減少乳房腫瘤切除後再度切除的新裝置


  【24drs.com】一種研發中的新裝置可以減少初期乳癌病患腫瘤切除後再度手術的需求,且不需要移除更多患部,可說是減少了病患的手術風險,且改善保留外觀的機會。
  
  這篇使用MarginProbe這項實驗裝置的大型隨機試驗,結果顯示乳管原位癌(DCIS)病患再度進行切除的需求顯著降低:使用該裝置組為13%、對照組為37%(P = .004)。
  
  在包括DCIS與侵犯性腫瘤的後續世代中,需再度切除者的需求也顯著降低(17% vs 33%;P < .001)。
  
  紐約貝絲以色列醫學中心乳房外科Susan K. Boolbol醫師表示,研究結果發現該裝置可以在術中確認需切除的陽性邊緣。她在美國臨床腫瘤協會舉辦2012年乳癌研討會前發表的簡報中發言指出,相較於標準的乳房腫瘤切除術,使用該裝置可降低再度切除率,重點是,降低了再度切除率且不會顯著增加需移除的組織量。
  
  約60%至75%的乳癌案例接受乳房保留手術作為初步治療,進行這個手術的病患,約45%至75%邊緣是陰性且完成手術治療,但不幸的是,約20%至40%的癌細胞靠近邊緣而需要再度手術切除。
  
  無法獲得適當的邊緣對病患而言是很重要的影響,何況還要進行額外手術。Boolbol醫師表示,這可能會延遲給予化療和放療等輔助治療的時機。病患有相當大的生理和心理壓力,此外,乳房保留手術可能會影響外觀。
  
  在單次手術內獲得陰性邊緣對外科醫師而言確實是個挑戰,特別是DCIS案例;有許多技術被發表用來降低陽性邊緣率,但代價是需要切除額外的組織。
  
  在這次於美國和以色列22處進行的前瞻式國際多中心研究中,病患進行標準乳房切除術後被隨機分組到MarginProbe組或對照組。
  
  Boolbol醫師表示,該裝置的探針放置在組織,一旦被切除,會回饋給系統是否有癌細胞靠近邊緣,若有需要,可即時切除更多組織。
  
  研究者紀錄切除的所有樣本和組織量進行分析,作者們指出,因為減少了需要移除更多組織的再度切除者,他們評估了術中所移除的總組織量以分析對病患的最後結果。
  
  所有手術(乳房切除術和再度切除)移除的總組織量,實驗組和對照組的DCIS病患結果相似(83 cc vs 76 cc)。
  
  Boolbol醫師解釋,但是當使用MarginProbe裝置於DCIS病患時,再度切除率降低50%,但組織移除量無顯著差異。
  
  侵犯性癌症和DCIS病患的結果相同,再度切除率也降低近半數,且組織量無顯著改變(94 cc vs 90 cc)。
  
  美國臨床腫瘤協會癌症溝通委員會委員Andrew Seidman醫師表示,身為治療乳癌病患的腫瘤科醫師,發現病患確實壓力很大,且要面對初次手術和預期再度切除的尷尬時刻。
  
  主持簡報的Seidman醫師表示,這個裝置聽起來很受歡迎,可降低焦慮、費用、時間,致力於讓病患在首次治療就獲得更好的結果。
  
  Boobol醫師結論指出,如同任何臨床裝置一樣,需要後續研究探討這個裝置在不同組織學分類時的應用,但這的確是個可以影響我們進行乳房腫瘤切除術方式的一個新裝置。
  
  資料來源:http://www.24drs.com/professional/list/content.asp?x_idno=6941&x_classno=0&x_chkdelpoint=Y
  

Novel Device Reduces Re-excision After Lumpectomy

By Roxanne Nelson
Medscape Medical News

September 11, 2012 — A new investigational device may reduce the need for further surgery following lumpectomy in patients with early breast cancer, without removing more volume. This can translate into less surgical risk for the patient, as well as improve the odds of preserving cosmetic appearance.

The results of a large randomized trial using the experimental device, MarginProbe (Dune Medical Devices, Inc), showed that among patients with ductal carcinoma in situ (DCIS), there was a significant decrease in the need for re-excision: 13% with the device vs 37% in controls (P = .004).

In a further cohort that included patients with both DCIS and invasive carcinoma, the decrease in re-excision candidates was also significant (17% vs 33%; P < .001).

"The results revealed the device is able to intraoperatively identify positive margins that require re-excision," said senior author Susan K. Boolbol, MD, a breast surgeon at Beth Israel Medical Center in New York. She was speaking at a press briefing organized by the American Society of Clinical Oncology in advance of the 2012 Breast Cancer Symposium.

"Using this device led to decreased re-excision rate compared to the standard procedure of lumpectomy," she added. "And the important thing is that it did this — it decreased the re-excision rate without significantly increasing the total amount of tissue we removed."

Re-Excision Procedure

About 60% to 75% of breast cancer cases undergo breast conservation surgery as an initial treatment. For approximately 45% to 75% of patients undergoing this procedure, the margins will be negative and the surgical phase of treatment is complete. "But unfortunately, for approximately 20 to 40%, we find that cancer cells are close to one of the margins," she explained, and this requires a re-excision procedure.

The failure to achieve appropriate margins has important consequences for the patient, other than the need to return for additional surgeries. "It can potentially delay administration of adjuvant therapies, such as chemotherapy and radiation," Dr. Boolbol said. "There is incredible psychological and physical stress for the patient and we also know that there is the potential for an inferior cosmetic result from the breast conservation surgery."

The ability to obtain negative margins within a single surgery does present a challenge to surgeons, particularly in DCIS cases, she commented. A number of techniques have been reported to lower the positive margin rate, but at the cost of needing to resect additional tissue.

In this prospective, international, multicenter study, which was conducted at 22 sites in the US and Israel, patients were randomized in the operating room after standard lumpectomy to either MarginProbe or a control group.

"The probe is placed on the tissue once it is excised, and it gives us feedback if there are cancer cells close to one of the margins," Dr. Boolbol said. If necessary, more tissue can be removed at that time.

The tissue volume of all specimens and resections was recorded, and the authors note that, because reducing candidates for re-excision requires removing additional tissue associated with cancer, they evaluated total tissue volume removed across all surgeries to assess the final effect on the patient.

The total tissue volumes removed during all surgeries (lumpectomy and re-excisions) for patients with DCIS alone was similar between the study group and control group ((83 cc vs 76 cc).

But when using the MarginProbe device for patients with DCIS alone, the re-excision rate declined by 50%, even with no significant difference in tissue volume removed, Dr. Boolbol explained.

The results were the same for patients with invasive cancer and DCIS, in that the re-excision rate also decreased by almost half, and with no significant change in tissue volume (94 cc vs 90 cc).

"As a medical oncologist who only sees breast cancer patients, I do see patients in that very stressful and awkward window of time between an initial surgical procedure and that anticipated re-excision," commented Andrew Seidman, MD, member of the American Society of Clinical Oncology Cancer Communications Committee.

This device sounds like "very welcomed news, in that it can reduce anxiety, cost, and perhaps time and effort for patients by getting it more right the first time," said Dr. Seidman, who moderated the briefing.

But as with any clinical device, further studies are needed to investigate device application in histologic subgroups, Dr. Boobol concluded. "But this is a novel device and can potentially affect the way we perform lumpectomies."

The authors have disclosed no relevant financial relationships.

2012 Breast Cancer Symposium. To be presented September 13, 2012. Abstract # 144.

    
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