Voulgaris Spyridoy, Partheni Melpomeni, Karamouzis Michalis, Dimopoulos Panayiotis, Papadakis Nicolaos, Kalofonos Haralabos P
Department of Medicine/Oncology, University Hospital of Patras, Rion 26500, Greece.
Am J Clin Oncol. 2002 Feb;25(1):60-4. doi: 10.1097/00000421-200202000-00013.
The objective of the study was to evaluate the safety and therapeutic efficacy of intralesional administration of doxorubicin in brain gliomas. Ten patients with recurrent grade III or IV glioma were enrolled in the study, after the second operation. All patients had not responded to radiation therapy. Chemotherapy was administered directly in the tumor through an Ommaya pump placed in the site of disease at the time of craniotomy. Doxorubicin 0.5 mg was administered in the Ommaya reservoir every 24 hours on days 1 to 10. Patients were evaluated at 6- to 8-week intervals until tumor progression and death. All patients were evaluated for response. Six of 10 patients had clinical improvement lasting from 12 to 73 weeks. Objective radiologic response was observed in 5 of 10 (50%) patients. One patient achieved complete response with time to disease progression of 119 weeks, and 4 patients had a partial response (duration 14-39 weeks) with 25% or more reduction of tumor volume on computed tomography scan compared with pretreatment measurements. Time to disease progression in patients who responded after the intratumoral chemotherapy was 39.83 +/- 40.5 weeks. One additional patient had stable disease for a duration of 12 weeks. The median survival of the patients with response was 55.17 +/- 54.22 weeks (range: 21-164 weeks), whereas survival of those who did not respond was 17.0 +/- 12.36 weeks (range: 8-35) (Mann Whitney U test: z = -2.13, p = 0.033). The median survival of all 10 patients was 39.9 +/- 45.52 weeks (range: 8-73 weeks). Bifrontal headache was reported in 4 of 10 patients immediately after the administration of doxorubicin. There were no other clinically significant adverse reactions either in the brain or systematically. Intralesional administration of doxorubicin appears to be a safe and effective treatment and should be further explored in the management of brain gliomas resistant to conventional forms of treatment.
本研究的目的是评估病灶内注射阿霉素治疗脑胶质瘤的安全性和疗效。10例复发性III级或IV级胶质瘤患者在第二次手术后入组本研究。所有患者对放射治疗均无反应。在开颅手术时，通过放置在病灶部位的Ommaya泵将化疗药物直接注入肿瘤内。在第1至10天，每24小时向Ommaya储液器中注入0.5mg阿霉素。每6至8周对患者进行评估，直至肿瘤进展和死亡。对所有患者进行反应评估。10例患者中有6例临床症状改善持续12至73周。10例患者中有5例（50%）观察到客观的影像学反应。1例患者达到完全缓解，疾病进展时间为119周，4例患者部分缓解（持续时间14 - 39周），与治疗前测量相比，计算机断层扫描显示肿瘤体积缩小25%或更多。瘤内化疗后有反应的患者疾病进展时间为39.83±40.5周。另有1例患者疾病稳定持续12周。有反应患者的中位生存期为55.17±54.22周（范围：21 - 164周），而无反应患者的生存期为17.0±12.36周（范围：8 - 35周）（曼 - 惠特尼U检验：z = -2.13，p = 0.033）。10例患者的中位生存期为39.9±45.52周（范围：8 - 73周）。10例患者中有4例在注射阿霉素后立即报告出现双侧额部头痛。在脑部或全身均未出现其他具有临床意义的不良反应。病灶内注射阿霉素似乎是一种安全有效的治疗方法，在对传统治疗方式耐药的脑胶质瘤治疗中应进一步探索。
