End of induction [ 18 F]FDG PET is prognostic for progression-free survival and overall survival in follicular lymphoma patients enrolled in the FOLL12 trial.

Autor: Guerra L; Nuclear Medicine, Fondazione IRCCS San Gerardo Dei Tintori, Monza, Italy. luca.guerra@unimib.it.; University of Milano Bicocca, Milan, Italy. luca.guerra@unimib.it., Chauvie S; Medical Physics, Ospedale Santa Croce E Carle, Cuneo, Italy., Fallanca F; Nuclear Medicine, IRCCS Ospedale San Raffaele, Milan, Italy., Bergesio F; Medical Physics, Ospedale Santa Croce E Carle, Cuneo, Italy., Marcheselli L; Fondazione Italiana Linfomi, Modena, Italy., Durmo R; Nuclear Medicine, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy., Peano S; Nuclear Medicine Azienda Ospedaliera S. Croce E Carle, Cuneo, Italy., Franceschetto A; Nuclear Medicine, Azienda Ospedaliero-Universitaria Di Modena, Modena, Italy., Monaco L; Nuclear Medicine, Fondazione IRCCS San Gerardo Dei Tintori, Monza, Italy., Barbieri E; Clinical and Experimental Medicine PhD Program, University of Modena E Reggio Emilia, Modena, Italy., Ladetto M; Hematology Unit, Azienda Ospedaliera Di Alessandria, Alessandria, Italy., Musuraca G; Hematology and HSC Transplantation, IRCCS Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori, Meldola, Italy., Tosi P; Hematology Unit, AUSL Della Romagna, Rimini, Italy., Bianchi B; Hematology Unit, Ospedale Di Circolo E Fondazione Macchi ASST Sette Laghi, Varese, Italy., Bolis SAM; Hematology Unit, Fondazione IRCCS San Gerardo Dei Tintori, Monza, Italy., Pavone V; Hematology and Bone Marrow Transplantation, Ospedale C. Panico, Tricase, Italy., Chiarenza A; Hematology and Bone Marrow Transplantation, AOU Policlinico S. Marco, Catania, Italy., Arcari A; Hematology Unit, Ospedale Guglielmo da Saliceto, Piacenza, Italy., Califano C; Hematology Unit, Ospedale Andrea Tortora, Pagani, Italy., Bari A; Oncology Unit, Azienda Ospedaliero-Universitaria Policlinico, Modena, University of Modena and Reggio Emilia, Modena, Italy., Massaia M; Hematology Unit, Ospedale Santa Croce E Carle, Cuneo, Italy., Conconi A; Hematology Unit, Ospedale Degli Infermi, Biella, Italy., Musto P; Hematology and Stem Cells Transplantation, IRCCS CROB, Rionero in Vulture, Italy., Mannina D; Hematology Unit, Azienda Ospedaliera Papardo, Messina, Italy., Roti G; Hematology Unit, Azienda Ospedaliero-Universitaria Di Parma, Parma, Italy., Galimberti S; Hematology Unit, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy., Gini G; Hematology Unit, Azienda Ospedaliero-Universitaria Delle Marche, Ancona, Italy., Falcinelli F; Hematology and Bone Marrow Transplantation, Azienda Ospedaliera Di Perugia, Perugia, Italy., Vitolo U; Hematology Unit, Candiolo Cancer Institute, FPO-IRCCS, Candiolo, Italy., Usai SV; Hematology and Bone Marrow Transplantation, Ospedale Brotzu, Cagliari, Italy., Stefani PM; Hematology Unit, General Hospital Ca' Foncello, Treviso, Italy., Ibatici A; Ematologia E Terapie Cellulari, IRCCS Ospedale Policlinico San Martino, Genoa, Italy., Liberati AM; Università Degli Studi Di Perugia, A.O. Terni, Terni, Italy., Pennese E; Hematology Unit, ASL Pescara, Pescara, Italy., Perrone T; Hematology and Stem Cells Transplantation, AOUC Policlinico, Bari, Italy., Versari A; Nuclear Medicine, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy., Luminari S; Hematology Unit, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.; Department Chimomo, Università Di Modena and Reggio Emilia, Modena, Italy.
Jazyk: angličtina
Zdroj: European journal of nuclear medicine and molecular imaging [Eur J Nucl Med Mol Imaging] 2024 Sep; Vol. 51 (11), pp. 3311-3321. Date of Electronic Publication: 2024 May 25.
DOI: 10.1007/s00259-024-06765-z
Abstrakt: Purpose: To evaluate the reliability of the Deauville score (DS) in therapy response assessment and to define the prognostic value of the metabolic response of end of induction (EOI) [ 18 F]FDG PET (PET) in follicular lymphoma patients.
Methods: Adult patients with untreated grade 1-3a FL/ stage II-IV enrolled in the multicentre, prospective, phase III FOLL12 trial (NCT02063685) were randomized to receive standard immunochemotherapy followed by rituximab maintenance (standard arm) versus standard immunochemotherapy followed by response-adapted post-induction management (experimental arm). Baseline and EOI PET were mandatory for the study. All PET scans were centralized on the WIDEN® platform and classified according to DS in a blind independent central review. DS1-3 was considered negative (CMR), whereas DS4-5 was considered positive (not CMR). The primary endpoint was PFS. The main secondary endpoint was overall survival (OS).
Results: Overall, 807 follicular lymphoma patients-52% women, 89% stage III-IV disease, 40% with a high-risk FLIPI-2 score (3-5)-were enrolled in the study; 729 (90.4%) baseline and EOI PET were available for the analysis. EOI PET was positive (DS4-5) in 88/729 (12.1%) cases. Overall inter-reviewer agreement on PET pos/neg result was 0.92, while agreement on positive and negative cases was 0.77 and 0.94, respectively. The median follow-up was 69 months; 247 events were registered in the 5-yr follow-up, with a 5-yr PFS of 67% (95%CI: 63%-70%). The 5-yr PFS rate for PET neg (DS1-3) and PET pos (DS4-5) patients was 71% (95%CI: 67%-75%) and 36% (95%CI: 25%-46%), respectively, with HR 3.49 (95%CI: 2.57-4.72). Five-year PFS was worse as DS increased, with 74% (70%-78%), 58% (48%-67%; HR 1.71; p = 0.001)] and 36% (25%-46%; HR 3.88; p < 0.001) in DS1-2, DS3 and DS4-5, respectively. EOI PET maintained its prognostic value in both the standard and experimental arms. In the whole population, 5-yr OS was 94% (95%CI: 92%-96%), with 96% (95%CI: 94-97) and 82% (95%CI: 72%-89%) in EOI PET negative (DS1-3) and positive (DS4-5), respectively (HR 4.48; p < 0.001). When DS was associated with FLIPI-2, patients with DS3 or DS1-2 with high FLIPI-2 (3-5) experienced worse OS than patients with DS1-2 and low FLIPI-2 (1-2) (p = 0.003).
Conclusion: This study shows that DS is a reliable prognostic tool to evaluate EOI PET in follicular lymphoma patients, with prognostic value maintained both in the standard and experimental arms, making metabolic imaging a robust tool to assess response in FL. Moreover, although preliminary, this study provides further information on DS3 patients, who are considered as CMR but show a less favourable PFS than DS1-2 patients.
(© 2024. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)
Databáze: MEDLINE