From the FDA Drug Label
The safety and effectiveness of RITUXAN were evaluated in three randomized, active-controlled, open-label, multicenter studies with a collective enrollment of 1854 patients Patients with previously untreated diffuse large B-cell NHL received RITUXAN in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) or other anthracycline-based chemotherapy regimens
NHL Study 7 A total of 632 patients age greater than or equal to 60 years with DLBCL (including primary mediastinal B-cell lymphoma) were randomized in a 1:1 ratio to treatment with CHOP or R-CHOP.
The recommended treatment for double-hit Diffuse Large B-Cell Lymphoma (DLBCL) is R-CHOP, which is a combination of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone.
- Key points:
- R-CHOP is the recommended treatment
- Rituximab is administered in combination with CHOP
- The main outcome measure of the study was progression-free survival 1
From the Research
The recommended treatment for double-hit Diffuse Large B-Cell Lymphoma (DLBCL) is an intensive chemotherapy regimen such as dose-adjusted EPOCH-R (etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab) rather than the standard R-CHOP regimen. This is based on the most recent and highest quality study available, which suggests that dose-adjusted EPOCH-R is a safe and well-tolerated outpatient treatment regimen in double-hit lymphoma, with a complete response rate of 69% and median event-free survival and overall survival durations of 61 months and 64 months, respectively 2.
Key Components of Treatment
- The regimen includes rituximab 375 mg/m² on day 1, etoposide 50 mg/m²/day as continuous infusion on days 1-4, prednisone 60 mg/m²/day on days 1-5, vincristine 0.4 mg/m²/day as continuous infusion on days 1-4, cyclophosphamide 750 mg/m² on day 5, and doxorubicin 10 mg/m²/day as continuous infusion on days 1-4.
- CNS prophylaxis is crucial due to the high risk of CNS involvement and typically includes intrathecal methotrexate or cytarabine.
- Double-hit DLBCL, characterized by MYC rearrangement along with BCL2 and/or BCL6 rearrangements, has a particularly aggressive course and poor prognosis with standard R-CHOP therapy.
Rationale for Intensive Regimen
- The more intensive regimens are recommended because they provide better penetration of the blood-brain barrier and have shown improved outcomes in this high-risk subtype.
- Recent studies have demonstrated the efficacy of dose-adjusted EPOCH-R in double-hit lymphoma, with improved complete response rates and overall survival compared to standard R-CHOP therapy 3, 2.
- The use of dose-adjusted EPOCH-R has been shown to be safe and well-tolerated in outpatient settings, with minimal treatment-related toxicity 2.
Monitoring and Follow-up
- After completion of therapy, patients require close monitoring with regular clinical examinations, laboratory tests, and imaging studies to assess for relapse.
- The high risk of CNS involvement necessitates regular monitoring for CNS symptoms and signs, with prompt evaluation and treatment if suspected.