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接受化疗的转移性结直肠癌患者血小板减少症的发生与管理:前瞻性临床试验数据的二次分析

Occurrence and Management of Thrombocytopenia in Metastatic Colorectal Cancer Patients Receiving Chemotherapy: Secondary Analysis of Data From Prospective Clinical Trials.

作者信息

Kilpatrick Karynsa, Shaw Jaime L, Jaramillo Renee, Toler Andrew, Eisen Melissa, Sangaré Laura, Soff Gerald A

机构信息

Amgen Inc, Thousand Oaks, CA.

Amgen Inc, Thousand Oaks, CA.

出版信息

Clin Colorectal Cancer. 2021 Jun;20(2):170-176. doi: 10.1016/j.clcc.2020.10.004. Epub 2020 Nov 1.

Abstract

INTRODUCTION

Chemotherapy-induced thrombocytopenia (CIT) contributes to treatment dose delay and/or modification, often resulting in poorer survival and disease progression. We explored the incidence and clinical consequences of CIT among metastatic colorectal cancer (mCRC) patients.

MATERIALS AND METHODS

Data from two prospective randomized phase 3 trials of mCRC patients receiving either first-line FOLFOX4 (fluorouracil, leucovorin, oxaliplatin) or second-line FOLFIRI (fluorouracil, leucovorin, irinotecan) were analyzed. Thrombocytopenia was defined by platelet count < 100 × 10/L (further categorized by grade) and by recorded adverse events (AEs). Co-occurrence of anemia (hemoglobin < 12 g/dL) and neutropenia (neutrophil count < 2 × 10/L) and clinical consequences of CIT were also evaluated.

RESULTS

Among 1078 mCRC patients in the FOLFOX4 study, cumulative incidence of CIT based on platelet count was 37% (grade 3, 2%; grade 4, 1%) during an average 8 months' follow-up. Neutropenia or anemia were absent in 44% of CIT episodes; 62% of CIT AEs led to chemotherapy dose delay, change, and/or discontinuation. Among 1067 mCRC patients in the FOLFIRI study, cumulative incidence of CIT based on platelet count was 4% (grade 3, < 1%; grade 4, 0) during an average 4 months' follow-up. Neutropenia or anemia were absent in 22% of CIT episodes; 32% of CIT AEs led to chemotherapy dose delay, change, and/or discontinuation. With both regimens, transfusions and hospitalizations after CIT AEs were rare (< 3%).

CONCLUSION

CIT was common among mCRC patients receiving the FOLFOX4 regimen. The most frequent consequence of CIT was a delay in chemotherapy, highlighting the unmet need in CIT management.

摘要

引言

化疗引起的血小板减少症(CIT)会导致治疗剂量延迟和/或调整,常常导致生存率降低和疾病进展。我们探讨了转移性结直肠癌(mCRC)患者中CIT的发生率及临床后果。

材料与方法

分析了两项前瞻性随机3期试验的数据,这些试验的对象为接受一线FOLFOX4(氟尿嘧啶、亚叶酸钙、奥沙利铂)或二线FOLFIRI(氟尿嘧啶、亚叶酸钙、伊立替康)治疗的mCRC患者。血小板减少症的定义为血小板计数<100×10⁹/L(进一步按分级划分)以及记录的不良事件(AE)。同时评估了贫血(血红蛋白<12 g/dL)和中性粒细胞减少症(中性粒细胞计数<2×10⁹/L)的并发情况以及CIT的临床后果。

结果

在FOLFOX4研究的1078例mCRC患者中,在平均8个月的随访期间,基于血小板计数的CIT累积发生率为37%(3级,2%;4级,1%)。44%的CIT发作不存在中性粒细胞减少症或贫血;62%的CIT不良事件导致化疗剂量延迟、改变和/或中断。在FOLFIRI研究的1067例mCRC患者中,在平均4个月的随访期间,基于血小板计数的CIT累积发生率为4%(3级,<1%;4级,0)。22%的CIT发作不存在中性粒细胞减少症或贫血;32%的CIT不良事件导致化疗剂量延迟、改变和/或中断。两种治疗方案中,CIT不良事件后的输血和住院情况均很少见(<3%)。

结论

接受FOLFOX4方案治疗的mCRC患者中CIT很常见。CIT最常见的后果是化疗延迟,凸显了CIT管理方面未满足的需求。

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