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Phase II Trial of the Antiestrogen Toremifene for Androgen‐Independent Prostate Cancer 抗雌激素托瑞米芬治疗雄激素不依赖型前列腺癌的II期试验
Pub Date : 1999-07-01 DOI: 10.1046/J.1525-1411.1999.14003.X
Matthew R. Smith, P. Kantoff, W. Oh, Grace A. Elson, J. Manola, M. McMullin, J. Jacobsen, A. Brufsky, D. Kaufman
Objectives: Estrogen receptors are expressed in healthy and malignant prostate epithelium. Previous studies of the antiestrogen tamoxifen (20–100 mg po qd) for recurrent or metastatic prostate cancer (CaP) reported response rates of 0–23%. These studies may have underestimated the activity of antiestrogens, however, because of their reliance on insensitive clinical and radiographic response criteria. In addition, treatment-related increases in androgen levels among men who initiated treatment with noncastrate testosterone levels may have confounded the results. The aims are to evaluate the activity of the antiestrogen toremifene, a triphenylethylene derivative antiestrogen related chemically and pharmacologically to tamoxifen, in men with androgen-independent CaP using prostate specific antigen (PSA) response criteria and to determine the effect of toremifene treatment on serum testosterone levels in castrated men. Materials and Methods: Fifteen men (median age 71 years; median PSA 58.5 ng/ml) with castrate testosterone levels, no disease-related symptoms, and rising PSA after androgen deprivation and antiandrogen withdrawal were treated with toremifene, 60 mg po qd, until it was determined that the patient was not responding to treatment. Nonresponse to treatment was defined as symptomatic disease progression or a PSA level 150% study nadir on two determinations at least 4 weeks apart. Response was defined as >50% PSA decrease on two determinations at least 4 weeks apart. Results: Twelve men were evaluable for response. Median time to determination of nonresponse to treatment was 16 weeks (range 8 to 19 weeks). There were no responses to treatment (response rate 0%; 95% confidence interval 0–22%). Treatment did not significantly change serum testosterone levels. Conclusions: These results indicate that toremifene is inactive for the treatment of androgen-independent CaP and suggest that antiestrogens should not be used routinely as secondary hormonal therapy. The treatment of castrated men with toremifene does not significantly change serum testosterone levels.
目的:雌激素受体在健康和恶性前列腺上皮中表达。先前的研究表明,抗雌激素他莫昔芬(20 - 100mg,每日一次)治疗复发或转移性前列腺癌(CaP)的有效率为0-23%。然而,这些研究可能低估了抗雌激素的活性,因为它们依赖于不敏感的临床和放射学反应标准。此外,在接受非阉割睾丸激素水平治疗的男性中,治疗相关的雄激素水平升高可能会混淆结果。目的是利用前列腺特异性抗原(PSA)反应标准评估抗雌激素药物托瑞米芬(一种与他莫昔芬在化学和药理学上相关的三苯乙烯衍生物抗雌激素药物)在雄激素非依赖性CaP患者中的活性,并确定托瑞米芬治疗对去势男性血清睾酮水平的影响。材料与方法:男性15例(中位年龄71岁;中位PSA 58.5 ng/ml),阉割睾酮水平,无疾病相关症状,雄激素剥夺和抗雄激素停药后PSA升高,用托瑞米芬治疗,60mg,每日一次,直到确定患者对治疗无反应。治疗无反应被定义为有症状的疾病进展或相隔至少4周的两次检测中PSA水平达到150%的研究最低点。缓解定义为间隔至少4周两次检测PSA降低>50%。结果:12名患者可评价疗效。确定治疗无反应的中位时间为16周(范围8至19周)。治疗无反应(有效率0%;95%置信区间0-22%)。治疗没有显著改变血清睾酮水平。结论:这些结果表明,托瑞米芬对雄激素非依赖性CaP的治疗无效,并提示抗雌激素不应常规用作辅助激素治疗。用托瑞米芬治疗去势男性不会显著改变血清睾酮水平。
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引用次数: 1
The Role of Laparoscopy in Prostate Cancer Staging 腹腔镜检查在前列腺癌分期中的作用
Pub Date : 1999-07-01 DOI: 10.1046/J.1525-1411.1999.14004.X
S. Jackman, L. Kavoussi
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引用次数: 0
Bacillus Calmette‐Guerin Immunotherapy Significantly Prolongs Survival of Animals with Prostate Cancer 卡介苗- Guerin免疫疗法显著延长前列腺癌动物的生存期
Pub Date : 1999-07-01 DOI: 10.1046/J.1525-1411.1999.14009.X
D. Lamm, D. Riggs, David A. Donley, Justin White, R. Yeater, R. Bryner
Objectives: Bacillus Calmette-Guerin (BCG) is the treatment of choice for carcinoma in situ of the bladder, but its application to other cancers is very limited. The current study evaluates the effect of intralesional BCG in the PA3 rat prostate cancer model. Materials and Methods: One hundred five rats were randomized to four groups. Each group received 1 × 106 PA3 cells subcutaneously on experiment Day 0. On experimental Day 7, the groups received the first of six weekly treatments. Treatments consisted of saline solution, BCG 1 × 104 colony-forming units (cfu), BCG 1 × 105 cfu, and BCG 1 × 106 cfu. All animals were monitored for tumor growth throughout the duration of the experiment. Results: Animals receiving treatments with BCG 1 × 106 cfu exhibited the greatest reduction in tumor volume ([mean ± SD] 4130.0 ± 1738.3 mm3; p = 0.0738), followed by those receiving BCG 1 × 104 cfu (4527.6 ± 1932.7 mm3; p = 0.1093) and BCG 1 × 105 cfu (4838.2 ± 1889.9 mm3; p = 0.5218), compared to those receiving the saline solution control (5445.0 ± 3119.5 mm3). Animal survival on Day 60 after transplantation was significantly increased in the group receiving BCG 1 × 106 cfu (19 [73.1%] of 26 animals; p = 0.0326) when compared to those receiving the saline solution control (12 [44%] of 27 animals). Treatment with BCG 1 × 105 cfu (11 [42.3%] of 26 animals survived; p = 0.5479) and BCG 1 × 104 cfu (13 [50%] of 26 animals survived; p = 0.4484) also reduced survival compared to the saline solution control, but not to the level of significance. Conclusions: The consistent reduction in tumor growth and animal mortality in animals receiving intralesional BCG demonstrates antitumor activity in this aggressive model of prostate cancer. The greatest efficacy was seen with the highest dose of BCG, suggesting that higher doses may be optimal in this model. BCG immunotherapy of prostate cancer warrants clinical evaluation.
目的:卡介苗(Bacillus calmetet - guerin, BCG)是膀胱原位癌的首选治疗方法,但在其他肿瘤中的应用非常有限。本研究评估局灶内BCG在PA3大鼠前列腺癌模型中的作用。材料与方法:将105只大鼠随机分为4组。实验第0天,每组皮下注射1 × 106个PA3细胞。在实验第7天,各组接受每周6次治疗中的第一次。处理方法为生理盐水、BCG 1 × 104菌落形成单位(cfu)、BCG 1 × 105菌落形成单位、BCG 1 × 106菌落形成单位。在整个实验过程中监测所有动物的肿瘤生长情况。结果:接受BCG 1 × 106 cfu治疗的动物肿瘤体积减少幅度最大([mean±SD] 4130.0±1738.3 mm3;p = 0.0738),其次是卡介苗1 × 104 cfu(4527.6±1932.7 mm3;p = 0.1093)和BCG 1 × 105 cfu(4838.2±1889.9 mm3;P = 0.5218),而生理盐水对照组(5445.0±3119.5 mm3)。接种BCG 1 × 106 cfu组动物移植后第60天存活率显著提高(26只动物中19只[73.1%];P = 0.0326),与接受生理盐水溶液对照组(27只动物中的12只[44%])相比。卡介苗1 × 105 cfu治疗(26只存活11只[42.3%];p = 0.5479)和卡介苗1 × 104 cfu(26只存活13只[50%];P = 0.4484)与生理盐水对照组相比,也降低了生存率,但没有显著性水平。结论:病灶内接种卡介苗的动物肿瘤生长和动物死亡率持续降低,表明在这种侵袭性前列腺癌模型中具有抗肿瘤活性。最高剂量的卡介苗效果最好,这表明在该模型中较高的剂量可能是最佳的。卡介苗免疫治疗前列腺癌值得临床评价。
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引用次数: 0
Understanding Barriers to the Early Detection of Prostate Cancer Among Men of Lower Socioeconomic Status 了解社会经济地位较低男性早期发现前列腺癌的障碍
Pub Date : 1999-07-01 DOI: 10.1046/J.1525-1411.1999.14005.X
W. Dale, O. Sartor, T. Davis, C. Bennett
Objectives: Prostate cancer accounted for more than 180,000 new cases and almost 40,000 deaths in the United States in 1998. Higher rates of mortality have been noted among racial minorities and lower socioeconomic status groups, primarily because of advanced stage of cancer at presentation. Understanding barriers toward early detection of prostate cancer may help diminish these variations. Materials and Methods: Thirty-two focus group sessions with individuals of lower socioeconomic status addressed attitudes toward physical examinations, prostate cancer, and sources of health-care information. Barriers to early detection were identified, based on transcripts that were analyzed using the Health Belief Model. Results: Most men of lower socioeconomic status viewed physical examinations negatively, with barriers including time, monetary costs, negative impressions of the prostate examination, and lack of belief in early detection. Among the minority of men who had had prostate examinations, they typically did so as part of examinations for chronic medical conditions or because of employer requirements for routine check-ups. The rectal examination was viewed very negatively because of concerns of physical pain, social embarrassment, and uncertain value. Fear and fatalism regarding prostate cancer were expressed by the majority of attendees. With respect to sources of health information, men typically received health-care information from the media, with television being the most common source. No significant differences in barriers to early detection efforts were observed between focus groups composed of white versus African American poor men. Conclusions: The Health Belief Model provides a framework for evaluating the perceptions of men of lower socioeconomic status toward the early detection of prostate cancer. Negative perceptions regarding physical examinations and skepticism about the value of early detection were major barriers to the early detection of prostate cancer. Targeted strategies directed at each of these barriers are needed to improve the rates of early detection in men of lower socioeconomic status.
目的:1998年,前列腺癌在美国造成180 000多例新病例和将近4万例死亡。在少数民族和社会经济地位较低的群体中,死亡率较高,这主要是因为癌症在发病时已处于晚期。了解早期发现前列腺癌的障碍可能有助于减少这些差异。材料和方法:与社会经济地位较低的个体进行32次焦点小组会议,讨论对体检、前列腺癌和保健信息来源的态度。根据使用健康信念模型分析的转录本,确定了早期发现的障碍。结果:大多数社会经济地位较低的男性对体检持消极态度,障碍包括时间、金钱成本、对前列腺检查的负面印象,以及缺乏对早期发现的信念。在少数接受过前列腺检查的男性中,他们通常是作为慢性疾病检查的一部分,或者是因为雇主要求进行例行检查。直肠检查被认为是非常消极的,因为担心身体疼痛,社交尴尬,和不确定的价值。大多数与会者表达了对前列腺癌的恐惧和宿命论。关于保健信息的来源,男子通常从媒体获得保健信息,电视是最常见的来源。在白人和非洲裔美国穷人组成的焦点小组之间,早期检测工作的障碍没有显著差异。结论:健康信念模型为评估社会经济地位较低的男性对前列腺癌早期发现的认知提供了一个框架。对身体检查的负面看法和对早期发现价值的怀疑是早期发现前列腺癌的主要障碍。需要针对这些障碍采取有针对性的战略,以提高社会经济地位较低的男性的早期检出率。
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引用次数: 15
A Phase II Trial of Oral Trimethylcolchicinic Acid in Patients with Hormone Refractory Prostate Cancer 口服三甲基秋水杨酸治疗激素难治性前列腺癌的II期临床试验
Pub Date : 1999-07-01 DOI: 10.1046/J.1525-1411.1999.14010.X
B. Brockstein, D. Shepard, J. Kugler, P. Fishkin, R. Arrieta, M. Ratain, E. Vokes, N. Vogelzang
Hormone refractory prostate cancer (HRPC) will affect more than 40,000 men in the United States in 1999, and only a few drugs have activity in this disease. We studied trimethylcolchicinic acid (TMCA), an oral colchicine derivative, in a Phase II trial involving 18 chemotherapy-naive men with HRPC. TMCA, 5 mg/m2/day, was given orally for 4 or 5 days with cycles repeated every 3 weeks. No patients showed an objective response by clinical or prostate specific antigen criteria. Neutropenia and stomatitis were common on this schedule. One fatal episode of neutropenic fever occurred. Pharmacokinetics suggested drug accumulation on Days 4 and 5. The cumulative area under the curve (AUC) of concentration × time correlated with the log neutrophil nadir, the log platelet nadir, and the severity of stomatitis. We conclude that TMCA has no clinical effect on HRPC despite severe hematologic toxicity and stomatitis, and that its hematologic toxicity is related to the AUC.
激素难治性前列腺癌(HRPC)将在1999年影响超过40,000名美国男性,只有少数药物对这种疾病有效。我们在一项II期试验中研究了口服秋水仙碱衍生物三甲基秋水仙酸(TMCA),该试验涉及18名HRPC患者。TMCA, 5 mg/m2/天,口服4或5天,每3周重复一次周期。没有患者表现出临床或前列腺特异性抗原标准的客观反应。中性粒细胞减少症和口炎在这个疗程中很常见。发生一例致死性中性粒细胞减少热。药代动力学提示第4、5天药物积累。浓度×时间的累积曲线下面积(AUC)与中性粒细胞最低点、血小板最低点和口腔炎严重程度相关。我们得出结论,尽管TMCA有严重的血液学毒性和口腔炎,但对HRPC没有临床作用,其血液学毒性与AUC有关。
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引用次数: 1
Androgen Deprivation and Osteoporosis 雄激素剥夺与骨质疏松症
Pub Date : 1999-07-01 DOI: 10.1046/J.1525-1411.1999.14002.X
Matthew R. Smith
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引用次数: 2
Hyperthermia for Prostate Cancer: A Review 热疗治疗前列腺癌:综述
Pub Date : 1999-07-01 DOI: 10.1046/J.1525-1411.1999.14001.X
M. Hurwitz
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引用次数: 5
Apoptotic Pathways in Normal Prostate and Prostate Cancers 正常前列腺和前列腺癌的凋亡通路
Pub Date : 1999-05-01 DOI: 10.1046/J.1525-1411.1999.09921.X
S. Denmeade
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引用次数: 2
The Role of the Endothelin Axis in Prostate Cancer 内皮素轴在前列腺癌中的作用
Pub Date : 1999-05-01 DOI: 10.1046/J.1525-1411.1999.09922.X
J. Nelson, M. Carducci
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引用次数: 15
Long‐Term Follow‐Up of Patients Treated with Intermittent Hormone Therapy for Advanced Prostate Cancer 晚期前列腺癌间歇激素治疗患者的长期随访
Pub Date : 1999-05-01 DOI: 10.1046/J.1525-1411.1999.09927.X
G. Hruby, H. Gurney, S. Turner, M. Berry, P. Harnett, V. Gebski
Background: To determine the feasibility of long-term use of intermittent hormone therapy (IHT) in patients with advanced prostate cancer.Methods: Sixteen hormone-naive patients were commenced on IHT and prospectively reviewed. IHT consisted of goserelin acetate alone (two patients) or combined with an antiandrogen. When the serum prostate specific antigen (PSA) level had fallen to 10 ng/ml, the same treatment was recommenced, constituting one complete cycle comprising both “on-treatment” and “off-treatment” phases. This was repeated until hormone independence (HI) occurred.Results: The median length follow-up was 49.9 months. Considering all patients, a mean of 41% of the total time was spent off hormone treatment, ranging from a median of 4.0 to 7.1 months for each cycle. Fifteen patients finished at least one complete cycle of IHT, and 7 patients completed two or more cycles. Nine patients became HI after a mean time period of 19.5 months. Six men remain on IHT; three are currently in their fourth or fifth cycle of treatment. For patients completing Cycles 1, 2, 3, 4, and 5, the median percentage time spent off treatment during each cycle was 41%, 54%, 58%, 53%, and 58%, respectively.Conclusions: Based on this pilot study, IHT would seem to allow considerable time off therapy without obviously affecting the time to HI. If the current randomized trials of IHT against continuous therapy demonstrate equivalent relapse-free survival, then quality of life and fiscal end points will be paramount in determining treatment options. An Australian intergroup study to examine these end points has already begun.
背景:确定晚期前列腺癌患者长期使用间歇激素治疗(IHT)的可行性。方法:对16例激素初治患者进行IHT治疗并进行前瞻性回顾。IHT包括单独使用醋酸戈舍林(2例)或联合使用抗雄激素。当血清前列腺特异性抗原(PSA)水平降至10 ng/ml时,重新开始相同的治疗,构成一个完整的周期,包括“治疗”和“停止治疗”阶段。这是重复的,直到激素独立(HI)发生。结果:中位随访时间为49.9个月。考虑到所有患者,平均41%的总时间用于激素治疗,每个周期的中位数为4.0至7.1个月。15例患者完成了至少一个完整的IHT周期,7例患者完成了两个或更多周期。9名患者在平均19.5个月后成为HI。六名男子留在IHT;其中三人目前正处于第四或第五个治疗周期。对于完成第1、2、3、4和5个周期的患者,每个周期中停止治疗的中位数百分比分别为41%、54%、58%、53%和58%。结论:根据这项初步研究,IHT似乎允许相当长的治疗时间,而不会明显影响到HI的时间。如果目前IHT与持续治疗的随机试验显示出相同的无复发生存率,那么生活质量和财政终点将是决定治疗方案的最重要因素。一项针对这些终点的澳大利亚跨群体研究已经开始。
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引用次数: 2
期刊
The open prostate cancer journal
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