This randomised study aimed to determine whether using more intensive chemotherapy improved long term tumour control in people with early unfavorable Hodgkin’s lymphoma (HL). Patients were recruited and treated in 407 hospitals and practices in Germany, Switzerland, the Netherlands, the Czech Republic, and Austria. Patients were randomised (1:1 ratio) to either four cycles of ABVD (standard arm A; adriamycin, bleomycin, vinblastine, and dacarbazine) with two cycles BEACOPPesc (intensified arm B; bleomycin, etoposide, adriamycin, cyclophosphamide, vincristine, procarbazine, and prednisone;) followed by two cycles of ABVD (2 + 2 regimen). Standard 30 Gy involved-field radiotherapy (IFRT) was administered as consolidation therapy in both arms.

The primary endpoint measure considered in the study was freedom from treatment failure (FFTF); secondary end points included progression free survival (PFS) and treatment-related toxicity. For the analysis of the results, the full analysis set (FAS) comprised 1,623 patients; 818 were randomly assigned to arm A and 805 to arm B. Seven patients who withdrew from the trial before starting chemotherapy and 88 patients with major inclusion or exclusion criteria violations were excluded from the primary analysis set of qualified patients (QAS), which was the main analysis set for the arm comparison and comprised 1,528 patients (765 in arm A; 763 in arm B).
The results found (direct from source)

• With a total of 1,528 qualified patients included, the 2 +2 regimen demonstrated superior FFTF compared with four cycles of ABVD (P <0.001; hazard ratio, 0.44; 95% CI, 0.30 to 0.66). Five-year FFTF rates of 87.7% (95% CI, 84.8% to 90.6%) and 94.8% (95% CI, 93.1% to 96.6%) in arms A and B, respectively, resulted in a difference of 7.2% (95% CI, 3.8% to 10.5%).

• The difference in 5-year PFS was 6.2% (95% CI, 3.0% to 9.5%).

• Overall survival (OS) was 97.0% at 5 years (95% CI, 95.9% to 98.1%) and did not differ between treatment arms (P=0.7308).

• There was more acute toxicity associated with 2 + 2 than with ABVD, but there were no overall differences in treatment-related mortality or secondary malignancies.

The authors conclude, “Intensified chemotherapy with two cycles of BEACOPP escalated followed by two cycles of ABVD followed by IFRT significantly improves tumour control in patients with early unfavourable HL.”