ESTRO 38: Radiotherapy After ABVD May Improve Survival in Advanced Hodgkin Lymphoma
Patients with advanced Hodgkin lymphoma with bulky lesions at the time of diagnosis may benefit from radiotherapy after chemotherapy, according to late-breaking results presented by Ricardi et al at ESTRO 38, the annual congress of the European Society for Radiotherapy & Oncology (ESTRO) (Abstract OC-0502).
Approximately 65% to 70% of patients with advanced-stage Hodgkin lymphoma can be treated with six cycles of ABVD chemotherapy (which includes doxorubicin, bleomycin, vinblastine, and dacarbazine), with or without subsequent radiotherapy. Currently, however, the addition of radiotherapy is controversial.
In a statement before ESTRO 38, study co-author Mario Levis, MD, a radiation oncologist at the University of Turin, Italy, explained, “These patients can often have four or five decades of life expectancy ahead of them but, given this cure rate, the cancer treatment can result in a high risk of complications for many long-term survivors. For this reason, it’s important that we give patients the most effective treatment for curing their cancer, while, at the same time, trying to keep the toxic side effects to a minimum.”
HD0801 Trial
To investigate whether radiotherapy after ABVD chemotherapy provided any benefit to these patients, researchers in several centers in Italy recruited 512 patients between 2008 and 2013 to the randomized phase III Italian Lymphoma Foundation HD0801 clinical trial.
Patients who had achieved a complete metabolic response in the earlier, phase II part of the trial and in whom positron-emission tomography (PET) scans showed no trace of cancer both during and at the end of chemotherapy were randomized to the phase III part of the trial. Patients received either radiotherapy or no further treatment.
In total, 354 patients had a negative PET finding after 6 courses of ABVD. Of these, 116 (32.7%) had bulky lesions (greater than 5 cm in diameter) at the time of their diagnosis, and they were randomly assigned to radiotherapy or no further treatment.
Findings
The intention-to-treat analysis showed a similar progression-free survival (PFS) at 3 and 5 years between the radiotherapy arm (86% and 83.7%, respectively) and no further treatment arm (85.8% at both timepoints). Nine patients enrolled in the radiotherapy arm did not receive consolidative radiation (physician’s decision), with five patients relapsing during follow-up. Therefore, after correction with a per-protocol analysis, consolidation radiotherapy provided a PFS benefit of 10.3% at 3 years (91.7% vs 81.4) and of 7.5% at 5 years (88.9% vs 81.5%) compared to no further treatment, without achieving a statistical significance (P = 0.24) mainly because of the limited sample and number of events (5 vs 13, respectively).
First study author Umberto Ricardi, MD, told the conference, “We found that 3 years later, 92% of patients who received radiotherapy were still alive without disease progression, compared to 82% of patients who did not receive it. After 5 years, these figures were 89% and 82%, respectively. This suggests that patients with large tumors, who have responded to six cycles of ABVD chemotherapy, may still benefit from the addition of radiotherapy, with a survival benefit ranging from 7% to 10% at 3 and 5 years.”
Dr. Ricardi continued, “This is something that should be considered carefully when deciding whether or not to give radiotherapy to these patients. The omission of radiotherapy would guarantee the prevention of radiation-induced toxic side effects, but, on the other hand, it exposes 10% of …frequently young patients to an increased risk of relapse and of even higher toxicity due to the heavy salvage therapies required when the disease returns.”
“The results of this trial do not provide definitive evidence on the role of radiotherapy after chemotherapy for patients with advanced Hodgkin’s lymphoma and large tumors. However, the improvement in survival among those who did receive radiotherapy is not negligible. We think that the next step is for a meta-analysis of this and similar randomized trials in order to increase the robustness of the information we have on the best way to treat this disease,” concluded Dr. Ricardi.
Disclosure: For full disclosures of the study authors, visit estro.org.
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