A clinical trial has shown that two strategies for treating advanced Hodgkin lymphoma are nearly equal in their long-term effectiveness, but one is associated with more severe side effects, including a greater risk of treatment-related deaths, infertility, and second cancers. The findings appeared in the July 21 New England Journal of Medicine.
In the study, researchers in Italy compared outcomes in patients randomly assigned to receive one of two multidrug chemotherapy regimens, known as BEACOPP and ABVD, as well as additional therapy for patients in either group who needed it. (Patients who had residual disease after initial therapy or who had a complete response and then relapsed were treated with high-dose salvage chemotherapy with autologous hematopoietic stem-cell transplantation.)
Dr. Alessandro Gianni of the Milan Cancer Institute and his colleagues found that the 7-year rate of freedom from first progression was 85 percent with BEACOPP versus 73 percent with ABVD. However, the 7-year survival rate for patients in the BEACOPP group was 89 percent, compared with 84 percent for the ABVD group. The difference was not statistically significant. Thus, after salvage therapy, the overall survival outcomes in the two groups were similar, and the ABVD regimen had a clear advantage in terms of side effects.
In the absence of a survival benefit, “patients should be informed of the trade-off involved in choosing between two initial therapies,” the study authors wrote. They noted that the BEACOPP therapy exposes patients who would have been cured by ABVD (i.e., the majority of patients) to an unnecessarily high risk of severe toxic effects, whereas the use of ABVD means that a small proportion (one of eight in this study) of patients will need high-dose salvage treatment, with its associated severe toxic side effects.
Three-quarters of the patients in the ABVD group who responded to treatment were spared infertility, the risk of leukemia, and other toxic effects of the more intense BEACOPP treatment, noted Dr. Joseph Connors, clinical director of the Center for Lymphoid Cancer at the British Columbia Cancer Agency and author of an accompanying editorial. Many patients with this disease are young adults who will have to live with the toxic side effects of their treatments for the rest of their lives.
“This study shows that you cure just as many people with either strategy,” said Dr. Connors. The findings reaffirm what many clinicians are doing, which is to use ABVD as the primary regimen, he noted.
Nonetheless, Dr. Connors continued, deciding which regimen to use has been an open question for the field, and the new study “clarifies the issue substantially.” The ABVD regimen has been used for several decades, and German researchers developed the more intensive BEACOPP regimen during the 1990s.
The new findings also establish an important principle, Dr. Connors added. “For diseases like this one that can often be cured, the proper way to compare outcomes of treatments is to look at overall management strategy as opposed to simply looking at the outcome of the primary therapy,” he said. “You need to look at the whole package.”
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