Fetscher S, Brugger W, Engelhardt R, Kanz L, Hasse J, Frommhold H, Lange W, Mertelsmann R
Department of Internal Medicine, University of Freiburg Medical Center, Freiburg im Breisgau, Germany.
Ann Oncol. 1999 May;10(5):605-7. doi: 10.1023/a:1026462707001.
We conducted a phase I-II trial to assess the activity of standard-dose (SDC) and high-dose chemotherapy (HDC) with etoposide, ifosfamide, cis/carboplatin, and epirubicin (VIP-E, VIC-E) in 107 patients with limited-stage (LS, stage I-IIIB) and extensive stage (ES, stage IV) non-small-cell lung cancer (NSCLC).
Updated results of a previously published trial are presented.
Response rates and survival after VIP-E were comparable to those of other standard-dose combination chemotherapies in NSCLC. Treatment-related mortality (TRM) in SDC was 3% in LS-NSCLC, and 8% in ES-NSCLC. TRM was 4% in patients selected for HDC by response rate and performance score. Five-year survival in LS-NSCLC was 12% after SDC, and 18% after HDC; it was 0% for both treatment protocols in ES-NSCLC.
The activity of VIP-E SDC and VIC-E HDC is not superior to that of established protocols in the treatment of NSCLC. In view of the toxicity and TRM associated with this protocol, less aggressive regimens should be preferred for most patients. Whether selected patients with chemosensitive disease could benefit from VIP-E SDC and/or VIC-E HDC in an adjuvant or neo-adjuvant setting could not be determined within the scope of this study.
我们开展了一项I-II期试验，以评估依托泊苷、异环磷酰胺、顺铂/卡铂和表柔比星（VIP-E、VIC-E）组成的标准剂量化疗（SDC）和高剂量化疗（HDC）方案对107例局限期（LS，I-IIIB期）和广泛期（ES，IV期）非小细胞肺癌（NSCLC）患者的疗效。
呈现了一项既往发表试验的更新结果。
VIP-E方案的缓解率和生存率与NSCLC中其他标准剂量联合化疗方案相当。局限期NSCLC患者接受SDC治疗的治疗相关死亡率（TRM）为3%，广泛期NSCLC患者为8%。根据缓解率和体能状态评分选择接受HDC治疗的患者TRM为4%。局限期NSCLC患者接受SDC治疗后的5年生存率为12%，接受HDC治疗后为;广泛期NSCLC患者接受这两种治疗方案的5年生存率均为0%。
VIP-E SDC和VIC-E HDC方案在NSCLC治疗中的活性并不优于既定方案。鉴于该方案的毒性和TRM，对于大多数患者而言，应优先选择侵袭性较小的治疗方案。在本研究范围内，无法确定经选择的化疗敏感疾病患者在辅助或新辅助治疗中是否能从VIP-E SDC和/或VIC-E HDC方案中获益。
