Response-Adapted Postinduction Strategy in Patients With Advanced-Stage Follicular Lymphoma: The FOLL12 Study.
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Luminari Stefano, Manni Martina, Galimberti Sara, Versari Annibale, Tucci Alessandra, Boccomini Carola, Farina Lucia, Olivieri Jacopo, Marcheselli Luigi, Guerra Luca, Ferrero Simone, Arcaini Luca, Cavallo Federica, Kovalchuk Sofya, Skrypets Tetiana, Del Giudice Ilaria, Chauvie Stephane, Patti Caterina, Stelitano Caterina, Ricci Francesca, Pinto Antonello, Margiotta Casaluci Gloria, Zilioli Vittorio R, Merli Anna, Ladetto Marco, Bolis Silvia, Pavone Vincenzo, Chiarenza Annalisa, Arcari Annalisa, Anastasia Antonella, Dondi Alessandra, Mannina Donato, Federico Massimo, Fondazione Italiana Linfomi
Аннотация
METHODS: We randomly assigned treatment-naïve, advanced-stage, high-tumor burden follicular lymphoma patients to receive standard RM or a response-adapted postinduction approach on the basis of metabolic response and molecular assessment of minimal residual disease (MRD). The experimental arm used three types of postinduction therapies: for complete metabolic response (CMR) and MRD-negative patients, observation; for CMR and MRD-positive (end of induction or follow-up) patients, four doses of rituximab (one per week, maximum three courses) until MRD-negative; and for non-CMR patients, one dose of ibritumomab tiuxetan followed by standard RM. The study was designed as noninferiority trial with progression-free survival (PFS) as the primary end point.
RESULTS: Overall, 807 patients were randomly assigned. After a median follow-up of 53 months (range, 1-92 months), patients in the standard arm had a significantly better PFS than those in the experimental arm (3-year PFS 86% v 72%; P < .001). The better PFS of the standard versus experimental arm was confirmed in all the study subgroups except non-CMR patients (n = 65; P = .274). The 3-year overall survival was 98% (95% CI, 96 to 99) and 97% (95% CI, 95 to 99) in the reference and experimental arms, respectively (P = .238).
CONCLUSION: A metabolic and molecular response-adapted therapy as assessed in the FOLL12 study was associated with significantly inferior PFS compared with 2-year RM. The better efficacy of standard RM was confirmed in the subgroup analysis and particularly for patients achieving both CMR and MRD-negative.