Ansari M S, Gupta N P
Department of Urology, All India Institute of Medical Sciences, New Delhi 110029, India.
Urol Oncol. 2004 Sep-Oct;22(5):415-20. doi: 10.1016/j.urolonc.2004.05.009.
In a prospective study we evaluated the efficacy of lycopene for the treatment of patients with metastatic hormone refractory prostate cancer.
Between January 2001 and December 2002, 20 consecutive patients (median age 72; range 56-90) with metastatic HRPC were enrolled in the study. Lycopene in the dose of 10 mg/day was administered for a period of 3 months. Inclusion criteria were patients previously treated with hormonal therapy now with clinical and biochemical evidence of disease progression. A complete response (CR) was defined as a normalization of PSA (<4 ng/mL) and the disappearance of any sign of disease for at least 8 weeks. A partial response was defined as a >50% decrease in PSA level for at least 8 weeks associated with improvement (or no worsening) in ECOG PS and relief of bone pain if present. Stable disease (SD) was defined as a <50% decrease or <25% increase in the PSA level associated with no worsening of ECOG PS and/or bone pain for at least 8 weeks.
One patient (5%) had complete response. Partial response was achieved in 6 (30%), disease remained stable in 10 (50%) and progressed in three (15%) patients. ECOG PS was Grade 0 in five, Grade I in 10 and Grade II in five of the 20 patients. It improved from Grade I to 0 in seven and Grade II to I in three patients. It deteriorated in three and remained unchanged in the rest seven patients. Bone pain was present in 16 (Grade 1 in six and Grade 2 in 10) of the 20 patients. Grade 1 changed to Grade 0 in five and Grade II changed to Grade 1 in five patients. Bone pain remained unchanged in 5 (31%) and worsened in 1 (6%). Ten (62%) patients managed to cut down the dose of analgesics on daily basis. Eighteen patients had associated LUTS, which improved (Q max > or = 12 mL/sec) in 11 (61%) patients. The median duration of response was 25 weeks (range 12-72 weeks). No drug intolerance or toxicity was encountered in any patient.
Lycopene therapy appears to be effective and safe in the treatment of HRPC. It not only takes care of the rising PSA but also improves the ECOG performance status, bone pain and LUTS. Because of its relative innocuousness it should be tried before the use of more toxic substances.
在一项前瞻性研究中，我们评估了番茄红素治疗转移性激素难治性前列腺癌患者的疗效。
2001年1月至2002年12月期间，20例连续的转移性激素难治性前列腺癌患者（中位年龄72岁；范围56 - 90岁）纳入本研究。给予剂量为10毫克/天的番茄红素，持续3个月。纳入标准为先前接受过激素治疗且目前有疾病进展的临床和生化证据的患者。完全缓解（CR）定义为前列腺特异性抗原（PSA）正常化（<4纳克/毫升）且疾病任何体征消失至少8周。部分缓解定义为PSA水平至少降低50%持续至少8周，同时伴有东部肿瘤协作组（ECOG）体能状态改善（或无恶化）以及若存在骨痛则疼痛缓解。疾病稳定（SD）定义为PSA水平降低<50%或升高<25%，同时ECOG体能状态和/或骨痛至少8周无恶化。
1例患者（5%）达到完全缓解。6例（30%）患者获得部分缓解，10例（50%）患者疾病稳定，3例（15%）患者病情进展。20例患者中，5例ECOG体能状态为0级，10例为I级，5例为II级。7例患者ECOG体能状态从I级改善为0级，3例从II级改善为I级。3例患者病情恶化，其余7例患者病情无变化。20例患者中有16例存在骨痛（6例为1级，10例为2级）。5例患者骨痛从1级变为0级，5例患者骨痛从2级变为1级。5例（31%）患者骨痛无变化，1例（6%）患者骨痛加重。10例（62%）患者成功减少了每日镇痛药剂量。18例患者伴有下尿路症状（LUTS），其中11例（61%）患者症状改善（最大尿流率Q max≥12毫升/秒）。缓解的中位持续时间为25周（范围12 - 72周）。未在任何患者中遇到药物不耐受或毒性反应。
番茄红素治疗在激素难治性前列腺癌治疗中似乎有效且安全。它不仅能控制PSA升高，还能改善ECOG体能状态、骨痛和下尿路症状。由于其相对无害，在使用毒性更大的物质之前应尝试使用。
