No Significant Difference in Outcome for ABVD Plus Radiotherapy vs Stanford V in Stage I or II Bulky Mediastinal Hodgkin Lymphoma
As reported in the Journal of Clinical Oncology by Advani et al, a subset analysis of the phase III North American Intergroup E2496 trial showed no significant difference in failure-free or overall survival between ABVD (doxorubicin, bleomycin, vinblastine, dacarbazine) plus radiotherapy vs the Stanford V regimen (mechlorethamine, doxorubicin, vincristine, bleomycin, vinblastine, etoposide, prednisone) in patients with stage I or II bulky mediastinal Hodgkin lymphoma. The analysis had limited statistical power to detect differences.
Study Details
In the Intergroup trial, 794 patients were randomly assigned to receive six to eight cycles of ABVD every 28 days or Stanford V once a week for 12 weeks. All patients received 36 Gy of modified involved-field radiotherapy to the mediastinum, hila, and supraclavicular regions at 2 to 3 weeks after chemotherapy, and the Stanford V group received involved-field radiotherapy to additional sites ≥ 5 cm at diagnosis.
Outcomes
A total of 264 patients had stage I or II bulky disease, with 135 receiving ABVD and 129 receiving Stanford V. The overall response rate was 83% with ABVD vs 88% with Stanford V. At median follow-up of 6.5 years, the study excluded a difference of > 21% in 5-year failure-free survival and a difference of > 16% in 5-year overall survival between the treatments. Five-year failure-free survival was 85% in the ABVD group vs 79% in the Stanford V group (hazard ratio [HR] = 0.68, 95% confidence interval [CI] = 0.37–1.25, P = .22), and 5-year overall survival was 96% vs 92% (HR = 0.49, 95% CI = 0.16–1.47, P = .19). In-field relapses occurred in < 10% of patients in each group.
The investigators concluded: “For patients with stage I or II bulky mediastinal [Hodgkin lymphoma], no substantial statistically significant differences were detected between the two regimens, although power was limited. To the best of our knowledge, this is the first prospective trial reporting outcomes specific to this subgroup, and it sets a benchmark for comparison of ongoing and future studies.”
Ranjana H. Advani, MD, of Stanford Cancer Institute, is the corresponding author of the Journal of Clinical Oncology article.
The study was supported by grants from the National Cancer Institute. For full disclosures of the study authors, visit jco.ascopubs.org.
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