The relationship between quality of response and clinical benefit for patients treated on the bortezomib arm of the international, randomized, phase 3 APEX trial in relapsed multiple myeloma
The relationship between quality of response and clinical benefit for patients treated on the bortezomib arm of the international, randomized, phase 3 APEX trial in relapsed multiple myeloma
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DOI：
10.1111/j.1365-2141.2008.07303.x
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发表时间：
2008-10-01
影响因子：
6.5
通讯作者：
Blade, Joan
中科院分区：
文献类型：
--
作者：
Niesvizky, Ruben;Richardson, Paul G.;Blade, Joan
缓解质量与新诊断多发性骨髓瘤患者的总生存期（OS）延长相关。在复发性骨髓瘤患者中进行的蛋白酶体抑制延长缓解（APEX）试验中的这项队列研究评估了硼替佐米与地塞米松的反应质量（n = 315）与临床获益之间的关系。在硼替佐米组的缓解可评价患者中，按照达到完全缓解定义的队列评估了无治疗间期（TFI）、至替代治疗时间（TTAT）、至疾病进展时间（TTP）和OS（CR; n = 27），非常好的部分缓解VGPR; n = 31）、部分缓解（PR; n = 77）、最小缓解（MR; n = 21）或无缓解（NR，包括疾病稳定和进展; n = 159）。CR与中位TFI（24.1 vs. 6.9/6.4个月）和TTAT（27.1 vs. 13.6/14个月）显著长于VGPR/PR相关。CR、VGPR和PR队列的中位TTP相似;未达到中位OS。与NR相比，达到MR的患者的中位TFI（3.8 vs. 2.3个月）、TTAT（8.7 vs. 6.2个月）、TTP（4.9 vs. 2.8个月）和OS（24.9 vs. 18.7个月）似乎延长。总之，硼替佐米在复发性骨髓瘤患者中具有显著活性; CR可能是硼替佐米显著临床获益的替代标志物。在这种情况下，MR作为单独的缓解类别似乎有效。
Quality of response is associated with prolonged overall survival (OS) in newly diagnosed multiple myeloma patients. This cohort study within the phase 3 Assessment of Proteasome Inhibition for Extending Remissions (APEX) trial of bortezomib versus dexamethasone in relapsed myeloma assessed the relationship between quality of response to bortezomib (n = 315) and clinical benefit. Treatment-free interval (TFI), time to alternative therapy (TTAT), time to progression (TTP) and OS were assessed in response-evaluable patients in the bortezomib arm in cohorts defined by achievement of complete response (CR; n = 27), very good partial response (VGPR; n = 31), partial response (PR; n = 77), minimal response (MR; n = 21) or non-response (NR, including stable and progressive disease; n = 159). CR was associated with significantly longer median TFI (24.1 vs. 6.9/6.4 months) and TTAT (27.1 vs. 13.6/14 months) versus VGPR/PR. Median TTP was similar in CR, VGPR and PR cohorts; median OS was not reached. Patients achieving MR appeared to have prolonged median TFI (3.8 vs. 2.3 months), TTAT (8.7 vs. 6.2 months), TTP (4.9 vs. 2.8 months) and OS (24.9 vs. 18.7 months) versus NR. In conclusion, bortezomib had substantial activity in relapsed myeloma patients; CR may be a surrogate marker for significant clinical benefit with bortezomib. MR appeared to be valid as a separate response category in this setting.