Bokemeyer C, Kollmannsberger C, Meisner C, Harstrick A, Beyer J, Metzner B, Hartmann J T, Schmoll H J, Einhorn L, Kanz L, Nichols C
Department of Hematology/Oncology, University of Tuebingen Medical Center, Tuebingen, Germany.
J Clin Oncol. 1999 Nov;17(11):3450-6. doi: 10.1200/JCO.1999.17.11.3450.
To compare first-line high-dose chemotherapy (HD-CT) with autologous blood stem-cell transplantation to standard-dose chemotherapy (SD-CT) in male patients with advanced germ cell tumors (GCTs), a matched-pair analysis was performed within a homogenous group of patients classified as having either Indiana advanced disease or a poor prognosis according to International Germ Cell Cancer Consensus Group (IGCCCG) criteria.
A multivariate analysis was performed that included 147 consecutive patients who had received sequential high-dose cisplatin, etoposide, and ifosfamide (VIP) therapy (HD-CT) in a German multicenter trial between 1993 and 1997 and 309 patients who had been treated with standard-dose cisplatin, etoposide, and bleomycin (PEB) or VIP chemotherapy (SD-CT) within two randomized trials at Indiana University between 1984 and 1992.
Multivariate analysis demonstrated HD-CT to be significantly superior to SD-CT when adjustments were made for prognostic factors (P =.021). Primary tumor site (mediastinal v retroperitoneal/gonadal, P =.035) and presence of visceral metastases (P =.0004) were shown to be significant prognostic factors for overall survival. On the basis of these factors, as well as on tumor marker levels (good, intermediate, or poor, according to IGCCCG criteria), 146 of 147 HD-CT patients were fully matched to an SD-CT patient. Median follow-up was 21 months (range, 0 to 70 months) for the HD-CT patients and 22 months (range, 0 to 90 months) for the SD-CT patients. Two-year progression-free survival (75% v 59%) and overall survival (82% v 71%) were significantly prolonged in HD-CT patients (P =.0056 and P =.0184, respectively).
The results indicate that first-line HD-CT in patients with poor-prognosis GCT may result in a significant improvement of progression-free and overall survival as compared with SD-CT. Salvage HD-CT seems not to compensate this survival advantage.
为比较一线大剂量化疗（HD-CT）联合自体血干细胞移植与标准剂量化疗（SD-CT）治疗晚期生殖细胞肿瘤（GCT）男性患者的疗效，在一组根据国际生殖细胞癌共识组（IGCCCG）标准被分类为患有印第安纳晚期疾病或预后不良的同质患者中进行了配对分析。
进行了一项多变量分析，纳入了1993年至1997年在一项德国多中心试验中连续接受序贯大剂量顺铂、依托泊苷和异环磷酰胺（VIP）治疗（HD-CT）的147例患者，以及1984年至1992年在印第安纳大学的两项随机试验中接受标准剂量顺铂、依托泊苷和博来霉素（PEB）或VIP化疗（SD-CT）的309例患者。
多变量分析显示，在对预后因素进行调整后，HD-CT显著优于SD-CT（P = 0.021）。原发肿瘤部位（纵隔对腹膜后/性腺，P = 0.035）和内脏转移的存在（P = 0.0004）被证明是总生存的显著预后因素。基于这些因素以及肿瘤标志物水平（根据IGCCCG标准为良好、中等或差），147例HD-CT患者中的146例与1例SD-CT患者完全匹配。HD-CT患者的中位随访时间为21个月（范围0至70个月），SD-CT患者为22个月（范围0至90个月） HD-CT患者的两年无进展生存率（75%对59%）和总生存率（82%对71%）显著延长（分别为P = 0.0056和P = 0.0184）。
结果表明，与SD-CT相比，一线HD-CT治疗预后不良的GCT患者可能会显著改善无进展生存率和总生存率。挽救性HD-CT似乎无法弥补这种生存优势。
