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對抗腦腫瘤 新療法很「科幻」

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一項大型研究的最終結果表明,儘管這聽起來像科幻小說,但一種能製造電場的帽狀裝置,在10年來首次為患有致命腦腫瘤的人提高了生存率。


?許多醫生對這種被稱為腫瘤治療電場的療法持懷疑態度,並不能治癒,且非常昂貴——每月要21000美元。?


但在研究中,接受此療法的患者,對比那些只常規化療的患者五年存活率數字是——13%與5%,相差兩倍以上。


這已經超出癌通常治療效果範圍,許多醫生還不了解它,芝加哥西北紀念醫院的腦腫瘤專家Roger Stupp博士說。

他領導了以前在瑞士蘇黎世大學醫院由公司贊助的研究,近日在華盛頓美國癌症研究會的會議上發布了結果。


「你不能跟他們爭論,他們是偉大的結果,「不可能是由於安慰劑的效應,獨立專家,波士頓布萊根和婦女醫院神經外科主任Antonio Chiocca博士說。


主持協會會議的波士頓丹娜法伯癌症研究所的George Demetri博士,表示同意但稱效益不大,因為大多數患者在五年內死亡。他補充說:「對於一種可怕的疾病,任何進步都是重要的。


關於治療


被稱為optune的該裝置,由總部在英國澤西島的Novocure公司製造。在美國,德國,瑞士和日本銷售給患有惡性多形性膠質母細胞瘤的成年人,和化療一起使用,用於手術和放療後避免腫瘤複發——大多數是這樣做。


病人通過電線把與口袋裡的小發電機相連接的電極覆蓋在剃光的頭上。他們可以戴一頂帽子,過日常生活,並且每天使用設備至少18小時。這不是電流或輻射,他們只感到輕微的熱。


它的作用是通過製造低強度的交變電場來破壞細胞分裂--使染色體排列紊亂--這會使細胞死亡。由於癌細胞經常分裂,而成人大腦中的正常細胞則不然,理論上主要危害疾病而不是病人。


研究表明了什麼


在2011年的研究中,該設備並沒有提高生存率,但相比標準治療後化療引發病人腫瘤惡化或複發,它所引發的癥狀更少。美國FDA因而批准了它。


在2014年對在初診患者中進行的第二個研究停止後,大約有一半695名參與者被跟蹤了至少18個月,因為使用該設備的患者平均比其他人多活幾個月。?

對抗腦腫瘤 新療法很「科幻」



??攝於2017年3月29日的照片,Joyce Endresen戴上optune療法裝置治療腦腫瘤,她在伊里諾斯州奧羅拉接受治療時打電話。她於2014年12月被診斷為膠質母細胞瘤。


?


FDA擴大批准但有些醫生懷疑,視之為虛假治療——每個人都知道得到什麼,研究負責人說,虛假治療是不現實的,因為病人感覺到熱,當他們得到真正的東西,如果治療可能是假的,很多人會拒絕每隔幾天就剃頭,多年使用一個不方便的設備。


一些醫生說,他們將保留判斷直到整個小組有了長期的結果。


新的研究結果


現在結果是:給予optune和化療中位生存中值是21個月,相比之下只是化療的為16個月。兩年生存率分別為43%和31%,三年生存率分別為26%和16%,五年生存率分別為13%和5%。


副作用是最小的,但會有與電極相關的包括血細胞計數問題,虛弱,疲勞和皮膚刺激。


「設備不可忽視…這絕對是一個進步,」哥倫比亞大學醫學中心/紐約長老會醫院腦腫瘤主任Andrew Lassman博士說。他與Novocure公司商議,召集一些醫生做了這個研究。

最新的國家綜合癌症中心指南包括optune作為腦腫瘤的適當治療。它也正在測試胰腺癌,卵巢癌和肺癌,電極穿戴在腹部或胸部的那些位置。


價格


一個大問題是成本——每天大約700美元。除了醫療照顧保險(Medicare),美國的大多數保險公司都有覆蓋,Novocure的首席執行官Bill Doyle說:「我們從來沒有拒絕病人,無論他的保險狀態。」


價格反映了「一個非常複雜的醫療設備,產量非常低,」一次性零件一州要更換幾次,每個病人配備一名助工,他說。加上17年的實驗室,動物和人體測試。


成本?「整個下來的數字是五億美元,」Doyle說。


一個病人的體驗


Joyce Endresen的保險涵蓋了所有費用——除了她一年約1000美元的裝置費用。「這是一個偉大的計劃,這就是為什麼我還在工作,」受雇於芝加哥郊區一家直接郵件公司,52歲的Endresen說。


她每兩個月檢查一次癌症,「他們都很好,」她說。「我們在12月慶祝兩年沒有腫瘤,然後去了南非。」


醫生說,許多患者不會嘗試該設備,因為涉及到的麻煩,或者因為他們不希望看到被提醒他們有癌症。——


Endresen沒有。「我戴著它,驕傲地戴著它,」她說。「這是一個令人難以置信的機器,我很好只是沒有頭髮。」

"Sci-fi" cancer therapy fights brain tumors, study finds


WASHINGTON -- Although it sounds like science fiction, a cap-like device that makes electric fields to fight cancer improved survival for the first time in more than a decade for people with deadly brain tumors, final results of a large study suggest.


Many doctors are skeptical of the therapy, called tumor treating fields, and it』s not a cure. It』s also ultra-expensive -- $21,000 a month.


But in the study, more than twice as many patients were alive five years after getting it, plus the usual chemotherapy, than those given just the chemo -- 13 percent versus 5 percent.


「It』s out of the box」 in terms of how cancer is usually treated, and many doctors don』t understand it or think it can help, said Dr. Roger Stupp, a brain tumor expert at Northwestern Memorial Hospital in Chicago.


He led the company-sponsored study while previously at University Hospital Zurich in Switzerland, and gave results Sunday at an American Association for Cancer Research meeting in Washington.


「You cannot argue with them -- they』re great results,」 and unlikely to be due to a placebo effect, said one independent expert, Dr. Antonio Chiocca, neurosurgery chief at Brigham and Women』s Hospital in Boston.


Dr. George Demetri of the Dana-Farber Cancer Institute in Boston and a board member of the association hosting the conference, agreed but called the benefit modest, because most patients still die within five years. 「It is such a horrible disease」 that any progress is important, he added.


About the treatment


The device, called Optune, is made by Novocure, based in Jersey, an island near England. It』s sold in the U.S., Germany, Switzerland and Japan for adults with an aggressive cancer called glioblastoma multiforme, and is used with chemo after surgery and radiation to try to keep these tumors from recurring, as most do.

Patients cover their shaved scalp with strips of electrodes connected by wires to a small generator kept in a bag. They can wear a hat, go about their usual lives, and are supposed to use the device at least 18 hours a day. It』s not an electric current or radiation, and they feel only mild heat.


It supposedly works by creating low intensity, alternating electric fields that disrupt cell division -- confusing the way chromosomes line up -- which makes the cells die. Because cancer cells divide often, and normal cells in the adult brain do not, this in theory mostly harms the disease and not the patient.


What studies show


In a 2011 study, the device didn』t improve survival but caused fewer symptoms than chemo did for people whose tumors had worsened or recurred after standard treatments. The U.S. Food and Drug Administration approved it for that situation.


A second study, in newly diagnosed patients, was stopped in 2014 after about half of the 695 participants had been tracked for at least 18 months, because those using the device were living several months longer on average than the rest.


The FDA expanded approval but some doctors were leery because the device wasn』t compared with a sham treatment -- everyone knew who was getting what. Study leaders say a sham was impractical, because patients feel heat when they get the real thing, and many would refuse to shave their heads every few days and use an inconvenient device for years if the treatment might be fake.


Some doctors said they would withhold judgment until there were long-term results on the whole group.


The new results


Now they』re in: Median survival was 21 months for those given Optune plus chemo versus 16 months for those on chemo alone. Survival rates were 43 percent versus 31 percent at two years; 26 percent versus 16 percent at three years, and 13 percent versus 5 percent at five years.


Side effects were minimal but included blood-count problems, weakness, fatigue and skin irritation from the electrodes.

「The device is now impossible to ignore ... it absolutely is an advance,」 said Dr. Andrew Lassman, brain tumor chief at the Columbia University Medical Center/New York-Presbyterian Hospital. He consults for Novocure, as do some doctors running the study.


The latest National Comprehensive Cancer Center guidelines include Optune as an appropriate treatment for brain tumors. It』s also is being tested for pancreatic, ovarian and lung cancers; electrodes are worn on the belly or chest for those.


The price


A big issue is cost -- roughly $700 a day. Most U.S. insurers cover it but Medicare does not and 「we are paying,」 said Novocure』s chief executive, Bill Doyle. 「We』ve never refused a patient regardless of insurance status.」


The price reflects 「an extremely sophisticated medical device, made in very low quantities,」 with disposable parts changed several times a week and a support person for each patient, he said. Plus 17 years of lab, animal and human testing.


That cost? 「The round number is half a billion dollars,」 Doyle said.


One patient』s experience


Joyce Endresen』s insurance covers all but about $1,000 a year for her device. 「It』s a great plan, and that』s why I still work,」 said Endresen, 52, employed by a direct mail company in suburban Chicago.


She has scans every two months to check for cancer and 「they』ve all been good,」 she said. 「We celebrated two years of no tumor in December and went to South Africa.」


Doctors say many patients won』t try the device because of the trouble involved or because they don』t want a visible reminder of their cancer. Not Endresen.

「I wear it and wear it proudly,」 she said. 「It』s an incredible machine and I』m fine not having hair.」


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