Prolonged survival in the absence of disease-recurrence in advanced-stage follicular lymphoma following chemo-immunotherapy: 13-year update of the prospective, multicenter randomized GITMO-IIL trial

• Published in: Haematologica (Roma) Vol. 104; no. 11; pp. 2241 - 2248
• Main Authors: Bruna, Riccardo, Benedetti, Fabio, Boccomini, Carola, Patti, Caterina, Barbui, Anna Maria, Pulsoni, Alessandro, Musso, Maurizio, Liberati, Anna Marina, Gini, Guido, Castellino, Claudia, Rossini, Fausto, Ciceri, Fabio, Rota-Scalabrini, Delia, Stelitano, Caterina, Di Raimondo, Francesco, Tucci, Alessandra, Devizzi, Liliana, Zoli, Valerio, Zallio, Francesco, Narni, Franco, Dondi, Alessandra, Parvis, Guido, Semenzato, Gianpietro, Lanza, Francesco, Perrone, Tommasina, Angrilli, Francesco, Billio, Atto, Gueli, Angela, Mantoan, Barbara, Rambaldi, Alessandro, Gianni, Alessandro Massimo, Corradini, Paolo, Passera, Roberto, Ladetto, Marco, Tarella, Corrado
• Format: Journal Article
• Language: English
• Published: Italy Ferrata Storti Foundation 01.11.2019
• ISSN: 0390-6078; 1592-8721; 1592-8721
• DOI: 10.3324/haematol.2018.209932

A prospective trial conducted in the period 2000-2005 showed no survival advantage for high-dose chemotherapy with rituximab and autograft (R-HDS) conventional chemotherapy with rituximab (CHOP-R) as first-line therapy in 134 high-risk follicular lymphoma patients aged <60 years. The study has been updated at the 13-year median follow up. As of February 2017, 88 (66%) patients were alive, with overall survival of 66.4% at 13 years, without a significant difference between R-HDS (64.5%) and CHOP-R (68.5%). To date, 46 patients have died, mainly because of disease progression (47.8% of all deaths), secondary malignancies (3 solid tumor, 9 myelodysplasia/acute leukemia; 26.1% of all deaths), and other toxicities (21.7% of all deaths). Complete remission was documented in 98 (73.1%) patients and associated with overall survival, with 13-year estimates of 77.0% and 36.8% for complete remission no-complete remission, respectively. Molecular remission was documented in 39 (65%) out of 60 evaluable patients and associated with improved survival. In multivariate analysis, complete remission achievement had the strongest effect on survival ( <0.001), along with younger age ( =0.002) and female sex ( =0.013). Overall, 50 patients (37.3%) survived with no disease recurrence (18 CHOP-R, 32 R-HDS). This follow up is the longest reported on follicular lymphoma treated upfront with rituximab-chemotherapy and demonstrates an unprecedented improvement in survival compared to the pre-rituximab era, regardless of the use of intensified or conventional treatment. Complete remission was the most important factor for prolonged survival and a high proportion of patients had prolonged survival in their first remission, raising the issue of curability in follicular lymphoma. (Registered at clinicaltrials.gov identifier: 00435955).