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First-line sequential high-dose VIP chemotherapy with autologous transplantation for patients with primary mediastinal nonseminomatous germ cell tumours: a prospective trial

机译:一线序贯大剂量VIP化疗加自体移植治疗原发性纵隔非精原细胞性生殖细胞瘤患者:一项前瞻性试验

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To determine the efficacy of first-line sequential high-dose VIP chemotherapy (HD-VIP) in patients with primary mediastinal nonseminomatous germ cell tumours (GCT), 28 patients were enrolled on a German multicentre trial. High-Dose VIP chemotherapy consisted of 3–4 cycles of dose-intensive etoposide and ifosfamide plus cisplatin, q22days, each cycle followed by autologous peripheral blood stem cell transplantation plus granulocyte-colony stimulating factor (G-CSF) support. One cycle of standard-dose VIP was applied to harvest peripheral blood stem cells. Ten patients had mediastinal involvement as the only manifestation (36 %), 18 of 28 patients had additional metastatic sites, such as lung (n=17; 61%), liver (n=7; 25%), bone (n=5; 18%), lymph nodes (n=3; 11%) and CNS (n=3; 11%). Median follow-up was 43 months (range, 7–113) for all patients and 52 months (range, 22–113) for surviving patients. Nineteen of 28 patients obtained a disease-free status; 11 with HD-VIP alone and eight with adjunctive surgery. In addition, one of the four patients with marker negative partial remission after HD-VIP without resection of residual masses is currently alive. Two patients developed recurrence of GCT or teratoma. Two patients have died due to an associated haematologic disorder. The 2-year progression-free survival and overall survival rates are 64 and 68%, respectively. This report represents a subgroup analysis of 28 patients with mediastinal nonsemina within the German first-line study for ‘poor prognosis’ GCT. Compared to data of an international database analysis including 253 patients with mediastinal nonseminoma treated with conventional chemotherapy, the results may indicate that HD-VIP results in an approximately 15% survival improvement.
机译:为了确定一线序贯大剂量VIP化疗(HD-VIP)在原发性纵隔非精原细胞性生殖细胞肿瘤(GCT)患者中的疗效,我们在德国的一项多中心试验中招募了28名患者。大剂量VIP化疗由3到4个剂量密集型依托泊苷和异环磷酰胺加顺铂组成,每22天一次,每个周期后进行自体外周血干细胞移植以及粒细胞集落刺激因子(G-CSF)支持。将一个周期的标准剂量VIP收集到外周血干细胞中。 10例患者以纵隔受累为唯一表现(36%),28例患者中有18例具有其他转移部位,例如肺(n = 17; 61 %),肝(n = 7; 25 %),骨骼( n = 5; 18%),淋巴结(n = 3; 11%)和CNS(n = 3; 11%)。所有患者的中位随访时间为43个月(范围7–113),存活患者的中位随访时间为52个月(范围22–113)。 28名患者中有19名获得了无病状态; 11例单独使用HD-VIP,8例进行辅助手术。此外,HD-VIP后未切除残余肿块的4例标志物阴性部分缓解的患者中,有1例仍活着。两名患者发生GCT或畸胎瘤复发。两名患者死于相关的血液系统疾病。 2年无进展生存率和总生存率分别为64%和68%。该报告代表了德国针对“预后不良” GCT的一线研究中对28例纵隔性非呕吐患者的亚组分析。与包括253例接受常规化学疗法治疗的纵隔非精原细胞瘤患者的国际数据库分析数据相比,结果可能表明HD-VIP可使生存率提高约15%。

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