| 作者：Roxanne Nelson | | 出處：WebMD醫學新聞 |
November 25, 2008 — 一項線上發表於11月25日美國國家癌症研究院期刊的一篇義大利研究報告顯示，系統性骨盆淋巴切除術無法改善早期子宮內膜癌病患之無病或整體存活。
在這有關第1期子宮內膜癌病患之傳統手術後，有無系統性骨盆淋巴切除術之比較研究的首次直接與完整報告中，存活率並無差異。
未接受淋巴切除術的病患和接受淋巴切除術的病患之5年無病存活率分別是81.7%和81%。同樣地，未接受淋巴切除術的病患和接受淋巴切除術的病患之整體存活率分別是90.0%和85.9% 。兩組發生復發的時間也相似：接受淋巴切除術的病患為14 個月，未接受淋巴切除術的病患為13 個月。
不過，雖然沒有存活利益，作者指出，淋巴切除術在確認預後和訂定輔助治療上仍然重要。
根據編輯評論，本研究發現與稍早的隨機控制試驗結果一致，該試驗發現骨盆淋巴切除術對早期子宮內膜癌沒有存活利益(Gynecol Oncol. 2006:101:S21–S22)。
主要作者、義大利羅馬La Sapienza大學婦產科主任Pierluigi Benedetti Panici醫師向Medscape Oncology表示，淋巴切除術看來無法改善整體存活；研究結論認為淋巴切除術維持它目前的角色。
Panici醫師指出，這特別重要，因為未完整分期的病患需要輔助治療，而過度治療— 通常是放射線治療 — 的結果是造成婦女的長期副作用。
洛杉磯Cedars-Sinai醫學中心的Christine Walsh醫師寫道，子宮內膜癌照護迅速演變朝向更個人化的治療建議，改善了結果與減少毒性和花費；但是他們也質疑這些新發現是否排除了早期子宮內膜癌之淋巴結評估的需求。
編輯寫道，這個問題的答案有一部份是因為個人的人生觀，我們有第一級的證據顯示，骨盆淋巴切除術和輔助放射治療都無法對早期子宮內膜癌提供任何存活利益，這些結果打破了之前回溯研究發現所認為的，淋巴切除術提供子宮內膜癌治療利益與存活利益的迷思。
他們結論表示，但是，該試驗持續支持淋巴切除術可以提供重要的預後資訊，也可以幫助建立輔助治療的方針。
【存活上沒有差異】
骨盆淋巴結是早期子宮內膜癌最常擴散的子宮外位置，但是截至目前為止，還沒有比較骨盆淋巴切除術和標準子宮切除術與單單進行雙側子宮附屬器腫瘤切除術(bilateral adnexectomy)之間結果的良好隨機試驗。在本研究中，Panici 醫師等人對第1期子宮內膜癌病患進行一個隨機控制試驗，隨機分派接受標準子宮切除術與併用或不併用淋巴切除術移除卵巢。
作者將514名術前第1期子宮內膜癌病患，隨機分派接受系統性骨盆淋巴切除術(n= 264)或者沒有進行此手術(n= 250)；術後可由主治醫師判斷進行輔助治療。初級結果是整體存活，定義是從隨機接受治療到任何原因導致之死亡的時間，次級終點是無病存活率與手術發病率。
在淋巴切除組中，整體平均移除淋巴數為30 (四分位間距：22 - 42)，當然，未進行淋巴切除組的移除淋巴數為0 (P< .001)；在平均49個月的追蹤期間，67名病患(13%)發生子宮內膜癌復發；這些病患中，34人(12.9%)屬於淋巴切除組，33人(13.2%)屬於未進行淋巴切除組。在這段期間，有53人死亡: 42人(8.2%) 死於子宮內膜癌，11人 (2.1%)為其他死因且無顯示復發。
兩組病患之間的首次發病部位復發比率相似。.
疾病復發部位 復發部位
| 淋巴切除組 , n (%)
| 未進行淋巴切除組 , n (%)
| 無復發
| 231 (87.5) | 217 (86.8) | 肺部
| 8 (3) | 8 (3.2) | 腹膜內
| 8 (3) | 7 (2.8) | 陰道
| 7 (2.6) | 6 (2.4) | 淋巴結
| 4 (1.5) | 4 (1.6) | 骨骼
| 4 (1.5) | 3 (1.2) | 肝臟
| 2 (0.7) | 3 (1.2) | 資料漏失
| 3 (1.1) | 3 (1.2) |
研究者也觀察發現，接受系統性骨盆淋巴切除術的病患中，有較高的早期和晚期術後併發症比率，兩組出現併發症的病患分別有81人和34人。
不過，系統性骨盆淋巴切除術可以改善疾病手術分期，統計上在淋巴切除組有較多病患出現淋巴結轉移，比率分別是13.3%與3.2%；差異為10.1%。
作者寫道，系統性骨盆淋巴切除術無法改變疾病的自然病史，一如可以從疾病復發模式推斷般，兩組之間是相似的；不過，骨盆淋巴切除術可使得以根據病理淋巴評估獲得準確預後，就我們的經驗，使將近10%的分期到手術IIIC分期。
因此，他們結論表示，淋巴切除術維持它在確認病患預後與制定輔助治療上的重要性。
本研究有部份接受Universit? di Roma La Sapienza 與義大利米蘭Mario Negri Institute之資金贊助。 | |
Pelvic Lymphadenectomy Does Not Improve Outcomes in Early-Stage Endometrial Cancer
By Roxanne Nelson
Medscape Medical News
November 25, 2008 — Systematic pelvic lymphadenectomy does not improve disease-free or overall survival in patients with early-stage endometrial cancer, according to a report by Italian researchers published online November 25 in the Journal of the National Cancer Institute.
In this first direct and fully reported survival comparison of systematic pelvic lymphadenectomy and no lymphadenectomy after conventional surgery in patients with stage?I endometrial carcinoma, no differences were seen in survival.
The 5-year disease-free survival rates were 81% among patients who underwent lymphadenectomy and 81.7% among patients who did not undergo lymphadenectomy. Similarly, overall survival rates were 85.9% in the lymphadenectomy group and 90.0% in the no-lymphadenectomy group. The median time to relapse was similar in both groups: 14 months in the lymphadenectomy group and 13 months in the no-lymphadenectomy group.
However, although there was no survival benefit, the authors note that lymphadenectomy is still important in determining prognosis and tailoring adjuvant therapies.
The findings from this study are consistent with those from an earlier randomized controlled trial that found no survival benefit associated with pelvic lymphadenectomy in early-stage endometrial cancer (Gynecol Oncol. 2006:101:S21–S22), according to an accompanying editorial.
"Lymphadenectomy does not appear to improve overall survival," lead author Pierluigi Benedetti Panici, MD, chair of the Department of Obstetrics and Gynecology at La Sapienza University, in Rome, Italy, told Medscape Oncology. "The study conclusion is that lymphadenectomy maintains its role for staging."
"This is particularly important because patients who are not completely 'staged' are addressed to adjuvant treatment," Dr. Panici added. "As a result of overtreatment — usually with radiotherapy — women suffer from long-term side effects."
Endometrial cancer care is rapidly evolving toward more personalized treatment recommendations, improving outcome and minimizing toxicity and cost, write Christine Walsh, MD, and Beth Karlan, MD, from the Cedars-Sinai Medical Center, in Los Angeles, California. But they also question whether these new findings "obviate the need for lymph-node assessment in early-stage endometrial cancer."
The answer to that question comes down, in part, to one's personal philosophy, the editorialists write. "We have level?I evidence demonstrating that neither pelvic lymphadenectomy nor adjuvant radiation therapy confers any survival benefit in early-stage endometrial cancer. These results bust the myth that is based on previous retrospective studies, that lymphadenectomy, in and of itself, provides therapeutic benefit and survival advantage in endometrial cancer."
"Yet, this trial continues to support the notion that lymphadenectomy can provide important prognostic information and can help guide adjuvant treatment recommendations," they conclude.
No Differences Noted in Survival
Pelvic lymph nodes are the most common site of extrauterine tumor spread in early-stage endometrial cancer, but to date, definitive results from well-designed randomized trials comparing outcomes of pelvic lymphadenectomy with standard hysterectomy and bilateral adnexectomy alone have not been forthcoming. In this study, Dr. Panici and colleagues conducted a randomized controlled trial in which women with stage?I endometrial cancer were assigned to have a standard hysterectomy and ovary removal with or without lymphadenectomy.
The authors randomized 514 patients with preoperative stage?I endometrial carcinoma to undergo pelvic systematic lymphadenectomy (n?= 264) or no lymphadenectomy (n?= 250). Adjuvant therapy could be administered after surgery at the discretion of the treating physician.
The primary outcome was overall survival, defined as the time from randomization to death from any cause, and secondary end points were disease-free survival and surgical morbidity.
In the lymphadenectomy group, the overall median number of lymph nodes removed was 30 (interquartile range, 22 - 42), whereas none were removed in the no-lymphadenectomy group (P?< .001). At a median follow-up of 49 months, 67 patients (13%) experienced a recurrence of endometrial cancer. Of these patients, 34 (12.9%) were in the lymphadenectomy group and 33 (13.2%) were in the no-lymphadenectomy group. During this time period, there were 53 deaths: 42 (8.2%) from endometrial cancer and 11 (2.1%) from other causes, without evidence of relapse.
The sites of first disease recurrences were similar between the 2 patient groups.
Sites of Disease Recurrence | Recurrence site | Lymphadenectomy group, n (%)
[td]No-lymphadenectomy group, n (%) | | No recurrence | 231 (87.5) | 217 (86.8) | | Lung | 8 (3) | 8 (3.2) | | Intraperitoneum | 8 (3) | 7 (2.8) | | Vagina | 7 (2.6) | 6 (2.4) | | Lymph node | 4 (1.5) | 4 (1.6) | | Bone | 4 (1.5) | 3 (1.2) | | Liver | 2 (0.7) | 3 (1.2) | | Missing data | 3 (1.1) | 3 (1.2) |
The researchers also observed a statistically significantly higher rate of early- and late-postoperative complications in patients who had undergone pelvic systematic lymphadenectomy (81 vs. 34 patients).
However, surgical staging of the disease was improved with the systematic use of lymphadenectomy, and statistically significantly more patients with lymph-node metastases were found in the lymphadenectomy group than in the no-lymphadenectomy group (13.3% vs 3.2%; difference, 10.1%)
"Pelvic systematic lymphadenectomy did not change the natural history of the disease, as can be inferred from the pattern of disease recurrence, which was similar between the 2 groups," write the authors. "However, pelvic lymphadenectomy did allow for an accurate prognosis on the basis of a pathological lymph-node assessment and, in our trial, provided for approximately 10% of the upstaging to surgical stage?IIIC."
Therefore, they conclude, "lymphadenectomy maintained its importance in determining a patient's prognosis and in tailoring adjuvant therapies."
The study was partially funded by grants from Universita di Roma La Sapienza and the Mario Negri Institute, in Milan, Italy.
J Natl Cancer Inst.2008;100:1707–1716.
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[ 本帖最後由 goodcat1111 於 2008-12-4 10:24 編輯 ] |
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