Exclusion of Involved-Node Radiotherapy Among ePET-Negative Vs ePET-Positive Patients With Localized Hodgkin Lymphoma

Long-Term Analysis from a Preplanned 10-Year Follow-Up of the EORTC/LYSA/FIL H10 Trial

According to an analysis of a 10-year follow-up of the EORTC/LYSA/FIL H10 trial, the exclusion of involved-node radiotherapy (INRT) was correlated with lower progression-free survival (PFS) among early positron emission tomography (ePET)-negative patients with localized Hodgkin lymphoma (HL), while the exclusion proposed no significant differences in efficacy or safety among ePET-positive patients. 

The original analysis of the EORTC/LYSA/FIL H10 trial indicated that the exclusion of INRT led to an increased risk of relapse among ePET-negative patients with localized HL. Additionally, it found that altering doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) to bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone (BEACOPPesc) plus INRT significantly improved 5-year PFS among ePET-positive patients. 

In this long-term follow-up, Massimo Federico, MD, University of Modena, and Reggio Emilia, Modena, Italy, and coauthors aimed to analyze the final results of the EORTC/LYSA/FIL H10 trial at 10 years. This follow-up indicated that the 10-year PFS rate was 98.8% among favorable ePET-negative patients who received ABVD plus INRT, versus 85.4% without INRT (HR [hazard ratio], 13.2; 95% confidence interval [CI], 3.1 to 55.8). Likewise, among unfavorable ePET-negative patients, the 10-year PFS rates were 91.4% in the ABVD plus INRT arm versus 86.5% in the ABVD-only arm (HR, 1.5; 95% CI, 0.84 to 2.75). The PFS among ePET-positive patients who received standard ABVD versus intensified BEACOPPesc was not significantly different. (HR, 0.67; 95% CI, 0.37 to 1.20.) 

Among ePET-negative patients, the cumulative incidence rate of late adverse events was comparable between the ABVD plus INRT arm and the ABVD-only arm. Among ePET-positive patients, the incidence rate of late adverse events was 30.7% in the ABVD plus INRT arms compared with 33.9% in the BEACOPPesc plus INRT arms. 

Federico and study authors concluded, “The present long-term analysis confirms that in ePET-negative patients, the omission of INRT is associated with lower 10-year PFS.”

“Instead, in ePET-positive patients, no significant difference between standard and experimental arms emerged although intensification with BEACOPPesc was safe, with no increase in late adverse events, namely, second malignancies,” they added. 

Source: 

Federico M, Fortpied C, Stepanishyna Y, et al. Long-term follow-up of the response-adapted intergroup EORTC/LYSA/FIL H10 trial for localized Hodgkin lymphoma. J Clin Oncol. Published online: November 15, 2023. doi: 10.1200/JCO.23.01745