Publications by authors named "Xinglei Chai"

Regulatory approvals of tisagenlecleucel (tisa-cel) and axicabtagene ciloleucel (axi-cel) have established the feasibility of chimeric antigen receptor T-cell therapies for the treatment of adults with relapsed or refractory follicular lymphoma (r/r FL). This study used individual patient data from ELARA (tisa-cel) and aggregate published patient data from ZUMA-5 (axi-cel) to compare efficacy and safety outcomes in r/r FL using matching-adjusted indirect comparison methods. After adjustment for baseline differences in the trial populations, the results suggested that tisa-cel ( = 52), compared with axi-cel ( = 86), had similar effects on overall response rate (91.

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Treatment for acute myeloid leukemia (AML) typically involves intensive chemotherapy (IC); however, there is an unmet need for approximately 50% of AML patients who are deemed unfit or ineligible for IC. The purpose of this study was to evaluate, from a Canadian perspective, the economic impact of venetoclax in combination with azacitidine (Ven+Aza) for the treatment of patients with newly diagnosed AML who are 75 years or older or who have comorbidities that preclude using IC. A lifetime partitioned survival model was developed to assess the cost-effectiveness of Ven+Aza compared with Aza.

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Article Synopsis
  • Venetoclax, when combined with azacitidine, decitabine, or LDAC, was approved by the FDA in 2020 for treating newly diagnosed AML in patients aged 75 and older or those who can't undergo intensive chemotherapy.
  • A study aimed to evaluate the economic value and costs associated with achieving remission using venetoclax combinations versus other treatments for newly diagnosed AML patients unfit for intensive chemotherapy.
  • The analysis found that venetoclax combinations had significantly lower costs per patient achieving remission (e.g., venetoclax + azacitidine: $473,960) compared to alternatives like azacitidine alone, which was the most expensive at $1,197,438.
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Objectives: Using individual patient-level data from the phase 3 VIALE-A trial, this study assessed the cost-effectiveness of venetoclax in combination with azacitidine compared with azacitidine monotherapy for patients newly diagnosed with acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy, from a United States (US) third-party payer perspective.

Methods: A partitioned survival model with a 28-day cycle and three health states (event-free survival (EFS), progressive/relapsed disease, and death) was developed to estimate costs and effectiveness of venetoclax + azacitidine versus azacitidine over a lifetime (25-year) horizon. Efficacy inputs (overall survival (OS), EFS, and complete remission (CR)/CR with incomplete marrow recovery (CRi) rate) were estimated using VIALE-A data.

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No head-to-head trials have compared the efficacy of tisagenlecleucel vs historical treatments for adults with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL). This study indirectly compared the overall survival (OS) and overall response rate (ORR) associated with tisagenlecleucel, using data from the JULIET study (Study of Efficacy and Safety of CTL019 in Adult DLBCL Patients; #NCT02445248), vs historical treatments assessed in the CORAL (Collaborative Trial in Relapsed Aggressive Lymphoma) study follow-up population. To assess treatment effects in the treated (full analysis set [FAS]) and enrolled (intention-to-treat [ITT]) study populations, the JULIET FAS vs the CORAL follow-up FAS and JULIET ITT vs CORAL follow-up ITT populations were separately compared.

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Article Synopsis
  • A phase 3 trial (PALISADE) showed that peanut allergen powder-dnfp (PTAH) treatment significantly increased the ability of peanut-allergic children to tolerate higher doses of peanut protein after one year.
  • The study used survival analysis to assess the risk of systemic allergic reactions (SAR) after accidental exposure to peanuts, comparing data from PTAH-treated and placebo participants.
  • Results indicated a 94.9% reduction in SAR risk for PTAH-treated children versus 6.4% for the placebo group, with even higher risk reductions for those tolerating larger doses at trial exit.
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There are limited treatment options and substantial unmet needs for adult patients with relapsed or refractory diffuse large B cell lymphoma (r/r DLBCL) in Japan. In 2019, tisagenlecleucel, a CD19-directed chimeric antigen receptor T cell therapy, was approved for r/r DLBCL in Japan. The efficacy and safety of tisagenlecleucel were demonstrated in the pivotal phase II single-arm JULIET trial.

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Until recently, treatment options were relatively limited for children and young adults with relapsed or refractory (r/r) acute lymphoblastic leukemia (ALL). Tisagenlecleucel is a chimeric antigen receptor T cell (CAR-T) immunotherapy with promising efficacy and manageable safety that was approved in Japan in 2019 for the treatment of CD19-positive r/r B cell ALL (B-ALL). However, there is no publication assessing the cost-effectiveness of CAR-T in Japan.

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Article Synopsis
  • - The text discusses the approval of tisagenlecleucel for treating relapsed/refractory B-cell acute lymphoblastic leukemia in children and young adults, based on its performance in the ELIANA trial.
  • - An economic model was created to estimate all costs associated with tisagenlecleucel treatment, considering factors from the pre-treatment phase to two months post-infusion, including various medical services and management of adverse events.
  • - The total estimated cost for tisagenlecleucel treatment was $612,779, primarily influenced by adverse event management, hospital admissions, and laboratory tests, with the infusion itself accounting for the majority of expenses at $476,659.
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Article Synopsis
  • The study evaluated the total costs of treating adult patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) using the CAR-T therapy tisagenlecleucel, focusing on a two-month period after infusion based on data from the JULIET trial.
  • It found that the average total cost per patient was $437,927, with a significant portion ($64,784) being additional costs beyond the drug's list price due to factors like management of adverse events and hospital stays.
  • The analysis highlighted that costs could vary significantly based on patient outcomes, ranging from $382,702 without complications to $469,006 in cases with severe side effects requiring hospitalization.
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Germline mutations in and () are associated with increased risk of breast and ovarian cancer. The penetrance of breast and ovarian cancer in mutation carriers has been well characterized in Caucasian but not in Asian. Two studies have investigated the breast cancer risk in Asian women with mutations, and no published estimates are available for ovarian cancer.

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Inherited mutations in BRCA1 or BRCA2 (BRCA1/2) confer very high risk of breast and ovarian cancers. Genetic testing and counseling can reduce risk and death from these cancers if appropriate preventive strategies are applied, including risk-reducing salpingo-oophorectomy (RRSO) or risk-reducing mastectomy (RRM). However, some women who might benefit from these interventions do not take full advantage of them.

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