tbuckley/cabot-search huggingface dataset:
Availability of Cost-effectiveness Studies for Drugs With High Medicare Part D Expenditures
Authors: Rebecca L. Tisdale, Iris Ma, Daniel Vail, Jay Bhattacharya, Jeremy D. Goldhaber-Fiebert, Paul A. Heidenreich, Alexander T. Sandhu
Journal: JAMA Network Open (2021)

Prescription drug spending in the US requires policy intervention to control costs and improve the value obtained from pharmaceutical spending. One such intervention is to apply cost-effectiveness evidence to decisions regarding drug coverage and pricing, but this intervention depends on the existence of such evidence to guide decisions.To characterize the availability and quality of cost-effectiveness studies for prescription drugs with the greatest Medicare Part D spending.In this national cross-sectional analysis, publicly available 2016 Medicare drug spending records were merged with 2016 US Food & Drug Administration Orange Book data and the Tufts Medical Center Cost-Effectiveness Analysis (CEA) Registry. All studies published through 2015 that evaluated the cost-effectiveness of the 250 drugs for which Medicare Part D spending was the greatest in US-based adult patient populations were included. Data were analyzed from September 2018 to June 2020.The presence and quality of published cost-effectiveness analyses for the 250 drugs for which Medicare Part D spending was greatest in 2016 were assessed based on the inclusion of key cost-effectiveness analysis elements and global ratings by independent reviewers for the Tufts CEA Registry.Medicare Part D spending on the 250 drugs in the sample totaled $122.8 billion in 2016 (84.1% of total spending). Of these 250 drugs, 91 (36.4%) had a generic equivalent and 159 (63.6%) retained some patent exclusivity. There were 280 unique cost-effectiveness analyses for these drugs, representing data on 135 (54.0%) of the 250 drugs included and 67.0% of Part D spending on the top 250 drugs. The 115 drugs (46.0%) without cost-effectiveness studies accounted for 33.0% of Part D spending on the top 250 drugs. Of the 280 available studies, 128 (45.7%) were industry sponsored. A large proportion of the studies (250 [89.3%]) did not meet the minimum quality requirements.In this cross-sectional study, a substantial proportion of 2016 Medicare Part D spending was for drugs with absent or low-quality cost-effectiveness analyses. The lack of quality analyses may present a challenge in efforts to develop policies addressing drug spending in terms of value.
Activity of daily living of elderly patients with gastric cancer after surgery.
Authors: Ayako Okuyama, Tomonori Mizutani, Tetsuya Hamaguchi, Takahiro Higashi, Asao Ogawa
Journal: Journal of Clinical Oncology (2021)

6588 Background: Elderly patients are concerned with the physical burden of cancer treatments. This study aimed at investigating the reduction of the activity of daily living (ADL), length of hospital stay and readmission rate after surgery for gastric cancer. Methods: Insurance claim data linked with hospital-based cancer registries in Japan for gastric cancer patients diagnosed in 2015 from 431 hospitals was used. This data is expected to cover 49.0% of new cancer cases in Japan. To compare the effect of the treatment by age group, we analyzed the reduction of ADL between admission and discharge, length of hospital stay and readmission rate after endoscopic submucosal dissection (ESD) or endoscopic mucosal resection (EMR) for patients with cT1N0M0, and open surgery for patients with cM0. Patients who aged 40 years or older with independent ADL at admission for their first-course treatment was included. ADL was assessed using Barthel index (0-100 points). ADL decrease by 10 points or more was identified as ADL reduction. Results: Overall, 25,521 patients receiving ESD/EMR and 10,527 patients receiving open surgery were identified. ADL reduction after ESD or EMR under 80 years old was less than 1%, while over 80 years old ADL reduction was more than 2.5%. Length of hospital stay (11 days) and unexpected readmission rate (2 to 3 %) was almost similar. ADL reduction after open surgery under 75 years old was less than 3%. This reduction rates have increased with age, 11.5% for over 85 years old. Length of hospital stay also tended to increase by age (21 days for under 65 years old, 29 days for over 85 years old). Unexpected readmission rate for over or 80 years old (1.4%) was slightly higher under 80 years old (less than 1%). Conclusions: The effect of ADL reduction after ESD/EMR was not so significant for patients over 80 years old. While ADL reduction after open surgery tended to increase for aged 80 years and older. Providing these information to elderly patients and their families can be important in deciding treatment options.[Table: see text]
Upfront or add-on combination therapeutic strategy exploration in unresectable hepatocellular carcinoma using sorafenib plus sintilimab: A retrospective analysis of real-world evidence.
Authors: Jiamin Cheng, Yinyin Li, Tong Wu, Zhen Zhang, Yan Chen, Guodong Su, Caiyun Peng, Linzhi Zhang, Yinying Lu, Zhen Zeng
Journal: Journal of Clinical Oncology (2021)

e16135 Background: Recently, tyrosine kinase inhibitor plus PD-1 inhibitor regimen has shown promising effects on hepatocellular carcinoma (HCC). So far, no study explored the effectiveness of upfront versus add-on combination therapy in patients with systemic treatment-naïve and treatment-experienced HCCThis study aimed to explore the effectiveness and safety of sintilimab combined sorafenib in patients with untreated or sorafenib monotherapy-refractory unresectable HCC. Methods: In this retrospective study, unresectable HCC patients received sintilimab plus sorafenib from January 2018 to December 2020 were enrolled. According to the prior treatment, patients were grouped as first-line and second-line (received sorafenib combined sintilimab after progression on sorafenib alone). Objective response rate (ORR), disease control rate (DCR), progression free survival (PFS), safety, and the change of Child-Pugh score from baseline to progression were recorded. The PFS was defined as the time from first dosing of sintilimab until disease progressive or death. Results: A total of 31 patients were reviewed, including 19 patients in first-line group and 12 patients in second-line group. There were two patients with Barcelona Clinic Liver Cancer (BCLC) stage B and 17 patients with BCLC stage C in first-line group, and one patient with BCLC stage A and 11 patients with BCLC stage C in second-line group, respectively. The ORR and DCR were 27.8% and 77.8% in first-line group, and 16.7% and 75.0% in second-line group, respectively. Fourteen cases in first-line group and 10 cases in second-line group showed PD during the follow-up. The 6-month PFS rate of first-line group and second-line group were 47.1% and 64.8%, respectively. Thirteen and 9 patients experienced AE in two groups. Four and 2 grade 3 AEs occurred in two groups, respectively. The most frequency AE were hand-foot-skin reaction in both group (58.0% and 50.0%, respectively). One patient discontinued sintilimab due to AE in second-line group. Among PD patients, the Child-Pugh score improved in 2 cases, maintained in 5 cases, and deteriorated in 7 cases in the first-line group; and improved in 3 cases, miantained in 3 cases, and deteriorated in 4 cases in the second-line group. Conclusions: Sorafenib plus sintilimab showed potential anti-tumor effect and tolerance on unresectable HCC, either as first-line therapy or after progression with sorafenib monotherapy. Outcomes.[Table: see text]
COVID-19 Vaccination–Associated Lymphadenopathy on FDG PET/CT
Authors: Muheon Shin, Chae Young Hyun, Yoon Ho Choi, Joon Young Choi, Kyung-Han Lee, Young Seok Cho
Journal: Clinical Nuclear Medicine (2021)

This study investigated 18F-FDG PET/CT features of adenovirus-vectored vaccination against COVID-19 in healthy subjects.
Comparing implementation of Telemedicine compliance and feasibility among oncology patients across countries during the COVID 19 pandemic.
Authors: Sharon Pelles, Shira Peleg Hasson, Barliz Waissengrin, Lior Hasid, Irad Deutsch, Tamar Safra, Ido Wolf, Ravit Geva
Journal: Journal of Clinical Oncology (2021)

e13622 Background: COVID19 pandemic expedited the use of telemedicine across nations. Oncology patients as at risk population especially needed the use of telemedicine to continue patient care. Evaluating patients' compliance and satisfaction with telemedicine is needed and might vary across nations and cultures. Experience from telemedicine during COVID might help shape oncology care in the future. Methods: A questionnaire that was locally validated in the Tel-Aviv Sourasky Oncology Division was distributed internationally using the BELONG.life digital health platform, a free and anonymous application (app) for cancer pts and caregivers. Results were compared between US pts replied through the app and Israeli patients. Results: The questionnaire was distributed to 232 Israeli patients and to 362 BELONG users in the US. The compliance was 74% and 35% pts respectively. Majority of users in Israel were male (54%) versus female in the US (77%). In the US 75% were Caucasian. More Israeli patients had a family member present in the call then in the corresponding US group (47% vs 64%). Both Israeli and US pts felt satisfied with the meeting and reported the willingness to continue with the same approach in the future regardless of the pandemic situation (84.9%, 63%, respectively). 95.9% of Israeli patients were attended by their regular doctor as opposed to 71% in the US. Call time duration was prolonging to 30-60 min and willingness to repeat the calls dropped to 47% when performed with a different doctor. In the US 76% of patients reported the telemedicine call saved them precious time. Conclusions: Patients' response to telemedicine meetings across countries was positive with oncology care visits being maintained successfully despite the ongoing COID19 pandemic. Most patients regardless of country of origin showed willingness to continue with telemedicine however maintaining the care with the patient's regular physician is important for the continued use of telemedicine in reducing visits time and improving the pts interaction and satisfaction. Clinical trial information: 0227-20.
Survival and organ preservation according to clinical response after total neoadjuvant therapy in locally advanced rectal cancer patients: A secondary analysis from the organ preservation in rectal adenocarcinoma (OPRA) trial.
Authors: Hannah Thompson, Jin Ki Kim, Jonathan B. Yuval, Floris Verheij, Sujata Patil, Marc J Gollub, Abraham Jing-Ching Wu, Meghan Lee, Aram F Hezel, Jorge Marcet, Peter Cataldo, Blase N. Polite, Daniel Herzig, David Liska, Samuel Oommen, Charles Friel, Charles A. Ternent, Andrew L. Coveler, Steven R. Hunt, Julio Garcia-Aguilar
Journal: Journal of Clinical Oncology (2021)

3509 Background: Clinical response following neoadjuvant therapy is paramount to identifying locally advanced rectal cancer (LARC) patients suitable for Watch and Wait (WW). A 3-tier schema was devised to stratify clinical response. Patients with a complete clinical response (cCR) are considered for WW, while those with an incomplete clinical response (iCR) are recommended for total mesorectal excision (TME). A near complete response (nCR) tier captures patients with significant, but not complete, response to be considered for WW. This schema’s efficacy has yet to be validated. We investigated survival and organ preservation (OP) rates based on this 3-tier clinical response assessment in patients with LARC who underwent total neoadjuvant therapy (TNT) in a prospective, multi-center clinical trial. Methods: Patients with MRI stage II and III rectal adenocarcinoma were randomized to either induction chemotherapy (FOLFOX or CAPEOX) followed by chemoradiation or chemoradiation followed by consolidation chemotherapy (FOLFOX or CAPEOX). At 8+/-4 weeks following TNT, response on digital rectal and endoscopic examinations was evaluated by the 3-tier schema. The date of this restaging clinical response assessment was used as time zero. The endpoints of rate of OP, disease-free survival (DFS), TME-free DFS, and overall survival (OS) were evaluated using the Kaplan-Meier method with differences analyzed by the log-rank test. Results: Clinical response assessments were available for 294 patients. The median time to assessment after neoadjuvant therapy was 7.9 weeks. Based on the 3-tier schema, 124 patients were categorized as cCR, 113 as nCR, and 57 as iCR. Baseline age, sex, average distance from the anal verge, clinical T classification, and clinical N classification were similar between the response groups. The table shows the 3-year rates of OP, DFS, TME-free DFS, and OS. The median follow-up was 2.36 years. Of the patients with a nCR, the 3-year TME rate was 48% compared with 21% in the cCR group. Conclusions: The 3-tier clinical response assessment has prognostic implications for OP and DFS in patients with LARC who underwent TNT. In patients with a nCR, more than half achieved OP at 3 years. This information should be utilized to counsel patients regarding their expected outcomes. Clinical trial information: NCT02008656. [Table: see text]
Preliminary results of anlotinib and niraparib dual therapy evaluation in platinum-resistant recurrent ovarian cancer.
Authors: Guochen Liu, Jihong Liu, Bingna Xian, Jing Li, Yanling Feng, He Huang, Ting Wan, Qidan Huang, Hua Tu, Haifeng Gu, Zhimin Liu
Journal: Journal of Clinical Oncology (2021)

e17532 Background: Patients with platinum-resistant ovarian cancer have a poor prognosis. Effective treatment options for these patients are limited. Combination of PARP inhibitors and antiangiogenic therapy is reported as an effective antitumor strategy. In this study (ANNIE), we evaluate the activity of niraparib combined with anlotinib in patients with platinum resistant recurrent ovarian carcinoma. Methods: The ANNIE trial (ClinicalTrials.gov identifier NCT04376073) was a multicentre, single-arm, phase 2 study that evaluated the safety and activity of niraparib combined with anlotinib in patients (≥18 &amp; ≤70 years, an Eastern Cooperative Oncology Group performance status of 0 or 1) with recurrent ovarian epithelial, fallopian tube, or primary peritoneal cancer cancer whose disease recurred in less than 6 months after the last administered platinum therapy, and with measurable disease according to the Response Evaluation Criteria in Solid Tumors. Patients received oral niraparib 300mg/200mg once daily continuously and anlotinib 12mg (The initial dose was reduced to 10mg on November 1, 2020) on day 1-14 of each 21-day cycle thereafter until disease progression or intolerable toxicity. The primary objective was to assess objective response rate (ORR; complete plus partial responses) according to RECIST version 1.1. 40 cases are planned to be enrolled. Results: Between May 22, 2020 and February 6, 2021, we enrolled 33 patients (median age, 56 years [range, 37-69 years]). Patients had received a median of six (range, 2-9) previous lines of therapy. The cut-off date of analysis was February 4, 2021, the median follow-up was 4.1 months (range, 0.1–8.1). At data cutoff, all but seven (2 voluntarily withdrew, 5 with progressive disease) of the patients were still on treatment. Twenty-five patients underwent imaging evaluation. The confirmed best overall response assessment showed 12 with partial responses, 12 with stable disease, yielding the ORR of 48.0% (95% CI, 27.0%̃69.0%). The median duration of response and the median PFS were not reached. Drug-related grade 3 or worse treatment-emergent adverse events were occurred in 39.4% patients, including hand-foot skin reaction (3 pts), thrombocytopenia (2 pts), hypertriglyceridemia (2 pts), neutropenia (2 pts), anemia (1 pts) and hypertension (1 pts). The most common treatment emergent adverse events were hand-foot skin reaction (36.4%), hypertension (36.4%), and thrombocytopenia (33.3%). No treatment-related death was recorded. Enrollment was ongoing so far. Conclusions: Niraparib in combination with anlotinib showed promising antitumor activity and tolerable toxicity in patients with platinum resistant recurrent ovarian cancer. The conclusion can be clarified after the research is completed. Clinical trial information: NCT04376073.
Cisplatin and capecitabine induction chemotherapy in nasopharyngeal carcinoma.
Authors: Zhiyuan Xu, Li Yang, Victor Ho-Fun Lee, Anne W. M. Lee
Journal: Journal of Clinical Oncology (2021)

6065 Background: Induction chemotherapy (IC) followed by concurrent chemoradiotherapy (CCRT) is now one of the standard treatment for locally advanced nasopharyngeal carcinoma (LANPC). Cisplatin/fluorouracil is one of the recommended IC regimens. Capecitabine is an oral fluoropyrimidine prodrug with higher concentrations of fluorouracil attained in the tumor cells after enzymatic conversions. We conducted this study to evaluate the feasibility, efficacy and safety of cisplatin and capecitabine (PX) IC followed by CCRT in LANPC. Methods: Newly diagnosed patients with LANPC (stage III-IVB according to 7 th edition of AJCC/UICC system [TNM-7] and stage III-IVA according to 8 th edition [TNM-8) were prospectively recruited from January 2015 to October 2019. They received induction PX (cisplatin: 80mg/m2 on day 1 + capecitabine: 1000mg/m2 twice daily from day 1 to 14 every 3 weeks for 3 cycles) followed by CCRT (cisplatin: 100mg/m2 every 3 weeks for a total of 2-3 cycles concurrent with intensity-modulated radiation therapy [IMRT]). IMRT with doses of 70Gy, 63Gy and 56Gy were delivered to 3 levels of planning target volumes (PTV) (high, intermediate and low risk) respectively and simultaneously in 35 fractions/7 weeks. Tumor response by MRI and CT was evaluated after completion of IC and 16 weeks after completion of CCRT according to RECIST v1.1. All adverse events were graded with NCI CTCAE v4.03. Results: One hundred and forty-five patients were recruited. The stage distributions according to TNM-8 were 82(56.6%) and 63(43.3%) for stage III and IVA, respectively. One hundred and thirty-seven patients completed 3 cycles of induction PX and 122 patients completed IMRT with 2 to 3 cycles of concurrent cisplatin. The median (interquartile range, IQR) tumor regression rates after 2-3 cycles of PX at the nasopharynx (NP) and the neck region (NK) were 51.2% (37.3%-66.5%) and 71.8% (56.7%-81.1%), respectively. At 16 weeks after CCRT, only one patient had residual disease. After a median follow-up of 33 months, 20 treatment failures and 8 deaths were observed. The estimated 2-year progression-free survival (PFS) and overall survival (OS) were 89.8% and 97.2%. The rates of grade 3/4 leukopenia, neutropenia, anemia, nausea/vomiting and electrolyte disturbance during IC were 6.2%, 15.9%, 6.9%, 4.1% and 9.0%, respectively. The corresponding rates were 45.1%, 24.6%, 27.5%, 2.8% and 11.3% during CCRT. Only 1 (0.7%) grade 3/4 hand-foot syndrome and 3 (2.1%) grade 3/4 diarrhea during IC were observed. The rates of grade 3/4 mucositis and dermatitis were 31.0% and 12.7%, respectively. There were no treatment-related deaths. Conclusions: Induction PX followed by CCRT was effective and well tolerated in patients with LANPC. Clinical trial information: NCT03427359.
Accuracy of Dexcom G6 Continuous Glucose Monitoring in Non–Critically Ill Hospitalized Patients With Diabetes
Authors: Georgia M. Davis, Elias K. Spanakis, Alexandra L. Migdal, Lakshmi G. Singh, Bonnie Albury, Maria Agustina Urrutia, K. Walkiria Zamudio-Coronado, William H. Scott, Rebecca Doerfler, Sergio Lizama, Medha Satyarengga, Kashif Munir, Rodolfo J. Galindo, Priyathama Vellanki, Saumeth Cardona, Francisco J. Pasquel, Limin Peng, Guillermo E. Umpierrez
Journal: Diabetes Care (2021)

Advances in continuous glucose monitoring (CGM) have transformed ambulatory diabetes management. Until recently, inpatient use of CGM has remained investigational, with limited data on its accuracy in the hospital setting.To analyze the accuracy of Dexcom G6, we compared retrospective matched-pair CGM and capillary point-of-care (POC) glucose data from three inpatient CGM studies (two interventional and one observational) in general medicine and surgery patients with diabetes treated with insulin. Analysis of accuracy metrics included mean absolute relative difference (MARD), median absolute relative difference (ARD), and proportion of CGM values within 15, 20, and 30% or 15, 20, and 30 mg/dL of POC reference values for blood glucose >100 mg/dL or ≤100 mg/dL, respectively (% 15/15, % 20/20, % 30/30). Clinical reliability was assessed with Clarke error grid (CEG) analyses.A total of 218 patients were included (96% with type 2 diabetes) with a mean age of 60.6 ± 12 years. The overall MARD (n = 4,067 matched glucose pairs) was 12.8%, and median ARD was 10.1% (interquartile range 4.6, 17.6]. The proportions of readings meeting % 15/15, % 20/20, and % 30/30 criteria were 68.7, 81.7, and 93.8%, respectively. CEG analysis showed 98.7% of all values in zones A and B. MARD and median ARD were higher in the case of hypoglycemia (<70 mg/dL) and severe anemia (hemoglobin <7 g/dL).Our results indicate that CGM technology is a reliable tool for hospital use and may help improve glucose monitoring in non-critically ill hospitalized patients with diabetes.
Case series of four secondary mucormycosis infections in COVID-19 patients, the Netherlands, December 2020 to May 2021
Authors: Jochem B Buil, Arthur R H van Zanten, Robbert G Bentvelsen, Tom A Rijpstra, Bram Goorhuis, Sanne van der Voort, Linda J. Wammes, Jeroen A Janson, Max Melchers, Moniek Heusinkveld, Willem J G Melchers, Ed J Kuijper, Paul E Verweij
Journal: Eurosurveillance (2021)

We describe four secondary fungal infections caused by Mucorales species in COVID-19 patients. Three COVID-19 associated mucormycosis (CAM) occurred in ICU, one outside ICU. All were men aged &gt; 50 years, three died. Clinical presentations included pulmonary, rhino-orbital cerebral and disseminated infection. Infections occurred in patients with and without diabetes mellitus. CAM is an emerging disease and our observations underscore the need to be aware of invasive mucormycosis, including in COVID-19 patients without (poorly controlled) diabetes mellitus and outside ICU.