Moore M
Department of Medicine, Princess Margaret Hospital, University of Toronto, Canada.
Cancer. 1996 Aug 1;78(3 Suppl):633-8. doi: 10.1002/(SICI)1097-0142(19960801)78:3<633::AID-CNCR44>3.0.CO;2-X.
In early phase II trials in advanced pancreatic cancer, gemcitabine demonstrated modest antitumor activity. The investigators in these studies reported that gemcitabine should be studied further in view of the degree and frequency of symptomatic improvement observed, the durability of some of the remissions, and the favorable toxicity profile.
In order to quantify such symptomatic improvement, a rigorous endpoint of Clinical Benefit was developed that incorporated measures including pain intensity, analgesic consumption and performance status, which have been shown to be reliable and valid endpoints in other studies.
Two trials have been conducted using this methodology in patients with advanced pancreatic carcinoma.
The results of these studies suggest that gemcitabine is the first cytotoxic agent with any meaningful impact on survival and disease-related symptoms in advanced pancreatic adenocarcinoma. The degree of improvement seen is one which patients with cancer often consider to be most important. Further studies will be required to define more fully the role of gemcitabine in the treatment of pancreatic cancer.
在晚期胰腺癌的早期II期试验中，吉西他滨显示出适度的抗肿瘤活性。这些研究的研究者报告称，鉴于观察到的症状改善程度和频率、部分缓解的持久性以及良好的毒性特征，应对吉西他滨进行进一步研究。
为了量化这种症状改善情况，制定了一个严格的临床获益终点，该终点纳入了疼痛强度、镇痛药使用量和体能状态等指标，这些指标在其他研究中已被证明是可靠且有效的终点。
已使用这种方法对晚期胰腺癌患者进行了两项试验。
这些研究结果表明，吉西他滨是首个对晚期胰腺腺癌的生存及疾病相关症状有显著影响的细胞毒性药物。所观察到的改善程度是癌症患者通常认为最为重要的。需要进一步研究以更全面地明确吉西他滨在胰腺癌治疗中的作用。
