (95% CI, 4.2–6.7 months). Conclusion: Results from this study provide real‐world evidence that although patients treated in the community oncology setting receive a wide variety of 2 L treatments, the regimens are consistent with those recommended by guidelines. Although responses are observed with 2 L treatment, duration is brief and associated with poor OS in patients with advanced or metastatic disease. [ABSTRACT FROM AUTHOR]

Background: Immunotherapy (IO) has been associated with improved outcomes in patients with locally advanced Merkel cell carcinoma (laMCC) and metastatic Merkel cell carcinoma (mMCC). The primary objective of SPEAR‐Merkel was to explore treatment patterns, clinical outcomes, and health care resource utilization (HCRU) in patients with laMCC or mMCC initiating first‐line (1L) treatment with avelumab, non‐avelumab IO, or chemotherapy in a U.S. community oncology setting. Methods: Adult patients with laMCC or mMCC initiating 1L avelumab, non‐avelumab IO, or chemotherapy from January 1, 2015, to March 31, 2019, were identified from the U.S. Oncology Network electronic health care record database and followed up through September 30, 2019. Baseline characteristics and HCRU were analyzed descriptively, including physician‐stated overall response rate in the real‐world clinical setting. Kaplan‐Meier methods were used to measure duration of response, real‐world progression‐free survival (rwPFS), and overall survival (OS). Results: Among the overall population (n = 94), 28 received 1L avelumab (9 laMCC, 19 mMCC), 26 received 1L non‐avelumab IO (8 laMCC, 18 mMCC), and 40 received 1L chemotherapy (10 laMCC, 30 mMCC). The real‐world overall response rate was 64.3%, 61.5%, and 42.5%, respectively. From 1L treatment initiation, median rwPFS was 11.4, 8.1, and 6.1 months, and median OS was 20.2 months, not reached, and 14.7 months for the respective cohorts. Conclusion: SPEAR‐Merkel showed that patients with laMCC or mMCC treated with IO had improved outcomes compared with chemotherapy in clinical practice. The study provides insight on utilization and clinical outcomes associated with newer, more innovative therapies in clinical practice, which may help clinicians understand the variety of newer treatment options for both laMCC and mMCC. Implications for Practice: To the authors' knowledge, SPEAR‐Merkel is the first study to evaluate real‐world clinical outcomes in patients with locally advanced Merkel cell carcinoma (laMCC) and metastatic Merkel cell carcinoma (mMCC) receiving first‐line (1L) avelumab, non‐avelumab immuno‐oncology therapies, or chemotherapy in a real‐world setting. SPEAR‐Merkel showed clinical benefit for immuno‐oncology therapies compared with chemotherapy. The study provides insight on uses and clinical outcomes associated with innovative therapies in clinical practice, which may help clinicians understand the variety of newer treatment options for both laMCC and mMCC. The study is of particular importance as it shows that chemotherapy is still being used as 1L treatment despite its inferior clinical and safety profile. The SPEAR‐Merkel study provides on current treatment patterns, real‐world clinical outcomes, and healthcare resource utilization in patients with locally advanced/metastatic Merkel cell carcinoma initiating first‐line treatment with avelumab, non‐avelumab immunotherapies, or chemotherapy within a large network of community‐based oncology practices in the U.S. Results are reported here. [ABSTRACT FROM AUTHOR]

Aims: Adjuvant chemotherapy has been shown to improve survival in patients with completely resected early-stage non-small cell lung cancer (NSCLC). This study evaluated real-world relapse rates and healthcare resource utilization in patients with stage II-IIIB NSCLC receiving adjuvant therapy in a community oncology setting after complete resection. Patients and Methods: The study included patients with stage II-IIIB NSCLC and complete resection receiving any adjuvant therapy during 06/2008-04/2017 at US Oncology Network clinics, with follow-up through 04/2019. Primary endpoints were rate of relapse, time to relapse (TTR), disease-free survival (DFS), overall survival (OS), and monthly emergency department (ED) visits and hospitalizations before and after relapse. Results: The study identified 456 patients; median age was 66 years, 50% were male. In patients with relapse (45.2%), median follow-up was 31.7 months and median TTR was 13.7 months. Median DFS in the overall population was 42.9 months. Median OS was 82.4 months in the overall population and shorter in patients with relapse than without relapse (41.6 months vs. not reached, p < 0.0001). Patients with relapse had significantly more monthly ED visits (mean [SD] 0.10 [0.24] vs. 0.03 [0.08], p < 0.0001) and hospitalizations (mean [SD] 0.20 [0.43] vs. 0.05 [0.10], p < 0.0001) following relapse than before relapse. Conclusions: Patients with stage II-IIIB NSCLC treated with adjuvant therapy after complete resection had high relapse rates, reduced survival, and significantly increased healthcare resource use when relapse occurred. New therapeutic options to reduce relapse rates in patients with early-stage NSCLC could reduce healthcare utilization and costs. [ABSTRACT FROM AUTHOR]

Aim: To assess clinical outcomes in patients with locally advanced (la) or metastatic (m) Merkel cell carcinoma (MCC) initiating first-line (1L) avelumab in a USA community oncology setting. Materials & methods: Adults with laMCC or mMCC initiating 1L avelumab were identified from The US Oncology Network electronic health record database and chart review. Results: Median overall survival and progression-free survival were not reached in laMCC (n = 9) vs 20.2 and 10.0 months in mMCC (n = 19); response rates were similar (66.7% vs 63.2%). Conclusion: This is the first study to show clinical benefit in patients with laMCC receiving 1L avelumab in a US real-world setting. Response rates in patients with mMCC were consistent with pivotal trials. [ABSTRACT FROM AUTHOR]

Aim: Many pivotal trials in advanced hepatocellular carcinoma (HCC) require participants to have Child-Pugh A disease. However, many patients in real-world practice are Child-Pugh B or C. This study examined treatment patterns and clinical outcomes in patients with advanced HCC treated with first-line systemic therapy., Materials & Methods: In this retrospective study, patients with HCC treated with first-line systemic therapy (2010-2017) were identified from US Oncology Network records. Outcomes included overall survival and progression-free survival, by Child-Pugh Class and prior liver-directed therapy., Results: Of 352 patients, 78.7% were Child-Pugh A or B, 96.6% received first-line sorafenib, and 33.8% received first-line-prior liver-directed therapy. Survival outcomes were similar for Child-Pugh A or B, and longer after first-line prior liver-directed therapy., Conclusion: First-line systemic therapy is beneficial in patients with Child-Pugh A or B, and after first-line prior liver-directed therapy. These findings may help position systemic therapy in the community setting., Competing Interests: The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed., (© 2023 The Authors.)

Objective: In addition to negative impacts on clinical effectiveness in treating secondary hyperparathyroidism, low adherence to cinacalcet may have negative impacts on healthcare costs. This study assessed the relationship between medication adherence and healthcare costs among US patients on dialysis given cinacalcet to manage secondary hyperparathyroidism., Methods: Retrospective cohort study of patients who were receiving dialysis with an initial cinacalcet prescription between January 2004 and April 2010 and who survived ≥12 months. Longitudinal, integrated medical, and pharmacy claims data from the MarketScan? database were used to calculate medication possession ratios (MPR) over 12 months and to examine the association of adherence with inpatient, outpatient, emergency room, outpatient medication, and total costs while controlling for patient characteristics, co-morbid medical conditions, and concomitant medication MPR in a multivariate regression model. Patients were dichotomized as adherent (<180 days refill gap) or non-adherent (≥180 day refill gap). Adherent patients were further dichotomized as low adherent (<0.8 MPR) and high adherent (≥0.8 MPR)., Results: The final study cohort included 4923 patients. After 12 months, 46% were non-adherent, 27% were low adherent, and 28% were high adherent. Greater cinacalcet adherence was associated with significantly lower inpatient costs with cost-savings of a greater magnitude than the increased medication costs., Conclusions: This study demonstrated that low adherence to cinacalcet, which may be associated with undesirable clinical and health-economic outcomes, is common. Despite limitations inherent in retrospective studies of claims databases, such as unobserved confounding, non-discrimination between prescription fill and actual use, and not knowing the reasons for non-adherence, these results suggest that inpatient cost savings of $8899, more than offset higher medication costs of $5858 associated with increased cinacalcet adherence.