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基于 GAINED 临床试验验证 ΔSUV 在弥漫性大 B 细胞淋巴瘤中用于中期 PET 解读的有效性。

Validation of the ΔSUV for Interim PET Interpretation in Diffuse Large B-Cell Lymphoma on the Basis of the GAINED Clinical Trial.

机构信息

Nuclear Medicine, CHU Henri Mondor, Paris-Est University, Créteil, France;

Nuclear Medicine, CHU Henri Mondor, Paris-Est University, Créteil, France.

出版信息

J Nucl Med. 2023 Nov;64(11):1706-1711. doi: 10.2967/jnumed.123.265871. Epub 2023 Sep 21.

DOI:10.2967/jnumed.123.265871
PMID:37734837
Abstract

The GAINED phase 3 trial (ClinicalTrials.gov identifier: NCT01659099) evaluated a PET-driven consolidative strategy in patients with diffuse large B-cell lymphoma. In this post hoc analysis, we aimed to compare the prognostic value of the per-protocol PET interpretation criteria (Menton 2011 consensus) with the change in the SUV (ΔSUV) alone. Real-time central review of F-FDG PET/CT was performed in 581 patients after 2 cycles (PET2) and 4 cycles (PET4) of immunochemotherapy using the Menton 2011 criteria, combining the ΔSUV (cutoffs of 66% and 70% at PET2 and PET4, respectively) and the Deauville scale. In "special cases," when the baseline SUV was less than 10.0 or the interim residual tumor SUV was greater than 5.0, the Menton 2011 experts' consensus agreed that the ΔSUV may not be reliable and that the Deauville score is preferable. Prognostic values of Menton 2011 and ΔSUV were evaluated by Kaplan-Meier analyses in terms of progression-free survival (PFS). Seventeen percent of patients at PET2 (100/581) and 8% at PET4 (49/581) had PET-negative results by ΔSUV but were considered to have PET-positive results according to Menton 2011 with residual SUV of greater than 5.0. For the population with PET2-positive results, 2-y PFS was 70% (range, 58%-80%) with ΔSUV alone, whereas the outcome tended to be better for those who were considered to have PET-positive results by Menton 2011, 81% (range, 72%-87%). Conversely, all 10 patients with baseline SUV of less than 10.0 had PET2-positive results by ΔSUV but were considered to have PET2-negative results by Menton 2011. These patients had the same 2-y PFS as patients with PET2-negative/PET4-negative results, indicating that the ΔSUV yielded false-positive results in this situation. We recommend the use of the ΔSUV alone rather than the Menton 2011 criteria for assessing the interim metabolic response in patients with diffuse large B-cell lymphoma, except when the baseline SUV is less than 10.0.

摘要

GAINED 阶段 3 试验(ClinicalTrials.gov 标识符:NCT01659099)评估了弥漫性大 B 细胞淋巴瘤患者的 PET 驱动巩固策略。在这项事后分析中,我们旨在比较协议 PET 解释标准(Menton 2011 共识)与单独 SUV 变化(ΔSUV)的预后价值。在接受 2 个周期(PET2)和 4 个周期(PET4)免疫化疗后,对 581 例患者进行了实时中心审查,使用 Menton 2011 标准,结合 ΔSUV(分别在 PET2 和 PET4 时的 66%和 70%的截止值)和 Deauville 量表。在“特殊情况下”,当基线 SUV 小于 10.0 或中间残留肿瘤 SUV 大于 5.0 时,Menton 2011 专家共识认为 ΔSUV 可能不可靠,Deauville 评分更可取。通过 Kaplan-Meier 分析评估 Menton 2011 和 ΔSUV 的预后价值,以评估无进展生存期(PFS)。在 PET2(100/581)时,17%的患者和 PET4(49/581)时的 8%的患者根据 ΔSUV 为 PET 阴性,但根据 Menton 2011,由于残留 SUV 大于 5.0,他们被认为是 PET 阳性。对于 PET2 阳性结果的人群,单独使用 ΔSUV 的 2 年 PFS 为 70%(范围为 58%-80%),而对于那些根据 Menton 2011 被认为是 PET 阳性结果的患者,结果往往更好,81%(范围为 72%-87%)。相反,所有 10 名基线 SUV 小于 10.0 的患者根据 ΔSUV 都有 PET2 阳性结果,但根据 Menton 2011,他们被认为是 PET2 阴性。这些患者与 PET2 阴性/PET4 阴性结果的患者具有相同的 2 年 PFS,表明在这种情况下 ΔSUV 产生了假阳性结果。我们建议在评估弥漫性大 B 细胞淋巴瘤患者的中期代谢反应时,单独使用 ΔSUV,而不是 Menton 2011 标准,除非基线 SUV 小于 10.0。

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