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Less intense chemotherapy may be effective in advanced Hodgkin’s lymphoma
Six cycles of the escalated BEACOPP regimen was linked to several improved outcomes, including OS, compared with eight cycles of the same chemotherapy regimen and eight cycles of BEACOPP14, the “baseline” dose of drugs.
The current study aimed to investigate two reduced-intensity chemotherapy variants among 2,182 patients with newly diagnosed advanced stage Hodgkin’s lymphoma. The parallel group, open-label, multicenter, noninferiority trial included patients aged 18 to 60 years.
Patients were treated with PET-guided radiotherapy after chemotherapy.
Treatment regimens included eight cycles of BEACOPPescalated (8×Besc group), six cycles of BEACOPPescalated (6×Besc group) or eight cycles of BEACOPP14 (8×B14 group).
The 1:1:1 randomization design was executed centrally by stratified minimization.
The primary endpoint was freedom from treatment failure. The researchers used repeated CIs for the HR according to the intention-to-treat principle to calculate the endpoint. The negative predictive value for tumor recurrence of PET at 12 months was calculated as an independent endpoint.
Additional radiotherapy with 30 Gy was administered to patients with a persistent mass after chemotherapy measuring 2.5 cm or larger and positive on PET scan
The final intention-to-treat analysis set included 2,126 patients. There were 705 patients in the 8×Besc group, 711 in the 6×Besc group and 710 in the 8×B14 group.
Patients in the 6×Besc and 8×B14 groups demonstrated sequentially non-inferior results with regard to freedom from treatment failure when compared with those in the 8×Besc group.
Freedom from treatment failure rates at 5 years were 84.4% (97.5% CI, 81-87.7) for the 8×Besc group, 89.3% (86.5-92.1) for 6×Besc group, and 85.4% (82.1-88.7) for the 8×B14 group (97.5% CI for difference between 6×Besc and 8×Besc, 0.5-9.3).
The 8×Besc regimen was linked to an OS of 91.9% vs. 95.3% for the 6×Besc regimen and 94.5% for 8×B14. The 6×Besc regimen was associated with a significantly better OS than the 8×Besc regimen (97.5% CI, 0.2-6.5).
The mortality rate in the 8×Besc arm was 7.5% vs. a 4.6% mortality rate in the 6×Besc arm and 5.2% for 8×B14. The researchers attributed this increased mortality rate to the 2.1% rate of treatment-related events in the 8×Besc arm vs. 0.8% treatment-related event rates in the other two arms.
Secondary malignancies were also higher in the 8×Besc arm than the other two arms, 1.8% vs. 0.7% and 1.1%.
Other results indicated that the negative predictive value for PET at 12 months was 94.1% (95% CI, 92.1-96.1). Additional radiotherapy was administered to 11% of 2,126 patients.
“Six cycles of BEACOPPescalated should be the treatment of choice for advanced stage Hodgkin’s lymphoma,” the researchers wrote. “PET done after chemotherapy can guide the need for additional radiotherapy in this setting.”