A new multi-center study provides compelling evidence for the effectiveness of Brentuximab vedotin (BV)-based therapy in treating systemic anaplastic large cell lymphoma (sALCL) in real-world clinical settings across China. The research, spanning from September 2020 to October 2023, offers crucial insights into treatment outcomes following BV's approval by China's National Medical Products Administration in May 2020.
Treatment Outcomes in Newly Diagnosed Patients
The study included 28 newly diagnosed sALCL patients treated with BV plus CHP (cyclophosphamide, doxorubicin, and prednisone). Results showed:
- 92.9% overall response rate at end of follow-up
- 89.3% complete response rate
- 100% one-year overall survival rate
- 90% one-year progression-free survival rate
These results align closely with or exceed those seen in the pivotal ECHELON-2 clinical trial, demonstrating BV's robust performance in routine clinical practice.
Efficacy in Relapsed/Refractory Cases
Among 10 relapsed/refractory sALCL patients treated with BV combined with various chemotherapy regimens:
- 70% achieved overall response at end of follow-up
- 50% reached complete response
- 90% one-year overall survival rate
- 75% one-year progression-free survival rate
Notably, all patients who achieved complete response maintained their status through the follow-up period, with a median response duration of 23.8 months.
Safety Profile and Tolerability
The treatment demonstrated manageable toxicity consistent with previous clinical trials:
- Peripheral sensory neuropathy was the most common adverse event (56.1%)
- Neutropenia occurred in 31.7% of patients
- No treatment-related deaths were reported
- No patients discontinued treatment due to BV toxicity
Key Clinical Implications
The study revealed several important findings for clinical practice:
- Complete responses achieved with BV-based therapy showed sustained durability
- Patients not achieving complete response after four treatment cycles rarely converted with additional cycles
- ALK-negative patients with relapsed/refractory disease showed potentially worse outcomes
- Elderly patients demonstrated comparable response rates to younger individuals
Treatment Duration and Follow-up
Patients received a median of 6.5 treatment cycles (range 4-8 cycles) with a median follow-up duration of 13.7 months. The study suggests that BV-based therapy could potentially eliminate the need for stem cell transplantation in some patients who achieve complete response, though larger studies are needed to confirm this finding.
The research represents the largest real-world cohort of newly diagnosed sALCL patients treated with BV-CHP combination therapy to date, providing valuable evidence for clinicians managing this challenging malignancy in everyday practice.
