iLife Discoveries: FDA核准基因檢測: 乳癌復發風險測試與用藥指引(MammaPrint & Blueprint)

FDA Approved New Gene Test can Help Some Breast Cancer Patients Avoid Chemoby Shirley Johanna onMay 28, 2015 at 6:41 PM Cancer News - A new gene test can help oncologists by providing deeper insights into tumors and reduce the use of unnecessary chemotherapy for some breast cancer patients. FDA Approved New Gene Test can Help Some Breast Cancer Patients Avoid Chemo Launched by genetics and genomics company ILife Discoveries in the capital on May 21, the new "MammaPrint & Blueprint" test will help evaluate the risk of distant recurrence of breast cancer. It will help oncologists in identifying patients who can safely forego chemotherapy. "The test can help doctors reduce the use of unnecessary chemotherapy by identifying the risks and its need," Anand Gupta, founder of iLife Discoveries, said in a statement. Not all cancers have the same physiology nor do all tumors follow the same path of development. MammaPrint is a 70-gene assay intended as a prognostic test for women of all ages. According to Ramesh Sarin, senior consultant (surgical oncology) at Indraprastha Apollo Hospitals, with an FDA approved 70 gene-Mammaprint test now available, "we can predict the behavior of tumor by looking at its genomic profiling and manage the patient accordingly". Blueprint is a molecular assay used in addition to the MammaPrint test in a target population of patients with early stage (stage I or II) breast cancer. By identifying the breast cancer subtype, BluePrint allows determination of a patient's potential level of responsiveness to chemotherapy more accurately as compared to currently available technologies, with better correlation to long-term clinical treatment outcomes. "Blueprint along with MammaPrint helps us to pick and choose a proper treatment for the patient based on their specific functional subtype and overall risk of recurrence," said Ajay Sharma, medical oncologist at Rajiv Gandhi Cancer Hospital. Through the gene test results, patients are stratified into two distinct groups - low risk (good prognosis) or high risk (poor prognosis) of distant recurrence. Unlike other tests, the patient is given definitive "low risk" and "high risk" results, eliminating the uncertainty of an intermediate risk score which can affect up to 39 percent of patients tested, the statement added. Source: Medindia

 

攝護腺肥大手術比一比: 紅光PK綠光 雷射攝護腺汽化術

紅光雷射攝護腺汽化術  公佈日期：2013-03-13財團法人彰化基督教醫院雲林分院泌尿科吳盛川醫師  攝護腺肥大治療新選擇【紅光雷射攝護腺汽化術 攝護腺肥大是許多年長男人的毛病，免不了要吃藥動刀。多數熟男都因攝護腺肥大的問題造成生活上極大的困擾，攝護腺肥大已經是五十歲以上男士的專利，年紀大的男性常會因為攝護腺肥大而造成夜尿、頻尿、排尿困難；還有另一種慢性攝護腺炎偏愛年輕及中年的男士，尤其是慢性攝護腺炎會有一些拖泥帶水的症狀，對日常生活常造成極大的困擾。攝護腺肥大是怎麼形成的？攝護腺又稱為前列腺，是專屬男性生殖系統的一部份，其功能是分泌部份的精液以及某些激素，可以幫助精液液化、保護及滋養精細胞，並保護泌尿生殖道免受感染。男人的攝護腺發育有兩個高峰期，一個是出生到十五歲，此時體積大約長到十五公克；第二個高峰大約是在四、五十歲以後，其發育原因不明，可能與男性賀爾蒙有關係。隨著年齡的增長，以及荷爾蒙的刺激，男人過了30歲後，攝護腺內尿道附近的腺體會出現增生現象，50歲以上開始有攝護腺腫大的毛病，影響排尿，因此中老年男性常發生解尿遲緩、頻尿、滴尿、夜尿或尿不乾淨的困擾。增生的組織一旦壓迫到尿道，就會有一直滴滴答答的現象產生，而影響到生活品質。依國民健康局的資料顯示，50歲的男性朋友約有50%以上會有攝護腺肥大的毛病，隨著年齡的增加，60歲以上有60%，80歲以上罹患此症的比例則高達百分之百。但根據統計一般民眾就醫率偏低；老先生們有的礙於面子羞於就診，有些人擔心年紀大無法承受手術的風險而置之不理；或是忍痛至膀胱漲痛無法忍受緊急送醫，成為急診的常客。泌尿科在過去二十年來一直在思考能否有更好的方式可以取代「經尿道攝護腺刮除術」，現在有了更好的選擇也就是「雷射攝護腺汽化術」。這個手術基本上是透過雷射光纖傳導經尿道膀胱鏡深入攝護腺組織，在光纖前端會有一個光指引需要汽化的地方，以高能量的雷射將多餘的攝護腺肥大組織瞬間汽化掉，有些患者因年邁，或合併其他疾病如腦中風、糖尿病、心臟血管疾病、慢性阻塞肺部疾病等，使用傳統手術時風險增加，較不適合施以傳統手術。因此，高齡患者可使用「紅光攝護腺汽化術」，不但安全性高、風險少且不會出血，也不會影響到性生活。目前，國內坊間頗熱門的綠光雷射手術，很多人都聽過，因為「綠光雷射攝護腺汽化手術」是以高能量532nm綠光雷射，透過汽化的方式，能夠在幾乎不出血的情況下除去多餘的攝護腺組織，解決排尿的困難，並可在短時間內恢復生活作息。而本院自德國引進的是能量提高至980nm的「紅光雷射攝護腺汽化手術」，提供更快速更好的治療。對於高危險患者如心臟病、氣喘方面疾病又患有攝護腺肥大的病患，可快速改善患者排尿異常的問題。這台機器提供了比綠光雷射更穩定的輸出能量與電壓，而且更提高能量的雷射光束照射，使組織汽化的速度優於綠光雷射。此外，由於凝結層比綠光雷射更薄，因此熱傷害將降到最低，目前國外已開始陸續有醫院放棄綠光雷射而改採紅光雷射了。一般病患若是擔心經尿道刮除術可能引發的副作用，可考慮選擇目前最先進的「紅光攝護腺汽化術」，一般術後1-2天即可出院。另外，因手術中出血量很少，更適合年紀大、健康狀況不佳或有心血管疾病或需長期服用抗凝血劑的患者。攝護腺肥大是男人的宿命，平日保養，除儘量避免酒精、辛辣等刺激性食物外，更應該多吃蔬果、適度運動、不要憋尿，當症狀開始影響到日常生活時，就應該找專業泌尿科醫師尋求治療，以免造成自身痛苦，家人困擾。

綠光雷射復原期短　攝護腺肥大患者新選擇NOWnews今日新聞 2015年 05月 28日10:20 「剛過完70大壽的吳爺爺，身體向來硬朗，最近感冒吃藥，沒想到幾天後卻因為尿不出來，膀胱脹痛而就醫，詳細檢查發現是攝護腺出問題……」、「年近花甲的父親，最近上廁所總是好久才出來，是攝護腺肥大嗎？」是不是只要年紀比較長的男性，就會有攝護腺問題的困擾呢？ 康寧醫院泌尿科主任林碧海表示，目前醫學上雖然尚未有證據證實造成攝護腺肥大的成因，但專家們大致認為年紀和雄性激素，是造成攝護腺組織增生的主因。一般來說，年過50歲的男性，攝護腺會隨著年齡逐漸增大，過於肥大的攝護腺會擋住膀胱的開口，進而影響排尿的功能。 為了讓尿液通過受到擠壓而變小的尿道，膀胱必須更加用力，膀胱壁也因此而增厚，使得膀胱的儲尿容量變小，也變得敏感容易受刺激，即使膀胱裡面只有少量尿液，也會增加收縮次數，造成嚴重頻尿。嚴重者，可能會導致急性尿滯留，甚至影響輸尿管以及腎臟的正常機能。康寧醫院泌尿科醫師胡光能進一步說明，微生物非常容易在膀胱滯留的尿液中孳生，且容易造成感染，滯留的尿液一旦濃縮結晶後，會引發膀胱結石，可能症狀包括腹部疼痛與壓迫感、不正常深色的尿液、血尿、排尿困難、頻尿、排尿中斷、陰莖疼痛或不適、尿路感染、排尿灼痛、發燒、尿失禁等。目前治療攝護腺肥大的方式，依照病況的程度有藥物治療、經尿道電刀攝護腺切除術及開腹手術等選擇。藥物為第一線治療法，有不必動刀、無麻醉風險的優點，若藥物無法控制時，則須透過電刀攝護腺切除術或開腹手術，但會有出血過多、尿失禁或勃起障礙等缺點。胡光能指出，隨科技進步，患者可以選擇綠光雷射攝護腺汽化術，這是一種低侵入性手術，利用高能量綠光雷射打通攝護腺尿道，將增生出來壓迫到尿道的攝護腺組織瞬間汽化分解，幾乎不會傷害周邊組織，且能馬上解除排尿困難的症狀，過程中幾乎不會出血，並減少術後導尿管留置時間，改善術後血尿狀況，縮短住院天數。 另外，對於患有高血壓、心臟病等慢性病、心血管疾病，或是不適合採用傳統攝護腺刮除手術等高風險族群來說，綠光雷射攝護腺汽化術是安全性高、併發症少的一項好選擇，術後僅需按照平日生活作息、多喝水即可。 臨床上，目前治療攝護腺肥大的雷射手術中，以綠光雷射汽化術的雷射燒灼深度影響周邊組織機率少，擁有超過500篇國際文獻佐證。至於攝護腺肥大會不會演變成攝護腺癌？胡光能解釋，雖然兩種病症是個別獨立不相干的，但有可能同時發生。因此，完整的鑑別檢查顯得格外重要。

 

Laser therapy for benign prostatic hyperplasia  BPH is the most prevalent disease entity in elderly men. In the late 1980s, lasers became a novel way to open a wider channel and improve voiding dynamics. Many different techniques under the term laser prostatectomy have evolved. Individual techniques may vary greatly, but the 2 main tissue effects include coagulation and vaporization. Coagulation occurs when somewhat diffusely focused laser energy heats tissue and temperatures reach as high as 100°C. Proteins denature, and necrosis ensues. This results in subsequent sloughing of necrotic tissue (ie, a debulking of the prostate). This process may take as long as several weeks to complete and often initially results in edema, which transiently increases prostate volume (and therefore may require short-term urethral catheterization). The principle representative procedures in the laser coagulation category include visual laser ablation of the prostate (VLAP) using Nd:YAG and interstitial laser coagulation (ILC). VLAP uses a direct transurethral viewing source (eg, cystoscope and video) along with a laser that is supplemented by a visible (usually helium-neon) aiming beam. Interstitial coagulation using a diode laser is another coagulative technique in which optical fibers are introduced transurethrally or perineally directly into the prostate. This can cause large-volume necrosis with atrophy while preserving the urethral mucosa. In several studies these coagulative procedures have proven to have unacceptably high adverse events, namely irritative voiding, dysuria, and other storage symptoms, as well as high reoperation rates. Additionally, more efficient and improved laser applications such as Ho:LEP and photo-vaporization (PVP) techniques have shown to be more effective largely replacing VLAP and ILC.43 Vaporization occurs when greater laser energy is focused (increased power density) and tissue temperatures reach as high as 300°C. This causes tissue water to vaporize and results in an instantaneous debulking of prostatic tissue. The high-power (80-W) potassium-titanyl phosphate laser (KTP, or Greenlight) is commonly used for its vaporization effects on prostate tissue. This procedure is associated with significantly less bleeding and fluid absorption than standard transurethral prostate resection. Because of this, the KTP laser is safely used in seriously ill patients or those receiving oral anticoagulants. Additionally, the KTP laser's ease of use has made it an attractive option for urologists. Drawbacks to the KTP procedure compared with traditional TURP include the lack of tissue obtained for postoperative pathological analysis and the inability to diagnose and unroof concomitant prostatic abscesses.

 

In a 2005 study of KTP laser treatment in candidates for transurethral resection of the prostate (TURP), no patients developed significant postoperative gross hematuria although more than half of the patients were on antiplatelet therapy immediately prior to surgery.[7] In this study, prostates with volumes of up to 136 mL were safely treated, although some required prolonged operative times of up to 99 minutes. After a mean follow-up of 3.5 years, most patients in this study saw at least a 50% improvement in their American Urological Association Symptom Index (AUA-SI) and a 100% improvement in peak urinary flow rate (Qmax). A higher-powered 120-W LBO laser (GreenLight HPS) was developed and even more recently the 180-W LBO system (GreenLight XPS) has been marketed to improve upon current vaporization speed. Whether these newer generation KTP lasers are clinically superior to their predecessor remains to be seen. Laser energy has been used to incise or enucleate prostate adenomas down to the capsule, making this procedure the endoscopic analog of open simple prostatectomy. The Ho:YAG is ideally suited for this task because it creates precise incisions, cuts by vaporizing tissue with adequate hemostasis, and leaves minimal collateral damage. Advantages of this method include the availability of a specimen for histologic examination, less postoperative catheter time, and the ability to excise large adenomas. Drawbacks include greater training time and the need to transport the adenoma (in toto or portioned) into the bladder to morcellate it prior to removal. Meta-analyses have shown the efficacy of Holmium laser enucleation of the prostate (HoLEP) to be similar to TURP, at times favoring TURP, particularly with larger glands. Gilling et al found that urodynamic proven relief of obstruction favored HoLEP for prostates of more than 50 g. When comparing HoLEP with traditional TURP using pooled data, Tan et al suggested that catheterization time, hospital stay, and blood loss were significantly lower in the HoLEP group. In addition, Jaeger et al found HoLEP for recurrent lower urinary tract symptoms after failed prior BPH surgery to be safe and effective, with similar efficacy and incidence of complications regardless of prior transurethral prostate surgery. HoLEP has also been shown to be a safe and effective treatment for BPH regardless of age, with similar overall morbidity, hospital stay, and 1-year functional outcomes among all age groups, ranging from age 50-59 year to up to 80 years. For some time, the criterion standard treatment for BPH has been TURP and the standard by which all of the above techniques are compared. TURP is used less frequently because of associated complications, including bleeding and transurethral resection (TUR) syndrome and the improved efficacy of medical therapies. Additionally, the preponderance of urology patients taking chronic oral anticoagulants and anti-platelet therapy mandate the need for techniques that can be safely performed in this setting. In general, the laser prostatectomies mentioned above have added safety and less perioperative pain compared with TURP. Less bleeding occurs and the operative time is usually less; therefore, most types may be performed on patients who are receiving anticoagulants. Laser modalities are safer than TURP in the perioperative period, although some may have a similar long-term complication profile. The coagulative approaches have been largely abandoned because of post-operative symptomatology and the availability of other modalities. Vaporization techniques, particularly Greenlight PVP, has achieved widespread popularity, largely because of its ease of use and the ability to perform these procedures on an outpatient basis. HoLAP is also a viable vaporization technique and in fact a RCT showed essentially equivalent efficacy and complication rates when compared with Greenlight PVP. Only operative time favored PVP.  HoLAP requires the most technical expertise with a correspondingly steep learning curve but is likely the optimal endoscopic approach to the very large gland. Although all of the modalities mentioned are efficacious, none is efficacious enough to make the old-fashioned TURP obsolete.

Laser treatment of urothelial malignancies Various laser energies have been used to treat bladder and upper urinary tract urothelial tumors. Most commonly, holmium and Nd:YAG are used in this setting. They are used through quartz fibers, which are directed endoscopically. The Nd:YAG laser energy is used to coagulate and ablate with a thermal effect that extends deeper than other lasers. Holmium is more precise, with less of a coagulative effect. The advantages of laser therapy for tumor ablation include less bleeding; consequently, catheter drainage is usually unnecessary. A lower incidence of stricture formation results when compared with electrocautery because fibrotic reaction is minimal. This technique decreases the need for anesthesia, causes less postoperative pain, and allows a quicker return to work. The Ho:YAG laser can be used through a flexible cystoscope to ablate recurrent superficial bladder tumors in an office setting. A recent review of patients treated with the flexible cystoscope reported a high degree of satisfaction because this method avoided the need for general anesthesia, and 83% of the patients scored their pain as 2 or less out of a possible 10.  No pathology specimen is available; thus, determining depth of invasion is impossible unless multiple prior biopsy samples were obtained. Another drawback, especially with the Nd:YAG laser, is that the area of destruction is deep and notfully visualized. Some reports of bowel perforation exist when treating bladder dome lesions even without visible bladder perforation secondary to the effect of Nd:YAG. In this setting, Ho:YAG is a better choice. Photodynamic therapy is another form of tumor ablation in which a systemically administered compound is absorbed or retained preferentially by cancer cells and converted by laser light to a toxic compound. This compound usually acts through oxygen radicals to destroy malignant cells. Lasers are ideally suited for this form of therapy because of their monochromaticity and small, maneuverable delivery systems. An example of this type of therapy involves Photofrin II, a hematoporphyrin that is retained by malignant cells long after it clears healthy epithelium. By using an argon laser to excite the dye rhodamine B, a red light of 630 nm is produced that can be aimed at the entire bladder several days after administering the Photofrin. This is especially promising for TCC–carcinoma in situ (CIS), which shows complete response

浩鼎員工貸款壓力大?! 浩鼎 2014淨損是4.46元 預今年將擴大

股價煞風景 浩鼎員工旅遊不開心 2015年05月19日 04:10 記者杜蕙蓉／台北報導 生技新藥股王浩鼎，由於新藥開發還屬於燒錢階段，第一季每股淨損擴大至2.43元，昨日成空頭摜壓標的，不僅股價創下上櫃以來的第一支跌停板，且以309元跌破承銷價格，也讓正在日本沖繩旅遊的員工倍覺錯愕，心情更是跌落谷底。今年3月23日風光掛牌上櫃的浩鼎，承銷價310元，但員工加計稅率後，每股成本約340元。由於浩鼎自掛牌以來，生技股一直都是回檔整理行情，也讓浩鼎沒有別人的蜜月行情，不少員工這波是被貸款逼得喘不過氣來，而成為重災區。近日浩鼎舉辦員工旅遊，不少人在沖繩聽到生技股慘綠，更是一點享樂的心情都沒有。法人表示，浩鼎昨天重挫，主要是首季財報不佳，稅後淨損3.73億元、每股淨損2.43元，該公司去年度每股淨損是4.46元，預期今年虧損額將擴大，也導致買盤縮手。不過，法人認為，浩鼎開發的新藥OBI-822是全球首個癌症主動性免疫療法，去年8月已完成349例台灣三期臨床收案，以用藥期9個月計算，今年5月所有收案個案將全數完成療程，8月最晚加入個案也已屆滿一年，該公司將在第三季評估解盲時機，並有機會在年底或明年中解盲。由於法人圈對浩鼎的解盲結果看法較正面，因此，外資已連續2天小買超。

(生技多頭) 柯登元…新藥併購利多發酵

醫療生技連7年多頭 啟動 2015年06月04日 04:10 記者陳欣文／台北報導 醫療生技股連走6年多頭，今年表現一樣搶眼，S&P500醫療保健指數上漲8.9％，遙遙領先其他類股，不僅如此，第一季EPS年增18.3％，高居10大產業之冠，強勢奪下漲幅、獲利雙冠王。法人表示，看來在堅實的獲利基本面支撐下，醫療生技股正如火如荼展開第七年的多頭行情。摩根環球醫療科技基金經理人瑪登（Anne Marden）表示，面對近年來的國際動盪，醫療生技股在防禦特質護體下，不僅企業獲利不易受到景氣循環的影響，股價表現也相對穩健，從S&P500醫療保健指數連六年走升可見一斑。瑪登分析，受惠於人口老化趨勢所帶來的長線需求潛力，加上新興市場中產階級崛起，拉抬醫療保健開支，以及製藥技術日臻純熟加速新藥開發蓬勃，挹注醫療生技股獲利成長爆發力十足。保德信全球醫療生化基金經理人江宜虔指出，根據高盛最新報告，回顧過去20年美國標普500指數（S&P 500），一年之中，醫療保健產業在6月表現最強，有8成機會打敗大盤，美股財報也同步傳來佳音，十大類產業中，醫療保健業預估獲利年增率居冠，在美股陷入震盪之際，可望持續打敗大盤，建議可將醫療生化產業類型的基金納入長期資產配置。新光全球生技醫療基金經理人柯登元表示，下半年Fed即將升息，全球股市震盪，醫療保健產業受惠新藥及併購利多持續發酵，未來基金漲升空間可期，是升息防震投資首選。另外，過去5年全球癌症藥物開支複合年成長率達6.5％，隨著免疫療法問市，從現在到2018年，新治療方法將提升年成長率到8％，成為全球製藥產業成長動能。

(浩鼎) 潤泰 護盤1880張/ 徐紅照、許慶祥各增2000多張/ 林滄海 下車2700多張

浩鼎新藥上市恐生變 股價重挫 2015-06-05 01:40:44 經濟日報 記者黃文奇／台北報導分析師仍看好雙優勢 取得藥證還有機會 16家券商買超力挺 力守300元大關分享台灣浩鼎因錯植「乳癌新藥OBI-822復發人數時間點」，造成昨（4）日股價重挫逾4%，雖然賣壓沈重，仍有日盛、法銀巴黎、元大寶來、德意志等16家券商買超，使股價力守300元大關。 由於浩鼎OBI-822的「疾病無惡化存活期」（PSF）最後數據，將牽動該產品能否順利上市，或影響上市時程，受到投資人關注。市場擔心，浩鼎若新藥失敗，是否將造成台灣生技夢碎。分析師表示，浩鼎仍有兩項優勢，首先是以地方判讀數據的惡化人數229人看來，要大幅優於目前市面上抗乳癌藥Herceptin恐不容易，但要跨越最低門檻、取得藥證，應仍有機會。其次是浩鼎產品線還有第二代免疫療法833、被動免疫療法、醣晶片及主動免疫療法的第三代產品正在規劃，不會有一蹶不振的問題。據了解，臨床試驗所指惡化人數（PD）有兩種定義：一是臨床醫師判讀的病患惡化人數（Local Read），另一是由獨立判讀中心（Central Read）根據影像學檢查結果後判定的惡化人數。依OBI-822試驗計畫書，當惡化人數達289人，公司得進行解盲，該計畫自2011年1月收第一位病人，迄今約四年半，至今年5月，病患惡化人數醫師報告為229人，公司將在今年8月召開專家會議，決定解盲時機。業界分析，以浩鼎目前狀況評估，解盲時間最快落在年底。浩鼎管理階層5月26日赴海外舉辦法說會，行前將法說簡報上傳，該投影片第22頁引用OBI-822臨床試驗數據安全監督委員會（DSMB）第八次報告，原應用今年1月復發人數187人，但高層錯植採用5月229人的數據。依臨床試驗相關法規規定，應採用獨立判讀中心的判定數據，浩鼎以臨床醫師判讀數據上傳，由於有時間差及引用來源不同，才會引起然大波。浩鼎指出，依OBI-822臨床試驗計畫，若惡化人數達142人，獨立判讀中心的判讀數據得進行期中分析，去年7月已完成342人收案目標，同年10月浩鼎徵詢並與醫藥品查驗中心（CDE）溝通，CDE評估後認為無安全疑慮，同意免除期中分析，去年11月正式獲得衛福部核准。

潤泰全護盤 大買1,880張 浩鼎在生技產業最艱難時期掛牌，上櫃後股價表現一直低迷，但仍獲大股東支持，潤泰集團近兩個月啟動護盤機制，其中潤泰全近期共買進1,880張，合計砸下6.1億元，受到市場矚目。過去一年浩鼎前十大股東持股出現變動，其中一般股東林滄海持有2,700多張，近半年來已陸續脫手；Alpha Corporate減少1,000多張、永豐銀託管薩摩亞全球策略公司投資專戶減少1,600張、玉山創投減少700餘張；但一般個人徐紅照、許慶祥等兩人反而各增持2,000多張。目前浩鼎最大股東是潤泰集團，對公司仍有信心，雖然部分股東分批換手，但浩鼎投資人在網路上組「浩友會」力挺，認為可以趁此機會將對浩鼎信心不足的人「洗出去」。