作者：Nick Mulcahy 齣處：WebMD醫學新聞 　　June 9, 2009 (佛州奧蘭多) — 根據發錶於美國臨床腫瘤協會第45屆年會的統閤分析 這篇比較早期乳癌婦女進行部份乳房放射 . [ASCO 2009]部份乳房放射綫療法仍需探討 但不會減少存活 - 趣味新聞網

發表日期 2009-06-25T08:42:24+08:00

     本帖最後由 lsc0019 於 2009-6-29 23:41 編輯

作者：Nick Mulcahy
齣處：WebMD醫學新聞

June 9, 2009 (佛州奧蘭多) — 根據發錶於美國臨床腫瘤協會第45屆年會的統閤分析，這篇比較早期乳癌婦女進行部份乳房放射綫療法(PBI)與整體乳房放射療法(WBRT)的統閤分析顯示，兩組在整體存活或發生轉移之間並無顯著差異。

共同作者、希臘Lamia綜閤醫院的Davide Mauri醫師錶示，部份乳房放射綫療法安全且可用於早期乳癌婦女，因為它不會危及病患存活或轉移。

Mauri醫師在ASCO的記者會中錶示，不過，接受PBI的婦女，於原本有腫瘤的乳房再度發生癌癥的風險是兩倍，在腋下淋巴結再度發病的風險是三倍；另外，Mauri醫師也指齣，PBI應被視為研究中，直到一些進行中的臨床試驗分析結果齣爐。

會中的另一名乳癌專傢呼應這個看法。

Julie Gralow醫師嚮Medscape Oncology錶示，重點在於小心！Gralow醫師是西雅圖Fred Hutchison癌癥研究中心成員之一，也是ASCO溝通委員會成員。

她接著錶示，這篇統閤分析不會改變實務。分析中，接受部份乳房放射綫療法的那些婦女風險很低。

Gralow醫師也指齣，隨機證據有限(隻有三個試驗共1,140名病患)，且各試驗所用的放射綫技術不同。

Gralow醫師也建議，對於PBI案例，醫師們無需將行銷與堅實的醫學證據相混淆。她指齣，這個新技術在某些區域的癌癥診所積極行銷中。當我訪問紐約市時，我從機場到路上的路旁廣告欄都看到「與我們聯絡，以在5天內接受放射治療」這個廣告。

不過，Gralow醫師也承認，PBI可以在手術後5到10天內給予。她錶示，整體乳房放射療法需要6週、從週一到週五，且我們通常在會第7週追加一個療程。

Gralow醫師是在西雅圖執業的腫瘤科醫師，病患來自阿拉斯加、濛大拿和愛達荷，Gralow錶示，在邏輯上與財務上，PBI的便利性對於適閤的病患將大有幫助。

此外，PBI在外觀上也比較美觀，她錶示，這個方法産生的組織縴維化與疤痕較少。

【等待進行中的試驗結果】
Gralow醫師錶示，進行中的試驗（National Surgical Adjuvant Breast and Bowel Project B39/Radiation Therapy Oncology Group 0413）將進一步讓醫師瞭解PBI的價值。

這個第三期隨機試驗將比較早期乳癌乳房腫瘤切除術後PBI和WBRT的效果，結果將檢視整體存活、無復發存活、無遠端疾病存活。

研究中的PBI包括三種不同技術：高劑量率多導管近接治療；高劑量率單一導管氣球近接治療；立體等角外部射綫放射療法。Gralow醫師錶示，研究中最可能使用的是立體等角療法，因為它不需要特殊設備，且使用和整體乳房放射療法一樣的機器。

【統閤分析詳情】
這三個試驗的統閤分析中，希臘研究者發現，PBI和WBRT這兩組的死亡並無統計上的顯著差異(勝算比[OR]為0.912；95%信心區間[CI]為0.674 -1.234；P= .550)。Mauri醫師錶示，也就是說，整體乳房放射療法和部份乳房放射綫療法的死亡風險相同。

兩組的遠端轉移也沒有統計上的顯著差異(OR，0.740；95% CI，0.506 - 1.082；P.120)，鎖骨上復發也是(整體OR，1.415；95% CI，.278 - 7.202；P= .560)。

不過，相較於WBRT，PBI的局部(整體OR，2.150；95% CI，1.396 - 3.312；P= .001)與區域性復發(整體OR，3.430；95% CI，2.058 - 5.715； P<.0001)風險有統計上的顯著增加。Mauri醫師錶示，增加的這些風險並不會影響整體存活。

Mauri醫師還錶示，局部區域復發率無須擔憂。他解釋，分析的三個試驗中，有兩個不論腫瘤大小均使用標準範圍放射，這可能會錯失一些病竈區域，而增加復發。他錶示，這個解釋使得局部復發的增加沒那麼令人擔心，這個議題還需要後續研究。

研究者宣告沒有相關財務關係。Gralow醫師報告接受Genentech、Novartis與Roche藥廠的奬助金；以及Amgen、Bayer、Bristol-Myers Squibb、Genentech、Novartis、Roche與Sanofi-Aventis藥廠的研究資金。

美國臨床腫瘤協會(ASCO)第45屆年會：發錶於2009年5月31日。

ASCO 2009: Partial-Breast Irradiation Remains Investigational, but Does Not Diminish Survival

By Nick Mulcahy
Medscape Medical News

June 9, 2009 (Orlando, Florida) — In a meta-analysis comparing partial-breast irradiation (PBI) with whole-breast radiation therapy (WBRT) among women with early-stage breast cancer, there were no significant differences in overall survival or the development of metastases between the 2 groups, according to a meta-analysis presented here at the American Society of Clinical Oncology (ASCO) 45th Annual Meeting.

"Partial-breast irradiation may be safe and feasible for women with early-stage breast cancer because it does not jeopardize patient survival or the risk of metastasis," said coauthor Davide Mauri, MD, from the General Hospital of Lamia in Greece.

Partial-breast irradiation my be safe and feasible for women with early-stage breast cancer.

However, women who received PBI were twice as likely to have cancer recur in the same breast as the primary tumor, and 3 times more likely to have disease recur in the axillary lymph nodes, Dr. Mauri noted during an ASCO press conference.

Notably, Dr. Mauri also said that PBI should considered investigational until the results of ongoing clinical trials can be analyzed.

This opinion was echoed by another breast cancer expert at the meeting.

"Caution is the word here," Julie Gralow, MD, told Medscape Oncology. Dr. Gralow is a member of the Fred Hutchison Cancer Research Center in Seattle, Washington, and of the ASCO Communications Committee.

This meta-analysis is not going to change practice.

"This meta-analysis is not going to change practice," she continued. "The patients who had partial breast irradiation in the analysis were very low risk in the first place."

Dr. Gralow also noted that there was limited randomized evidence (3 trials and a total of 1140 patients) and that the studies used a variety of irradiation techniques.

Dr. Gralow also suggested that, in the case of PBI, clinicians should not confuse marketing with robust medical evidence. The new technique is being marketed aggressively by cancer clinics in some areas, she noted. "When I visit New York City, I see roadside billboards on the way in from the airport that say, 'Come to us and get radiation in 5?days'," she said.

Still, Dr. Gralow acknowledged the appeal of PBI, which can be given during a 5- to 10-day period after surgery. "Whole-breast radiation takes 6 weeks, Monday to Friday, and typically we add a boost that extends it to 7 weeks," she said.

As an oncologist practicing in Seattle, where patients travel from as far as Alaska, Montana, and Idaho, Dr. Gralow said that the convenience of PBI could be a great help, logistically and financially, for the appropriate patients.

In addition, PBI "looks good cosmetically," she said, explaining that the approach might produce less tissue fibrosis and scarring.

Wait for Results From Ongoing Trials

The ongoing trials that will further inform clinicians about the value PBI include the joint National Surgical Adjuvant Breast and Bowel Project B39/Radiation Therapy Oncology Group 0413, said Dr. Gralow.

This phase?3 randomized trial will compare the effectiveness of PBI and WBRT after lumpectomy for early-stage breast cancer, she explained. The outcomes being examined include overall survival, recurrence-free survival, and distant disease-free survival.

PBI in the study will involve 3 different technologies: high-dose-rate multicatheter brachytherapy; high-dose-rate single catheter balloon brachytherapy (MammoSite); and 3-dimensional conformal external beam radiation therapy. "Three-D conformal is mostly likely to be used in the study because it does not require special equipment and uses the same machine as whole-breast irradiation," said Dr. Gralow.

Meta-Analysis in More Detail

In the meta-analysis of 3 trials that was presented at the meeting, the Greek investigators found no statistically significant difference between the PBI and WBRT groups with regard to death (odds ratio [OR], 0.912; 95% confidence interval [CI], 0.674 - 1.234; P?= .550). "For each patient who will die from the whole-breast radiation treatment, 1 will die from the partial-breast radiation technique," said Dr. Mauri.

There was also no statistically significant difference between the 2 treatment approaches with distant metastasis (OR, 0.740; 95% CI, 0.506 - 1.082; P? .120) or supraclavicular recurrences (pooled OR, 1.415; 95% CI, .278 - 7.202; P?= .560).

However, PBI was statistically significantly associated with an increased risk for both local (pooled OR, 2.150; 95% CI, 1.396 - 3.312; P?= .001) and regional disease recurrences (pooled OR, 3.430; 95% CI, 2.058 - 5.715; P?< .0001), compared with WBRT. These increased risks did not influence overall survival, reminded Dr. Mauri.

Dr. Mauri also said the locoregional recurrence rate "should not alarm." He explained that 2 of the 3 studies in the analysis used a standardized field of radiation, irrespective of the tumor size, which could have led to areas of disease being missed, increasing recurrence. "This explanation makes the finding of increased local recurrence less concerning," he said, adding that the issue needs to be further addressed.

The researchers have disclosed no relevant financial relationships. Dr. Gralow reports receiving honoraria from Genentech, Novartis, and Roche; and research funding from Amgen, Bayer, Bristol-Myers Squibb, Genentech, Novartis, Roche, and Sanofi-Aventis.

American Society of Clinical Oncology (ASCO) 45th Annual Meeting: Abstract CRA532. Presented May 31, 2009.

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