van Ijken M G A, van Etten B, Guetens G, de Bruijn E A, Ten Hagen T L M, Wiggers Th, Eggermont A M M
Department of Surgical Oncology, Erasmus Medical Center Rotterdam, Daniel den Hoed Cancer Center, Groene Hilledijk 301, 3075 EA Rotterdam, The Netherlands.
Eur J Surg Oncol. 2005 Oct;31(8):897-904. doi: 10.1016/j.ejso.2005.06.004.
To investigate the feasibility of hypoxic pelvic perfusion (HPP), using balloon catheter techniques as treatment modality for locally advanced pelvic malignancies.
In a phase I--II study, 16 patients with various non-resectable pelvic tumours were treated with two HPP with MMC and melphalan, followed by radiotherapy (25 Gy) and surgical resection if feasible. Toxicity and procedure related complications were documented. Tumour responses were assessed by MRI or CT. Pain reductive effects were assessed by evaluation of pain registration forms.
HPP resulted in augmented regional drug concentrations with relatively low systemic levels. Some severe systemic toxicity was observed. One procedure related death occurred. Pain reduction effects were short-lived. Ten patients had radiological NC, two PD and one PR. In 11 patients surgical resection was performed, which was microscopically radical in six cases. Mean survival was 26.8 months (range 1--86).
The seemingly favorable pharmacokinetic profiles observed with HPP in this and other studies can still lead to severe systemic toxicity. In terms of survival, local (re-)recurrence and pain reduction there seems no benefit of addition of HPP to pre-operative radiotherapy. HPP with MMC and melphalan, does not seem a therapeutic option in patients with locally advanced pelvic tumours.
探讨使用球囊导管技术进行低氧盆腔灌注（HPP）作为局部晚期盆腔恶性肿瘤治疗方式的可行性。
在一项I-II期研究中，16例患有各种不可切除盆腔肿瘤的患者接受了两次使用丝裂霉素和马法兰的HPP治疗，随后进行放射治疗（25 Gy），若可行则进行手术切除。记录毒性和与手术相关的并发症。通过MRI或CT评估肿瘤反应。通过评估疼痛登记表评估疼痛减轻效果。
HPP导致局部药物浓度增加而全身水平相对较低。观察到一些严重的全身毒性。发生了1例与手术相关的死亡。疼痛减轻效果是短暂的。10例患者影像学检查为疾病稳定（NC），2例为疾病进展（PD），1例为部分缓解（PR）。11例患者进行了手术切除，其中6例在显微镜下达到根治。平均生存期为26.8个月（范围1-86个月）。
在本研究和其他研究中观察到的HPP看似有利的药代动力学特征仍可能导致严重的全身毒性。在生存、局部（再）复发和疼痛减轻方面，在术前放疗中添加HPP似乎没有益处。使用丝裂霉素和马法兰的HPP似乎不是局部晚期盆腔肿瘤患者的治疗选择。
