Zampino M G, Verri E, Locatelli M, Curigliano G, Ascione G, Sbanotto A, Rocca A, Verweij F, Matei V, Scardino E, Decobelli O, Goldhirsch A, Nolè F
Department of Medicine, European Institute of Oncology, 20141 Milan, Italy.
Anticancer Res. 2006 May-Jun;26(3B):2375-80.
No consensus exists regarding further therapy for the management of hormone-refractory prostate cancer. In this phase II study, the combination of Vinorelbine with 5-Fluorouracil and folinic acid (FLN regimen) was evaluated in patients with progressive or resistant disease after hormone therapy.
Thirty-four patients were treated with Vinorelbine at a dose of 20 mg/m2 intravenously (i.v.) on days 1 and 3, folinic acid (FA), 100 mg/m2 i.v. and 5-Fluorouracil (5-FU), 350 mg/m2 i.v. as a short infusion on days 1 to 3. The therapy was given in an out-patient setting, every 3 weeks.
All of the 34 eligible patients were evaluable for toxicity and 30 for activity. A total of 127 cycles was administered (91% at full dose). Among thelS5 patients with measurable disease, four had a partial response (26.6%; C.I. 95%, 28.3% to 65.7%) and four achieved stable disease. In 14 patients (47%) a clinical benefit was documented. Six out of 15 patients with bone-only involvement had stable disease (40%). The median duration of stabilization and partial response was 16 weeks (range 4-24 weeks). The most common toxicity was hematological: Grade 4 (NCI-CTC scale) in five patients at re-cycle. Other toxicities were of low incidence and easy to manage.
The encouraging results obtained with the FLN regimen in terms of clinical benefit and its predictable and manageable toxicity support the palliative role of this chemotherapeutic strategy in hormone-refractory prostate patients.
对于激素难治性前列腺癌的进一步治疗，目前尚无共识。在这项II期研究中，对激素治疗后病情进展或耐药的患者评估了长春瑞滨联合5-氟尿嘧啶和亚叶酸（FLN方案）的疗效。
34例患者接受长春瑞滨治疗，剂量为20mg/m²，于第1天和第3天静脉注射，亚叶酸（FA）100mg/m²静脉注射，5-氟尿嘧啶（5-FU）350mg/m²静脉注射，在第1天至第3天进行短时间输注。治疗在门诊进行，每3周一次。
34例符合条件的患者均可评估毒性，30例可评估疗效。共进行了127个周期的治疗（91%为全剂量）。在155例可测量疾病的患者中，4例出现部分缓解（26.6%；95%置信区间，28.3%至65.7%），4例病情稳定。14例患者（47%）有临床获益记录。15例仅骨转移的患者中有6例病情稳定（40%）。稳定和部分缓解的中位持续时间为16周（范围4 - 24周）。最常见的毒性是血液学毒性：5例患者在再治疗周期出现4级（NCI-CTC标准）毒性。其他毒性发生率低且易于处理。
FLN方案在临床获益方面取得的令人鼓舞的结果及其可预测和可管理的毒性，支持了这种化疗策略在激素难治性前列腺癌患者中的姑息治疗作用。
