Christman K, Kelsen D, Saltz L, Tarassoff P G
Department of Medicine, Memorial Sloan-Kettering Cancer Center, Cornell University Medical College, New York, New York.
Cancer. 1994 Jan 1;73(1):5-7. doi: 10.1002/1097-0142(19940101)73:1<5::aid-cncr2820730103>3.0.co;2-#.
Approximately 22,000 new cases of gastric cancer are diagnosed each year in the United States, most of which are advanced disease and thus are not curable by surgery. Chemotherapy has had little impact on patient survival. Consequently, the evaluation of new agents is needed. Gemcitabine, a cytosine arabinoside analogue, was evaluated in a Phase II trial to assess its efficacy in previously untreated patients with advanced gastric cancer.
Patients were treated with weekly gemcitabine, 800 mg/m2, for 3 consecutive weeks, followed by a 1-week rest period. Eighteen patients were enrolled. Fifteen patients were evaluable for response; 2 patients refused therapy before the completion of one cycle of treatment, and one patient was found to have nonmeasurable disease.
No major objective responses were seen. Two minor responses occurred. One patient with a minor response was removed from the study at his request after ten cycles of treatment. The other patient remains on the study with stable disease at more than 17 months. Toxicities on this study were mild. Median leukocyte count and platelet nadirs were 5.0 (range, 2.2-51.0) and 234,000/microliters (range, 59,000-554,000/microliters), respectively.
Gemcitabine at this dose and schedule has no significant antitumor activity in gastric cancer.
在美国，每年约有22000例新确诊的胃癌病例，其中大多数为晚期疾病，因此无法通过手术治愈。化疗对患者生存率影响甚微。因此，需要评估新的药物。吉西他滨是一种阿糖胞苷类似物，在一项II期试验中对其在先前未接受治疗的晚期胃癌患者中的疗效进行了评估。
患者接受每周一次的吉西他滨治疗，剂量为800mg/m²，连续3周，随后休息1周。共招募了18名患者。15名患者可评估疗效；2名患者在完成一个治疗周期前拒绝治疗，1名患者被发现患有不可测量的疾病。
未观察到主要客观缓解。出现了2例轻微缓解。1例出现轻微缓解的患者在接受10个周期治疗后应其要求退出研究。另一名患者仍在研究中，疾病稳定超过17个月。本研究中的毒性反应较轻。白细胞计数中位数和血小板最低点分别为5.0（范围2.2 - 51.0）和234,000/微升（范围59,000 - 554,000/微升）。
该剂量和方案的吉西他滨在胃癌中无显著抗肿瘤活性。
