Prescrire Int. 2012 Oct;21(131):242-8.
Localised prostate cancer, confined to the prostate gland, occurs mainly in men over 65 years of age. The principal management options are watchful waiting, prostatectomy and radiation therapy. Which of these options has the best harm-benefit balance for patients with localised prostate cancer? To answer this question, we conducted a review of the literature using the standard Prescrire methodology. The natural history of localised prostate cancer depends on the extent and histologic grade of the tumour, and pretreatment PSA level. Without immediate treatment, the risk of death from prostate cancer that only one involves one lobe, a Gleason histological score of 7 or less, and a PSA level of 20 ng/ml or lower is less than 0.5% per year. The risk is about 4% per year in patients with larger tumours, poorly differentiated cancer cells (Gleason score above 7), or an elevated PSA level. Most data on radical prostatectomy come from a randomised trial versus watchful waiting in 695 men with localised cancer. Prostatectomy reduced all-cause mortality after a median followup of about 13 years (46% versus 53% without treatment), but this benefit was only seen in patients younger than 65 years at diagnosis. After 4 years of follow-up, prostatectomy was associated with erectile dysfunction in approximately 40% of patients and with incontinence in about 25% of patients. External beam radiation therapy reduced overall mortality to a lesser degree than prostatectomy, but the level of evidence is lower for this modality. Brachytherapy (implantation of a radioactive isotope in the prostate) has not been compared directly with other treatments. Transient radiation proctitis is common after external beam radiation therapy. About 15% of patients treated with external beam radiation therapy and 10% of patients treated with brachytherapy experience long-term intestinal disorders. About half of patients treated with external beam radiation therapy and the majority of patients treated with brachytherapy have transient symptoms of radiation cystitis. In the long term, about 5% of patients treated with radiation therapy have urinary incontinence, versus 12% to 25% of surgical patients. In the long term, about 75% of surgical patients experience erectile dysfunction, compared to about 60% of patients treated with external beam radiation therapy and about 50% of patients who opt for watchful waiting. Brachytherapy appears to cause less erectile dysfunction than external beam radiation therapy. In patients treated with external beam radiation therapy, the addition of hormone therapy for 4 to 6 months reduced all-cause mortality in two randomised trials but caused gynaecomastia, more erectile dysfunction, hot flashes, and hepatitis. Hormone therapy has an unfavourable harm-benefit balance when used alone to treat localised prostate cancer. Further studies of cryotherapy and high-intensity focused ultrasound therapy are needed to determine their respective benefits and harms. In practice, watchful waiting is the most reasonable option for men with low-risk localised prostate cancer and a life expectancy of less than 10 years. In men with low- or intermediate-risk localised prostate cancer and a life expectancy of more than 10 years, there is insufficient data available in early 2012 to show which of the following options is preferable: watchful waiting, radical prostatectomy, external beam radiation therapy, or brachytherapy. Patients should be informed of the risks associated with each of these options and should be actively involved in the choice of treatment. Treatment is often warranted for patients with high-risk localised prostate cancer.The main options are either radical prostatectomy or external beam radiation therapy combined with hormone therapy.
局限性前列腺癌局限于前列腺腺体内,主要发生在65岁以上男性中。主要的治疗选择包括观察等待、前列腺切除术和放射治疗。对于局限性前列腺癌患者,这些选择中哪一种具有最佳的利弊平衡?为回答这个问题,我们使用标准的Prescrire方法对文献进行了综述。局限性前列腺癌的自然病程取决于肿瘤的范围、组织学分级以及治疗前的前列腺特异性抗原(PSA)水平。若不立即治疗,仅累及一个叶、Gleason组织学评分7分或更低且PSA水平为20 ng/ml或更低的前列腺癌患者每年死于前列腺癌的风险低于0.5%。对于肿瘤较大、癌细胞分化差(Gleason评分高于7分)或PSA水平升高的患者,该风险约为每年4%。大多数关于根治性前列腺切除术的数据来自一项针对695例局限性癌症男性患者与观察等待进行对比的随机试验。前列腺切除术在中位随访约13年后降低了全因死亡率(46%对比未治疗的53%),但这种益处仅在诊断时年龄小于65岁的患者中可见。随访4年后,前列腺切除术在约40%的患者中与勃起功能障碍相关,在约25%的患者中与尿失禁相关。外照射放疗降低总体死亡率的程度低于前列腺切除术,但该治疗方式的证据级别较低。近距离放射治疗(在前列腺内植入放射性同位素)尚未与其他治疗方法直接比较。外照射放疗后短暂性放射性直肠炎很常见。约15%接受外照射放疗的患者和10%接受近距离放射治疗的患者会出现长期肠道疾病。约一半接受外照射放疗的患者和大多数接受近距离放射治疗的患者有放射性膀胱炎的短暂症状。从长期来看,约5%接受放疗的患者会出现尿失禁,而手术患者为12%至25%。从长期来看,约75%的手术患者会出现勃起功能障碍,相比之下,接受外照射放疗的患者约为60%,选择观察等待的患者约为50%。近距离放射治疗似乎比外照射放疗导致的勃起功能障碍更少。在接受外照射放疗的患者中,两项随机试验表明添加4至6个月的激素治疗可降低全因死亡率,但会导致男性乳房发育、更多勃起功能障碍、潮热和肝炎。单独使用激素治疗局限性前列腺癌时利弊平衡不佳。需要对冷冻疗法和高强度聚焦超声疗法进行进一步研究以确定它们各自的益处和危害。在实际操作中,对于低风险局限性前列腺癌且预期寿命小于10年的男性,观察等待是最合理的选择。对于低风险或中风险局限性前列腺癌且预期寿命超过10年的男性,在2012年初尚无足够数据表明以下哪种选择更优:观察等待、根治性前列腺切除术、外照射放疗或近距离放射治疗。应告知患者这些选择各自相关的风险,并且患者应积极参与治疗选择。对于高风险局限性前列腺癌患者通常需要进行治疗。主要选择是根治性前列腺切除术或外照射放疗联合激素治疗。