Pace Marcello, Gattai Riccardo, Matteini Maria, Mascitelli Erminia Macera, Bechi Paolo
Dept, of Medical and Surgical Critical Care, University of Florence, Regional Reference Centre of Tuscany for Locoregional Perfusional Therapies in Oncology, Florence, Italy.
J Exp Clin Cancer Res. 2008 Nov 12;27(1):67. doi: 10.1186/1756-9966-27-67.
The aim of this retrospective study was to assess the results concerning the regional and systemic toxicity and complications in 242 chemo-hyperthermal treatments (HILPs) for lower limb melanoma.
60 HILPs (G-A) were performed with mild HT plus L-PAM (10 mg/lt) +/- D-actimomycin; 74 HILPs (G-B) with true HT (40-41.8 degrees C) plus L-PAM (10 mg/lt) +/- D-act; 108 HILPs (G-C) with true HT plus L-PAM (10 mg/lt) +/- D-act plus L-PAM (5 mg/lt) additional bolus.
Limb toxicity was very low in G-A and in G-B; increasing toxicity (grade III = 37%) in G-C; no grade IV statistical difference was registered in all three groups, with percentage values among 1.6% and 2.7%. Systemic toxicity showed itself only in the haemopoietic parameters. No differences were registered in G-B vs G-A group. In G-C vs G-B a significative increase of systemic toxicity was seen in grade 3 (p < 0.05). Postoperative complications were acceptable. Local and systemic side-effects were transient; no permanent neurological limb deficit was registered. The postoperative mortality was recorded in 3/182 HILPs (1.6%) of the G-B and G-C groups.
These data suggested that the technical implementations reduced the occurrence and the severity of the side effects and complications. The essential requirement for HILP is the quality assurance of the procedures. Although higher regional and systemic toxicity were observed in the G-C group caused by L-PAM additional bolus, the safeness of the procedures under the true hyperthermal regimen and the time increase of the high L-PAM concentration have assured the treatment reliability along with the increased clinical efficacy expectations of the treatments.
这项回顾性研究的目的是评估242例下肢黑色素瘤化学热疗（热灌注隔离肢体化疗，HILPs）的局部和全身毒性及并发症结果。
60例热灌注隔离肢体化疗（G-A组）采用温和热疗加左旋苯丙氨酸氮芥（L-PAM，10mg/L）+/-放线菌素D进行；74例热灌注隔离肢体化疗（G-B组）采用真正的热疗（40 - 41.8摄氏度）加左旋苯丙氨酸氮芥（10mg/L）+/-放线菌素D；108例热灌注隔离肢体化疗（G-C组）采用真正的热疗加左旋苯丙氨酸氮芥（10mg/L）+/-放线菌素D加额外推注左旋苯丙氨酸氮芥（5mg/L）。
G-A组和G-B组肢体毒性非常低；G-C组毒性增加（III级 = 37%）；所有三组中均未记录到IV级统计学差异，百分比值在1.6%至2.7%之间。全身毒性仅在造血参数方面表现出来。G-B组与G-A组之间未记录到差异。G-C组与G-B组相比，3级全身毒性有显著增加（p < 0.05）。术后并发症可接受。局部和全身副作用是短暂的；未记录到永久性神经肢体功能缺损。G-B组和G-C组的182例热灌注隔离肢体化疗中有3例（1.6%）记录到术后死亡率。
这些数据表明技术实施降低了副作用和并发症的发生率及严重程度。热灌注隔离肢体化疗的基本要求是程序的质量保证。尽管G-C组因额外推注左旋苯丙氨酸氮芥观察到更高的局部和全身毒性，但在真正的热疗方案下程序的安全性以及高左旋苯丙氨酸氮芥浓度的时间增加确保了治疗的可靠性以及对治疗临床疗效期望的提高。
