Langer Thorsten, Stöhr Wolfgang, Bielack Stefan, Paulussen Michael, Treuner Jörn, Beck Jörn D
LESS Center, University Hospital for Children and Adolescents, Department of Pediatric Oncology, Erlangen, Germany.
Pediatr Blood Cancer. 2004 Apr;42(4):373-9. doi: 10.1002/pbc.10325.
In 1998, a prospective multicenter pilot study of the 'Late Effects Surveillance System' (LESS) was started to investigate late effects of patients with Ewing, osteo- or soft-tissue sarcoma.
Two hundred thirty patients were included in this pilot study. The patients were treated between 1/1/1998 and 6/30/1999 according to the sarcoma protocols COSS-96, CWS-96, and EICESS-92, the median cumulative doses of the focussed drugs were for cisplatin: 360 mg/m(2), for doxorubicin: 270 mg/m(2), and for ifosfamide: 24 g/m(2). The patients were investigated using an organ related standardized screening methodology. We report on toxicities in the first year after cessation of therapy-the beginning of the patient follow-up-and the feasibility of LESS.
Cardiotoxicity: 16/129 (12%) patients treated with doxorubicin exhibited a reduced systolic heart function (fractional shortening (FS) <29%). Altogether three patients required cardiac drug therapy. Ototoxicity: In 5/73 (7%) patients treated with cisplatin a hearing deficit <4 kHz (>20 dB) was found. One patient needed a hearing aid. Nephrotoxicity: 2 of 214 (1%) patients treated with ifosfamide suffered from a tubulopathy, which required supplementation therapy. 10/50 (20%) showed a reduced fractional phosphate reabsorption. Incidence of hypomagnesemia was significantly increased in patients additionally treated with cisplatin.
Some relevant impairments are noted in the first year after antineoplastic therapy. We expect to detect more major late sequelae in our prospective study during the increasing posttherapeutic interval. Our pilot study shows the feasibility of the methodology.
1998年,启动了一项关于“晚期效应监测系统”(LESS)的前瞻性多中心试点研究,以调查尤因肉瘤、骨肉瘤或软组织肉瘤患者的晚期效应。
230名患者纳入了这项试点研究。这些患者在1998年1月1日至1999年6月30日期间根据肉瘤治疗方案COSS - 96、CWS - 96和EICESS - 92进行治疗,所关注药物的中位累积剂量分别为:顺铂360mg/m²、阿霉素270mg/m²、异环磷酰胺24g/m²。采用与器官相关的标准化筛查方法对患者进行调查。我们报告治疗停止后第一年(患者随访开始)的毒性以及LESS的可行性。
心脏毒性:129名接受阿霉素治疗的患者中有16名(12%)出现收缩期心脏功能降低(缩短分数(FS)<29%)。共有3名患者需要心脏药物治疗。耳毒性:73名接受顺铂治疗的患者中有5名(7%)发现听力障碍<4kHz(>20dB)。1名患者需要助听器。肾毒性:214名接受异环磷酰胺治疗的患者中有2名(1%)患有肾小管病,需要补充治疗。50名患者中有10名(20%)显示磷酸盐重吸收分数降低。额外接受顺铂治疗的患者低镁血症发生率显著增加。
在抗肿瘤治疗后的第一年发现了一些相关损伤。我们预计在后续前瞻性研究的治疗后间隔期延长过程中会发现更多严重的晚期后遗症。我们的试点研究表明了该方法的可行性。