Primary Central Nervous System Lymphoma
Conditions
Brief summary
This study was a single-centre, retrospective study that retrospectively collected first-line PCNSL patients receiving methotrexate-based chemotherapy ± orelabrutinib at Huashan Hospital of Fudan University. The study was divided into two retrospective cohorts, Cohort A was a cohort of patients receiving methotrexate-based chemotherapy alone, and Cohort B was a cohort of patients receiving methotrexate-based chemotherapy + orelabrutinib.
Detailed description
The study was divided into two retrospective cohorts of approximately 35-40 patients each. Cohort A was the cohort of patients who received methotrexate-based chemotherapy alone, and cohort B was the cohort of patients who received methotrexate-based chemotherapy + orelabrutinib. Statistical analyses such as propensity score analysis (PSM) and inverse probability weighted (IPTW) analysis were performed, focusing on comparing and analysing the short-term efficacy data (ORR, CR) and long-term efficacy data (PFS, OS) of the two cohorts.
Interventions
DRUGOrelabrutinib
Combination of orelabrutinib on a methotrexate-based chemotherapy regimen with a starting dose of 150 mg/d
Sponsors
Huashan Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Inclusion criteria
* Pathologically confirmed primary central nervous system lymphoma * Methotrexate-based chemotherapy ± orelabrutinib regimen as first-line treatment for patients
Exclusion criteria
* Patients receiving ≤2 cycles of treatment without efficacy evaluation * Those with uncontrolled or significant cardiovascular disease, including: uncontrolled diabetes mellitus, severe cardiac, pulmonary, hepatic, renal insufficiency) and haematological, endocrine system lesions, history of other uncontrollable malignancies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) | At the end of induction therapy, Cycle 6-8 (each cycle is 28 days) | ORR is defined as the proportion of patients with a best response of CR, CRu or PR during induction therapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PFS | Up to 2 years | Progression-free survival is calculated from the date of start of therapy until the date of first documented progress or death due to any cause |
Countries
China
Outcome results
None listed