Contributions
Abstract: S209
Type: Oral Presentation
Session title: Hodgkin lymphoma - Clinical
Background
Patients with newly diagnosed advanced classical Hodgkin lymphoma (cHL) receiving intensive treatment with escalated BEACOPP (bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, prednisone) (eBEACOPP) have excellent outcomes. However, especially late sequelae represent an ongoing concern in connection with the eBEACOPP protocol. Recent eBEACOPP-based approaches therefore aim at reducing treatment toxicity without compromising efficacy. The BrECADD (brentuximab vedotin, etoposide, doxorubicin, cyclophosphamide, dacarbazine, dexamethasone) and BrECAPP (brentuximab vedotin, etoposide, doxorubicin, cyclophosphamide, procarbazine, prednisone) protocols combining an eBEACOPP backbone with the CD30-directed antibody-drug conjugate brentuximab vedotin (BV) were evaluated in a randomized phase II study conducted by the German Hodgkin Study Group (GHSG). Results at a median observation time of 17 months were published previously. High response rates and reduced acute toxicity in comparison with standard eBEACOPP have been reported.
Aims
To investigate efficacy and safety of the BrECADD and BrECAPP protocols after extended follow-up.
Methods
Between October 2012 and May 2014, a total 104 patients (aged 18 to 60) who had the initial diagnosis of advanced cHL were included in the study. Study participants were randomly assigned to receive either BrECADD or BrECAPP. PFS and OS were estimated using the Kaplan-Meier method.
Results
After a median observation time of 34 months (IQR: 28.7-39.5), the 3-year PFS estimates for patients treated with BrECADD and BrECAPP were 89.7% (95%>CI: 81.0%>98.3%) and 90.2% (95%>CI: 80.9%>99.5%), respectively. Overall, 8 patients had primary disease progression or cHL recurrence (BrECADD: 4 patients; BrECAPP: 4 patients). The median time between the end of first-line treatment and disease progression or relapse was 13 months. Second-line treatment consisted of high-dose chemotherapy and autologous stem cell transplantation in all cases. There were 2 deaths of whom 1 was cHL-related. No second primary malignancies occurred. The 3-year OS estimates were 95.4% (95%>CI: 89.2%>100%) for patients who had received BrECADD and 100% for patients who had been treated with BrECAPP.
Conclusion
The present follow-up analysis of a randomized phase II study evaluating the BrECADD and BrECAPP protocols in newly diagnosed advanced cHL confirmed the high efficacy of these regimens. There were no new safety signals. The BrECADD protocol currently challenges standard eBEACOPP in the randomized GHSG phase III HD21 study.
Keyword(s): Chemotherapy, Hodgkin's lymphoma
Abstract: S209
Type: Oral Presentation
Session title: Hodgkin lymphoma - Clinical
Background
Patients with newly diagnosed advanced classical Hodgkin lymphoma (cHL) receiving intensive treatment with escalated BEACOPP (bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, prednisone) (eBEACOPP) have excellent outcomes. However, especially late sequelae represent an ongoing concern in connection with the eBEACOPP protocol. Recent eBEACOPP-based approaches therefore aim at reducing treatment toxicity without compromising efficacy. The BrECADD (brentuximab vedotin, etoposide, doxorubicin, cyclophosphamide, dacarbazine, dexamethasone) and BrECAPP (brentuximab vedotin, etoposide, doxorubicin, cyclophosphamide, procarbazine, prednisone) protocols combining an eBEACOPP backbone with the CD30-directed antibody-drug conjugate brentuximab vedotin (BV) were evaluated in a randomized phase II study conducted by the German Hodgkin Study Group (GHSG). Results at a median observation time of 17 months were published previously. High response rates and reduced acute toxicity in comparison with standard eBEACOPP have been reported.
Aims
To investigate efficacy and safety of the BrECADD and BrECAPP protocols after extended follow-up.
Methods
Between October 2012 and May 2014, a total 104 patients (aged 18 to 60) who had the initial diagnosis of advanced cHL were included in the study. Study participants were randomly assigned to receive either BrECADD or BrECAPP. PFS and OS were estimated using the Kaplan-Meier method.
Results
After a median observation time of 34 months (IQR: 28.7-39.5), the 3-year PFS estimates for patients treated with BrECADD and BrECAPP were 89.7% (95%>CI: 81.0%>98.3%) and 90.2% (95%>CI: 80.9%>99.5%), respectively. Overall, 8 patients had primary disease progression or cHL recurrence (BrECADD: 4 patients; BrECAPP: 4 patients). The median time between the end of first-line treatment and disease progression or relapse was 13 months. Second-line treatment consisted of high-dose chemotherapy and autologous stem cell transplantation in all cases. There were 2 deaths of whom 1 was cHL-related. No second primary malignancies occurred. The 3-year OS estimates were 95.4% (95%>CI: 89.2%>100%) for patients who had received BrECADD and 100% for patients who had been treated with BrECAPP.
Conclusion
The present follow-up analysis of a randomized phase II study evaluating the BrECADD and BrECAPP protocols in newly diagnosed advanced cHL confirmed the high efficacy of these regimens. There were no new safety signals. The BrECADD protocol currently challenges standard eBEACOPP in the randomized GHSG phase III HD21 study.
Keyword(s): Chemotherapy, Hodgkin's lymphoma