“激光+细菌”让癌症消失无影踪,47所欧洲医院正在测试| 柳叶刀新疗法
2016/12/22
一束光,一种细菌制成的药物,就能彻底的消除癌症?如今科学家做到了,他们在《柳叶刀肿瘤学》杂志上表明,利用激光以及深海细菌制成的药物来消除肿瘤,不仅不会产生严重的副作用,而且49%的患者体内前列腺肿瘤完全缓解。


12月20日,英国BBC网站报道了一种前列腺癌革命性疗法——利用激光以及深海细菌制成的药物来消除肿瘤,不仅不会产生严重的副作用,并且能让肿瘤消失不再有痕迹。目前这种疗法已在47所欧洲医院进行测试,已进入三期临床试验,相关结果发表在《柳叶刀肿瘤学》杂志上。

触发杀死,不产生明显副作用


共有413名患者加入了该试验。新疗法使用了一种药物,这种药物由深海底黑暗处的细菌制成,只有暴露于光线下才会产生毒性。研究人员将光纤激光器通过会阴插入到癌变的前列腺中,当红色激光接通时,它会激活药物杀死癌细胞,对健康的前列腺不产生影响。

全欧洲共有47所医院开展了这项试验,结果发现将近49%的患者体内前列腺肿瘤完全缓解。在随访期间,只有6%的患者需要切除前列腺,而未使用新疗法的患者中,有30%需要切除前列腺。最重要的是,新疗法对性活动和排尿的影响不超过3个月,患者接受新疗法2年后未出现明显副作用。

终身阳萎和失禁往往是前列腺癌手术或放疗的代价。10名患者中大约有9名会出现勃起障碍,1/5的患者面临控制膀胱的斗争。这就是为何许多早期肿瘤患者选择等待和观望的原因,只有发展成为侵袭性肿瘤时他们才会接受治疗。研究该疗法的伦敦大学学院Mark Emberton教授说,“这种疗法改变了一切。”

英国西萨塞克斯一位68岁的患者Gerald Capon告诉BBC,“我现在已经完全治愈了,接受这种新疗法我感到非常幸运,如今我又可以无忧无虑的生活了。”在接受治疗的第二天,他就可以出院了。

有待监管机构评估

目前,这种新疗法尚未提供给患者,它将在明年年初接受监管机构的评估。Emberton教授表示,这项技术对男性而言正如乳房切除术对乳腺癌患者一样重要,“传统上认为,做治疗决策需要衡量利益和危害。新疗法可以人为控制,并且不会产生副作用,这是一场真正的变革。”

来自英国前列腺癌慈善机构的 Matthew Hobbs博士说,“类似的聚焦治疗方法有可能为前列腺癌之外的癌症患者提供治疗的选择。”其他杀死前列腺癌的疗法,如高强度聚焦超声(focal Hifu)副作用的风险也比较低,但这些疗法并未得到普遍使用。

研究人员表示,下一个挑战是找出哪些患者仍需等待和观察,哪些患者应该采用这种疗法,哪些患者需要更多的侵入性治疗,这样才不会导致低风险人群的过度治疗。

参考资料:

Prostate cancer laser treatment 'truly transformative'

Padeliporfin vascular-targeted photodynamic therapy versus active surveillance in men with low-risk prostate cancer (CLIN1001 PCM301): an open-label, phase 3, randomised controlled trial

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  • Padeliporfin vascular-targeted photodynamic therapy versus active surveillance in men with low-risk prostate cancer (CLIN1001 PCM301): an open-label, phase 3, randomised controlled trial

    Background Vascular-targeted photodynamic therapy, a novel tissue-preserving treatment for low-risk prostate cancer, has shown favourable safety and efficacy results in single-arm phase 1 and 2 studies. We compared this treatment with the standard of care, active surveillance, in men with low-risk prostate cancer in a phase 3 trial. Methods This randomised controlled trial was done in 47 European university centres and community hospitals. Men with low-risk, localised prostate cancer (Gleason pattern 3) who had received no previous treatment were randomly assigned (1:1) to vascular-targeted photodynamic therapy (4 mg/kg padeliporfin intravenously over 10 min and optical fibres inserted into the prostate to cover the desired treatment zone and subsequent activation by laser light 753 nm with a fixed power of 150 mW/cm for 22 min 15 s) or active surveillance. Randomisation was done by a web-based allocation system stratified by centre with balanced blocks of two or four patients. Best practice for active surveillance at the time of study design was followed (ie, biopsy at 12-month intervals and prostate-specific antigen measurement and digital rectal examination at 3-month intervals). The co-primary endpoints were treatment failure (histological progression of cancer from low to moderate or high risk or death during 24 months' follow-up) and absence of definite cancer (absence of any histology result definitely positive for cancer at month 24). Analysis was by intention to treat. Treatment was open-label, but investigators assessing primary efficacy outcomes were masked to treatment allocation. This trial is registered with ClinicalTrials.gov, number NCT01310894. Findings Between March 8, 2011, and April 30, 2013, we randomly assigned 206 patients to vascular-targeted photodynamic therapy and 207 patients to active surveillance. Median follow-up was 24 months (IQR 24–25). The proportion of participants who had disease progression at month 24 was 58 (28%) of 206 in the vascular-targeted photodynamic therapy group compared with 120 (58%) of 207 in the active surveillance group (adjusted hazard ratio 0·34, 95% CI 0·24–0·46; p<0·0001). 101 (49%) men in the vascular-targeted photodynamic therapy group had a negative prostate biopsy result at 24 months post treatment compared with 28 (14%) men in the active surveillance group (adjusted risk ratio 3·67, 95% CI 2·53–5·33; p<0·0001). Vascular-targeted photodynamic therapy was well tolerated. The most common grade 3–4 adverse events were prostatitis (three [2%] in the vascular-targeted photodynamic therapy group vs one [<1%] in the active surveillance group), acute urinary retention (three [2%] vs one [<1%]) and erectile dysfunction (two [1%] vs three [1%]). The most common serious adverse event in the vascular-targeted photodynamic therapy group was retention of urine (15 patients; severe in three); this event resolved within 2 months in all patients. The most common serious adverse event in the active surveillance group was myocardial infarction (three patients). Interpretation Padeliporfin vascular-targeted photodynamic therapy is a safe, effective treatment for low-risk, localised prostate cancer. This treatment might allow more men to consider a tissue-preserving approach and defer or avoid radical therapy.

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