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一项线上发表于11月25日美国国家癌症研究院期刊的一篇义大利研究报告显示，系统性骨盆淋巴切除术无法改善早期子宫内膜癌病患之无病或整体存活。
在这有关第1期子宫内膜癌病患之传统手术后，有无系统性骨盆淋巴切除术之比较研究的首次直接与完整报告中，存活率并无差异。
未接受淋巴切除术的病患和接受淋巴切除术的病患之5年无病存活率分别是81.7%和81%。同样地，未接受淋巴切除术的病患和接受淋巴切除术的病患之整体存活率分别是90.0%和85.9% 。两组发生复发的时间也相似：接受淋巴切除术的病患为14 个月，未接受淋巴切除术的病患为13 个月。
不过，虽然没有存活利益，作者指出，淋巴切除术在确认预后和订定辅助治疗上仍然重要。
根据编辑评论，本研究发现与稍早的随机控制试验结果一致，该试验发现骨盆淋巴切除术对早期子宫内膜癌没有存活利益(Gynecol Oncol. 2006:101:S21–S22)。
主要作者、义大利罗马La Sapienza大学妇产科主任Pierluigi Benedetti Panici医师向Medscape Oncology表示，淋巴切除术看来无法改善整体存活；研究结论认为淋巴切除术维持它目前的角色。
Panici医师指出，这特别重要，因为未完整分期的病患需要辅助治疗，而过度治疗— 通常是放射线治疗 — 的结果是造成妇女的长期副作用。
洛杉矶Cedars-Sinai医学中心的Christine Walsh医师写道，子宫内膜癌照护迅速演变朝向更个人化的治疗建议，改善了结果与减少毒性和花费；但是他们也质疑这些新发现是否排除了早期子宫内膜癌之淋巴结评估的需求。
编辑写道，这个问题的答案有一部份是因为个人的人生观，我们有第一级的证据显示，骨盆淋巴切除术和辅助放射治疗都无法对早期子宫内膜癌提供任何存活利益，这些结果打破了之前回溯研究发现所认为的，淋巴切除术提供子宫内膜癌治疗利益与存活利益的迷思。
他们结论表示，但是，该试验持续支持淋巴切除术可以提供重要的预后资讯，也可以帮助建立辅助治疗的方针。
【存活上没有差异】
骨盆淋巴结是早期子宫内膜癌最常扩散的子宫外位置，但是截至目前为止，还没有比较骨盆淋巴切除术和标准子宫切除术与单单进行双侧子宫附属器肿瘤切除术(bilateral adnexectomy)之间结果的良好随机试验。在本研究中，Panici 医师等人对第1期子宫内膜癌病患进行一个随机控制试验，随机分派接受标准子宫切除术与并用或不并用淋巴切除术移除卵巢。
作者将514名术前第1期子宫内膜癌病患，随机分派接受系统性骨盆淋巴切除术(n= 264)或者没有进行此手术(n= 250)；术后可由主治医师判断进行辅助治疗。初级结果是整体存活，定义是从随机接受治疗到任何原因导致之死亡的时间，次级终点是无病存活率与手术发病率。
在淋巴切除组中，整体平均移除淋巴数为30 (四分位间距：22 - 42)，当然，未进行淋巴切除组的移除淋巴数为0 (P< .001)；在平均49个月的追踪期间，67名病患(13%)发生子宫内膜癌复发；这些病患中，34人(12.9%)属于淋巴切除组，33人(13.2%)属于未进行淋巴切除组。在这段期间，有53人死亡: 42人(8.2%) 死于子宫内膜癌，11人 (2.1%)为其他死因且无显示复发。
两组病患之间的首次发病部位复发比率相似。.
疾病复发部位
|
复发部位 |
淋巴切除组 , n (%) |
未进行淋巴切除组 , n (%) |
|
无复发 |
231 (87.5)
|
217 (86.8)
|
|
肺部 |
8 (3)
|
8 (3.2)
|
|
腹膜内 |
8 (3)
|
7 (2.8)
|
|
阴道 |
7 (2.6)
|
6 (2.4)
|
|
淋巴结 |
4 (1.5)
|
4 (1.6)
|
|
骨骼 |
4 (1.5)
|
3 (1.2)
|
|
肝脏 |
2 (0.7)
|
3 (1.2)
|
|
资料漏失 |
3 (1.1)
|
3 (1.2)
|
Pelvic Lymphadenectomy Does Not Improve Outcomes in Early-Stage Endometrial Cancer
By Roxanne Nelson
Medscape Medical News
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 (%) | 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.