Clinical evaluation and safety of loxiglumide (CCK-A receptor antagonist) in nonresectable pancreatic cancer patients. Italian Pancreatic Cancer Study Group.
Clinical evaluation and safety of loxiglumide (CCK-A receptor antagonist) in nonresectable pancreatic cancer patients. Italian Pancreatic Cancer Study Group.
复制标题
洛昔格鲁米特（CCK-A 受体拮抗剂）在不可切除的胰腺癌患者中的临床评估和安全性。
作者：
C. Militello;C. Sperti;F. Di Prima;S. Pedrazzoli
目的：观察胆囊收缩素A（CCK-A）受体拮抗剂洛昔鲁胺（loxiglumide）治疗晚期胰腺癌的疗效和安全性。在64例组织学诊断为不可切除的胰腺癌患者中进行了一项前瞻性、对照（2.4 g/天vs.安慰剂）、随机、双盲、平行组研究。根据性别和分期对患者进行分层（A，T3/N 0-N1/M0; B，T1-T2-T3/N 0-N1/M1; C，手术切除后复发）。肿瘤大小（通过计算机断层扫描）和死亡率作为疗效标准进行评价。每6周检查一次临床症状和体征、实验室检查和不良反应，作为疗效/耐受性标准。考虑了42名男性和22名女性患者。在两个治疗组中证实了患者的均匀分布。由于C组患者数量较少，因此未对生存率和肿瘤进展进行统计学评价。3名患者因与治疗无关的原因退出。未报告药物毒性反应。A组和B组中的肿瘤大小监测表明，洛昔鲁胺组和安慰剂组中的肿瘤大小增加相似。A组的生存率高于B组（p = 0.0003）。在B组中，女性（F）的生存期低于男性（M）（F = 61.00 +/- 6.47天，M = 140.44 +/- 22.15天; p = 0.012），而A组和总体分析中按性别列出的生存期相似。A组和B组的治疗生存率相似。手术缓解患者的手术生存率高于非手术患者（p = 0.049）。肿瘤分级影响生存率，但不因治疗而异。总之，我们的结果并未证实洛昔谷胺在晚期胰腺癌中的确切疗效。考虑到其记录的肿瘤生长抑制作用，我们建议对洛昔谷胺进行切除术后复发预防试验。
The effects and safety of loxiglumide, a cholecystokinin-A (CCK-A) receptor antagonist, on advanced pancreatic cancer were investigated in humans. A perspective, controlled (2.4 g/day vs. placebo), randomized, double-blind, parallel-group study was performed in 64 patients affected by nonresectable histologically diagnosed pancreatic cancer. The patients were stratified according to sex and stage (A, T3/N0-N1/M0; B, T1-T2-T3/N0-N1/M1; C, relapse after surgical exeresis). Tumor size (by computed tomography scan) and mortality rate were evaluated as efficacy criteria. Clinical symptoms and physical signs, laboratory tests, and adverse reactions were checked every 6 weeks as efficacy/tolerability criteria. Forty-two male and twenty-two female patients were considered. A homogeneous distribution of the patients was demonstrated in the two treatment groups. Group C was not statistically evaluated for survival and tumor evolution because of its small number. Three patients dropped out for causes not related to the therapy. No toxic reactions to the drug were reported. Tumor size monitoring within groups A and B demonstrated a similar increase in both the loxiglumide and the placebo group. Survival in group A was higher than in group B (p = 0.0003). In group B, survival was lower in females (F) than in males (M) (F = 61.00 +/- 6.47 days, M = 140.44 +/- 22.15 days; p = 0.012), while survival by sex was similar in group A and in global analysis. Survival by treatment was similar for groups A and B. Survival by surgery was higher (p = 0.049) for surgical palliation than for nonoperated patients. The tumor grade affected survival but it did not vary by therapy. In conclusion, sure efficacy of loxiglumide in advanced pancreatic cancer was not demonstrated by our results. In consideration of its documented tumor growth inhibiting action, we suggest that loxiglumide be tested for recurrence prevention after resective surgery.