替莫唑胺在标准放疗和化疗后复发的间变性少突胶质细胞瘤患者中的安全性和有效性。
Safety and efficacy of temozolomide in patients with recurrent anaplastic oligodendrogliomas after standard radiotherapy and chemotherapy.
作者信息
Chinot O L, Honore S, Dufour H, Barrie M, Figarella-Branger D, Muracciole X, Braguer D, Martin P M, Grisoli F
机构信息
Service de Neurochirurgie, Hôpital de la Timone, and Faculté de Médecine, Laboratoire de Cancérologie Expérimentale, Marseille, France.
出版信息
J Clin Oncol. 2001 May 1;19(9):2449-55. doi: 10.1200/JCO.2001.19.9.2449.
PURPOSE
Most primary oligodendrogliomas and mixed gliomas (oligoastrocytoma) respond to treatment with procarbazine, lomustine, and vincristine (PCV), with response rates of approximately 80%. However, limited data on second-line treatments are available in patients with recurrent tumors. A novel second-generation alkylating agent, temozolomide, has recently demonstrated efficacy and safety in patients with recurrent glioblastoma multiforme and anaplastic astrocytoma. This study describes the effects of temozolomide in patients with recurrent anaplastic oligodendroglioma (AO) and anaplastic mixed oligoastrocytoma (AOA).
PATIENTS AND METHODS
Forty-eight patients with histologically confirmed AO or AOA who had received previous PCV chemotherapy were treated with temozolomide (150 to 200 mg/m2/d for 5 days per 28-day cycle). The primary end point was objective response. Secondary end points included progression-free survival (PFS), time to progression, overall survival (OS), safety, and tolerability.
RESULTS
Eight patients (16.7%) experienced a complete response, 13 patients (27.1%) experienced a partial response (objective response rate, 43.8%), and 19 patients (39.6%) experienced stable disease. For the entire treatment group, median PFS was 6.7 months and median OS was 10 months. For objective responders, median PFS was 13.1 months and median OS was 16 months. For complete responders, PFS was more than 11. 8 months and OS was more than 26 months. Response correlated with improved survival. Temozolomide was safe and well tolerated. Twelve patients developed grade 1/2 thrombocytopenia and three patients developed grade 3/4 thrombocytopenia.
CONCLUSION
Temozolomide is safe and effective in the treatment of recurrent AO and AOA.
目的
大多数原发性少突胶质细胞瘤和混合性胶质瘤(少突星形细胞瘤)对丙卡巴肼、洛莫司汀和长春新碱(PCV)治疗有反应,缓解率约为80%。然而,关于复发性肿瘤患者二线治疗的数据有限。一种新型的第二代烷化剂替莫唑胺最近已在复发性多形性胶质母细胞瘤和间变性星形细胞瘤患者中显示出疗效和安全性。本研究描述了替莫唑胺对复发性间变性少突胶质细胞瘤(AO)和间变性混合性少突星形细胞瘤(AOA)患者的影响。
患者和方法
48例经组织学确诊为AO或AOA且先前接受过PCV化疗的患者接受替莫唑胺治疗(每28天周期中150至200mg/m²/d,连用5天)。主要终点为客观缓解。次要终点包括无进展生存期(PFS)、进展时间、总生存期(OS)、安全性和耐受性。
结果
8例患者(16.7%)完全缓解,13例患者(27.1%)部分缓解(客观缓解率43.8%),19例患者(39.6%)病情稳定。对于整个治疗组,中位PFS为6.7个月,中位OS为10个月。对于客观缓解者,中位PFS为13.1个月,中位OS为16个月。对于完全缓解者,PFS超过11.8个月,OS超过26个月。缓解与生存期改善相关。替莫唑胺安全且耐受性良好。12例患者出现1/2级血小板减少,3例患者出现3/4级血小板减少。
结论
替莫唑胺治疗复发性AO和AOA安全有效。