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Sarah Gillessen and others recently reported the long-term follow-up results of the HD14 trial.
The HD14 trial is a randomized, international, multi-center phase III clinical study conducted by the German Hodgkin’s Lymphoma Research Group (GHSG) to evaluate the early poor prognosis of Hodgkin’s lymphoma (HL) patients receiving standard-intensity chemotherapy and Strengthen the efficacy and safety of chemotherapy.
Research background and purpose: In order to improve the long-term prognosis of HL patients with poor early prognosis, GHSG carried out HD14 trial and compared the standard ABVD regimen (doxorubicin, bleomycin, vinblastine and dacarbazine) with enhancement in 4 cycles.
Chemotherapy regimen (including 2 cycles of escalating BEACOPP [bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine and prednisone] and 2 cycles of ABVD) Efficacy and safety of treatment for HL patients with early poor prognosis.
The final analysis results of the HD14 trial showed that patients who received 2 cycles of dose-escalation BEACOPP and 2 cycles of ABVD (2+2 group) had a significant advantage in avoiding treatment failure compared with patients with 4 cycles of ABVD (ABVD group) (5 The difference between the two at year time was 7.
2% [95% CI: 3.
8-10.
5]).
However, there was no significant difference in overall survival (OS) rates between the two groups.
In order to evaluate the long-term efficacy and toxicity of standard ABVD and 2+2 intensive chemotherapy regimens in patients with early-stage poor prognosis HL, the investigators of the HD14 trial conducted extended follow-up and updated the corresponding data.
Research method HD14 trial is an international, randomized, open-label phase III clinical trial, which included 18-60 years old, Eastern Cooperative Oncology Group (ECOG) physical status score of 0-2, and histopathological diagnosis of HL.
And the clinical stage is the patients with early stage and poor prognostic factors.The patients included in the study were randomly assigned to ABVD group or 2+2 group for corresponding treatment.
Patients in both groups received 30 Gy of Involved Field Radiotherapy (IFRT) after chemotherapy.
The specific drugs and doses of the ABVD regimen are: doxorubicin 25mg/m2, IV (days 1 and 15), bleomycin 10mg/m2, IV (days 1 and 15), vinblastine 6mg/ m2, IV (days 1 and 15) and dacarbazine 375mg/m2, IV (days 1 and 15), every 28 days is a treatment cycle.
The specific drugs and doses of the escalated BEACOPP regimen are: Cyclophosphamide 1250mg/m2, IV (Day 1), Adriamycin 35mg/m2, IV (Day 1), Etoposide 200mg/m2, IV (Day 1) 1-3 days), carbachol 100mg/m2, PO (day 1-7), prednisone 40mg/m2, PO (day 1-14), vincristine 1.
4 mg/m2, IV (day 8 ; Maximum 2mg) and bleomycin 10mg/m2, IV (day 8), every 21 days is a treatment cycle.
After closing the ABVD group according to the pre-set rules, subsequent patients were assigned to receive 2 cycles of increasing dose BEACOPP and 2 cycles of ABVD treatment (non-randomized 2+2 group), which lasted until the pre-set 5-year recruitment period the end.
In this long-term follow-up analysis, the researchers aimed to evaluate the study’s secondary endpoints, progression-free survival (PFS), OS, and long-term toxicity.
In this analysis, the researchers divided all eligible intent-to-treat (ITT) populations into ABVD group, 2+2 group and non-random 2+2 group.
Results of the study: During the HD14 trial from January 28, 2003 to December 29, 2009, a total of 1686 eligible HL patients were randomly divided into ABVD group (847 cases, 50.
2%) and 2+2 group (839 cases) Accounted for 49.
8%).
In addition, 370 patients were recruited into the non-random 2+2 group.
Can be used for analysis of 1550 patients (92%) randomly assigned to the 2+2 group, with a median follow-up time of 112 months; 339 patients (92%) in the non-random 2+2 group, with a median observation time For 74 months.
The results of this long-term follow-up data analysis showed that the 10-year OS rate of patients participating in random assignment was 94.
1% (95% CI: 92.
0-95.
7) and 94.
1% (95% CI: 91.
8-95.
7) in the ABVD group and 2+2 group, respectively ) (P=0.
88); the 10-year PFS rate in ABVD group and 2+2 group was 85.
6% and 91.
2%, respectively (P=0.
0001).
However, the 8-year OS rate of patients in the non-randomized 2+2 group was 95.
1% (95% CI: 91.
6-97.
2), and the 8-year PFS rate was 94.
5% (95% CI: 91.
1-96.
6).
The standardized incidence of second malignancies between the ABVD group and the 2+2 group who participated in the random allocation was similar to 2.
3% vs 2.
5% (p=0.
80).
In the non-randomized 2+2 group, the standardized incidence of second malignancy was 3.
1% (95% CI: 1.
7-5.
0).
Research conclusions The analysis of follow-up data for more than 10 years in the HD14 trial confirms that 2+2 intensive chemotherapy has better tumor focus control ability than standard ABVD treatment in HL patients with early poor prognosis, and has a significant 10-year PFS rate advantage , But there was no significant difference in the 10-year OS rate.
In addition, there was no significant difference in the long-term incidence of second malignant tumors between the two groups.
In general, compared with the standard ABVD regimen, the 2+2 intensive chemotherapy regimen can reduce the recurrence rate of HL patients with poor early prognosis without increasing long-term toxicity.
References: Sarah Gillessen, Annette Plütschow, Michael Fuchs, et al.
Intensified treatment of patients with early stage, unfavourable Hodgkin lymphoma: long-term follow-up of a randomised, international phase 3 trial of the German Hodgkin Study Group (GHSG HD14 ).
Lancet Haematol.
2021 Apr;8(4):e278-e288.
Stamp "read the original text", we make progress together
The HD14 trial is a randomized, international, multi-center phase III clinical study conducted by the German Hodgkin’s Lymphoma Research Group (GHSG) to evaluate the early poor prognosis of Hodgkin’s lymphoma (HL) patients receiving standard-intensity chemotherapy and Strengthen the efficacy and safety of chemotherapy.
Research background and purpose: In order to improve the long-term prognosis of HL patients with poor early prognosis, GHSG carried out HD14 trial and compared the standard ABVD regimen (doxorubicin, bleomycin, vinblastine and dacarbazine) with enhancement in 4 cycles.
Chemotherapy regimen (including 2 cycles of escalating BEACOPP [bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine and prednisone] and 2 cycles of ABVD) Efficacy and safety of treatment for HL patients with early poor prognosis.
The final analysis results of the HD14 trial showed that patients who received 2 cycles of dose-escalation BEACOPP and 2 cycles of ABVD (2+2 group) had a significant advantage in avoiding treatment failure compared with patients with 4 cycles of ABVD (ABVD group) (5 The difference between the two at year time was 7.
2% [95% CI: 3.
8-10.
5]).
However, there was no significant difference in overall survival (OS) rates between the two groups.
In order to evaluate the long-term efficacy and toxicity of standard ABVD and 2+2 intensive chemotherapy regimens in patients with early-stage poor prognosis HL, the investigators of the HD14 trial conducted extended follow-up and updated the corresponding data.
Research method HD14 trial is an international, randomized, open-label phase III clinical trial, which included 18-60 years old, Eastern Cooperative Oncology Group (ECOG) physical status score of 0-2, and histopathological diagnosis of HL.
And the clinical stage is the patients with early stage and poor prognostic factors.The patients included in the study were randomly assigned to ABVD group or 2+2 group for corresponding treatment.
Patients in both groups received 30 Gy of Involved Field Radiotherapy (IFRT) after chemotherapy.
The specific drugs and doses of the ABVD regimen are: doxorubicin 25mg/m2, IV (days 1 and 15), bleomycin 10mg/m2, IV (days 1 and 15), vinblastine 6mg/ m2, IV (days 1 and 15) and dacarbazine 375mg/m2, IV (days 1 and 15), every 28 days is a treatment cycle.
The specific drugs and doses of the escalated BEACOPP regimen are: Cyclophosphamide 1250mg/m2, IV (Day 1), Adriamycin 35mg/m2, IV (Day 1), Etoposide 200mg/m2, IV (Day 1) 1-3 days), carbachol 100mg/m2, PO (day 1-7), prednisone 40mg/m2, PO (day 1-14), vincristine 1.
4 mg/m2, IV (day 8 ; Maximum 2mg) and bleomycin 10mg/m2, IV (day 8), every 21 days is a treatment cycle.
After closing the ABVD group according to the pre-set rules, subsequent patients were assigned to receive 2 cycles of increasing dose BEACOPP and 2 cycles of ABVD treatment (non-randomized 2+2 group), which lasted until the pre-set 5-year recruitment period the end.
In this long-term follow-up analysis, the researchers aimed to evaluate the study’s secondary endpoints, progression-free survival (PFS), OS, and long-term toxicity.
In this analysis, the researchers divided all eligible intent-to-treat (ITT) populations into ABVD group, 2+2 group and non-random 2+2 group.
Results of the study: During the HD14 trial from January 28, 2003 to December 29, 2009, a total of 1686 eligible HL patients were randomly divided into ABVD group (847 cases, 50.
2%) and 2+2 group (839 cases) Accounted for 49.
8%).
In addition, 370 patients were recruited into the non-random 2+2 group.
Can be used for analysis of 1550 patients (92%) randomly assigned to the 2+2 group, with a median follow-up time of 112 months; 339 patients (92%) in the non-random 2+2 group, with a median observation time For 74 months.
The results of this long-term follow-up data analysis showed that the 10-year OS rate of patients participating in random assignment was 94.
1% (95% CI: 92.
0-95.
7) and 94.
1% (95% CI: 91.
8-95.
7) in the ABVD group and 2+2 group, respectively ) (P=0.
88); the 10-year PFS rate in ABVD group and 2+2 group was 85.
6% and 91.
2%, respectively (P=0.
0001).
However, the 8-year OS rate of patients in the non-randomized 2+2 group was 95.
1% (95% CI: 91.
6-97.
2), and the 8-year PFS rate was 94.
5% (95% CI: 91.
1-96.
6).
The standardized incidence of second malignancies between the ABVD group and the 2+2 group who participated in the random allocation was similar to 2.
3% vs 2.
5% (p=0.
80).
In the non-randomized 2+2 group, the standardized incidence of second malignancy was 3.
1% (95% CI: 1.
7-5.
0).
Research conclusions The analysis of follow-up data for more than 10 years in the HD14 trial confirms that 2+2 intensive chemotherapy has better tumor focus control ability than standard ABVD treatment in HL patients with early poor prognosis, and has a significant 10-year PFS rate advantage , But there was no significant difference in the 10-year OS rate.
In addition, there was no significant difference in the long-term incidence of second malignant tumors between the two groups.
In general, compared with the standard ABVD regimen, the 2+2 intensive chemotherapy regimen can reduce the recurrence rate of HL patients with poor early prognosis without increasing long-term toxicity.
References: Sarah Gillessen, Annette Plütschow, Michael Fuchs, et al.
Intensified treatment of patients with early stage, unfavourable Hodgkin lymphoma: long-term follow-up of a randomised, international phase 3 trial of the German Hodgkin Study Group (GHSG HD14 ).
Lancet Haematol.
2021 Apr;8(4):e278-e288.
Stamp "read the original text", we make progress together
