End of induction [18F]FDG PET is prognostic for progression-free survival and overall survival in follicular lymphoma patients enrolled in the FOLL12 trial
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) [18F]FDG PET (PET) in follicular lymphoma patients. Methods Adult patients with untreated grade 1–3a FL/ stage II‐IV e...
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© The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature 2024. Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law. |
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Enthalten in: European journal of nuclear medicine and molecular imaging - Springer Berlin Heidelberg, 2002, 51(2024), 11 vom: 25. Mai, Seite 3311-3321 |
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volume:51 ; year:2024 ; number:11 ; day:25 ; month:05 ; pages:3311-3321 |
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10.1007/s00259-024-06765-z |
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| 245 | 1 | 0 | |a End of induction [18F]FDG PET is prognostic for progression-free survival and overall survival in follicular lymphoma patients enrolled in the FOLL12 trial |
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| 520 | |a 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) [18F]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. | ||
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| 650 | 4 | |a Therapy response |7 (dpeaa)DE-He213 | |
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| 650 | 4 | |a F]FDG PET/CT |7 (dpeaa)DE-He213 | |
| 650 | 4 | |a Prognosis |7 (dpeaa)DE-He213 | |
| 650 | 4 | |a FOLL12 trial |7 (dpeaa)DE-He213 | |
| 700 | 1 | |a Chauvie, Stephane |e verfasserin |4 aut | |
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10.1007/s00259-024-06765-z doi (DE-627)SPR057177813 (SPR)s00259-024-06765-z-e DE-627 ger DE-627 rakwb eng 610 VZ 44.64 bkl Guerra, Luca verfasserin (orcid)0000-0003-4197-2060 aut End of induction [18F]FDG PET is prognostic for progression-free survival and overall survival in follicular lymphoma patients enrolled in the FOLL12 trial 2024 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature 2024. Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law. 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) [18F]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. Follicular lymphoma (dpeaa)DE-He213 Therapy response (dpeaa)DE-He213 [ (dpeaa)DE-He213 F]FDG PET/CT (dpeaa)DE-He213 Prognosis (dpeaa)DE-He213 FOLL12 trial (dpeaa)DE-He213 Chauvie, Stephane verfasserin aut Fallanca, Federico verfasserin aut Bergesio, Fabrizio verfasserin aut Marcheselli, Luigi verfasserin aut Durmo, Rexhep verfasserin aut Peano, Simona verfasserin aut Franceschetto, Antonella verfasserin aut Monaco, Lavinia verfasserin aut Barbieri, Emiliano verfasserin aut Ladetto, Marco verfasserin aut Musuraca, Gerardo verfasserin aut Tosi, Patrizia verfasserin aut Bianchi, Benedetta verfasserin aut Bolis, Silvia Anna Maria verfasserin aut Pavone, Vincenzo verfasserin aut Chiarenza, Annalisa verfasserin aut Arcari, Annalisa verfasserin aut Califano, Catello verfasserin aut Bari, Alessia verfasserin aut Massaia, Massimo verfasserin aut Conconi, Annarita verfasserin aut Musto, Pellegrino verfasserin aut Mannina, Donato verfasserin aut Roti, Giovanni verfasserin aut Galimberti, Sara verfasserin aut Gini, Guido verfasserin aut Falcinelli, Flavio verfasserin aut Vitolo, Umberto verfasserin aut Usai, Sara Veronica verfasserin aut Stefani, Piero Maria verfasserin aut Ibatici, Adalberto verfasserin aut Liberati, Anna Marina verfasserin aut Pennese, Elsa verfasserin aut Perrone, Tommasina verfasserin aut Versari, Annibale verfasserin aut Luminari, Stefano verfasserin aut Enthalten in European journal of nuclear medicine and molecular imaging Springer Berlin Heidelberg, 2002 51(2024), 11 vom: 25. Mai, Seite 3311-3321 (DE-627)359787258 (DE-600)2098375-X 1619-7089 nnns volume:51 year:2024 number:11 day:25 month:05 pages:3311-3321 https://dx.doi.org/10.1007/s00259-024-06765-z X:SPRINGER Resolving-System lizenzpflichtig Volltext SYSFLAG_0 GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_152 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4328 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 44.64 VZ AR 51 2024 11 25 05 3311-3321 |
| spelling |
10.1007/s00259-024-06765-z doi (DE-627)SPR057177813 (SPR)s00259-024-06765-z-e DE-627 ger DE-627 rakwb eng 610 VZ 44.64 bkl Guerra, Luca verfasserin (orcid)0000-0003-4197-2060 aut End of induction [18F]FDG PET is prognostic for progression-free survival and overall survival in follicular lymphoma patients enrolled in the FOLL12 trial 2024 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature 2024. Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law. 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) [18F]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. Follicular lymphoma (dpeaa)DE-He213 Therapy response (dpeaa)DE-He213 [ (dpeaa)DE-He213 F]FDG PET/CT (dpeaa)DE-He213 Prognosis (dpeaa)DE-He213 FOLL12 trial (dpeaa)DE-He213 Chauvie, Stephane verfasserin aut Fallanca, Federico verfasserin aut Bergesio, Fabrizio verfasserin aut Marcheselli, Luigi verfasserin aut Durmo, Rexhep verfasserin aut Peano, Simona verfasserin aut Franceschetto, Antonella verfasserin aut Monaco, Lavinia verfasserin aut Barbieri, Emiliano verfasserin aut Ladetto, Marco verfasserin aut Musuraca, Gerardo verfasserin aut Tosi, Patrizia verfasserin aut Bianchi, Benedetta verfasserin aut Bolis, Silvia Anna Maria verfasserin aut Pavone, Vincenzo verfasserin aut Chiarenza, Annalisa verfasserin aut Arcari, Annalisa verfasserin aut Califano, Catello verfasserin aut Bari, Alessia verfasserin aut Massaia, Massimo verfasserin aut Conconi, Annarita verfasserin aut Musto, Pellegrino verfasserin aut Mannina, Donato verfasserin aut Roti, Giovanni verfasserin aut Galimberti, Sara verfasserin aut Gini, Guido verfasserin aut Falcinelli, Flavio verfasserin aut Vitolo, Umberto verfasserin aut Usai, Sara Veronica verfasserin aut Stefani, Piero Maria verfasserin aut Ibatici, Adalberto verfasserin aut Liberati, Anna Marina verfasserin aut Pennese, Elsa verfasserin aut Perrone, Tommasina verfasserin aut Versari, Annibale verfasserin aut Luminari, Stefano verfasserin aut Enthalten in European journal of nuclear medicine and molecular imaging Springer Berlin Heidelberg, 2002 51(2024), 11 vom: 25. Mai, Seite 3311-3321 (DE-627)359787258 (DE-600)2098375-X 1619-7089 nnns volume:51 year:2024 number:11 day:25 month:05 pages:3311-3321 https://dx.doi.org/10.1007/s00259-024-06765-z X:SPRINGER Resolving-System lizenzpflichtig Volltext SYSFLAG_0 GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_152 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4328 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 44.64 VZ AR 51 2024 11 25 05 3311-3321 |
| allfields_unstemmed |
10.1007/s00259-024-06765-z doi (DE-627)SPR057177813 (SPR)s00259-024-06765-z-e DE-627 ger DE-627 rakwb eng 610 VZ 44.64 bkl Guerra, Luca verfasserin (orcid)0000-0003-4197-2060 aut End of induction [18F]FDG PET is prognostic for progression-free survival and overall survival in follicular lymphoma patients enrolled in the FOLL12 trial 2024 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature 2024. Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law. 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) [18F]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. Follicular lymphoma (dpeaa)DE-He213 Therapy response (dpeaa)DE-He213 [ (dpeaa)DE-He213 F]FDG PET/CT (dpeaa)DE-He213 Prognosis (dpeaa)DE-He213 FOLL12 trial (dpeaa)DE-He213 Chauvie, Stephane verfasserin aut Fallanca, Federico verfasserin aut Bergesio, Fabrizio verfasserin aut Marcheselli, Luigi verfasserin aut Durmo, Rexhep verfasserin aut Peano, Simona verfasserin aut Franceschetto, Antonella verfasserin aut Monaco, Lavinia verfasserin aut Barbieri, Emiliano verfasserin aut Ladetto, Marco verfasserin aut Musuraca, Gerardo verfasserin aut Tosi, Patrizia verfasserin aut Bianchi, Benedetta verfasserin aut Bolis, Silvia Anna Maria verfasserin aut Pavone, Vincenzo verfasserin aut Chiarenza, Annalisa verfasserin aut Arcari, Annalisa verfasserin aut Califano, Catello verfasserin aut Bari, Alessia verfasserin aut Massaia, Massimo verfasserin aut Conconi, Annarita verfasserin aut Musto, Pellegrino verfasserin aut Mannina, Donato verfasserin aut Roti, Giovanni verfasserin aut Galimberti, Sara verfasserin aut Gini, Guido verfasserin aut Falcinelli, Flavio verfasserin aut Vitolo, Umberto verfasserin aut Usai, Sara Veronica verfasserin aut Stefani, Piero Maria verfasserin aut Ibatici, Adalberto verfasserin aut Liberati, Anna Marina verfasserin aut Pennese, Elsa verfasserin aut Perrone, Tommasina verfasserin aut Versari, Annibale verfasserin aut Luminari, Stefano verfasserin aut Enthalten in European journal of nuclear medicine and molecular imaging Springer Berlin Heidelberg, 2002 51(2024), 11 vom: 25. Mai, Seite 3311-3321 (DE-627)359787258 (DE-600)2098375-X 1619-7089 nnns volume:51 year:2024 number:11 day:25 month:05 pages:3311-3321 https://dx.doi.org/10.1007/s00259-024-06765-z X:SPRINGER Resolving-System lizenzpflichtig Volltext SYSFLAG_0 GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_152 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4328 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 44.64 VZ AR 51 2024 11 25 05 3311-3321 |
| allfieldsGer |
10.1007/s00259-024-06765-z doi (DE-627)SPR057177813 (SPR)s00259-024-06765-z-e DE-627 ger DE-627 rakwb eng 610 VZ 44.64 bkl Guerra, Luca verfasserin (orcid)0000-0003-4197-2060 aut End of induction [18F]FDG PET is prognostic for progression-free survival and overall survival in follicular lymphoma patients enrolled in the FOLL12 trial 2024 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature 2024. Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law. 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) [18F]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. Follicular lymphoma (dpeaa)DE-He213 Therapy response (dpeaa)DE-He213 [ (dpeaa)DE-He213 F]FDG PET/CT (dpeaa)DE-He213 Prognosis (dpeaa)DE-He213 FOLL12 trial (dpeaa)DE-He213 Chauvie, Stephane verfasserin aut Fallanca, Federico verfasserin aut Bergesio, Fabrizio verfasserin aut Marcheselli, Luigi verfasserin aut Durmo, Rexhep verfasserin aut Peano, Simona verfasserin aut Franceschetto, Antonella verfasserin aut Monaco, Lavinia verfasserin aut Barbieri, Emiliano verfasserin aut Ladetto, Marco verfasserin aut Musuraca, Gerardo verfasserin aut Tosi, Patrizia verfasserin aut Bianchi, Benedetta verfasserin aut Bolis, Silvia Anna Maria verfasserin aut Pavone, Vincenzo verfasserin aut Chiarenza, Annalisa verfasserin aut Arcari, Annalisa verfasserin aut Califano, Catello verfasserin aut Bari, Alessia verfasserin aut Massaia, Massimo verfasserin aut Conconi, Annarita verfasserin aut Musto, Pellegrino verfasserin aut Mannina, Donato verfasserin aut Roti, Giovanni verfasserin aut Galimberti, Sara verfasserin aut Gini, Guido verfasserin aut Falcinelli, Flavio verfasserin aut Vitolo, Umberto verfasserin aut Usai, Sara Veronica verfasserin aut Stefani, Piero Maria verfasserin aut Ibatici, Adalberto verfasserin aut Liberati, Anna Marina verfasserin aut Pennese, Elsa verfasserin aut Perrone, Tommasina verfasserin aut Versari, Annibale verfasserin aut Luminari, Stefano verfasserin aut Enthalten in European journal of nuclear medicine and molecular imaging Springer Berlin Heidelberg, 2002 51(2024), 11 vom: 25. Mai, Seite 3311-3321 (DE-627)359787258 (DE-600)2098375-X 1619-7089 nnns volume:51 year:2024 number:11 day:25 month:05 pages:3311-3321 https://dx.doi.org/10.1007/s00259-024-06765-z X:SPRINGER Resolving-System lizenzpflichtig Volltext SYSFLAG_0 GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_152 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4328 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 44.64 VZ AR 51 2024 11 25 05 3311-3321 |
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10.1007/s00259-024-06765-z doi (DE-627)SPR057177813 (SPR)s00259-024-06765-z-e DE-627 ger DE-627 rakwb eng 610 VZ 44.64 bkl Guerra, Luca verfasserin (orcid)0000-0003-4197-2060 aut End of induction [18F]FDG PET is prognostic for progression-free survival and overall survival in follicular lymphoma patients enrolled in the FOLL12 trial 2024 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature 2024. Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law. 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) [18F]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. Follicular lymphoma (dpeaa)DE-He213 Therapy response (dpeaa)DE-He213 [ (dpeaa)DE-He213 F]FDG PET/CT (dpeaa)DE-He213 Prognosis (dpeaa)DE-He213 FOLL12 trial (dpeaa)DE-He213 Chauvie, Stephane verfasserin aut Fallanca, Federico verfasserin aut Bergesio, Fabrizio verfasserin aut Marcheselli, Luigi verfasserin aut Durmo, Rexhep verfasserin aut Peano, Simona verfasserin aut Franceschetto, Antonella verfasserin aut Monaco, Lavinia verfasserin aut Barbieri, Emiliano verfasserin aut Ladetto, Marco verfasserin aut Musuraca, Gerardo verfasserin aut Tosi, Patrizia verfasserin aut Bianchi, Benedetta verfasserin aut Bolis, Silvia Anna Maria verfasserin aut Pavone, Vincenzo verfasserin aut Chiarenza, Annalisa verfasserin aut Arcari, Annalisa verfasserin aut Califano, Catello verfasserin aut Bari, Alessia verfasserin aut Massaia, Massimo verfasserin aut Conconi, Annarita verfasserin aut Musto, Pellegrino verfasserin aut Mannina, Donato verfasserin aut Roti, Giovanni verfasserin aut Galimberti, Sara verfasserin aut Gini, Guido verfasserin aut Falcinelli, Flavio verfasserin aut Vitolo, Umberto verfasserin aut Usai, Sara Veronica verfasserin aut Stefani, Piero Maria verfasserin aut Ibatici, Adalberto verfasserin aut Liberati, Anna Marina verfasserin aut Pennese, Elsa verfasserin aut Perrone, Tommasina verfasserin aut Versari, Annibale verfasserin aut Luminari, Stefano verfasserin aut Enthalten in European journal of nuclear medicine and molecular imaging Springer Berlin Heidelberg, 2002 51(2024), 11 vom: 25. Mai, Seite 3311-3321 (DE-627)359787258 (DE-600)2098375-X 1619-7089 nnns volume:51 year:2024 number:11 day:25 month:05 pages:3311-3321 https://dx.doi.org/10.1007/s00259-024-06765-z X:SPRINGER Resolving-System lizenzpflichtig Volltext SYSFLAG_0 GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_152 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4328 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 44.64 VZ AR 51 2024 11 25 05 3311-3321 |
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Guerra, Luca @@aut@@ Chauvie, Stephane @@aut@@ Fallanca, Federico @@aut@@ Bergesio, Fabrizio @@aut@@ Marcheselli, Luigi @@aut@@ Durmo, Rexhep @@aut@@ Peano, Simona @@aut@@ Franceschetto, Antonella @@aut@@ Monaco, Lavinia @@aut@@ Barbieri, Emiliano @@aut@@ Ladetto, Marco @@aut@@ Musuraca, Gerardo @@aut@@ Tosi, Patrizia @@aut@@ Bianchi, Benedetta @@aut@@ Bolis, Silvia Anna Maria @@aut@@ Pavone, Vincenzo @@aut@@ Chiarenza, Annalisa @@aut@@ Arcari, Annalisa @@aut@@ Califano, Catello @@aut@@ Bari, Alessia @@aut@@ Massaia, Massimo @@aut@@ Conconi, Annarita @@aut@@ Musto, Pellegrino @@aut@@ Mannina, Donato @@aut@@ Roti, Giovanni @@aut@@ Galimberti, Sara @@aut@@ Gini, Guido @@aut@@ Falcinelli, Flavio @@aut@@ Vitolo, Umberto @@aut@@ Usai, Sara Veronica @@aut@@ Stefani, Piero Maria @@aut@@ Ibatici, Adalberto @@aut@@ Liberati, Anna Marina @@aut@@ Pennese, Elsa @@aut@@ Perrone, Tommasina @@aut@@ Versari, Annibale @@aut@@ Luminari, Stefano @@aut@@ |
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Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law.</subfield></datafield><datafield tag="520" ind1=" " ind2=" "><subfield code="a">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) [18F]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. 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|
| author |
Guerra, Luca |
| spellingShingle |
Guerra, Luca ddc 610 bkl 44.64 misc Follicular lymphoma misc Therapy response misc [ misc F]FDG PET/CT misc Prognosis misc FOLL12 trial End of induction [18F]FDG PET is prognostic for progression-free survival and overall survival in follicular lymphoma patients enrolled in the FOLL12 trial |
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Guerra, Luca |
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Guerra, Luca Chauvie, Stephane Fallanca, Federico Bergesio, Fabrizio Marcheselli, Luigi Durmo, Rexhep Peano, Simona Franceschetto, Antonella Monaco, Lavinia Barbieri, Emiliano Ladetto, Marco Musuraca, Gerardo Tosi, Patrizia Bianchi, Benedetta Bolis, Silvia Anna Maria Pavone, Vincenzo Chiarenza, Annalisa Arcari, Annalisa Califano, Catello Bari, Alessia Massaia, Massimo Conconi, Annarita Musto, Pellegrino Mannina, Donato Roti, Giovanni Galimberti, Sara Gini, Guido Falcinelli, Flavio Vitolo, Umberto Usai, Sara Veronica Stefani, Piero Maria Ibatici, Adalberto Liberati, Anna Marina Pennese, Elsa Perrone, Tommasina Versari, Annibale Luminari, Stefano |
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end of induction [18f]fdg pet is prognostic for progression-free survival and overall survival in follicular lymphoma patients enrolled in the foll12 trial |
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End of induction [18F]FDG PET is prognostic for progression-free survival and overall survival in follicular lymphoma patients enrolled in the FOLL12 trial |
| abstract |
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) [18F]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. © The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature 2024. Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law. |
| abstractGer |
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) [18F]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. © The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature 2024. Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law. |
| abstract_unstemmed |
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) [18F]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. © The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature 2024. Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law. |
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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). 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