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Abstract：
BACKGROUND: This study aimed to investigate the efficacy and safety of pegylated recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF) for primary prophylaxis of neutropenia in patients with cervical cancer receiving concurrent chemoradiotherapy.
METHODS: In this prospective, single-center, single-arm study, we enrolled patients (18-70 years) with 2018 International Federation of Gynecology and Obstetrics (FIGO) stage IIIC1r-IVA and IVB (distant metastasis only with inguinal lymph node metastasis) cervical cancer. Eligible patients should have normal function of the bone marrow (absolute neutrophil count (ANC) ≥ 2.0 × 109/L) and adequate hepatic and renal functions. Key exclusion criteria included: previous chemotherapy and/or radiotherapy; a history of bone marrow dysplasia or other hematopoietic abnormalities. All patients underwent radical radiotherapy (pelvic radiotherapy or extended-field irradiation) plus brachytherapy. The chemotherapy regimen included four cycles of 3-weekly paclitaxel and cisplatin. PEG-rhG-CSF was administered 48-72 h after each treatment cycle. Salvage granulocyte colony-stimulating factor (G-CSF) was only permitted in certain circumstances. The primary endpoint was the incidence of grade 3-4 neutropenia. The secondary endpoints included frequency of febrile neutropenia (FN), chemotherapy completion rate in cycles 2-4, time to complete radiotherapy, and safety.
RESULTS: Overall, 52 patients were enrolled in this study from July 2019 to October 2020. The incidence of grade 3-4 neutropenia was 28.8%, with an average duration of grade 3-4 neutropenia persistence of 3.85 days (1-7 days). The incidence rate of FN was 3.8%. The chemotherapy completion rate was 94.2%, 82.7%, and 75.0% for cycles 2-4, respectively. The incidences of grade 3-4 neutropenia for cycles 1-4 were 9.6% (5/52), 8.2% (4/49), 14.0% (6/43), and 2.6% (1/39), respectively. All patients completed radiotherapy within 8 weeks (median, 48 days; range: 41-56 days), except one patient who withdrew consent and did not receive radiotherapy. Severe non-hematologic toxicity was not observed in any patient.
CONCLUSIONS: PEG-rhG-CSF is an effective and safe prophylactic treatment for neutropenia in patients with cervical cancer undergoing concurrent chemoradiotherapy.
BACKGROUND: Chinese Clinical Trial Registry, ChiCTR1900024494. Date of Registration:13/July/2019.
METHODS: In this prospective, single-center, single-arm study, we enrolled patients (18-70 years) with 2018 International Federation of Gynecology and Obstetrics (FIGO) stage IIIC1r-IVA and IVB (distant metastasis only with inguinal lymph node metastasis) cervical cancer. Eligible patients should have normal function of the bone marrow (absolute neutrophil count (ANC) ≥ 2.0 × 109/L) and adequate hepatic and renal functions. Key exclusion criteria included: previous chemotherapy and/or radiotherapy; a history of bone marrow dysplasia or other hematopoietic abnormalities. All patients underwent radical radiotherapy (pelvic radiotherapy or extended-field irradiation) plus brachytherapy. The chemotherapy regimen included four cycles of 3-weekly paclitaxel and cisplatin. PEG-rhG-CSF was administered 48-72 h after each treatment cycle. Salvage granulocyte colony-stimulating factor (G-CSF) was only permitted in certain circumstances. The primary endpoint was the incidence of grade 3-4 neutropenia. The secondary endpoints included frequency of febrile neutropenia (FN), chemotherapy completion rate in cycles 2-4, time to complete radiotherapy, and safety.
RESULTS: Overall, 52 patients were enrolled in this study from July 2019 to October 2020. The incidence of grade 3-4 neutropenia was 28.8%, with an average duration of grade 3-4 neutropenia persistence of 3.85 days (1-7 days). The incidence rate of FN was 3.8%. The chemotherapy completion rate was 94.2%, 82.7%, and 75.0% for cycles 2-4, respectively. The incidences of grade 3-4 neutropenia for cycles 1-4 were 9.6% (5/52), 8.2% (4/49), 14.0% (6/43), and 2.6% (1/39), respectively. All patients completed radiotherapy within 8 weeks (median, 48 days; range: 41-56 days), except one patient who withdrew consent and did not receive radiotherapy. Severe non-hematologic toxicity was not observed in any patient.
CONCLUSIONS: PEG-rhG-CSF is an effective and safe prophylactic treatment for neutropenia in patients with cervical cancer undergoing concurrent chemoradiotherapy.
BACKGROUND: Chinese Clinical Trial Registry, ChiCTR1900024494. Date of Registration:13/July/2019.
摘要：
背景：本研究旨在探讨聚乙二醇化重组人粒细胞集落刺激因子（PEG-rhG-CSF）对宫颈癌同步放化疗患者中性粒细胞减少症的初步预防效果和安全性。
方法：在此前瞻性中，单中心,单臂研究，我们纳入了2018年国际妇产科联合会(FIGO)IIIC1r-IVA和IVB期(仅远处转移伴腹股沟淋巴结转移)宫颈癌患者(18~70岁).符合条件的患者应具有正常的骨髓功能（绝对中性粒细胞计数（ANC）≥2.0×109/L）和足够的肝和肾功能。主要排除标准包括：既往化疗和/或放疗；骨髓发育不良或其他造血异常病史。所有患者均接受根治性放射治疗（骨盆放射治疗或扩展视野照射）加近距离放射治疗。化疗方案包括4个周期的3周紫杉醇和顺铂。在每个治疗周期后48-72小时施用PEG-rhG-CSF。救助粒细胞集落刺激因子（G-CSF）仅在某些情况下才允许。主要终点是3-4级中性粒细胞减少症的发生率。次要终点包括发热性中性粒细胞减少症（FN）的频率，2-4周期化疗完成率，完成放疗的时间，和安全。
结果：总体而言，从2019年7月至2020年10月，该研究纳入了52名患者。3-4级中性粒细胞减少的发生率为28.8%,3-4级中性粒细胞减少症的平均持续时间为3.85天（1-7天）。FN的发生率为3.8%。化疗完成率为94.2%,82.7%,周期2-4分别为75.0%。第1-4周期3-4级中性粒细胞减少症的发生率为9.6%(5/52),8.2%（4/49），14.0%（6/43），2.6%(1/39)，分别。所有患者在8周内完成放疗（中位数，48天；范围：41-56天），除了1例撤回同意且未接受放疗的患者.在任何患者中均未观察到严重的非血液学毒性。
结论：PEG-rhG-CSF是宫颈癌同步放化疗患者中性粒细胞减少的有效且安全的预防性治疗方法。
背景：中国临床试验注册中心，ChiCTR1900024494。注册日期：2019年7月13日。
方法：在此前瞻性中，单中心,单臂研究，我们纳入了2018年国际妇产科联合会(FIGO)IIIC1r-IVA和IVB期(仅远处转移伴腹股沟淋巴结转移)宫颈癌患者(18~70岁).符合条件的患者应具有正常的骨髓功能（绝对中性粒细胞计数（ANC）≥2.0×109/L）和足够的肝和肾功能。主要排除标准包括：既往化疗和/或放疗；骨髓发育不良或其他造血异常病史。所有患者均接受根治性放射治疗（骨盆放射治疗或扩展视野照射）加近距离放射治疗。化疗方案包括4个周期的3周紫杉醇和顺铂。在每个治疗周期后48-72小时施用PEG-rhG-CSF。救助粒细胞集落刺激因子（G-CSF）仅在某些情况下才允许。主要终点是3-4级中性粒细胞减少症的发生率。次要终点包括发热性中性粒细胞减少症（FN）的频率，2-4周期化疗完成率，完成放疗的时间，和安全。
结果：总体而言，从2019年7月至2020年10月，该研究纳入了52名患者。3-4级中性粒细胞减少的发生率为28.8%,3-4级中性粒细胞减少症的平均持续时间为3.85天（1-7天）。FN的发生率为3.8%。化疗完成率为94.2%,82.7%,周期2-4分别为75.0%。第1-4周期3-4级中性粒细胞减少症的发生率为9.6%(5/52),8.2%（4/49），14.0%（6/43），2.6%(1/39)，分别。所有患者在8周内完成放疗（中位数，48天；范围：41-56天），除了1例撤回同意且未接受放疗的患者.在任何患者中均未观察到严重的非血液学毒性。
结论：PEG-rhG-CSF是宫颈癌同步放化疗患者中性粒细胞减少的有效且安全的预防性治疗方法。
背景：中国临床试验注册中心，ChiCTR1900024494。注册日期：2019年7月13日。
