Brett B T, Smith S C, Bouvier C V, Michaeli D, Hochhauser D, Davidson B R, Kurzawinski T R, Watkinson A F, Van Someren N, Pounder R E, Caplin M E
Department of Medicine, Royal Free Hospital National Health Service Trust, London, United Kingdom.
J Clin Oncol. 2002 Oct 15;20(20):4225-31. doi: 10.1200/JCO.2002.11.151.
The prognosis for advanced pancreatic cancer remains poor. Gastrin acts as a growth factor for pancreatic cancer. We describe the first study of the antigastrin immunogen G17DT in pancreatic cancer. Our aims were to determine the antibody response, safety, tolerability, and preliminary evidence of efficacy of G17DT in advanced pancreatic cancer.
Thirty patients with advanced pancreatic cancer were immunized with three doses of either 100 micro g or 250 micro g of G17DT.
In the whole group, 20 (67%) of 30 patients produced an antibody response. The 250- micro g dose resulted in a significantly greater response rate of 82% compared with 46% for the 100- micro g group (P =.018). The most significant side effects, seen in three patients, were local abscess and/or fever. The median survival for the whole group from the date of the first immunization was 187 days; median survival was 217 days for the antibody responders and 121 days for the antibody nonresponders. The difference in survival between the antibody responders and nonresponders was significant (P =.0023).
Patients with advanced pancreatic cancer are able to mount an adequate antibody response to G17DT. The 250- micro g dose is superior to the 100- micro g dose, and it appears to be generally well tolerated. Antibody responders demonstrate significantly greater survival than antibody nonresponders. Phase III studies are currently underway in order to determine efficacy.
晚期胰腺癌的预后仍然很差。胃泌素作为胰腺癌的一种生长因子。我们描述了抗胃泌素免疫原G17DT在胰腺癌中的首次研究。我们的目的是确定G17DT在晚期胰腺癌中的抗体反应、安全性、耐受性以及疗效的初步证据。
30例晚期胰腺癌患者接受了三剂100μg或250μg的G17DT免疫接种。
在整个研究组中，30例患者中有20例（67%）产生了抗体反应。250μg剂量组的反应率显著更高，为82%，而100μg剂量组为46%（P = 0.018）。在3例患者中观察到的最显著副作用是局部脓肿和/或发热。从首次免疫接种之日起，整个研究组的中位生存期为187天；抗体反应者的中位生存期为217天，抗体无反应者为121天。抗体反应者和无反应者之间的生存期差异显著（P = 0.0023）。
晚期胰腺癌患者能够对G17DT产生足够的抗体反应。250μg剂量优于100μg剂量，并且似乎总体耐受性良好。抗体反应者的生存期明显长于抗体无反应者。目前正在进行III期研究以确定疗效。
