本帖最後由 lsc0019 於 2009-5-31 00:27 編輯
作者：Zosia Chustecka
出處：WebMD醫學新聞
May 15, 2009 — 美國一項兩個中心參與的臨床試驗，研究一種雷射間質熱能療法(laser interstitial thermal therapy，LITT)用於復發或惡化多形性膠質母細胞瘤(glioblastoma multiforme)病患腦部的效果。
LITT也被稱為熱凝集，以雷射熱能摧毀組織達到治療效果。已經被研究用於治療無法切除的肝轉移，之前由Medscape Oncology進行報導。同樣的技術也被用在良性前列腺肥大的門診病患。
現在，Monteris Medical公司研發的AutoLITT裝置，獲得美國食品藥物管理局的501k許可證，用於神經外科。該公司表示，起初將用於無法動手術的腦部腫瘤。使用磁振造影導引雷射探針，通過頭顱的一個小洞，以讓高密度的雷射能可以直接運用到腦部腫瘤組織。
本試驗將於克里夫蘭診所進行，主持人是腦腫瘤與神經腫瘤中心主任Gene Barnett醫師，以及在俄亥俄州克里夫蘭大學醫院案例醫學中心進行，主持人是腦腫瘤與神經腫瘤中心主任Andrew Sloan醫師。納入試驗的病患是復發或以手術、放射、和/或化療治療仍惡化的等級4多形性膠質母細胞瘤病患。
【歐洲試驗中，同樣的方法，不同的裝置】
歐洲放射學期刊(2006;59:208-215)曾發表一篇使用同樣方法但不同裝置的試驗，該試驗包括16名復發多形性膠質母細胞瘤病患，領銜的研究者是德國杜塞道夫大學醫學院的Hans-Joachim Schwarzmaier醫師，報告指出他們有比較長的存活。
研究者指出，復發多形性膠質母細胞瘤病患的餘命不佳，一般預測存活5個月以下。約有三分之一病患接受再度手術，僅再增加8週餘命；使用temozolomide的標準化療增加平均存活到5.4-7.1個月。
在LITT研究中，平均整體存活時間為6.9± 1.7個月(95%信心區間[CI]為3.7- 10.2個月)。不過，研究者指出，有明顯的學習曲線存在。在第1期(2001/02年)接受治療的10個病患中，LITT之後的平均存活時間只有5.2± 0.6個月(95% CI為4.1- 6.3個月)。但是第2期(2003/04年)治療的6個病患中，LITT之後的平均存活時間增加到11.2± 2.0個月(95% CI為7.4- 15.0個月)。研究者指出，兩段期間的存活時間分布顯著不同(P= .0267)。
研究者認為，這些存活時間比合併化療的時間更久，但是他們也強調，需要進行控制臨床試驗。
Laser Interstitial Thermal Therapy Cleared for Use In Brain Tumors
By Zosia Chustecka
Medscape Medical News
May 15, 2009 — A device that can deliver laser interstitial thermal therapy (LITT) into the brain is being investigated in patients with recurrent or progressive glioblastoma multiforme in clinical trials in 2 centers in the United States.
LITT, also referred to as thermocoagulation, offers a way of destroying tissue with laser heat treatment. It has already been explored for use in the treatment of unresectable liver metastases, as previously reported by Medscape Oncology . The same technique has also been used in an outpatient setting for benign prostatic hypertrophy.
Now the AutoLITT device, developed by Monteris Medical Inc, has 501k clearance from the US Food and Drug Administration for use in a neurosurgery application. Initial use will be in patients with inoperable brain tumors, the company says. The laser probe is guided by magnetic resonance imaging, and is passed through a small hole in the skull so that the high-intensity laser energy can be applied directly to brain tumor tissue.
The trials will be carried out at the Cleveland Clinic, under the direction of Gene Barnett, MD, FACS, director of the Brain Tumor and Neuro-Oncology Center, and at the University Hospitals Case Medical Center in Cleveland, Ohio, under the direction of Andrew Sloan, MD, FACS, director of the Brain Tumor and Neuro-Oncology Center. Patients being recruited to the trial have recurrent or progressive grade?4 glioblastoma multiforme that is progressing despite treatment with surgery, radiation, and/or chemotherapy.
Same Approach, Different Device in European Trial
A trial using the same approach, but with different devices, has already been published in the European Journal of Radiology (2006;59:208-215). The trial involved 16 patients with recurrent glioblastoma multiforme, and the researchers, headed by Hans-Joachim Schwarzmaier, MD, from the University of Dusseldorf Medical School in Krefeld, Germany, report that they had a "comparatively long survival."
The life expectancy of patients with recurrent glioblastoma multiforme is poor, with a natural history predicting survival of 5 months or less, the researchers state. About one third of patients can undergo repeat surgery, which adds another 8 weeks to their life expectancy; standard chemotherapy using temozolomide increases the median survival to 5.4 to 7.1 months, they note.
In the LITT study, the median overall survival time was 6.9?± 1.7 months (95% confidence interval [CI], 3.7?- 10.2 months). However, the researchers point out that there was a substantial learning curve. For the 10 patients treated during the first phase (2001/02), the median survival time after LITT was only 5.2?± 0.6 months (95% CI, 4.1?- 6.3 months). But for the 6 patients treated in the second phase (2003/04), the median survival time after the first LITT increased to 11.2?± 2.0 months (95% CI, 7.4?- 15.0 months). The distributions of the survival time in the 2 periods were significantly different (P?= .0267), the researchers point out.
The researchers comment that these survival times are longer than have been reported for combination chemotherapy, but they also emphasize the need for controlled clinical trials. |
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