本帖最後由 goodcat1111 於 2009-4-5 08:11 編輯
作者：Roxanne Nelson
出處：WebMD醫學新聞
March 11, 2009(加州聖地牙哥) — 研究者表示，介入性冷凍治療是小腎腫瘤的一個有效治療方式，應作為病灶在4公分以下病患的治療黃金標準或者第一線治療選項。
根據介入性放射線協會(SIR)第34屆年度科學會議中發表的研究，對於希望避免手術或者無法手術的病患，達7公分的較大腫瘤也可能是可行的。
SIR總裁候選人、未參與本研究的Brian Stainken醫師表示，這些新手術是大轉折，改變了我們原本的想法；但是重點在於知道，在提供扭轉乾坤的解決方法之前，我們要先有好的資料。
他在訪問中向Medscape Oncology表示，根據資料中的優勢，此技術已經可以用於一般臨床實務；超過四分之三腎臟癌患者的腫瘤小於4公分。對於小腫瘤病患，此方法可以取代摘除整顆腎臟，它可以取代必須接受的大手術，甚至可以在門診進行。
在本研究中，約翰霍普金斯醫院血管與介入性放射線科的Christos Georgiades博士，發表了在84名腎臟腫瘤1到10公分之病患進行的90例冷凍治療手術的效果資料；這個手術於2006年4月至2008年12月在約翰霍普金斯醫院進行，病患在第一年時每三個月追蹤一次，之後每年追蹤一次。
【各機構間的使用各異】
在去年的SIR會議中，Georgiades博士發表研究的初步資料，當時由Medscape Oncology加以報導。Georgiades博士表示，他最初是在因為共病症而無法手術的病患進行冷凍治療，但現在可以作為可接受手術之病患的替代治療。
紐約市Sloan-Kettering癌症紀念中心的冷凍治療專家Stephen Solomon醫師在去年向Medscape Oncology表示，冷凍治療尚未成為標準照護方式，許多醫師仍偏好切除腫瘤。
Solomon醫師未參與本研究，他向Medscape Oncology表示，各機構對腎臟腫瘤使用冷凍治療的情形各有不同；有些完全不做，有些以此方法治療腫瘤小於4公分的那15%腫瘤；他表示，此技術在兩家公司(Endocare與Galil)參與下，現在廣為接受，市場也在成長。
在今年的發表中，Georgiades博士報告指出，介入性冷凍治療現在在約翰霍普金斯醫院已經變成小腫瘤的第一線治療方式。
【小腫瘤有100%的反應】
Georgiades博士指出，他們最初並未設定4公分以下才適於進行手術；他在記者會簡報時表示，我們曾經治療腫瘤達10公分的病患—不可否認，這些病患因為某些原因而無法手術；但是我們發現，腫瘤4公分以下的病患有100%的反應，所以提出前述4公分大小的建議。
他指出，我們在病灶達7公分案例有一樣好的結果，不過，此類案例只有5到10名病患，所以無法對較大腫瘤提出一個一般性建議。
這些病患中，88個腫瘤完全治療，沒有癌症殘留跡象。兩位病患有小量殘留疾病(~1公分)，一位病患再度治療後有完全反應，另一位病患拒絕後續治療。
Georgiades博士解釋，現在已經有病患追蹤2.5年的資料；他表示，效果依舊是100%，且無人顯示有局部腫瘤復發或者轉移。
相較於其他手術，經皮冷凍治療有許多好處。Georgiades博士解釋，這不是手術，沒有切口，不用全身麻醉。腫瘤開始解凍時會有一點疼痛、一點發炎，但可以輕易加以解決。
他指出，多數病患在當天或者隔天清晨返家；相較於手術，併發症較少且費用較低。他表示，若冷凍治療失敗，病患仍然可以進行手術。
【安全資料有力】
相關的安全研究中，Georgiades博士評估無法接受手術或者選擇進行介入性放射線治療之73名病患的81例電腦斷層導引經皮冷凍治療結果。於第3、6、12個月時於門診追蹤，之後每年追蹤一次。
病灶大小從1到10公分都有，13處(16%)是良性。根據「常見不良事件評價標準(CTCAE)」對手術前後與長期併發症進行分類。
整體來說，研究者發現CT導引經皮冷凍治療有相當傑出的安全資料，他們觀察總共只有6例(7.4%) CTCAE 分類大於1的併發症，包括冷休克、出血、肋膜積液、氣胸與廔管。此外，22例(27%)自限式CTCAE分類1事件；沒有手術相關死亡。
Stainken醫師表示，更積極的治療與傳統治療都各有可用之處；我們現在要釐清的是，何時微創手術較佳，何時傳統手術較優；不過，這些都必須提供給病患知悉。
Georgiades 博士宣告沒有相關財務關係。
介入性放射線協會(SIR)第34屆年度科學會議：摘要18與19。發表於2009年3月9日。
SIR 2009: Percutaneous Cryoablation May Be New Standard of Care for Small Renal Tumors
By Roxanne Nelson
Medscape Medical News
March 11, 2009 (San Diego, California) — Interventional cryoablation is an effective treatment for small renal tumors, and should be the gold standard or first treatment option for all patients with lesions that are 4?cm in size or smaller, researchers say.
It might also be a viable option for larger tumors, up to about 7?cm in size, for patients who wish to avoid or cannot have surgery, according to a study presented here at the Society of Interventional Radiology (SIR) 34th Annual Scientific Meeting.
"These new types of procedures are game changers, and they change the way we think," said Brian Stainken, MD, president-elect of SIR, who was not involved in the study. "But it is important to know that we have good data before we offer game-changing solutions."
Based on a preponderance of data, this technique is ready to be used in general clinical practice, he told Medscape Oncology in an interview. "More than three quarters of individuals with kidney cancer have tumors that are 4?cm or less in size," he said. "For patients with small tumors, this procedure can take the place of removing the entire kidney. It can replace having to undergo significant surgery, and might even be possible to conduct on an outpatient basis."
In this study, Christos Georgiades, MD, PhD, from the Division of Vascular & Interventional Radiology at Johns Hopkins Hospital, in Baltimore, Maryland, presented efficacy data from 90 cryoablation procedures that were performed on 84 patients with renal tumors ranging in size from 1 to 10?cm. The procedures were conducted at Johns Hopkins Hospital from April 2006 through December 2008, and patients were followed every 3 months during the first year, and annually thereafter.
Usage Varies Among Facilities
At last year's SIR meeting, Dr. Georgiades presented preliminary data from the study, which was reported by Medscape Oncology. At that time, Dr. Georgiades said that he initially performed cryoablation on patients who could not undergo surgery because of comorbidities, but now offers the procedure as an alternative to patients who can undergo surgery.
Stephen Solomon, MD, a cryoablation specialist from Memorial Sloan-Kettering Cancer Center, in New York City, spoke with Medscape Oncology last year. Cryoablation was "still relatively far from becoming the standard of care," he said, and "many surgeons still prefer to cut out the tumor."
Dr. Solomon, who was not involved in the study, also told Medscape Oncology that the proportion of kidney tumors treated with cryoablation varies among institutions; some do not use it at all, whereas others treat 15% of tumors smaller than 4?cm with this method. The technology is widely available, with 2 companies involved (Endocare and Galil), and the market is growing, he said.
At this year's presentation, Dr. Georgiades reported that interventional cryoablation has now become the first-line treatment for small tumors at Hopkins.
Small Tumors Had 100% Response
Dr. Georgiades noted that they didn't initially set a threshold of 4?cm or less as the optimal size for the procedure. "We have treated patients with tumors up to 10?cm — admittedly, these are patients who could not have surgery for whatever reason," he said during a press briefing. "But we found that patients with tumors that were 4?cm or smaller were the ones with a 100% response, so that's why our recommendation stops at 4?cm."
"We have had equally good results with lesions up to 7?cm, but we've only treated between 5 and 10 patients with lesions that size, so I cannot make a generalized conclusion for larger tumors," he added.
Within this cohort, 88 tumors were treated completely, without any evidence of cancer remaining. Two patients had a small amount of residual disease (~1?cm), and 1 patient was retreated with a complete response. The other patient refused further treatment.
Follow-up data are available in a subgroup of patients for 2.5 years, explained Dr. Georgiades. "Efficacy is still 100% and none have shown any local tumor recurrence or metastatic disease," he said.
There are major advantages to percutaneous cryoablation, compared with other procedures. "There is no surgery, no incision, and no general anesthesia," Dr. Georgiades explained. "There is some pain when the tumor begins to thaw, and some inflammation, but we can easily address that."
Most patients go home the same day or the following morning, he added. Compared with surgery, there are also fewer complications and lower cost. "In the unlikely case that cryoablation fails, the patient can still undergo surgery," he said.
Strong Safety Profile Reported
In a related safety study, Dr. Georgiades evaluated the results of 81 computed tomography (CT)-guided percutaneous cryoablations conducted in 73 patients who either couldn't undergo surgery or who elected to undergo the interventional radiology treatment. Patients were followed in the clinic at 3, 6, and 12 months, and annually thereafter.
The lesions ranged in size from 1 to 10?cm, and 13 (16%) were benign. All peri-procedural and long-term complications were categorized according to the Common Terminology Criteria for Adverse Events (CTCAE).
Overall, the researchers found that CT-guided percutaneous cryoablation had an "excellent safety profile." They observed a total of 6 (7.4%) CTCAE category?>1 complications, including cryoshock, bleeding, pleural effusion, pneumothorax, and fistula. In addition, 22 (27%) self-limiting CTCAE category?1 events were noted; there were no procedure-related deaths.
"There is always going to be a role for more aggressive and conventional therapies," said Dr. Stainken. "What we need to do now is sort out when minimal is best and when conventional is best. But all of these choices need to be available to patients."
Dr. Georgiades has disclosed no relevant financial relationships.
Society of Interventional Radiology (SIR) 34th Annual Scientific Meeting: Presented March 9, 2009. |
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