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高压氧联合化疗后放疗用于高级别胶质瘤的II期试验

Phase II trial of radiotherapy after hyperbaric oxygenation with chemotherapy for high-grade gliomas.

作者信息

Ogawa K, Yoshii Y, Inoue O, Toita T, Saito A, Kakinohana Y, Adachi G, Iraha S, Tamaki W, Sugimoto K, Hyodo A, Murayama S

机构信息

Department of Radiology, University of the Ryukyus School of Medicine, 207 Uehara, Nishihara-cho, and Department of Radiology, Naha City Hospital, Okinawa 903-0215, Japan.

出版信息

Br J Cancer. 2006 Oct 9;95(7):862-8. doi: 10.1038/sj.bjc.6603342. Epub 2006 Sep 5.

DOI:10.1038/sj.bjc.6603342
PMID:16953239
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC2360529/
Abstract

We conducted a phase II trial to evaluate the efficacy and toxicity of radiotherapy immediately after hyperbaric oxygenation (HBO) with chemotherapy in adults with high-grade gliomas. Patients with histologically confirmed high-grade gliomas were administered radiotherapy in daily 2 Gy fractions for 5 consecutive days per week up to a total dose of 60 Gy. Each fraction was administered immediately after HBO with the period of time from completion of decompression to irradiation being less than 15 min. Chemotherapy consisted of procarbazine, nimustine (ACNU) and vincristine and was administered during and after radiotherapy. A total of 41 patients (31 patients with glioblastoma and 10 patients with grade 3 gliomas) were enrolled. All 41 patients were able to complete a total radiotherapy dose of 60 Gy immediately after HBO with one course of concurrent chemotherapy. Of 30 assessable patients, 17 (57%) had an objective response including four CR and 13 PR. The median time to progression and the median survival time in glioblastoma patients were 12.3 months and 17.3 months, respectively. On univariate analysis, histologic grade (P=0.0001) and Karnofsky performance status (P=0.036) had a significant impact on survival, and on multivariate analysis, histologic grade alone was a significant prognostic factor for survival (P=0.001). Although grade 4 leukopenia and grade 4 thrombocytopenia occurred in 10 and 7% of all patients, respectively, these were transient with no patients developing neutropenic fever or intracranial haemorrhage. No serious nonhaematological or late toxicities were seen. These results indicated that radiotherapy delivered immediately after HBO with chemotherapy was safe with virtually no late toxicity in patients with high-grade gliomas. Further studies are required to strictly evaluate the effectiveness of radiotherapy after HBO for these tumours.

摘要

我们开展了一项II期试验,以评估高压氧疗(HBO)联合化疗后立即进行放疗对成人高级别胶质瘤的疗效和毒性。组织学确诊为高级别胶质瘤的患者每周连续5天每天接受2 Gy分次放疗,总剂量达60 Gy。每次分次放疗在HBO后立即进行,减压完成至照射的时间间隔小于15分钟。化疗由丙卡巴肼、尼莫司汀(ACNU)和长春新碱组成,在放疗期间及放疗后进行。共纳入41例患者(31例胶质母细胞瘤患者和10例3级胶质瘤患者)。所有41例患者均能够在HBO联合一个疗程同步化疗后立即完成60 Gy的总放疗剂量。在30例可评估患者中,17例(57%)有客观缓解,包括4例完全缓解(CR)和13例部分缓解(PR)。胶质母细胞瘤患者的中位进展时间和中位生存时间分别为12.3个月和17.3个月。单因素分析显示,组织学分级(P = 0.0001)和卡诺夫斯基功能状态(P = 0.036)对生存有显著影响,多因素分析显示,仅组织学分级是生存的显著预后因素(P = 0.001)。尽管4级白细胞减少和4级血小板减少分别发生在所有患者的10%和7%,但这些均为短暂性,无患者发生中性粒细胞减少性发热或颅内出血。未观察到严重的非血液学或晚期毒性。这些结果表明,HBO联合化疗后立即进行放疗是安全的,高级别胶质瘤患者几乎无晚期毒性。需要进一步研究来严格评估HBO后放疗对这些肿瘤的有效性。

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