Real-world treatment patterns and the uptake of biologics in elderly medicare patients with metastatic colon cancer.

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 540-540
Author(s):  
C. Daniel Mullins ◽  
Kaloyan A. Bikov ◽  
Brian S. Seal ◽  
Anna Hung ◽  
Nader Hanna

540 Background: Metastatic colon cancer (mCC) patients may receive multiple lines of treatment (Tx1, Tx2, etc.) consisting of one or more cytotoxic (CYT: 5FU/LV, oxaliplatin [OX], irinotecan [IRI]) and biologic (BIO: bevacizumab [BEV], cetuximab [CET], panitumumab [PAN]) drugs. The National Comprehensive Cancer Network (NCCN) provides evidence-based Tx recommendations for each line. The objective of this study was to examine real-world clinical practice patterns between 2002 and 2010. In particular, we compared the most common regimens across Tx lines and how Tx patterns changed over time. We also documented the uptake and use of new BIOs. Methods: We used population-based SEER-Medicare data to determine Tx1, Tx2, and Tx3 regimens of 4,616 mCC patients (the median age at diagnosis was 78) diagnosed in 2003-2009 and followed through 2010. We will use an algorithm previously developed by us to identify regimens. Results: The most common CYT backbone in Tx1 was OX (51% of patients) followed by 5FU/LV (30%). In comparison, IRI was a preferred choice in Tx2 (65%) and Tx3 (31%). In 2003, the most common Tx1 regimens were 5FU/LV- (56%) and IRI-based (35%). 5FU/LV and IRI use decreased to 22% and 9% respectively in 2009, while OX use increased from 7% in 2003 to 63% in 2009. In 2004, the FDA approved BEV for Tx1. BEV’s share increased from 9% in 2004 to 53% in 2005. BEV was used in 9% of Tx2 regimens in 2004 and 46% in 2005. CET was approved in 2004. CET was used in less than 5% of Tx1 regimens in any year up to 2010. CET use in Tx2 increased from 19% to 27% between 2005 and 2007, and declined to 23% in 2010. The FDA approved PAN in September 2006 for treatment after failure of CYT-based regimens, i.e., primarily in Tx3 and beyond. Only 350 (8%) of patients received Tx3, and of these 59 (17%) received PAN without a CYT backbone. One in three Tx3 regimens consisted of biologics only (54% CET, 43% PAN). Conclusions: This study used SEER-Medicare registry data to examine and document real-world clinical practice patterns in treatment of elderly mCC patients between 2003 and 2010. We observed that as new biologic agents were introduced to the market, variations in the combinations and the number of treatment have significantly and rapidly changed.

2013 ◽  
Vol 31 (4_suppl) ◽  
pp. 553-553
Author(s):  
Kaloyan A Bikov ◽  
C. Daniel Mullins ◽  
Ebere Onukwugha ◽  
Brian S. Seal ◽  
Nader Hanna

553 Background: Patients with metastatic colon cancer (mCC) often receive multiple lines of chemotherapy treatment (TX) in response to disease progression or toxicities. A claims-based algorithm that identifies TX lines can provide information on “real world” clinical practice patterns that may not be captured by clinical trials. Methods: Our claims-based algorithm was applied to SEER-Medicare data of elderly mCC patients diagnosed in ‘03-‘07 and followed through ‘09. The algorithm included 17 clinical rules for identifying the beginning and end TX lines. The face validity of the algorithm was assessed by 1) examining the output against a TX map for a random sample of patients; 2) evaluating the overall results; and 3) conducting a sensitivity analysis, which evaluated the variability in the number of detected TX lines as a function of key algorithm parameters. Results: Of 7,951 mCC patients, 3,266 (41%) received TX; 1,440 (18% of all, 44% of TX) and 274 (3% of all, 8% of TX) received 2nd and 3rd line TX, respectively. Fewer than 1% of treated patients had a 4th TX line. The utilization patterns in terms of number and type of TX lines were robust to changes in the algorithm parameters. OX±BEV (45%), 5FU/LV±BEV (33%) and IRI±BEV (16%) were the three most common initial TXs. 2nd line TX most commonly consisted of IRI±BIOLOGIC (62%) and OX±BIOLOGIC (26%), but 6% of patients received only BIOLOGICS. CETUX (19%), PANIT (15%), IRI alone (17%) and OX alone (12%) were the most common 3rd line TXs. OX to IRI (49%), IRI to OX (14%), 5FU/LV to OX (12%), and 5FU/LV to IRI (12%) were the most frequent TX progressions for those with 2nd line TX. 5FU/LV to OX to IRI (26%), OX to IRI to BIOLOGICS alone (25%), 5FU/LV to IRI to OX (14%) and IRI to OX to BIOLOGICS alone (6%) were the most frequent TX progressions for those with 3rd line TX. Conclusions: Our claims-based algorithm suggests that during 2003-2009 relatively few elderly mCC patients received 2nd and 3rd line TX. Sensitivity analysis confirmed the robustness of the algorithm. Future observational studies should address the “real world” benefits and risks of 2nd and 3rd line TX among elderly mCC patients.


Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 2374-2374
Author(s):  
Yuji Yamada ◽  
Hiroyuki Ohbe ◽  
Hideo Yasunaga ◽  
Yoshitaka Miyakawa

Introduction: Acquired thrombotic thrombocytopenic purpura (TTP) is a medically emergent disorder that is almost always fatal without proper treatment. While daily plasma exchange is recommended by several guidelines, its optimal frequency is unclear, and until March 2018 plasma exchange up to only three times a week was reimbursed by Japanese health insurance. In addition, rituximab has not been approved for acquired TTP in Japan. While it is known that clinical practice guidelines for TTP treatment in Japan may differ from those in other countries, real-world practice patterns remain unknown. Thus, we evaluated patients' characteristics and clinical practice patterns using a large nationwide inpatient database. Methods: For this nationwide epidemiologic study, we used the Japanese Diagnosis Procedure Combination inpatient database, which includes discharge abstracts and administrative claims data from more than 1,200 acute-care hospitals and covers approximately 90% of all tertiary-care emergency hospitals in Japan. All hospitalized patients who were diagnosed with TTP (International Classification of Diseases-Tenth Revision, code M311) on admission and who received plasma exchange during hospitalization were included in the study. Patients younger than 18 years were excluded. When patients with the ICD code for TTP were admitted more than once during the study period, we used data only from the first admission. We then evaluated patients' characteristics and clinical practice patterns. Results: We identified 1,638 patients who were newly diagnosed with acquired TTP from July 2010 to March 2017. The median (interquartile range [IQR]) age was 64 (47-74) years, and 674 (41%) patients were male; 648 (40%) required ICU admission, 447 (34%) required catecholamine, and 497 (30%) required mechanical ventilation. Although relatively contraindicated, 658 (40%) patients received platelet transfusion. In-hospital mortality was 32% (n=529/1,638). Median (IQR) length of hospital stay was 45 (25-78) days, and median total cost was US$40,897 ($24,204-$64,012). Among survivors, 856 (77%) were discharged home and 235 (21%) required subacute rehabilitation or chronic care facility. The median (IQR) interval from admission to plasma exchange was 4 (2-10) days; 385 (24%) patients received plasma exchange on the day of admission. Median (IQR) frequency of plasma exchange within 7 days of initial exchange was 3 (2-5) days; median (IQR) duration of plasma exchange was 10 (4-21) days. Of the 1,519 (93%) patients who received steroids, 1,071 (71%) received steroid pulse therapy. Among the 529 (32%) patients administered immunosuppressants, 221 (13%) received cyclophosphamide, 152 (9.3%) rituximab, 140 (8.6%) cyclosporine, and 86 (5.3%) tacrolimus. Conclusions: We assessed real-world clinical practice for TTP patients in Japan for the first time using the nationwide inpatient database. Our analysis showed a disparity between guidelines and real-world clinical practice, especially regarding frequency of plasma exchange. Optimal treatment strategy, efficacy, and safety should be evaluated in future studies. Disclosures Miyakawa: Zenyaku Kogyo: Consultancy; Sanofi: Speakers Bureau; Ablynx: Speakers Bureau; Chugai: Speakers Bureau.


2021 ◽  
Vol 42 (6) ◽  
pp. 1116
Author(s):  
Andrés Redondo ◽  
Regina Girones ◽  
Nuria Ruiz ◽  
Maria Iglesias ◽  
Cesar Mendiola ◽  
...  

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 17039-17039
Author(s):  
K. Rowe ◽  
M. Patwardhan ◽  
J. E. Herndon ◽  
M. G. Martin ◽  
Y. Zafar ◽  
...  

17039 Background: CT choice is influenced by many factors including published evidence, guidelines, cost, reimbursement, patient considerations, key opinion leaders, and anecdote. Substantial locoregional variation in practice patterns can exist, and therefore studies of locoregional practice provide important information on local drivers of care. Methods: Using a population-based strategy, we identified CRC patients who developed metastatic disease since 6/1/03 from 9 Duke Oncology Network community practices and 1 academic practice in North and South Carolina. Demographic, comorbidity, diagnostic, stage, initial treatment, and metastatic treatment data were abstracted by retrospective chart review, double-entered and verified for accuracy. Results: Of the first 743 charts screened, 306 were eligible (mean age 61 (SD 13), 49% male; 65% white; 22% black; 77% colon cancer and 19% rectal; stages II 8%, III 16%, IV 64%). 26 earlier stage rectal cancer patients received neoadjuvant treatment, 50% infusional fluorouracil (5FU) and 42% capecitabine (Cap). 46 colon cancer patients received adjuvant CT, including 5FU/leucovorin (LVN; 54%), 5FU/LVN/oxaliplatin (21%), Cap (9%), and 5FU/LVN/irinotecan (7%). First-line CT for metastatic colon cancer (n=149) included FOLFOX+-bevacizumab (Bev; 42%), Cap/oxaliplatin +- Bev (23%), 5FU/LVN + Bev (9%), FOLFIRI +- Bev (7%), IFL +- Bev (7%), clinical trial (7%), Cap (3%), and unknown (1%). 54% of patients received Bev overall, reflecting 49% usage before 6/05 and 69% after 6/05. CT was not offered for 25 (8%) at initial diagnosis. Conclusion: Locoregional practice patterns in the Carolinas suggest that for adjuvant treatment of CRC, oxaliplatin has been used in 21% of adjuvant and 75% of first-line metastatic colon CT regimens, and that bevacizumab use has increased to 69% of first-line metastatic CRC patients. No significant financial relationships to disclose.


2015 ◽  
Vol 60 (10) ◽  
pp. 3149-3150 ◽  
Author(s):  
Jessica Davis ◽  
Brandon Rieders ◽  
Marie L. Borum

Author(s):  
Léo Mas ◽  
Jean-Baptiste Bachet ◽  
Valérie Jooste ◽  
Côme Lepage ◽  
Anne-Marie Bouvier

2019 ◽  
Vol 25 (1) ◽  
pp. 55-61 ◽  
Author(s):  
Shlomit Koren ◽  
Miriam Shteinshnaider ◽  
Karen Or ◽  
Dror Cantrell ◽  
Carlos A. Benbassat ◽  
...  

2021 ◽  
Vol 25 (3) ◽  
pp. 221-229
Author(s):  
Tae Gyu Ahn ◽  
Yeon Hee Kim ◽  
Yun Sook Kim ◽  
Jae Eun Shin ◽  
Young-Lim Oh ◽  
...  

Purpose: The purpose of this study was to investigate the clinical practice patterns of Korean obstetricians and gynecologists the diagnosis and management of hypertensive disease in pregnant women. Methods: From April 2015 to October 2015, questionnaire was distributed via email to obstetricians who were members of the Society for Maternal and Fetal Medicine. The survey consisted of 37 questions in 6 categories. Responses to the questions on the management of hypertensive disorders of pregnancy, from diagnosis to treatment, were evaluated. Results: A total of 93 obstetricians and gynecologists responded to the survey. High blood pressure was allocated the highest priority as an index mainly used when deciding to hospitalize patients with hypertensive disease during pregnancy, followed by pregnancy symptoms, proteinuria, and blood test results. Calcium channel blocker (CCB) for oral administration and hydralazine for injection were preferred as antihypertensive drugs mainly used to control severe hypertension. Regarding the delivery method for hypertensive disease during pregnancy, in cases of preeclampsia, 63% of the respondents chose the delivery method according to the cervical status, and in cases of hemolysis, elevated liver enzymes and low platelets (HELLP) syndrome and eclampsia, which increased in severity, 52% and 31% responded that the delivery method was determined according to the cervical status, respectively. In cases of mild preeclampsia, the 70% of respondents preferred 37–38 weeks of gestation for the delivery time. Regarding the use of aspirin in patient with hypertension during pregnancy, 52% of the respondents occasionally administered aspirin, and in patients with a history of hypertensive disease during pregnancy, only 43% were administered prophylactic aspirin. Conclusion: Domestic obstetricians regarded blood pressure as the most meaningful factor when treating women with hypertension during pregnancy and considered blood pressure control as important. The preferred antihypertensive agents were oral CCB and hydralazine injections, and the choice of delivery method was determined according to the condition of the cervix and severity of the disease. Even in women with high risk factors for preeclampsia, prophylactic aspirin was administered in as low as 50%, of patients, possibly may due to the absence of domestic guidelines for aspirin use during pregnancy. Korean guidelines for prophylactic aspirin administration during pregnancy is needed based on additional research on the efficacy of aspirin for domestic women in the future.


2021 ◽  
Vol 09 (11) ◽  
pp. E1704-E1711
Author(s):  
Pauline M.C. Stassen ◽  
Pieter Jan F. de Jonge ◽  
George J.M. Webster ◽  
Mark Ellrichmann ◽  
Arno J. Dormann ◽  
...  

Abstract Background and aims Indirect peroral cholangiopancreatoscopy (IPOC) is a relatively new diagnostic and therapeutic tool for biliopancreatic diseases. This international survey aimed to evaluate clinical practice patterns in IPOC among endoscopists in Europe. Methods An online survey was developed comprising 66 questions on the use of IPOC. Questions were grouped into four domains. The survey was sent to 369 endoscopists who perform IPOC. Results 86 respondents (23.3 %) from 21 different countries across Europe completed the survey. The main indications for cholangioscopy were determination of biliary strictures (85 [98.8 %]) and removal of common bile duct or intrahepatic duct stones (79 [91.9 %]), accounting for an estimated use of 40 % (interquartile range [IQR] 25–50) and 40 % (IQR 30–60), respectively, of all cases undergoing cholangioscopy. Pancreatoscopy was mainly used for removal of pancreatic duct stones (68/76 [89.5 %]), accounting for an estimated use of 76.5 % (IQR 50–95) of all cases undergoing pancreatoscopy. Only 13/85 respondents (15.3 %) had an institutional standardized protocol for targeted cholangioscopy-guided biopsy sampling. IPOC with lithotripsy was used as first-line treatment in selected patients with bile duct stones or pancreatic stones by 24/79 (30.4 %) and 53/68 (77.9 %) respondents, respectively. Conclusions This first European survey on the clinical practice of IPOC demonstrated wide variation in experience, indications, and techniques. These results emphasize the need for prospective studies and development of an international consensus guideline to standardize the practice and quality of IPOC.


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