在MONITOR-GCSF研究化疗诱导的(发热性)中性粒细胞减少与生物仿制药非格司亭,56.6%的患者根据修订的EORTC指南进行了预防,但17.4%的患者被预防低于指南建议,26.0%高于指南建议。
MONITOR-GCSF是一种潜在的,观察性研究纳入了来自12个欧洲国家140个癌症中心的1447名可评估患者,这些患者接受了多达6个周期的骨髓抑制化疗,并接受了GCSF预防.患者被归类为-,正确-,或相对于基于化疗风险的指南建议过度预防GCSF,个别危险因素,和GCSF预防类型(原发性与继发性)。
under-(17.4%)之间的差异,正确-(56.6%),或过度预防组(26.0%)在患者危险因素方面(年龄,性能状态,FN的历史,合并症)以及预防模式(预防类型,GCSF起始日,和GCSF持续时间)。化疗诱导的中性粒细胞减少症(CIN)的发生率(所有等级),FN,与预防不足和正确的患者相比,过度预防患者与CIN相关的住院率始终较低.除了与CIN/FN相关的化疗障碍外,未预防和正确预防的患者之间没有观察到差异。组间没有发现GCSF安全性差异(头痛除外)。
MONITOR-GCSF研究提供的真实世界证据表明,提供GCSF支持可能会产生更好的CIN,FN,和CIN/FN相关的住院结局,如果患者的预防水平高于指南建议。预防不足的患者化疗方案受到干扰的风险较高。我们的发现支持在每个化疗周期开始时评估CIN/FN风险的指南建议。
In the MONITOR-GCSF study of chemotherapy-induced (febrile) neutropenia with biosimilar filgrastim, 56.6% of patients were prophylacted according to amended EORTC
guidelines, but 17.4% were prophylacted below and 26.0% above
guideline recommendations.
MONITOR-GCSF is a prospective, observational study of 1447 evaluable patients from 140 cancers centers in 12 European countries treated with myelosuppressive chemotherapy for up to 6 cycles receiving biosimilar GCSF prophylaxis. Patients were classified as under-, correctly-, or over-prophylacted with GCSF relative to
guideline recommendations based on their chemotherapy risk, individual risk factors, and type of GCSF prophylaxis (primary versus secondary).
Differences between under- (17.4%), correctly- (56.6%), or over-prophylacted (26.0%) groups were found in terms of patient risk factors (age, performance status, history of FN, comorbid conditions) as well as prophylaxis patterns (type of prophylaxis, day of GCSF initiation, and GCSF duration). Rates of chemotherapy-induced neutropenia (CIN) (all grades), FN, and CIN-related hospitalizations were consistently lower in over-prophylacted patients relative to under- and correctly-prophylacted patients. No differences were observed between under- and correctly-prophylacted patients except for CIN/FN-related chemotherapy disturbances. No GCSF safety differences were found between groups (except for headaches).
The real-world evidence provided by the MONITOR-GCSF study indicates that providing GCSF support may yield better CIN, FN, and CIN/FN-related hospitalization outcomes if patients are prophylacted at levels above
guideline recommendations. Patients who are under-prophylacted are at higher risk for disturbances to their chemotherapy regimens. Our findings support the
guideline recommendation that CIN/FN risk be assessed at the beginning of each chemotherapy cycle.