Dose-dense ABVD as first-line therapy in early-stage unfavorable Hodgkin lymphoma: results of a prospective, multicenter double-step phase II study by Fondazione Italiana Linfomi

Armando Santoro, Rita Mazza, Michele Spina, Catello Califano, Giorgina Specchia, Michele Carella, Ugo Consoli, Francesca Palombi, Maurizio Musso, Alessandro Pulsoni, Sofya Kovalchuk, Maurizio Bonfichi, Francesca Ricci, Alberto Fabbri, Anna Marina Liberati, Marcello Rodari, Laura Giordano, Emanuela Chimienti, Monica Balzarotti, Roberto SorasioAndrea Gallamini, Chiara Ghiggi, Patrizia Ciammella, Umberto Ricardi, Stephane Chauvie, Carmelo Carlo-Stella, Francesco Merli

Research output: Contribution to journalArticlepeer-review

Abstract

We investigated the feasibility and activity of an intensified dose-dense ABVD (dd-ABVD) regimen in patients with early-stage unfavorable Hodgkin lymphoma (HL). This prospective, multicenter, phase II study enrolled 96 patients with newly diagnosed, unfavorable stage I or II classical HL. The patients received four cycles of dd-ABVD followed by radiotherapy. Interim PET (PET-2) was mandatory after two courses. Primary endpoints were the evaluation of dd-ABVD feasibility and activity (incidence of PET-2 negativity). The feasibility endpoint was achieved with 48/52 (92.3%) patients receiving > 85% of the programmed dose. The mean dose intensity in the overall patient population (n = 96) was 93.7%, and the median duration of dd-ABVD was 85 days (range, 14–115) versus an expected duration of 84 days. PET-2 was available for 92/96 (95.8%) patients, of whom 79 were PET-2 negative (85.9%). In total, 90 (93.8%) patients showed complete response at the end of treatment. With a follow-up of 80.9 months (3.3–103.2), the median progression-free survival (PFS) and overall survival (OS) were not reached. At 84 months, PFS and OS rates were 88.4% and 95.7%, respectively. No evidence for a difference in PFS or OS was observed for PET-2-negative and PET-2-positive patients. Infections were documented in 8.3% and febrile neutropenia in 6.2% of cases. Four patients died: one had alveolitis at cycle 3, one death was unrelated to treatment, and two died from a secondary cancer. dd-ABVD is feasible and demonstrates activity in early-stage unfavorable HL. The predictive role of PET-2 positivity in early-stage unfavorable HL remains controversial. The study was registered in the EudraCT (reference number, 2011–003,191-36) and the ClinicalTrials.gov (reference number, NCT02247869) databases.

Original languageEnglish
JournalAnnals of Hematology
DOIs
Publication statusAccepted/In press - 2021

Keywords

  • ABVD
  • Dose intensification
  • Early unfavorable stages
  • Feasibility
  • Hodgkin lymphoma

ASJC Scopus subject areas

  • Hematology

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