Trial reportBlood advances2021
Role of radiotherapy to bulky sites of advanced Hodgkin lymphoma treated with ABVD: final results of FIL HD0801 trial.
Trial report in Blood advances, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00784537 (Early Salvage With High Dose Chemotherapy and Stem Cell Transplantation in Advanced Stage Hodgkin's Lymphoma Patients With Positive PET After Two Courses of ABVD), which is not on this map. Cited by 16 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Early Salvage With High Dose Chemotherapy and Stem Cell Transplantation in Advanced Stage Hodgkin's Lymphoma Patients With Positive PET After Two Courses of ABVD (PET-2 Positive) and Comparison of RT Versus no RT in PET-2 Negative Patients
Who cites it
16 citing papers in PubMed, 2 syntheses or guidelines pooled it, 30 citations in OpenAlex.
- Positron emission tomography-adapted therapy for first-line treatment in adults with Hodgkin lymphoma.The Cochrane database of systematic reviews · 2025Pooled it
- Chemotherapy alone versus chemotherapy plus radiotherapy for adults with early-stage Hodgkin's lymphoma.The Cochrane database of systematic reviews · 2024Pooled it
- The predictive and prognostic role of baseline 2-[18F]FDG PET/CT volumetric and dissemination features in classical Hodgkin lymphoma.European journal of nuclear medicine and molecular imaging · 2026Article
- An efficient single-arm Bayesian adaptive trial algorithm to evaluate de-intensified oncologic treatment.Trials · 2025Article
- Definitions and use of tumor bulk in phase 3 lymphoma trials: a comprehensive literature review.Blood advances · 2025Review
- Long-term follow-up of bulky classic Hodgkin lymphoma managed with ABVD and PET-guided RT demonstrates excellent outcomes in PET-negative cases.British journal of haematology · 2025Article
- The Effect of Diagnostic and Therapeutic Changes on the Survival of Hodgkin's Lymphoma Patients (1980-2019).Medicina (Kaunas, Lithuania) · 2024Article
- Treatment Strategies in Advanced-Stage Hodgkin Lymphoma.Cancers · 2024Review
- Radiotherapy for Advanced Hodgkin Lymphoma with Initial Bulk: A Combined Analysis of Two Randomized Trials.Advances in radiation oncology · 2024Article
- Immune checkpoint inhibitors in advanced and relapsed/refractory Hodgkin lymphoma: current applications and future prospects.Frontiers in oncology · 2024Review
- Fluorodeoxyglucose-Positron Emission Tomography in Relapsed/Refractory Hodgkin Lymphoma: A Practical Approach.Chemotherapy · 2024Review
- Estimated impact of ECHELON-1 overall survival on productivity costs in stage III/IV classical Hodgkin lymphoma in the United States.Journal of managed care & specialty pharmacy · 2023Article
- Application of interim PET-CT in first-line treatment decision-making for lymphoma.Journal of Zhejiang University. Science. B · 2023Review
- Incorporating Monoclonal Antibodies into the First-Line Treatment of Classical Hodgkin Lymphoma.International journal of molecular sciences · 2023Review
- Survival rates of adult patients with Hodgkin lymphoma who underwent ABVD versus escalated BEACOPP in a resource-limited country: An observational study.Cancer reports (Hoboken, N.J.) · 2023Observational
- Consolidative mediastinal radiotherapy for advanced-stage classical Hodgkin lymphoma with bulky disease in patients who achieve complete response after chemotherapy in PET-CT era.Reports of practical oncology and radiotherapy : journal of Greatpoland Cancer Center in Poznan and Polish Society of Radiation Oncology · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
29 authors at 20 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The role of consolidation radiotherapy (RT) for bulky lesions is controversial in patients with advanced-stage Hodgkin lymphoma who achieve complete metabolic response (CMR) after doxorubicin, bleomycin, vinblastine, dacarbazine (ABVD)-based chemotherapy. We present the final results of the Fondazione Italiana Linfomi HD0801 trial, which investigated the potential benefit of RT in that setting. In this phase 3 randomized study, patients with a bulky lesion at baseline (a mass with largest diameter ≥5 cm) who have CMR after 2 and 6 ABVD cycles were randomly assigned 1:1 to RT vs observation (OBS) with a primary endpoint of event-free survival (EFS) at 2 years. The sample size was calculated estimating an EFS improvement for RT of 20% (from 60% to 80%). The secondary end point was progression-free survival (PFS). One hundred sixteen patients met the inclusion criteria and were randomly assigned to RT or OBS. Intention-to-treat (ITT) analysis showed a 2-year EFS of 87.8% vs 85.8% for RT vs OBS (hazard ratio [HR], 1.5; 95% confidence interval [CI], 0.6-3.5; P = .34). At 2 years, ITT-PFS was 91.3% vs 85.8% (HR, 1.2; 95% CI, 0.5-3; P = .7). Patients in CMR randomly assigned to OBS had a good outcome, and the primary end point of a 20% benefit in EFS for RT was not met. However, the sample size was underpowered to detect a benefit of 10% or less, keeping open the question of a potential, more limited role of RT in this setting. This trial was registered at www.clinicaltrials.gov as #NCT00784537.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.