From the Guidelines
The most effective treatment for mantle cell lymphoma (MCL) is a dose-intensified approach, such as R-CHOP plus high-dose Ara-C followed by autologous stem cell transplantation (ASCT), which has been shown to improve progression-free survival (PFS) and overall survival (OS) in fit patients 1.
Key Considerations
- The choice of treatment depends on the patient's age, fitness, and disease characteristics.
- Rituximab in combination with chemotherapy, such as CHOP or bendamustine, is a recommended first-line treatment for MCL 1.
- In younger patients, a dose-intensified approach with ASCT has been shown to improve outcomes 1.
- The role of maintenance therapy, such as rituximab, is still being investigated, but it may improve PFS and OS in some patients 1.
Treatment Regimens
- R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) is a commonly used first-line treatment for MCL.
- R-Hyper-CVAD (rituximab, hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone) is a dose-intensified regimen that has been shown to improve outcomes in fit patients.
- ASCT (autologous stem cell transplantation) is a recommended consolidation therapy for patients who respond to initial treatment.
Monitoring and Side Effects
- Regular monitoring for cardiac arrhythmias, bleeding, and infections is essential during treatment.
- Common side effects of treatment include diarrhea, fatigue, and bruising, with more serious concerns being atrial fibrillation and bleeding risk.
Conclusion Not Allowed, only the above information is provided.
From the FDA Drug Label
The major efficacy outcome was progression-free survival (PFS) as assessed by an Independent Review Committee (IRC) using the Lugano Classification. Efficacy results are presented in Table 12. Table 12. Efficacy Results in Patients with Previously Untreated MCL in ECHO Outcomes per IRC CALQUENCE plus BR N= 299 Placebo plus BR N= 299 Progression-Free Survivala Median (95% CI), months 66.4 (55.1, NE) 49.6 (36.0,64.1) HRb (95% CI) 0.73 (0.57,0.94) P-valuec 0. 016 Overall Response Rate (ORR) (CR + PR) ORR n (%) 272 (91) 263 (88) 95% CI 87,94 84,91 CR n (%) 199 (67) 160 (54) PR n (%) 73 (24) 103 (34) p-value 0. 220
The Enrich mantle cell trial results show that the median progression-free survival (PFS) was 66.4 months for patients treated with CALQUENCE plus bendamustine and rituximab, compared to 49.6 months for patients treated with placebo plus bendamustine and rituximab. The overall response rate (ORR) was 91% for CALQUENCE plus BR and 88% for placebo plus BR. The complete response (CR) rate was 67% for CALQUENCE plus BR and 54% for placebo plus BR 2.
From the Research
Enrich Mantle Cell Trial Results
- The management of patients with newly diagnosed mantle cell lymphoma (MCL) depends on the age and fitness of the patient 3.
- For younger patients, the commonly accepted standard of care is a high-dose cytarabine-based induction chemotherapy followed by autologous stem cell transplantation (ASCT) 3.
- In newly diagnosed patients with MCL ineligible for intensive therapy and ASCT, the standard-of-care has generally been R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone), followed by rituximab maintenance 3.
- Bendamustine-based therapy has been increasingly adopted for older MCL patients, and vincristine has been replaced by bortezomib in the R-CHOP combination as VR-CAP for previously untreated patients 3, 4.
- Novel targeted agents, such as acalabrutinib, offer more promise than traditional chemotherapy or immunochemotherapy for both previously treated and untreated disease, and may improve outcomes for older MCL patients 5.
- The combination of acalabrutinib with bendamustine-rituximab significantly improved progression-free survival in untreated MCL patients, with manageable toxicity 5.
- Bendamustine or high-dose cytarabine-based induction with rituximab has been explored in transplant-eligible MCL patients, with comparable outcomes between the two approaches 6.
- R-CHOP or R-HyperCVAD with or without autologous stem cell transplantation has been evaluated in older patients with MCL, with intensifying therapy associated with prolonged progression-free survival and similar rates of toxicity 7.
Treatment Options
- R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) followed by rituximab maintenance 3
- Bendamustine-based therapy 3, 4
- VR-CAP (bortezomib, rituximab, cyclophosphamide, doxorubicin, and prednisone) 3, 4
- Acalabrutinib with bendamustine-rituximab 5
- R-HyperCVAD (rituximab plus hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone alternating with high-dose methotrexate and cytarabine) with or without ASCT 7