Department of Oncology, S. Raffaele Scientific Institute, Milan, Italy.
Chemotherapy. 2011;57(2):156-61. doi: 10.1159/000324865. Epub 2011 Mar 31.
At the time of upfront treatment failure, over half of the patients with advanced pancreatic cancer are candidates for further treatment.
Patients with metastatic gemcitabine-resistant pancreatic cancer were treated with mitomycin 8 mg/m(2) on day 1, ifosfamide 2,500 mg/m(2) and mesna 3,000 mg/m(2) on days 1-3 every 28 days until progressive disease. A positive responder was defined as a patient who was progression free at 6 months from trial enrollment. According to the Fleming design, a sample size of 34 patients was estimated assuming p0 = 0.05 and p1 = 0.20.
Between May 2006 and December 2007, 21 patients (median age 56 years; median Karnofsky performance score 80) were enrolled. One patient died before receiving any treatment. Eighteen patients interrupted chemotherapy due to progressive disease (n = 15), toxicity (n = 2) or refusal (n = 1). Grade >2 toxicity consisted of neutropenia in 80% of patients, thrombocytopenia and fatigue in 20% and anemia in 10%. Only 1 patient was progression free at 6 months (5%). One patient had a partial response (5%) and 2 patients had stable disease (10%). Median survival was 3.7 months.
Based on the poor outcome observed and on the high level of grade 3-4 toxicity, the trial was prematurely stopped and the mitomycin and ifosfamide regimen was considered insufficiently active in gemcitabine-pretreated advanced pancreatic cancer.
在初始治疗失败时，超过一半的晚期胰腺癌患者是进一步治疗的候选者。
转移性吉西他滨耐药性胰腺癌患者接受丝裂霉素 8mg/m²（第 1 天）、异环磷酰胺 2500mg/m² 和美司钠 3000mg/m²（第 1-3 天），每 28 天一次，直至疾病进展。阳性反应者定义为从试验入组起 6 个月时无进展的患者。根据 Fleming 设计，假设 p0=0.05 和 p1=0.20，估计需要 34 例患者的样本量。
2006 年 5 月至 2007 年 12 月，共入组 21 例患者（中位年龄 56 岁；中位 Karnofsky 表现评分 80）。1 例患者在接受任何治疗前死亡。18 例患者因疾病进展（n=15）、毒性（n=2）或拒绝（n=1）中断化疗。>2 级毒性包括 80%的患者中性粒细胞减少症、20%的血小板减少症和疲劳以及 10%的贫血。仅 1 例患者在 6 个月时无进展（5%）。1 例患者有部分缓解（5%），2 例患者有稳定疾病（10%）。中位生存期为 3.7 个月。
根据观察到的不良结果和 3-4 级毒性的高发生率，该试验提前终止，丝裂霉素和异环磷酰胺方案被认为在吉西他滨预处理的晚期胰腺癌中活性不足。
