Schmidt-Sandte W, Dageförde J, Klapdor R, Wagner T, Wiedemann G J
Medizinische Universität Lübeck, Medizinische Klinik 1, Germany.
Anticancer Res. 1999 Jul-Aug;19(4A):2485-7.
In a previous phase II trial of ifosfamide (IFO) several patients with pancreatic cancer responded to therapy (1). Trofosfamide (TROFO) is an orally taken oxazaphosphorine prodrug. Metabolic products of TROFO include ifosfamide (IFO) and cyclophosphamide (CYCLO). In clinical pilot studies with TROFO against refractory malignancies mild toxicity was reported.
Since virtually all patients with advanced pancreatic cancer are symtomatic, we designed and conducted a prospective phase II trial to evaluate the activity of single agent therapy with TROFO given orally continuously (three times 50 mg daily), and to assess the toxicity, duration of remission, and overall survival of the treated patients.
16 patients were enrolled onto the study. In one patient a PR has been observed; the mayor response rate was 6%. The mayor toxicity was bone marrow toxicity with granulocytopenia (WHO grade II) and anemia (WHO grade II) in virtually all patients.
Single agent therapy with TROFO in patients with pancreatic cancer is safe and well tolerated; however, it shows low clinical activity.
在先前一项关于异环磷酰胺（IFO）的II期试验中，数名胰腺癌患者对治疗有反应（1）。曲磷胺（TROFO）是一种口服的氧氮磷啶前体药物。TROFO的代谢产物包括异环磷酰胺（IFO）和环磷酰胺（CYCLO）。在针对难治性恶性肿瘤的TROFO临床初步研究中，报告了轻度毒性。
由于几乎所有晚期胰腺癌患者都有症状，我们设计并开展了一项前瞻性II期试验，以评估持续口服TROFO单药治疗（每日3次，每次50mg）的活性，并评估治疗患者的毒性、缓解持续时间和总生存期。
16名患者入组该研究。在1名患者中观察到部分缓解（PR）；主要缓解率为6%。主要毒性是骨髓毒性，几乎所有患者都出现粒细胞减少（WHO II级）和贫血（WHO II级）。
TROFO单药治疗胰腺癌患者安全且耐受性良好；然而，其临床活性较低。
