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肿瘤第一线 · 学术知识传播

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Front Oncol:替莫唑胺联合阿帕替尼治疗复发性胶质母细胞瘤的疗效和安全性

2021-12-17 MedSci原创 MedSci原创

复发性胶质母细胞瘤的治疗效果很差。探索更好的治疗方案很有必要。因此,来自首都医科大学三博脑科医院团队开展了相关研究,回顾性评估了替莫唑胺联合阿帕替尼(一种口服的靶向VEGFR-2的小分子酪氨酸激酶抑制

复发性胶质母细胞瘤的治疗效果很差。探索更好的治疗方案很有必要。因此,来自首都医科大学三博脑科医院团队开展了相关研究,回顾性评估了替莫唑胺联合阿帕替尼(一种口服的靶向VEGFR-2的小分子酪氨酸激酶抑制剂)治疗复发性胶质母细胞瘤的疗效和毒性。相关结果发表在Frontiers in Oncology杂志上。


该研究回顾性分析了阿帕替尼联合替莫唑胺治疗复发性胶质母细胞瘤的患者。阿帕替尼500mg,每日1次。根据患者之前是否服用过替莫唑胺治疗,给药剂量为200mg / m2 /d,第1-5天或50 mg/ m2 /d,连续每日给药。主要收集的临床资料包括肿瘤特征、MGMT启动子状态、IDH突变、复发次数、应答、生存、不良反应、挽救治疗等。
2016年4月至2019年8月,共纳入31例患者。31例患者中有20例(64.5%)为男性,中位年龄为53岁(范围21-70岁)。9例(29%)患者在治疗前经历了两次或两次以上的进展。7例患者仅接受放射治疗,同时接受替莫唑胺治疗,未接受维持治疗。19例(61.3%)患者MGMT启动子非甲基化。20例(64.5%)患者为IDH野生型肿瘤。
31例患者中,CR 3例,PR 5例,SD 17例,PD 6例。5例无法测量病变的患者均达到SD。客观有效率(ORR)为26.3%,疾病控制率(DCR)为84.2%。22例初发恶性胶质瘤患者中,CR 3例,PR 4例,SD 11例,PD 4例。ORR为31.8%,DCR为81.8%。


疗效评估


中位随访时间为7.9个月(范围3.2 ~ 38.7个月)。在最后一次随访(2019年12月31日),1例患者仍在接受治疗,1例患者在三次评估后失去随访。对于所有患者,评估的6个月PFS率为44.6% (95% CI, 27 - 62.2%)。12个月的OS率为30.2% (95% CI, 13.7 - 46.7%)。中位无进展生存期(PFS)为4.9个月(95%CI, 2.8 ~ 7个月)。中位OS为8.2个月(95%CI, 6.9 - 9.5个月)。疾病进展至死亡的中位时间间隔为3.2个月。


PFS和OS


令人兴奋的发现是,两例患者治疗2年后无肿瘤进展而停止治疗的PFS分别为30.9和38.7+个月,而他们之前的复发间隔时间分别为12和14个月。它们都含有未甲基化的MGMT和野生型IDH。1例在最后一次复发时接受了肿瘤全切除,另1例只接受了局部肿瘤而没有切除。
20例野生型IDH患者中位PFS和6个月PFS率分别为5.7个月(95%CI, 3.6 ~ 7.8个月)和48.7%,中位OS和12个月OS率分别为8.2个月(95%CI, 6.8 ~ 9.6个月)和37.1%。24例在替莫唑胺治疗(5天治疗方案)病情进展的患者中位PFS为5.7个月(95%CI, 2.2 - 9.2个月),OS为8.5个月(95 CI, 6.2 - 10.8个月)。6m-PFS和12m-OS分别为49.4和35.1%。


不同预后因素分层对预后影响


无肿瘤播散的患者可能比播散的患者预后更好(PFS为7.9个月比4个月,OS为12.1个月比7.5个月),但无统计学差异。进展后,28例患者中有9例接受了挽救性贝伐单抗治疗。有或没有贝伐单抗的患者进展后的中位生存时间分别为5.1个月(95%CI, 4.5 - 5.8)和1.2个月(95%CI, 0 - 2.6)。Log-Rank P = 0.174, Breslow P = 0.031。这表明进展后使用贝伐单抗可能进一步延长生存时间。
常见的3级或4级毒性反应是高血压(5.8%)、食欲下降(5.8%)、血小板减少(4.3%)和白细胞减少(3.6%)。大多数3级或4级毒性是在早期治疗周期中发现的,对症治疗,剂量调整或减少等处理后好转。


不良事件


综上,研究表明,阿帕替尼加替莫唑胺是复发性胶质母细胞瘤有效的挽救方案,且毒性可控,同时不降低后续贝伐单抗治疗的敏感性。
原始出处:
Ge J, Li C, Xue F, Qi S, Gao Z, Yu C and Zhang J (2021) Apatinib Plus Temozolomide: An Effective Salvage Treatment for Recurrent Glioblastoma. Front. Oncol. 10:601175. doi: 10.3389/fonc.2020.601175.

 

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    2022-03-20 minlingfeng
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