Role of radiotherapy to bulky sites of advanced Hodgkin lymphoma treated with ABVD: final results of FIL HD0801 trial.
Umberto RicardiMario LevisAndrea EvangelistaDaniela Maria GioiaGian Mauro SacchettiManuel GottiAlessandro ReMichela BuglioneVincenzo PavoneAntonio NardellaLuca NassiManuela ZanniPaola FranzoneGiovanni Piero FrezzaAlessandro PulsoniLavinia GrapulinArmando SantoroLuigi RigacciGabriele SimontacchiMonica TaniFrancesco ZajaElisabetta AbruzzeseBarbara BottoVittorio Ruggero ZilioliDelia Rota-ScalabriniRoberto FreiloneGiovannino CicconeAndrea Riccardo FilippiPier Luigi Luigi ZinzaniPublished in: Blood advances (2021)
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.
Keyphrases
- hodgkin lymphoma
- free survival
- end stage renal disease
- newly diagnosed
- ejection fraction
- clinical trial
- early stage
- study protocol
- radiation therapy
- locally advanced
- peritoneal dialysis
- phase iii
- squamous cell carcinoma
- phase ii
- radiation induced
- randomized controlled trial
- patient reported outcomes
- minimally invasive
- high resolution
- climate change