Doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) is the standard of care for patients with early-stage favorable Hodgkin’s lymphoma.
Due to the toxic effects of bleomycin and dacarbazine, however, investigators sought to determine whether the omission of either or both agents from the ABVD regimen would reduce the efficacy of the treatment for Hodgkin’s lymphoma.
Investigators conducted an open-label, randomized, multicenter study, and the primary objective was to show non-inferiority of the reduced-intensity regimens of doxorubicin, bleomycin, and vinblastine (ABV), doxorubicin, vinblastine, dacarbazine (AVD), and doxorubicin and vinblastine (AV) compared with ABVD.
Noninferiority was determined by the freedom from treatment failure (FFTF), which excluded the difference of 6% after 5 years corresponding to a hazard ratio (HR) of 1.72, 95% CI.
There were 1,502 patients enrolled in the study who were randomly assigned to receive either ABVD, ABV, AVD, or AV. Inferiority was detected for the ABV and AV group with the 5 year differences of -11.5% (95% CI -18.3 to -4.7; HR 2.06 [1.21 to 3.52]) and 15.2% (-23.0 to -7.4; HR 2.57 [1.51 to 4.40]), respectively.
The AVD group did not show noninferiority compared with patients receiving ABVD and showed a 5 year difference of -3.9%, -7.7 to -0.1; HR 1.50, 1.00 to 2.26.
The findings indicate that dacarbazine and bleomycin cannot be omitted from ABVD without effecting efficacy, and the treatment for early-stage favorable Hodgkin’s lymphoma should remain ABVD.
The role of bleomycin and dacarbazine in the ABVD regimen (ie, doxorubicin, bleomycin, vinblastine, and dacarbazine) has been questioned, especially for treatment of early-stage favourable Hodgkin’s lymphoma, because of the drugs’ toxicity. Authors aimed to investigate whether omission of either bleomycin or dacarbazine, or both, from ABVD reduced the efficacy of this regimen in treatment of Hodgkin’s lymphoma.