Radiotherapy for Advanced Hodgkin Lymphoma with Initial Bulk: A Combined Analysis of Two Randomized Trials.

Autor:	Hughes RT; Department of Radiation Oncology, Wake Forest University School of Medicine, Winston Salem, North Carolina., Razavian NB; Department of Radiation Oncology, Wake Forest University School of Medicine, Winston Salem, North Carolina., Shenker RF; Department of Radiation Oncology, Duke University School of Medicine, Durham, North Carolina., Kelsey CR; Department of Radiation Oncology, Duke University School of Medicine, Durham, North Carolina., Smith S; Department of Biostatistics and Data Science, Wake Forest University School of Medicine, Winston Salem, North Carolina., D'Agostino RB Jr; Department of Biostatistics and Data Science, Wake Forest University School of Medicine, Winston Salem, North Carolina., Winkfield KM; Department of Radiation Oncology, Vanderbilt University Medical Center, Nashville, Tennessee.
Jazyk:	angličtina
Zdroj:	Advances in radiation oncology [Adv Radiat Oncol] 2024 Jan 30; Vol. 9 (5), pp. 101450. Date of Electronic Publication: 2024 Jan 30 (Print Publication: 2024).
DOI:	10.1016/j.adro.2024.101450
Abstrakt:	Purpose: The role of consolidative radiation therapy (RT) in patients with advanced Hodgkin lymphoma with initial bulk is unclear. GITIL/FIL HD0607 and FIL HD0801, 2 randomized controlled trials with similar design and methodologies, did not identify a benefit to consolidative RT after a metabolic complete response to 6 cycles of doxorubicin, bleomycin, vinblastine and dacarbazine. However, their limited sample sizes reduced statistical power to detect a small but clinically meaningful benefit to RT. Methods and Materials: In a secondary analysis of these 2 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 to 32 years, 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%, respectively ( P = .81). Five-year PP PFS rates were 90.9% versus 92.9%, respectively ( P = .31). There was no observed difference between no RT and RT groups in subgroups according to size of bulky disease: 5 to 7 cm ( P = .78), 7 to 10 cm ( P = .25), and >10 cm ( P = .69). Conclusions: In this combined analysis of 2 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 Hodgkin lymphoma in metabolic complete response after 2 and 6 cycles of doxorubicin, bleomycin, vinblastine and dacarbazine. Competing Interests: The authors have no conflict of interest to disclose. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. (© 2024 The Author(s).)
Databáze:	MEDLINE
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