Kilpatrick Karynsa, Shaw Jaime L, Jaramillo Renee, Toler Andrew, Eisen Melissa, Sangaré Laura, Soff Gerald A
Amgen Inc, Thousand Oaks, CA.
Amgen Inc, Thousand Oaks, CA.
Clin Colorectal Cancer. 2021 Jun;20(2):170-176. doi: 10.1016/j.clcc.2020.10.004. Epub 2020 Nov 1.
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.
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.
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%).
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.
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。
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。
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%)。
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。