Paclitaxel in the neoadjuvant treatment for adeno carcinoma of the distal esophagus (AEG I).: A comparison of two phase II trials with long-term follow-up
Paclitaxel in the neoadjuvant treatment for adeno carcinoma of the distal esophagus (AEG I).: A comparison of two phase II trials with long-term follow-up
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DOI：
10.1159/000135515
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发表时间：
2008-01-01
期刊：
影响因子：
0.3
通讯作者：
Ott, Katja
中科院分区：
文献类型：
--
作者：
Bader, Franz G.;Lordick, Florian;Ott, Katja
前言：我们报道了两项关于铂/亚叶酸钙/5-氟尿嘧啶(PLF)+/-紫杉醇(T-PLF)新辅助治疗食管腺癌(AEG I)的序贯、前瞻性II期试验的对比分析。患者和方法：纳入标准为组织学证实的局部晚期AEG I期uT3/4anyN cM0/M1a。67例患者接受PLF(n=32)或T-PLF(n=35)治疗。分别于第1、15、29天加入紫杉醇(80 mg/m(2))。主要终点是响应。此外，对5年生存率进行了分析。结果：除了临床cm1a失衡(33.3%的PLF与8.6%的T-PLF；p=0.01)外，研究人群是很平衡的。组织病理学有效率(23.3%PLF vs.25.0%T-PLF)差异无统计学意义。T-PLF的临床有效率有所提高(21.9%vs.45.7%；p=0.04)。临床和组织病理学应答者的中位总存活率在T-PLF组显著提高(p=0.005.0 5，p=0.0 1)，但在PLF组(p=0.0 8，p=0.2 5)无明显改善。T-PLF组的中位总生存期较好，但无统计学意义(18.9个月与43.1个月；p=0.27)。紫杉醇的毒性略有增加。没有发生与治疗相关的死亡。结论：除临床反应外，我们的数据未能显示T-PLF方案在统计学上的显著优势。然而，有一种提高存活率的趋势。
Introduction: We report a comparative analysis of 2 sequential, prospective phase II trials on the efficacy of platinum/leucovorin/5-fluorouracil (PLF) +/- paclitaxel (T-PLF) in the neoadjuvant treatment of adenocarcinoma of the esophagus (AEG I). Patients and Methods: Inclusion criteria were histologically proven, locally advanced AEG I stage uT3/4 anyN cM0/M1a. 67 patients were treated with either PLF (n = 32) or T-PLF ( n = 35). Paclitaxel (80 mg/m(2)) was added to PLF on days 1, 15, and 29. Primary endpoint was the response. Additionally, 5-year survival was analyzed. Results: The study population was well balanced, apart from an imbalance in clinical cM1a (33.3% PLF vs. 8.6% T-PLF; p = 0.01). Histopathological response rates (23.3% PLF vs. 25.0% T-PLF) showed no significant difference. Clinical response rates were improved for T-PLF (21.9 vs. 45.7%; p = 0.04). Median overall survival for clinical and histopathological responders was significantly improved for T-PLF ( p = 0.005, p = 0.01), but not for PLF (p = 0.08, p = 0.25). Median overall survival was better with T-PLF without reaching statistical significance (18.9 months PLF vs. 43.1 months T-PLF; p = 0.27). Toxicity was slightly increased by paclitaxel. No treatment-related deaths occurred. Conclusion: Our data failed to demonstrate statistically significant superiority of the T-PLF regimen except for clinical response. However, there was a trend towards improved survival.