Response assessment in lymphoma: Concordance between independent central review and local evaluation in a clinical trial setting.
Response assessment in lymphoma: Concordance between independent central review and local evaluation in a clinical trial setting.
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淋巴瘤的反应评估：在临床试验环境中独立中央审查与局部评估之间的一致性。
DOI：
10.1177/1740774516645338
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发表时间：
2016-10
期刊：
影响因子：
--
通讯作者：
Sievers EL
中科院分区：
文献类型：
--
作者：
Gopal AK;Pro B;Connors JM;Younes A;Engert A;Shustov AR;Chi X;Larsen EK;Kennedy DA;Sievers EL
临床影像学的独立中心审查仍然是具有注册潜力的肿瘤学临床试验的标准。基于中心和当地缓解评价之间的一致性，针对实体瘤试验提出了有限的独立中心审查策略。尚不清楚独立中心审查与当地血液恶性肿瘤缓解评价之间的一致性。我们回顾性评价了在复发性或难治性霍奇金淋巴瘤（N = 102）或系统性间变性大细胞淋巴瘤（N = 58）患者中进行的维布妥昔单抗国际、开放标签、单组、注册研究中，使用修订的恶性淋巴瘤缓解标准前瞻性进行的中心和当地缓解评估之间的一致性。霍奇金淋巴瘤试验（75%独立中心审查，72%当地评价）和间变性大细胞淋巴瘤试验（86%独立中心审查，83%当地评价）的评估者之间的总体客观缓解率相似。患者特异性客观缓解一致性也很高（霍奇金淋巴瘤：kappa = 0.68;间变性大细胞淋巴瘤：kappa = 0.74）。评估者之间间变性大细胞淋巴瘤患者的中位无进展生存期相似（独立中心审查为14.3个月（95%置信区间：6.9，−）;当地评价为14.5个月（95%可信区间：9.4，−）），但霍奇金淋巴瘤患者的局部评估时间更长（独立中心审查为5.8个月（95%置信区间：5.0，9.0）;当地评价为9.0个月（95%置信区间：7.1，12.0））。两种恶性肿瘤的局部评价中位缓解持续时间较长，这主要归因于独立中心审查的早期计算机断层扫描和基于正电子发射断层扫描的进展评分。基于两项国际、前瞻性、淋巴瘤注册试验中中心和当地评价的总体客观缓解评估的实质一致性，某些淋巴瘤临床试验的有限独立审查稽查策略似乎是可行和实用的。观察到评估者之间在至事件发生时间终点方面存在一些变异性，这似乎可归因于独立中心审查较当地评估更早分配进展。
Independent central review of clinical imaging remains the standard for oncology clinical trials with registration potential. A limited independent central review strategy has been proposed for solid tumor trials based on concordance between central and local evaluation of response. Concordance between independent central review and local evaluation of response in hematological malignancies is not known. We retrospectively evaluated concordance between prospectively performed central and local assessments of response using the Revised Response Criteria for Malignant Lymphoma across two international, open-label, single-arm, registration studies of brentuximab vedotin in patients with relapsed or refractory Hodgkin lymphoma (N = 102) or systemic anaplastic large-cell lymphoma (N = 58). Overall objective response rates were similar between assessors for both the trial in Hodgkin lymphoma (75% independent central review, 72% local evaluation) and the trial in anaplastic large-cell lymphoma (86% independent central review, 83% local evaluation). Patient-specific objective response concordance was also substantial (Hodgkin lymphoma: kappa = 0.68; anaplastic large-cell lymphoma: kappa = 0.74). Median progression-free survival was similar between assessors for patients with anaplastic large-cell lymphoma (14.3 months by independent central review (95% confidence interval: 6.9, −); 14.5 months by local evaluation (95% confidence interval: 9.4, −)), but longer by local evaluation in patients with Hodgkin lymphoma (5.8 months by independent central review (95% confidence interval: 5.0, 9.0); 9.0 months by local evaluation (95% confidence interval: 7.1, 12.0)). Median duration of response was longer by local evaluation in both malignancies, which was primarily attributable to earlier computed tomography and positron emission tomography–based scoring of progression by independent central review. A limited independent review audit strategy for clinical trials of some lymphomas appears feasible and practical based on substantial concordance in assessments of overall objective response by central and local evaluation in two international, prospective, registration trials in lymphoma. Some variability between assessors in the time-to-event endpoints was observed, which appeared attributable to earlier assignments of progression by independent central review compared with local evaluation.
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影响因子：
45.3
作者：
Dodd, Lori E.;Korn, Edward L.;Mooney, Margaret M.
通讯作者：
Mooney, Margaret M.
影响因子：
8.4
作者：
Eisenhauer, E. A.;Therasse, P.;Verweij, J.
通讯作者：
Verweij, J.
影响因子：
45.3
作者：
Pro, Barbara;Advani, Ranjana;Shustov, Andrei
通讯作者：
Shustov, Andrei
影响因子：
1.9
作者：
LANDIS, JR;KOCH, GG
通讯作者：
KOCH, GG
影响因子：
45.3
作者：
Cheson, Bruce D.;Fisher, Richard I.;Lister, T. Andrew
通讯作者：
Lister, T. Andrew