Lancet Onco：前列腺癌新疗法可减少副作用

4月17日，英国伦敦大学学院等机构研究人员在医学刊物《柳叶刀—肿瘤学》The Lancet Oncology上报告说，他们开发出利用超声波治疗前列腺癌的新方法，可大幅减少尿失禁、性功能障碍等副作用。
 
研究者的这种疗法的原理是，在用磁共振成像等技术确定肿瘤位置后，用高度集中的超声波照射肿瘤细胞，将其加热并杀死。其优点是超声波可集中在只有一个米粒大小的目标部位，在杀死肿瘤细胞同时不影响周围的健康组织，从而减少副作用。
 
治疗前列腺癌的传统方法，比如放射疗法或手术切除，常会影响整个前列腺部位，从而导致许多副作用，比如尿失禁、性功能障碍和肠道出血等。不出现这些副作用且治疗后一年内病情都能得到控制的成功率仅50%左右。
 
在本次临床试验中，41名前列腺癌患者接受了新疗法治疗，没有人出现尿失禁，出现性功能障碍者只有约十分之一。
 
领导研究的哈希姆·艾哈迈德说，本次试验的结果非常令人鼓舞，接下来还会进行更大规模的临床试验，争取尽早为前列腺癌患者正式提供这种新疗法，帮助他们提高生活质量。

doi:10.1016/S1470-2045(12)70121-3
PMC:
PMID:

Focal therapy for localised unifocal and multifocal prostate cancer: a prospective development study

Dr Hashim U Ahmed MRCS a b , Richard G Hindley FRCS e, Louise Dickinson MRCS a b, Alex Freeman FRCPath c, Alex P Kirkham FRCR d, Mahua Sahu MRCS b, Rebecca Scott RN a, Clare Allen FRCR d, Prof Jan Van der Meulen PhD f g, Prof Mark Emberton FRCS a

Background Radical whole-gland therapy can lead to significant genitourinary and rectal side-effects for men with localised prostate cancer. We report on whether selective focal ablation of unifocal and multifocal cancer lesions can reduce this treatment burden. Methods Men aged 45—80 years were eligible for this prospective development study if they had low-risk to high-risk localised prostate cancer (prostate specific antigen [PSA] ≤15 ng/mL, Gleason score ≤4 + 3, stage ≤T2), with no previous androgen deprivation or treatment for prostate cancer, and who could safely undergo multiparametric MRI and have a general anaesthetic. Patients received focal therapy using high-intensity focused ultrasound, delivered to all known cancer lesions, with a margin of normal tissue, identified on multiparametric MRI, template prostate-mapping biopsies, or both. Primary endpoints were adverse events (serious and otherwise) and urinary symptoms and erectile function assessed using patient questionnaires. Analyses were done on a per-protocol basis. This study is registered with ClinicalTrials.gov, number NCT00561314. Findings 42 men were recruited between June 27, 2007, and June 30, 2010; one man died from an unrelated cause (pneumonia) 3 months after treatment and was excluded from analyses. After treatment, one man was admitted to hospital for acute urinary retention, and another had stricture interventions requiring hospital admission. Nine men (22%, 95% CI 11—38) had self-resolving, mild to moderate, intermittent dysuria (median duration 5·0 days [IQR 2·5—18·5]). Urinary debris occurred in 14 men (34%, 95% CI 20—51), with a median duration of 14·5 days (IQR 6·0—16·5). Urinary tract infection was noted in seven men (17%, 95% CI 7—32). Median overall International Index of Erectile Function-15 (IIEF-15) scores were similar at baseline and at 12 months (p=0·060), as were median IIEF-15 scores for intercourse satisfaction (p=0·454), sexual desire (p=0·644), and overall satisfaction (p=0·257). Significant deteriorations between baseline and 12 months were noted for IIEF-15 erectile (p=0·042) and orgasmic function (p=0·003). Of 35 men with good baseline function, 31 (89%, 95% CI 73—97) had erections sufficient for penetration 12 months after focal therapy. Median UCLA Expanded Prostate Cancer Index Composite (EPIC) urinary incontinence scores were similar at baseline as and 12 months (p=0·045). There was an improvement in lower urinary tract symptoms, assessed by International Prostate Symptom Score (IPSS), between baseline and 12 months (p=0·026), but the IPSS-quality of life score showed no difference between baseline and 12 months (p=0·655). All 38 men with no baseline urinary incontinence were leak-free and pad-free by 9 months. All 40 men pad-free at baseline were pad-free by 3 months and maintained pad-free continence at 12 months. No significant difference was reported in median Trial Outcomes Index scores between baseline and 12 months (p=0·113) but significant improvement was shown in median Functional Assessment of Cancer Therapy (FACT)-Prostate (p=0·045) and median FACT-General scores (p=0·041). No histological evidence of cancer was identified in 30 of 39 men biopsied at 6 months (77%, 95% CI 61—89); 36 (92%, 79—98) were free of clinically significant cancer. After retreatment in four men, 39 of 41 (95%, 95% CI 83—99) had no evidence of disease on multiparametric MRI at 12 months. Interpretation Focal therapy of individual prostate cancer lesions, whether multifocal or unifocal, leads to a low rate of genitourinary side-effects and an encouraging rate of early absence of clinically significant prostate cancer. Funding Medical Research Council (UK), Pelican Cancer Foundation, and St Peters Trust.