In March 2018, Michelle Fanalefrom the University of Texas MD Anderson Cancer Center, Houston, TX, and colleagues, published online in Blood , results from the phase I trial that evaluated the use of brentuximab vedotin (BV) and cyclophosphamide, doxorubicin, and prednisone (CHP), in CD30-expressing peripheral T-cell lymphoma (PTCL) patients.
BV is a CD30-directed antibody that has been successfully used as monotherapy across various PTCL subtypes. It is worth mentioning that, a phase III trial comparing frontline BV + CHP to CHOP for PTCL is ongoing (ECHELON-2; NCT01777152). In this study, the 5-year durability of response, overall survival (OS) and peripheral neuropathy occurrence after BV + CHP was summarized in CD30-expressing PTCL patients, who remained in remission with no additional therapy.
Patient characteristics & study design
- N = 26 treatment-naïve patients with CD30-expressing PTCL
- Patient diagnosis:
- Systemic anaplastic large cell lymphoma (ALCL): n = 19
- CD30 +PTCL: n = 7
- n = 13 patients in remission with no additional therapy
- Dosing (once every 3 weeks):
- BV: 1.8 mg/kg intravenously (two cycles)
- CHP: standard CHOP dose intravenously (six cycles)
- After 6 cycles, patients with objective response (OR) could receive up to 10 cycles of BV monotherapy
- Median BV cycle administration (range): 13 (3–16)
Key findings
- All patients achieved OR (100%; 24 complete responses [CR], 2 partial responses [PR])
- Median observation time (range): 59.6 (4.6–66.0) months (5 years)
- At 5-year follow-up:
- Median OS: not reached
- Estimated 5-year OS: 80% (95% CI, 59–91)
- 50% of the patients were in remission with no additional therapy and all of then achieved CR (n = 13)
- Patients remaining in remission had received a median of 16 treatment cycles, as opposed to a median of 10 cycles for the other patients
- Peripheral neuropathy (PN) occurred in 73% (n = 19) of the total patient population and in 92% (n = 12) of patients in remission
- Median time to any grade PN onset (range): 11 (0–34) weeks
- PN treatment resolution or improvement occurred in 95% of the patients (n =18/19) with a median time of 4.2 and 2.6 months, respectively
- Ongoing PN at last follow-up in 53% of the patients (n = 10)
This long-term evaluation of the BV + CHP regimen in PTCL, demonstrated that of the 100% of the patients responding to the treatment initially, 50% stayed in remission without the use of any other cancer treatment, at 5-year follow-up. Moreover, despite PN occurrence in 73% of the patients, this resolved or improved with PN-targeted treatment in 95% of the cases. The authors concluded that the duration of response and favorable safety profile of BV + CHP, makes this regimen comparable to anthracycline-based therapies combined with consolidative stem cell transplants.