Burris H, Storniolo A M
Brooke Army Medical Center, Fort San Houston 78234 Texas, USA.
Eur J Cancer. 1997 Jan;33 Suppl 1:S18-22. doi: 10.1016/s0959-8049(96)00324-3.
An early study with gemcitabine in pancreas cancer indicated greater relief of disease-related symptoms than expected from the objective tumour response rate. A novel design was created to assess changes in symptomatology prospectively in two studies. The design focuses on typical features seen in patients with advanced pancreas cancer (pain, impaired function, weight loss) and the endpoint is 'clinical benefit response'. Traditional endpoints of objective tumour response and survival were also included. In a randomised study, the clinical benefit response rate for gemcitabine was 24% compared with 5% for 5-fluorouracil (5-FU) (P = 0.0022). The median survival was 5.65 months for gemcitabine compared with 4.41 months for 5-FU (P = 0.0025). The corresponding objective response rates were 5.4% and 0%. Disease stabilised in 39% and 19% of gemcitabine and 5-FU patients, respectively. In a second study of 5-FU-refractory patients, 27.0% of patients were clinical benefit responders. The median survival in this second study was 3.8 months; the objective response rate was 11%, and 30% of patients had stable disease. These trials show that gemcitabine improves disease-related symptoms and survival in patients with pancreas cancer.
一项早期使用吉西他滨治疗胰腺癌的研究表明，与根据客观肿瘤缓解率预期的情况相比，疾病相关症状得到了更大程度的缓解。在两项研究中设计了一种新方法来前瞻性地评估症状学变化。该设计聚焦于晚期胰腺癌患者的典型特征（疼痛、功能受损、体重减轻），终点为“临床获益反应”。还纳入了客观肿瘤反应和生存等传统终点。在一项随机研究中，吉西他滨的临床获益反应率为24%，而5-氟尿嘧啶（5-FU）为5%（P = 0.0022）。吉西他滨组的中位生存期为5.65个月，5-FU组为4.41个月（P = 0.0025）。相应的客观缓解率分别为5.4%和0%。吉西他滨组和5-FU组分别有39%和19%的患者疾病稳定。在第二项针对5-FU难治性患者的研究中，27.0%的患者为临床获益反应者。第二项研究的中位生存期为3.8个月；客观缓解率为11%，30%的患者疾病稳定。这些试验表明，吉西他滨可改善胰腺癌患者的疾病相关症状并延长生存期。
