Neurosurgery, Departement of Neurosciences, Padova University Hospital, Padova, Italy.
Acta Neurochir (Wien). 2010 Nov;152(11):1923-31. doi: 10.1007/s00701-010-0759-6. Epub 2010 Aug 13.
Carmustine (1,3-bis[2-chloroetyl]-1-nitrosurea (BCNU)) wafers are approved for the local treatment of newly diagnosed and recurrent malignant glioma. Reassuring data on both safety and efficacy of treatment have been previously reported by phase III studies. Although most of related adverse events are reported in the first few months after surgery, there is a lack in the literature of radiological data regarding this period. Few anecdotal experiences have been reported about surgical bed cyst occurrence. The aim of our study is to analyse the radiological course of patients treated with wafers implantation focusing on the relationship between radiological data, and in particular bed cyst occurrence, and safety data.
Forty-three patients affected by malignant glioma underwent surgical removal and BCNU wafers implantation at the Department of Neurosurgery of Padova from April 2007 to October 2009. Safety data were collected according to previously reported phase III studies. Patients underwent clinical and radiological evaluation (MRI) postoperatively, then before discharge, at 1 month, then every 2 months. In the study were included only patients whose both 1- and 3-month MRIs were available. Finally, 36 out of 43 patients were available for the revision.
Fifty-eight percent of patients treated with BCNU wafers presented a bed cyst of the surgical cave at the 1-month MRI. Forty-eight percent of them were symptomatic. Conversely, among patients who presented one or more adverse event (27%), bed cyst was detected in up to 90% of cases (OR 7.35), being intracranial hypertension more frequently associated (OR 7.35; p value <0.05). In general, cysts presented a benign behaviour in the sense that patients promptly improved with corticosteroid treatment, never required surgery, never reported permanent neurological deficits.
Surgical bed cyst occurrence in BCNU wafer-treated patients resulted more frequent than expected. Familiarity with the event is important to correctly handle a possible evolving phenomenon. However, only further larger experiences and prospective studies could reveal how the understanding of such event might be helpful to improve safety data.
卡莫司汀(1,3-双[2-氯乙基]-1-亚硝基脲(BCNU))植入物已被批准用于治疗新诊断和复发性恶性神经胶质瘤。此前的 III 期研究报告了关于该治疗的安全性和疗效的令人放心的数据。尽管大多数相关不良事件发生在手术后的头几个月内,但文献中缺乏该期间的放射学数据。已经报道了一些关于手术床囊肿发生的轶事经验。我们的研究旨在分析接受植入物治疗的患者的放射学过程,重点是放射学数据,特别是床囊肿的发生,以及安全性数据之间的关系。
2007 年 4 月至 2009 年 10 月,帕多瓦神经外科部门对 43 名恶性神经胶质瘤患者进行了手术切除和 BCNU 植入物治疗。安全性数据是根据以前报道的 III 期研究收集的。患者术后接受临床和放射学评估(MRI),然后在出院前、术后 1 个月、然后每 2 个月进行一次。在研究中,仅包括术后 1 个月和 3 个月 MRI 均可用的患者。最后,43 名患者中有 36 名可供复查。
在接受 BCNU 植入物治疗的患者中,58%的患者在术后 1 个月的 MRI 上出现手术腔的床囊肿。其中 48%的患者有症状。相反,在出现 1 种或多种不良事件的患者中(27%),高达 90%的患者检测到床囊肿(OR 7.35),更常伴有颅内压升高(OR 7.35;p 值<0.05)。一般来说,囊肿表现出良性行为,因为患者在皮质类固醇治疗后迅速改善,从未需要手术,也从未报告永久性神经功能缺损。
BCNU 植入物治疗患者中手术床囊肿的发生频率高于预期。熟悉这种情况对于正确处理可能出现的进展现象非常重要。然而,只有进一步的更大规模的经验和前瞻性研究才能揭示对这种情况的了解如何有助于提高安全性数据。