帕米膦酸二钠联合^89Sr治疗激素非依赖型前列腺癌骨转移疗效观察

目的：观察帕米膦酸二钠与^89Sr联合应用对激素非依赖型前列腺癌（PCa）伴骨转移的治疗效果。方法：将我院收治的29例激素非依赖型PCa伴骨转移患者随机分成A、B两组,A组采用帕米膦酸二钠90mg溶于5％葡萄糖500ml,缓慢滴注4周1次,共2次;B组静脉注射^89Sr Cl21．48mBq／kg,1周后与A组治疗方法相同。采用疼痛视觉模拟法（VAs）评定患者主观骨痛,生活质量（QOL）评分来判定疗效。结果：在疼痛评分方面B组治疗后评分显著低于A组,生活质量评分有效率的差异无统计学意义。结论：帕米膦酸二钠联合^89Sr治疗激素非依赖型PCa伴骨转移在疼痛缓解有效率上高于单独使用帕米膦酸二钠,同时表明帕米膦酸二钠与^89Sr具有协同作用,其在不良反应方面无明显增加。     

^89Sr联合放疗和帕米膦酸二钠治疗肺癌多发骨转移

目的：探讨89Sr联合放疗和帕米膦酸二钠治疗肺癌多发骨转移的临床疗效。方法：选取478例肺癌多发骨转移患者,采用89Sr、博宁和放疗3种方法进行联合治疗。结果：疼痛缓解率为82.4%,78例骨转移灶消退,206例治疗结束6个月以内未出现新的转移灶,总有效率59.4%。结论：89Sr联合放疗和帕米膦酸二钠治疗肺癌骨转移简便,无痛苦,无创伤,副作用较低,治疗效果较好。     

骨显像联合B-AKP测定评价~(89)Sr治疗前列腺癌骨转移疗效

目的 :联合应用骨显像与骨型碱性磷酸酶 (B AKP)测定 ,对89Sr治疗前列腺癌骨转移疗效进行评价。　方法 :前列腺癌骨转移患者 73例 ,89Sr治疗前 1周及治疗后半年内进行全身骨显像及B AKP测定。①根据骨病灶数目骨显像分为 0、1、2、3共 4级 ,治疗前后病灶数目的变化采用配对t检验 ,骨显像各级别组间B AKP比较采用t检验。②计算病灶的摄取比值 (T/NT比值 ) ,其变化采用t检验。③治疗前后B AKP的变化采用t检验。　结果 :①治疗前骨转移病灶为 1～ 36 ( 8.6± 7.4 )个 ,共 6 18个 ,治疗后 0～ 34( 3.8± 6 .7)个 ,共 349个 ,明显减少 (t=4 .0 79,P<0 .0 1)。②治疗前T/NT值为 1.12～ 15 .38( 5 .36± 4 .6 7) ,治疗后为 1.2 8～ 16 .5 2 ( 3.17± 2 .95 ) ,降低显著 (t =7.90 7,P <0 .0 1)。③治疗前B AKP为 9.6～ 6 5 .5 ( 2 8.4± 14 .8) μg/L ,治疗后为10 .9～ 5 4 .7( 2 0 .9± 11.7) μg/L ,降低显著 (t=3.349,P <0 .0 0 2 )。④骨显像结合B AKP联合评估 ,ECT显像 5例假阳性与 6例假阴性得到纠正。　结论 :全身骨显像与B AKP测定有一定的互补性。89Sr治疗后疗效监测应以骨显像与B AKP测定结合进行 ,以准确评估疗效 ,指导临床治疗     

~(89)Sr治疗前列腺癌骨转移疗效分析

目的:评价89Sr治疗前列腺癌骨转移的临床疗效。方法:对确认前列腺癌骨转移伴骨痛的116例患者,行双侧睾丸切除术+内分泌药物+89Sr治疗。89Sr治疗静脉给药,剂量1.48～2.22MBq(40～60μCi)/kg。随访分析临床疗效。结果:①33.6%的患者食欲明显改善,56.0%的患者睡眠明显改善,61.2%的患者止痛药用量显著减少;②骨转移性疼痛缓解总有效率为83.6%,24.1%的患者完全缓解;③骨痛缓解开始出现时间3～21d,平均10.2d;④骨痛缓解维持时间3～12个月,平均5.3个月;⑤31.9%的患者出现"闪烁"痛;⑥生活质量(KPS评分)平均升高20.0%;⑦治疗后18.1%的患者血液白细胞由正常水平下降至3.0～3.9×106/L(Ⅰ度血液毒性反应);⑧随访53例骨显像,治疗后73.6%(39例)骨转移灶数目较治疗前明显减少,18.9%(10例)稳定,7.5%(4例)恶化。结论:89Sr治疗能有效抑制骨转移,缓解骨痛,改善生存质量,不良反应轻,是前列腺癌骨转移性疼痛较理想的治疗方法。     

Combination chemotherapy following adrenal suppression in androgen- independent prostate cancer

OBJECTIVES: Recent trials with modern chemotherapy have demonstrated activity in androgen-independent prostate cancer, but all focused on patients with progression following androgen suppression or antiandrogen withdrawal. Limited data are available on the activity of chemotherapy in androgen-independent, hormone-refractory (progressing following adrenal suppression) prostate cancer. We evaluated the activity of estramustine combined with vinblastine in this subset of androgen-independent prostate cancer. METHODS: From January 1995 until April 1999, 19 patients with hormone-refractory prostate cancer received estramustine 140 mg p.o., three times daily along with weekly vinblastine 5 mg/m(2). RESULTS: A decrease in prostate-specific antigen of 50% or more was noted in 12 patients (63.1%, 95% CI 38.3-83.7%). The median decrease in prostate-specific antigen was 71.2% (range 50.5-85.2%). None of the 7 patients with measurable soft-tissue disease showed an objective response. The median survival from onset of chemotherapy was 6 (range 1.4-27.7) months and from initiation of adrenal suppression 16.9 (range 3.8-40. 5) months. CONCLUSIONS: The combination of estramustine and vinblastine is capable of inducing activity in androgen-independent prostate cancer progressing after adrenal suppression. In our small sample, the survival rate was low, and we obtained no response in soft-tissue sites. Future prospective trials are needed to determine the benefit of sequential versus simultaneous incorporation of adrenal suppression with chemotherapy in the management of androgen-independent prostate cancer.     

~(89)Sr联合"云克"治疗前列腺癌骨转移疼痛

目的 评价~(89)Sr联合"云克"(~(99)Tc-MDP)治疗前列腺癌骨转移性疼痛的临床疗效.方法 确 认前列腺癌去势术后骨转移伴骨痛患者138例,年龄58～95岁,平均(69.3±8.2)岁,随机分组治疗.(1)对照组73例,单纯~(89)Sr治疗:一次性静注,剂量1.48～2.22 MBq(40～60 μCi)/kg.(2)联合组65例,~(89)Sr+云克治疗:~(89)Sr方案,同对照组:云克200rag,每日1次静滴,共计5次.每月一次随访临床疗效,两组对比分析.结果 (1)对照组与联合组骨痛缓解总有效率分别为73.97%和90.77%,差异具统计学意义;(2)"闪烁"痛发生率两组分别为30.14%和27.69%,差异无统计学意义;(3)治疗后分别有72.60%和83.08%的病例镇痛药量减少或停用,差异显著;(4)骨痛缓解持续时间,两组各平均为(4.41±1.57)个月和(5.64±2.52)个月,差异具统计学意义;(5)两组治疗后活动能力提高的例数百分比分别为64.38%和81.54%,差异显著.结论 ~(89)Sr联合云克治疗对缓解前列腺癌骨转移性疼痛有协同作用,可减少镇痛药用量,延长疼痛缓解的持续时间,改善患者的活动能力.     

前列腺癌骨转移性疼痛的综合治疗

目的 :探讨晚期前列腺癌骨转移性疼痛的综合治疗方法。　方法 :16例确诊为前列腺癌且有多个部位骨转移病灶伴有疼痛的患者 ,采用口服抗雄激素药物治疗的同时 ,辅以核素89Sr静脉内注射治疗和部分病灶放射治疗。　结果 :治疗后 ,疼痛缓解率 3个月为 75 .6 % ,6个月为 80 .5 % ,9个月为 6 3.4 % ;骨转移病灶数量明显减少。结论 :经过综合治疗后 ,本组晚期前列腺癌伴骨转移性疼痛的患者疼痛获得较为满意的缓解、甚至消失 ,从而改善了患者的生活质量。     

单纯内分泌与内分泌加内照射治疗晚期前列腺癌的疗效对比分析

目的：研究核素内照射改善前列腺癌骨转移引起的疼痛及对骨转移治疗的疗效，并与内分泌治疗进行比较。方法：对52例前列腺癌骨转移患者均采用双侧睾丸切除加氟他胺（250mg,3次／d)治疗。所有患者均于术前不同时间出现明显的疼痛症状，其中15例接受^89锶内照射治疗（148MBq静脉注射），8例接受^153Sm-EDT-MP内照射治疗（37MBq/kg静脉注射，1次／月）；29例未接受内照射治疗者作为对照组。结果：^89锶治疗组有14例患者疼痛明显缓解，占93．3％（14／15）；^153Sm-EDTMP治疗组有6例疼痛明显缓解，占75．0％（6／8）；单纯内分泌治疗组经调整药物剂量或结构后，疼痛明显缓解者仅9例，占31．0％（9／29）。^99Tcm-MDP全身骨显像示骨转移病灶出现不同程度的好转，其中^89锶治疗组有11例，占73．3％（11／15）；^153Sm-EDTMP治疗组有5例，占62．5％（5／8），而单纯内分泌组有7例，占24．1％（7／29）。^89锶治疗组3例、^153Sm-EDTMP治疗组有2例出现血白细胞和血小板明显下降，经对症治疗后恢复。结论：核素内照射治疗能改善前列腺癌骨转移引起的疼痛，并可不同程度地抑制肿瘤骨转移灶的生长，但必须密切观察血红蛋白、白细胞及血小板的变化。     

~(89)Sr治疗前列腺癌骨转移的研究进展

89Sr发射最大能量为1.46MeV的纯β射线,物理半衰期50.5d,很快在体内被成骨组织摄取,完全滞留在成骨性骨转移病灶内。在转移灶内的生物半衰期大于50d,而在正常骨内只有14d。在前列腺癌患者的肿瘤骨吸收剂量是正常骨的2～25倍。在骨肿瘤中的吸收剂量是(21±4)至(231±56)cGy/MBq。89Sr是前列腺癌骨转移患者骨痛的有效缓解药物,对骨疼痛的止痛有效率为80%。     

Low PSA metastatic androgen- independent prostate cancer

OBJECTIVES: To describe the clinical parameters of low PSA, progressive metastatic androgen-independent prostate cancer. METHODS: From April 1995 to May 1999, we selected 18 patients with clinically progressive androgen-independent prostate cancer and low PSA (相似文献   

Trabecular bone remodeling and bone balance in hyperthyroidism

In vivo tetracycline double-labeled iliac crest bone biopsies from 15 hyperthyroid patients were used for the reconstruction of curves describing the variation of resorption depth and formation thickness with time. The curves emerging were compared to curves reconstructed from 13 age- and sex-matched normal individuals (mean age 44 years). The median function period for resorptive cells in hyperthyroid patients (16 days) was about one-third the resorptive period in normals (51 days). No significant difference between the osteoclast-, mononuclear-, or preosteoblast-like cell resorption depths could be demonstrated between the two groups. Consequently, the median resorption rate in hyperthyroid patients (3.8 μm/day) was more than 3 times higher than the value in the control group (1.1 μm/day). Median Sigma_f, was shorter in the hyperthyroid group (109 days) than in the control group (151 days, P < 0.05), as was the median initial mineralization lag time (5 and 16 days, respectively, P < 0.01). No significant difference between the measured mean completed wall thickness (mcwT) values in the hyperthyroid groups and the control group could be demonstrated (58.1 and 60.5 μm respectively). Median initial mineralization rate in the hyperthyroid group (1.2 μm³/μm² per day) was not significantly higher than the value calculated in the control group (0.9 μm³/ μm² per day), but median initial matrix appositional rate in hyperthyroids (4.8 μm³/μm² per day) was 3 times higher than the value calculated for normals (1.6 μm³/μm² per day) (P < 0.01). Direct measurements of mean completed wall thickness in the hyperthyroid group gave results (58.1 μm) that were not in accordance with the mean completed wall thickness calculated from the growth curve (52.1 μm, P < 0.02). In normals no such discrepancy could be demonstrated. Using the mcwT value estimated from the growth curve, the bone formation period was calculated to 90 days for hyperthyroid patients. This maximal estimate for mcwT was also significantly lower than the mean resorption depth measured in the hyperthyroid group (61.7 μm, P < 0.05), which means that a net negative balance per remodeling cycle existed in the hyperthyroid group. Bone balance was preserved in the control group.     

放射性核素89Sr治疗前列腺癌骨转移疼痛的临床研究

目的:探讨晚期前列腺癌骨转移疼痛治疗的方法,评价放射性核素89Sr的疗效与安全性。方法:对15例未接受过任何放疗的晚期前列腺癌骨转移疼痛患者,经静脉注射放射核素89Sr治疗。结果:疼痛治疗的有效率为86.7%,80%患者的肿瘤标记物PSA水平较治疗前轻度下降,26.6%患者出现造血功能抑制。结论:放射性核素89Sr治疗前列腺癌骨转移疼痛较为安全、有效,可以提高患者生活质量。     

A phase II trial of gallium nitrate in patients with androgen-metastatic prostate cancer

Introduction: Due to in vitro data suggesting antitumor activity with gallium nitrate, we sought to evaluate the safety and activity in patients with androgen-independent prostate cancer. Method: Patients were eligible for this study if they had an ECOG performance status of < or = 2, stage D2 metastatic prostate cancer that was progressing following combined androgen ablation (medical or surgical castration plus antiandrogen) and had failed antiandrogen withdrawal. Therapy consisted of gallium nitrate (200 mg/m(2)/day) as a continuous infusion for 7 days, administered every 21 days, with hydration (100 ml/m(2)/h). Individuals that had previously received suramin were treated at a dose of 150 mg/m(2)/day of gallium nitrate. Results: Eight patients were enrolled: 4 patients at the 200 mg/m(2)/day dose level and 4 patients at the lower dosage (150 mg/m(2)/day). One of 8 patients had a >75% decline in prostate-specific antigen (PSA), 3 patients had stable PSA values for 17, 18 and 22 weeks, and 4 patients had progression by PSA (>50% increase over baseline). Anemia requiring transfusion occurred in 5 of 8 patients (63%). Two patients (25%) developed grade 4 toxicity: 1 patient developed complete blindness with partial reversal over 12 months, and another patient had pulmonary infiltrates, hypoxemia, and fever. Serious adverse events were not correlated to prior suramin exposure, or gallium plasma concentrations (total or free), but appeared to be related to cumulative cycles of gallium nitrate. Remaining adverse events were grade 1 or 2. No patients developed renal or neurological toxicity. Conclusion: This trial was prematurely terminated because repeated administration of gallium nitrate was poorly tolerated in an elderly population with androgen-independent prostate cancer. Gallium had modest clinical activity in this disease. Copyright Copyright 1999 S. Karger AG, Basel     

Evidence for palliative enlargement of the right ventricular outflow tract in severe tetralogy of Fallot

Objective: If the pulmonary artery (PA) tree in patients with Fallot's tetralogy (TOF) is extremely hypoplastic, a shunt procedure may be difficult and not desirable because of side-effects. Moreover, the failing catch-up growth of the pulmonary annulus is well known. In patients with a severe form of TOF, we performed palliative transannular patching of the right ventricular outflow tract. The early and long-term follow-up was evaluated. Methods: Eleven patients (93 days (10–245 days); 3.5±0.7 kg (2.5–4.3 kg)) had highly symptomatic TOF (Hb: 18±2 g/dl, SO₂: 68±11%); angiographic diameters: RPA: 4.1 mm (2.5–6.4 mm), LPA: 3.4 mm (1.6–7.0 mm), PA trunc: 4.4 mm (2.5–7.0 mm). All 11 underwent transannular enlargement of the right ventricular outflow tract without closure of the ventricular septum defect. A PA index (cross-sectional area of the pulmonary arteries to BSA) was used to compare pre- and postoperative data. For follow-up, the patients were repetitively examined clinically and echocardiographically. Results: Preoperative PA index was 87±40 mm²/m² (normal: 330±35 mm²/m²). Postpalliation angiograms (age: 10–14 months) demonstrated a significant catch-up growth in nine patients (PA index from 99±40 to 310±54 mm²/m²) and inadequate growth in two patients (PA index 63 and 115 mm²/m²). Perioperative mortality was zero. Ten patients (43 months; 6–105 months) underwent elective repair. Six patients received pulmonary homograft valves (6–15 years after repair) because of severe pulmonary valve insufficiency and severe RV dilation. Complications: One patient died 10 months postpalliation due to pneumonia, one patient received a pacemaker after repair and died (2 months post-repair) due to pacemaker failure, a 5-year-old patient died 1 month after repair due to sepsis. All eight long-term survivors (12–17years) are in excellent clinical condition. Echocardiography revealed good RV function and near normal diameters at peak systolic pressures between 25 and 50 mmHg. Only one patient developed brady-arrhythmia; a pacemaker was implanted 8 years after repair and 2 years after homograft implantation. Conclusions: In a very severe form of TOF, palliative right ventricular outflow tract construction may provide the potential for complete repair. In the presented high-risk patient group, mortality was not related to the hypoplastic pulmonary arteries. Obviously, all patients need pulmonary valve implantation in the long run.     

肥胖与前列腺癌根治术后病理特征变化的相关性

目的 探讨肥胖与前列腺癌根治术（RP）后病理特征变化的相关性。方法 回顾性分析2014年1月至2019年1月于本院收治的120例RP患者。收集并分析患者年龄、身高、体质量、前列腺体积、穿刺活检病理结果、术前前列腺特异性抗原（PSA）水平和术后病理结果。根据体质量指数（BMI）将患者分为三组：正常组（18.5 kg/m²≤BMI＜24kg/m²）30例、超重组（24kg/m²≤BMI＜28kg/m²）66例、肥胖组（BMI≥28kg/m²）24例。结果 RP后，肥胖组患者Gleason评分高于其他组，差异具有统计学意义（P＜0.01）。48例患者诊断为局部进展期前列腺癌（PCa），其中BMI正常组6例，超重组27例，肥胖组15例，差异有统计学意义（P＜0.01）。28例患者出现Gleason评分升级，其中BMI正常组5例，超重组13例，肥胖组10例，差异有统计学意义（P=0.04）。30例患者术后切缘阳性，其中BMI正常组4例，超重组17例，肥胖组9例，差异具有统计学意义（P=0.04）。结论 肥胖患者在RP后Gleason评分以及病理分期更高，同时具有较高的切缘阳性率，Gleason评分升级发生率也较高。     

综合治疗中晚期前列腺癌的疗效分析

目的 探讨一种对中晚期前列腺癌较理想的治疗方法。方法 回顾性分析2001年3月～2005年1月收治的前列腺癌临床病例78例，采用综合治疗：经尿道等离子束腔内微创手术加双侧睾丸白膜下切除去势，术后应用抗雄激素药物阻断治疗，对伴有骨转移者同时行核素89^Sr内放射治疗。与同期用单纯膀胱造瘘加双侧睾丸切除的45例病人进行比较。结果 随访3～48个月，综合治疗后下尿路梗阻症状明显改善，血清PsA水平下降，骨痛缓解，生活质量显著提高，生存时间明显延长。结论 对于中晚期前列腺癌采取积极的综合治疗可取得较好的疗效，是一种较为理想的治疗手段。     

Short-course induction chemoradiotherapy with paclitaxel for stage III non-small-cell lung cancer

Background. This study assessed toxicity, tumor response, disease control, and survival after short-course induction chemoradiotherapy and surgical resection in patients with stage III non-small-cell lung carcinoma.

Methods. Forty-five patients with stage III non-small-cell lung carcinoma received 12-day induction therapy of a 96-hour continuous infusion of cisplatin (20 mg/m² per day), 24-hour infusion of paclitaxel (175 mg/m²), and concurrent accelerated fractionation radiation therapy (1.5 Gy twice daily) to a dose of 30 Gy. Surgical resection was scheduled for 4 weeks later. Postoperatively, a second identical course of chemotherapy and concurrent radiation therapy (30 to 33 Gy) was given.

Results. Induction toxicity resulted in hospitalization of 18 (40%) patients for neutropenic fever. No induction deaths occurred. Of 40 (89%) patients who underwent thoracotomy, resection for cure was possible in 32 (71%) patients. Pathologic response was noted in 21 (47%) patients, and 14 (31%) were downstaged to mediastinal node negative (stage 0, I, or II). At a median follow-up of 19 months, 24 patients were alive, 10 with recurrent disease. Of 21 deaths, 16 were from recurrent disease, three were from treatment, and two were unrelated. Recurrent disease was distant in 21 patients, distant and locoregional in 2, and locoregional in 3. The Kaplan-Meier projected 24-month survival is 49%. Projected 24-month survival is 61% for stage IIIA, 17% for stage IIIB (p = 0.035); 84% for pathologic responders, 22% for nonresponders (p < 0.001); 83% for downstaged patients (stage 0, I, or II), 33% for those not downstaged (p = 0.005); and 63% for resectable patients, 14% for unresectable patients (p = 0.007).

Conclusions. We conclude that short-course neoadjuvant therapy with paclitaxel (1) has manageable toxicity and a low treatment mortality, (2) results in good tumor response and downstaging, (3) provides excellent locoregional control with most recurrences being distant, and (4) has improved the median survival compared with historical controls. Survival was better in stage IIIA patients, resectable patients, pathologic responders, and patients downstaged to mediastinal node negative disease (stage 0, I, or II).     

Selected ventriculoplasty for idiopathic dilated cardiomyopathy with advanced congestive heart failure: midterm results and risk analysis

Background: To treat advanced heart failure due to idiopathic dilated cardiomyopathy, surgical ventricular restoration with mitral reconstruction was conducted and evaluated. Methods: In 95 patients (81 men, mean age: 54 years), New York Heart Association class III/IV was 44/51, and 33 patients (36%) were inotropic dependent preoperatively. Mitral regurgitation (≥2+) was noted in all patients. All patients underwent left ventriculoplasty (septal anterior ventricular exclusion in 38, partial left ventriculectomy in 57) and mitral reconstruction (repair 53, replacement 42). Fifty-two patients (55%) had concomitant tricuspid repair. Intra-aortic balloon pumping and left ventricular assist device was used in 24 patients and two patients, respectively. Results: Hospital mortality was 11.6% (11 of 95), with 6.6% (5 of 76) in elective and 31.6% (6 of 19) in emergency operations. The ejection fraction and cardiac index increased from 22.3 ± 6.3% to 27.2 ± 8.0% and from 2.3 ± 0.5 ml/m²/min to 2.8 ± 0.5 ml/m²/min, respectively (p < 0.001). The endodiastolic volume index, endosystolic volume index and diastolic dimension decreased from 232.9 ± 56.1 ml/m² to 160.0 ± 49.8 ml/m², from 178.9 ± 46.7 ml/m² to 113.8 ± 44.7 ml/m² and from 82.0 ± 9.0 mm to 68.9 ± 11.6 mm, respectively (p < 0.001). Late death occurred in 27 patients with 22 cardiac deaths. The mean NYHA class was 1.7 among the survivors. One-, 3- and 5-year survival rates were 72.8%, 61.4% and 50.5%, respectively. In the 62 patients who were non-inotropic dependent preoperatively, 1-, 3-, and 5-year survival rates (81.8%, 73.7% and 62.9%) were significantly better than the inotropic-dependent group (55.3%, 37.3% and 28.0%). Patients with mitral annuloplasty showed a significantly higher 5-year survival rate than patients with mitral valve replacement (59.6% vs 43.6%) in univariate analysis. By application of the exclusion site selection method, the two different ventriculoplasty procedures did not show significant difference in survival rates. Multivariate analysis showed that preoperative inotropes and old age were significant predictors for postoperative mortality. Conclusion: The selected ventriculoplasty in combination with mitral annuloplasty is a useful option for patients with an extremely dilated left ventricle in idiopathic dilated cardiomyopathy. Surgery should be considered before inotropic dependency occurs when prior medical treatment has failed.     

Suppression of bone density loss and bone turnover in patients with hormone-sensitive prostate cancer and receiving zoledronic acid

OBJECTIVE: To report a randomized, placebo-controlled study of treatment with zoledronic acid every 3 months in patients with hormone-sensitive prostate cancer, both with and without bone metastases, to assess the effect on bone mineral density (BMD) and markers of bone turnover. PATIENTS AND METHODS: Eligible patients included those with prostate cancer and on androgen-deprivation therapy for <12 months. Patients received zoledronic acid 4 mg intravenously, or placebo, every 3 months for four treatments. BMD, urinary N-telopeptides of type I collagen (NTX), and serum bone alkaline phosphatase (BAP) were measured every 3 months. In all, 42 patients were randomized. RESULTS: After excluding BMD data from sites of known metastases, patients receiving zoledronic acid had a relative increase in BMD compared with those receiving placebo, of 4.2% and 7.1% at the femoral neck and lumbar spine, respectively. NTX and BAP decreased significantly in patients receiving zoledronic acid. NTX and BAP levels were significantly higher at baseline in patients with bone metastases than in those without. CONCLUSIONS: Treatment with zoledronic acid every 3 months preserved bone density and suppressed markers of bone turnover in patients with androgen-deprived prostate cancer, both with and without bone metastases.     

Phase II study of capecitabine single-agent therapy in patients with metastatic renal cell carcinoma

Fluoropyrimidines are known to have modest activity in the treatment of metastatic renal cell carcinoma (RCC). Capecitabine is an orally administered prodrug that is converted to fluorouracil and is of potential use in the treatment of this disease. We conducted a Phase II clinical trial of capecitabine administered as a single agent to patients with metastatic RCC. The treatment consisted of 1250 mg/m² capecitabine orally, twice daily (2500 mg/m² per day) days 1–14, repeated every 21 days. There were 15 patients, including 13 men and 2 women, who underwent a total of 67 cycles (median 3.5; range 1–15). Nine patients had undergone prior systemic therapy consisting of interferon- in 3, interleukin-2 in 1, interferon- plus interleukin-2 in 4, and investigational therapy with bryostatin-1 in 1. There were 14 patients assessable for response (one withdrew), and no responses were seen. Median time to progression was 9 weeks (range 1–45). There were 3 patients (21%) who had stable disease for 18, 39, and 45 weeks. Hematologic toxicity was mild. Three patients had grade 3 or 4 gastrointestinal toxicity, and 3 required dose reductions. There were 2 early deaths, including 1 patient with pulmonary edema and 1 with hypotension. The study was terminated because there were no responses in the first 14 assessable patients, indicating that the response rate was likely to be less than 20%. We conclude that single-agent capecitabine has minimal activity for the treatment of metastatic RCC.