Radiotherapy for Advanced Hodgkin Lymphoma with Initial Bulk: A Combined Analysis of Two Randomized Trials
Advances in Radiation Oncology(2024)
摘要
Purpose
The role of consolidative radiotherapy (RT) in patients with advanced Hodgkin lymphoma (HL) with initial bulk is unclear. GITIL/FIL HD0607 and FIL HD0801, two randomized controlled trials with similar design and methodologies, did not identify a benefit to consolidative RT after a metabolic complete response (CR) to 6 cycles of ABVD. However, their limited sample sizes reduced statistical power to detect a small but clinically meaningful benefit to RT.
Materials and Methods
In a secondary analysis of these two phase 3 trials, reconstructed patient data were used to compare outcomes for early and complete responders randomized to no RT or RT to the site(s) of initial bulk. Estimates of progression-free survival (PFS) in the intent-to-treat (ITT) and per-protocol (PP) analyses were generated using the combined data and compared between groups using the log-rank test.
Results
A total of 412 patients were included in the ITT analysis and 373 patients were included in the PP analysis. Median age was 30-32, 42% of patients were stage IIB, and 73% of bulky sites were located in the mediastinum. For the no RT versus RT groups, 5-year ITT PFS estimates were 90.1% versus 90.1% (p=0.81). Five-year PP PFS rates were 90.9% versus 92.9% (p=0.31), respectively. There was no observed difference between no RT and RT groups in subgroups according to size of bulky disease: 5-7 cm (p=0.78), 7-10 cm (p=0.25), and >10 cm (p=0.69).
Conclusion
In this combined analysis of two randomized phase 3 clinical trials, consolidative RT to initial sites of bulky nodal involvement was not associated with a PFS benefit in patients with advanced HL in metabolic CR after 2 and 6 cycles of ABVD.
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