Kollmannsberger C, Schleucher N, Rick O, Metzner B, Hartmann J T, Schöffski P, Beyer J, Casper J, Sosada M, Schmoll H-J, Böhlke I, Meisner C, Kanz L, Bokemeyer C
Department of Hematology/Oncology, University of Tuebingen, Germany.
Eur J Cancer. 2003 Apr;39(6):775-82. doi: 10.1016/s0959-8049(03)00003-0.
The aim of this study was to identify treatment strategies and therapeutic or clinical factors that predict for response to salvage therapy and survival in patients with metastatic 'Indiana advanced' or International Germ-Cell Cancer Collaborative Group (IGCCCG) poor prognosis' germ cell cancer (GCT) failing first-line sequential high-dose chemotherapy plus autologous stem cell support (HD-CT). A total of 58 'poor prognosis' patients who had relapsed after HD-CT were identified within two large prospective German first-line HD-CT trials (n=286) performed between March 1993 and March 2001. Salvage treatment consisted of the following: cisplatin-based conventional dose CTx+/-resection (19/58; 33%), non-cisplatin based CTx (16/58; 28%) or salvage HD-CT (14/58; 24%)+/-resection; resection (n=3) and/or radiation (n=5) only: 7 patients (12%); no specific therapy: 2 patients. 21 (38%) patients responded favourably (Complete Response (CR)/Partial Response (PR) marker-negative) to salvage therapy. The use of salvage HD-CT (2-year survival 48%; P=0.03, the complete resection of residual masses (2-year survival 42%; P=0.015) as well as a favourable response to salvage therapy (2-year survival: 31%, P=0.014) were the only variables on univariate analysis associated with an improved survival. The estimated 2-year overall survival rate is 32% (95% Confidence Interval CI: 29-45%). Approximately 30% of patients relapsing after first-line HD-CT will survive>2 years, particularly those patients who can be treated with a second HD-CT +and/or surgical resection. If feasible, complete surgical resection of residual tumours appears to be the most efficient treatment.
本研究的目的是确定治疗策略以及治疗或临床因素,这些因素可预测转移性“印第安纳晚期”或国际生殖细胞癌协作组(IGCCCG)预后不良的生殖细胞癌(GCT)患者在一线序贯大剂量化疗加自体干细胞支持(HD-CT)失败后对挽救治疗的反应及生存情况。在1993年3月至2001年3月期间进行的两项大型德国前瞻性一线HD-CT试验(n = 286)中,共确定了58例HD-CT后复发的“预后不良”患者。挽救治疗包括以下几种:以顺铂为基础的常规剂量化疗±手术切除(19/58;33%)、非顺铂为基础的化疗(16/58;28%)或挽救性HD-CT(14/58;24%)±手术切除;仅手术切除(n = 3)和/或放疗(n = 5):7例患者(12%);未进行特定治疗:2例患者。21例(38%)患者对挽救治疗反应良好(完全缓解(CR)/部分缓解(PR),标志物阴性)。单因素分析显示,挽救性HD-CT的使用(2年生存率48%;P = 0.03)、残留肿块的完全切除(2年生存率42%;P = 0.015)以及对挽救治疗的良好反应(2年生存率:31%,P = 0.014)是与生存改善相关的唯一变量。估计2年总生存率为32%(95%置信区间CI:29 - 45%)。一线HD-CT后复发的患者中约30%将存活超过2年,尤其是那些能够接受第二次HD-CT和/或手术切除治疗的患者。如果可行,残留肿瘤的完全手术切除似乎是最有效的治疗方法。