Pilot Study of Oral Eniluracil/5-FU in the Palliation of Hormone-Refractory Prostate Cancer

M. Rosenthal, David M. Thomas, I. Davis, G. Toner, N. Noordin, J. Zalcberg
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引用次数: 1

Abstract

Objectives: Chemotherapy has an established role in the palliative therapy of patients with hormone-refractory prostate cancer (HRPC). However, optimal chemotherapy for HRPC remains poorly defined. This pilot study examined the activity and toxicity of oral 5-fluorouracil (5-FU) in combination with eniluracil for the treatment of patients with HRPC. Materials and Methods: Eighteen patients with HRPC and painful bone metastases were enrolled, although 1 patient was deemed ineligible because of incidental gastric cancer. The median age was 69 years (range, 57–82 years), median Eastern Cooperative Oncology Group performance status was 1 (range, 0–2) and median prostate specific antigen (PSA) level was 146 μg/l (range 4–2020 μg/l). Eniluracil (10 mg/m2) and 5-FU (1 mg/m2) were given orally, twice daily, for 28 days in 35-day cycles. Results: Two patients (11%) had partial pain responses (95% confidence interval, 0–29%), and 6 patients (35%) had stable pain for a minimum of 8 weeks. A reduction in analgesic use occurred in four patients (23%), and five patients (29%) experienced stable analgesic use. A partial PSA response (>50% reduction on at least two occasions, 5 weeks apart) was achieved in three patients (18%), and eight patients (48%) had stable PSA responses (PSA was rising pretreatment). Grade 4 diarrhea occurred in one patient. Grade 3 toxicities were as follows: anemia, 1 patient; lethargy, 1 patient; and deterioration in liver function, 1 patient. Conclusions: Oral eniluracil/5-FU is well tolerated in this patient population but has only modest activity. Studies in combination with other active agents may be warranted in patients with HRPC.
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口服依纽尿嘧啶/5-FU治疗激素难治性前列腺癌的初步研究
目的:化疗在激素难治性前列腺癌(HRPC)患者的姑息治疗中已经确立了作用。然而,HRPC的最佳化疗方案仍不明确。本初步研究考察了口服5-氟尿嘧啶(5-FU)联合伊纽尿嘧啶治疗HRPC患者的活性和毒性。材料与方法:纳入了18例HRPC伴疼痛性骨转移患者,其中1例患者因偶发胃癌而被认为不合格。年龄中位数为69岁(范围,57 ~ 82岁),东部肿瘤合作组表现状态中位数为1(范围,0 ~ 2),前列腺特异性抗原(PSA)水平中位数为146 μg/l(范围4 ~ 2020 μg/l)。依纽尿嘧啶(10 mg/m2)和5-FU (1 mg/m2)口服,每日2次,以35天为周期,疗程28天。结果:2例患者(11%)有部分疼痛反应(95%置信区间0-29%),6例患者(35%)至少有8周的稳定疼痛。4例患者(23%)镇痛药使用减少,5例患者(29%)镇痛药使用稳定。3例患者(18%)达到部分PSA缓解(至少两次,间隔5周降低50%),8例患者(48%)具有稳定的PSA缓解(PSA预处理上升)。1例患者出现4级腹泻。3级毒副反应如下:贫血1例;嗜睡1例;肝功能恶化,1例。结论:口服依纽尿嘧啶/5-FU在该患者群体中耐受性良好,但只有适度的活性。HRPC患者联合其他活性药物的研究可能是有必要的。
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