A multicenter study of romiplostim for chemotherapy-induced thrombocytopenia in solid tumors and hematologic malignancies.
A multicenter study of romiplostim for chemotherapy-induced thrombocytopenia in solid tumors and hematologic malignancies.
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罗米普替丁治疗实体瘤和血液系统恶性肿瘤化疗所致血小板减少的多中心研究。
DOI：
10.3324/haematol.2020.251900
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发表时间：
2021-04-01
期刊：
影响因子：
10.1
通讯作者：
Kuter DJ
中科院分区：
文献类型：
--
作者：
Al-Samkari H;Parnes AD;Goodarzi K;Weitzman JI;Connors JM;Kuter DJ
化疗引起的血小板减少症（CIT）经常使癌症治疗复杂化，导致化疗治疗延迟、剂量减少和停药。目前还没有美国食品和药物管理局（FDA）批准的药物可用于治疗CIT。本研究回顾性评估了美国四家中心的机构romiplostim治疗方法治疗的CIT患者。主要终点是罗米plostim疗效的实现（罗米plostim对血小板计数中位数≥75x109/L和≥30x109/L高于基线）。次要结局包括血小板计数≥100x109/L的时间和以下发生率：血小板计数<100×109/L，血小板计数<75x109/L，血小板计数<50x109/L，血小板增多，化疗剂量减少/治疗延迟，血小板输注，出血和血栓栓塞。多变量回归用于确定罗米普罗斯汀无反应的预测因素，并比较每周给药与周期内/间歇给药。共有173例患者（153例实体瘤，20例淋巴瘤或骨髓瘤）接受了治疗，其中170例（98%）接受了中位数为4个（范围：1-36）的romiplostim额外化疗周期。Romiplostim对实体瘤患者有效：71%的患者达到了Romiplostim反应，79%的患者避免了化疗剂量减少/治疗延迟，89%的患者避免了血小板输注。romiplostim组中位患者血小板计数显著高于基线（116 × 109/L vs. 60 × 109/L； P<0.001）。骨髓（BM）肿瘤侵袭、既往盆腔照射和既往替莫唑胺暴露均可预测罗米plostim无反应。出血率低于历史CIT组，血栓形成率未升高。每周给药优于周期内给药，反应率更高，化疗剂量减少/治疗延迟/出血较少；与每周给药相比，周期内给药减少/治疗延迟的发生率比（IRR）为3.00 (95%CI: 1.30-6.91； P=0.010)，出血的发生率比（IRR）为4.84 （95%CI: 1.18-19.89， P=0.029）。脑转移的非髓系恶性血液病患者反应迟钝（有效率为10%）。结论：在大多数实体瘤患者中，罗米普罗斯汀治疗CIT是安全有效的。
Chemotherapy-induced thrombocytopenia (CIT) frequently complicates cancer treatment causing chemotherapy treatment delays, dose reductions, and discontinuation. There is no US Food and Drug Administration (FDA)-approved agent available to manage CIT. This study retrospectively evaluated patients with CIT treated on institutional romiplostim treatment pathways at four US centers. The primary outcome was achievement of a romiplostim response (median on-romiplostim platelet count ≥75x109/L and ≥30x109/L above baseline). Secondary outcomes included time to platelet count ≥100x109/L and rates of the following: platelet count <100×109/L, platelet count <75x109/L, platelet count <50x109/L, thrombocytosis, chemotherapy dose reduction/treatment delay, platelet transfusion, bleeding, and thromboembolism. Multivariable regression was used to identify predictors of romiplostim non-response and compare weekly dosing with intracycle/intermittent dosing. A total of 173 patients (153 solid tumor, 20 lymphoma or myeloma) were treated, with 170 (98%) receiving a median of four (range: 1-36) additional chemotherapy cycles on romiplostim. Romiplostim was effective in solid tumor patients: 71% of patients achieved a romiplostim response, 79% avoided chemotherapy dose reductions/treatment delays, and 89% avoided platelet transfusions. Median per-patient platelet count on romiplostim was significantly higher than baseline (116x109/L vs. 60x109/L; P<0.001). Bone marrow (BM) tumor invasion, prior pelvic irradiation, and prior temozolomide exposure predicted romiplostim non-response. Bleeding rates were lower than historical CIT cohorts and thrombosis rates were not elevated. Weekly dosing was superior to intracycle dosing with higher response rates and less chemotherapy dose reductions/treatment delays/bleeding; intracycle dosing had an incidence rate ratio (IRR) for dose reduction/treatment delay of 3.00 (95%CI: 1.30-6.91; P=0.010) and an IRR for bleeding of 4.84 (95%CI: 1.18-19.89, P=0.029) compared with weekly dosing. Blunted response (10% response rate) was seen in non-myeloid hematologic malignancy patients with BM involvement. In conclusion, romiplostim was safe and effective for CIT in most solid tumor patients.
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影响因子：
158.5
作者：
Kuter, David J.;Rummel, Mathias;Berger, Dietmar P.
通讯作者：
Berger, Dietmar P.
影响因子：
29.4
作者：
Terrault, Norah;Chen, Yi-Cheng;Hassanein, Tarek
通讯作者：
Hassanein, Tarek
影响因子：
4.7
作者：
Hanna, Rabbie K.;Poniewierski, Marek S.;Lyman, Gary H.
通讯作者：
Lyman, Gary H.
影响因子：
45.3
作者：
Elting, LS;Rubenstein, EB;Benjamin, RS
通讯作者：
Benjamin, RS
影响因子：
39.2
作者：
Vadhan-Raj, S;Verschraegen, CF;Kavanagh, JJ
通讯作者：
Kavanagh, JJ