Guadagni S, Fiorentini G, Palumbo G, Valenti M, Russo F, Cantore M, Deraco M, Vaglini M, Amicucci G
Department of Surgery, University of L'Aquila, L'Aquila, Italy.
Arch Surg. 2001 Jan;136(1):105-12. doi: 10.1001/archsurg.136.1.105.
To evaluate the role of hypoxic pelvic perfusion in providing therapeutic options for palliation without relevant complications in a homogeneous group of patients with unresectable locally recurrent rectal cancer who are nonresponders or have disease progression after the standard treatments.
Nonrandomized and noncontrolled phase II experimental study.
University hospital, L'Aquila, and the National Cancer Institute, Naples and Milan, Italy.
Eleven patients had symptomatic unresectable pelvic recurrent rectal cancer. The mean +/- SD product of the 2 maximum perpendicular diameters of the recurrent cancer was 24.2 +/- 11.0 cm(2) (range, 10-48 cm(2)). Tumor fixation to the pelvic side walls or proximal sacrum were the main criteria for unresectability. All patients were free from extrapelvic disease and had a life expectancy longer than 3 months.
Patients were submitted to one course of pelvic perfusion with mitomycin C (MMC) (25 mg/m(2)) by means of a simplified balloon occlusion technique. A pharmacokinetic evaluation of the procedure was also performed.
Response rate and time to disease progression were the primary endpoints; overall survival was the secondary endpoint.
Mean +/- SD value of the ratios of pelvic MMC area under the plasma concentration curve (0 to 20 minutes) (AUC(0-20)) to systemic MMC AUC(0-20) was 13.30 +/- 6.52. During the procedures there were no technical, hemodynamic, or vascular complications, and no deaths occurred during surgery or in the postoperative period. The response rate was 36.3% (95% confidence interval [CI], 6.5%-66.1%). Pain response rate was 45.4% (95% CI, 16.6%-76.2%). Median survival was 12.2 months (range, 5.7-19.5 months). Median time to disease progression was 6 months (range, 3-8 months). Two-year overall survival was 9.1%.
Hypoxic pelvic perfusion with MMC is a safe and good palliative treatment for patients with unresectable locally recurrent rectal cancer. Further studies are necessary to establish if a different sequence in the multimodular treatment of these patients could be more useful.
评估低氧盆腔灌注在为一组同质的不可切除的局部复发性直肠癌患者提供姑息治疗选择且无相关并发症方面的作用，这些患者对标准治疗无反应或疾病进展。
非随机、非对照的II期实验研究。
意大利拉奎拉大学医院以及那不勒斯和米兰的国家癌症研究所。
11例有症状的不可切除的盆腔复发性直肠癌患者。复发性癌最大垂直直径的2个乘积的平均值±标准差为24.2±11.0 cm²（范围为10 - 48 cm²）。肿瘤固定于盆腔侧壁或近端骶骨是不可切除的主要标准。所有患者均无盆腔外疾病，预期寿命超过3个月。
患者通过简化球囊阻塞技术接受1个疗程的丝裂霉素C（MMC）（25 mg/m²）盆腔灌注。还对该操作进行了药代动力学评估。
缓解率和疾病进展时间为主要终点；总生存期为次要终点。
盆腔MMC血浆浓度曲线下面积（从0至20分钟）（AUC(0 - 20)）与全身MMC AUC(0 - 20)比值的平均值±标准差为13.30±6.52。操作过程中未出现技术、血流动力学或血管并发症，手术期间或术后均未发生死亡。缓解率为36.3%（95%置信区间[CI]，6.5% - 66.1%）。疼痛缓解率为45.4%（95% CI，16.6% - 76.2%）。中位生存期为12.2个月（范围为5.7 - 19.5个月）。疾病进展的中位时间为6个月（范围为3 - 8个月）。两年总生存率为9.1%。
MMC低氧盆腔灌注对不可切除的局部复发性直肠癌患者是一种安全且良好的姑息治疗方法。有必要进一步研究确定这些患者多模式治疗的不同顺序是否更有用。
