Table 3.

Prognostic value of EOI PET in prospective clinical trials

StudyPatients, nPET response criteriaPET+ or non-CMR patients n (%)Median follow-up, moPFS PET+ or non-CMR vs PET or CMR (95% CI)OS PET+ or non-CMR vs PET or CMR (95% CI)
PET in PRIMA1  122 Local assessment 32 (26) 42 3.5-y PFS 32.9% (17.2-49.5) vs 70.7% (59.3-79.4); HR, 3.3 (1.9-5.9); P < 0.001 3.5-y OS 78.5% (57.6-89.9) vs 96.5% (89.7-98.9) HR, 7.0 (1.8-27.0); P = 0.0011 
PET in PRIMA (central review)41  — 5 PS with cutoff ≥4 — 42 3.5-y PFS 25.0%, (3.7-55.8) vs 61.4% (45.4-74.1). P = 0.01; HR, 3.1 (1.2-7.8) — 
FOLL057  202 Local assessment 49 (24) 34 3-y PFS 35% (18-52) vs 66% (57-74); HR, 2.59 (1.59-4.24); P < 0.001 Overall 3-y OS 99% (94-100); 3 deaths in both PET-positive and PET-negative groups 
PET Folliculaire3  121 DS ≥ 4 15 (12) 23 2-y PFS 61% vs 86%; P = 0.0046 2-y OS 88% vs 100%; P = 0.0128 
FOLLCOLL, (central review of PRIMA, FOLL05 and PET Folliculaire patients)40  246 DS ≥ 4 41 (17) 55 4-y PFS 23.2% (11.1-37.9) vs 63.4% (55.9-70.0), HR, 3.9 (2.5-5.9); P < 0.0001 4-y OS 87.2% (71.9-94.5) vs 97.1% (93.2-98.8); P < 0.0001 
GALLIUM4  508 Lugano 2014 criteria (incorporating DS ≥4) 58 (25) 43 2.5-y from EOI, 87.3% (83.7-90.2) vs 54.9% (40.5-67.3), HR, 5.0 (3.3-10)* 2.5-y from EOI, 84·0% (95% Cl 72·9-90·8) vs 96·6% (95% CI, 94·4-97·9), HR, 5 (2.0-10.0)*; P < 0.0001 
StudyPatients, nPET response criteriaPET+ or non-CMR patients n (%)Median follow-up, moPFS PET+ or non-CMR vs PET or CMR (95% CI)OS PET+ or non-CMR vs PET or CMR (95% CI)
PET in PRIMA1  122 Local assessment 32 (26) 42 3.5-y PFS 32.9% (17.2-49.5) vs 70.7% (59.3-79.4); HR, 3.3 (1.9-5.9); P < 0.001 3.5-y OS 78.5% (57.6-89.9) vs 96.5% (89.7-98.9) HR, 7.0 (1.8-27.0); P = 0.0011 
PET in PRIMA (central review)41  — 5 PS with cutoff ≥4 — 42 3.5-y PFS 25.0%, (3.7-55.8) vs 61.4% (45.4-74.1). P = 0.01; HR, 3.1 (1.2-7.8) — 
FOLL057  202 Local assessment 49 (24) 34 3-y PFS 35% (18-52) vs 66% (57-74); HR, 2.59 (1.59-4.24); P < 0.001 Overall 3-y OS 99% (94-100); 3 deaths in both PET-positive and PET-negative groups 
PET Folliculaire3  121 DS ≥ 4 15 (12) 23 2-y PFS 61% vs 86%; P = 0.0046 2-y OS 88% vs 100%; P = 0.0128 
FOLLCOLL, (central review of PRIMA, FOLL05 and PET Folliculaire patients)40  246 DS ≥ 4 41 (17) 55 4-y PFS 23.2% (11.1-37.9) vs 63.4% (55.9-70.0), HR, 3.9 (2.5-5.9); P < 0.0001 4-y OS 87.2% (71.9-94.5) vs 97.1% (93.2-98.8); P < 0.0001 
GALLIUM4  508 Lugano 2014 criteria (incorporating DS ≥4) 58 (25) 43 2.5-y from EOI, 87.3% (83.7-90.2) vs 54.9% (40.5-67.3), HR, 5.0 (3.3-10)* 2.5-y from EOI, 84·0% (95% Cl 72·9-90·8) vs 96·6% (95% CI, 94·4-97·9), HR, 5 (2.0-10.0)*; P < 0.0001 
*

The HRs for the GALLIUM study are presented as the reciprocal of the values originally reported (PFS 0.2; 95% CI, 0.1-0.3, and OS 0.2; 95% CI, 0.1-0.5) to align its directionality with that of the other studies.

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