實驗設計如下: 子宮頸癌病人, stage IB, 接受過"radical hysterectomy", margin negative, node negative, risk factor 三個裡面有兩個以上(LVSI(+), tumor >4cm, >1/3 stromal invasion), 分成兩組, 一組接受放射治療(WPRT, 46-50.4Gy), 另外一組觀察, RT 在統計上顯著減少recurrence risk by 46% (hazard ratio = 0.54, 90% CI = 0.35 to 0.81, p = 0.007), RT在OS尚有改善, 但未達統計學上顯著意義 (HR = 0.70, 90% CI = 0.45 to 1.05, p = 0.074); 後來在red journal 發表長期追蹤的結果也是RT 在統計上顯著減少recurrence risk, 但在OS尚未達顯著意義
從這個研究裡, 出現了一個很有名的準則, 被稱為 Sedlis criteria, 子宮頸癌接受過radical hysterectomy後, 需要做放射治療的條件如下:
LVSI
|
Stromal invasion
|
Tumor size(用摸的)
|
+
|
Deep 1/3
|
any
|
+
|
Middle 1/3
|
>=2 cm
|
+
|
Superficial 1/3
|
>=5cm
|
-
|
Middle or deep
1/3
|
>=4cm
|
reference:
1. Sedlis, Alexander, et al. "A randomized trial of pelvic radiation therapy versus no further therapy in selected patients with stage IB carcinoma of the cervix after radical hysterectomy and pelvic lymphadenectomy: A Gynecologic Oncology Group Study." Gynecologic oncology 73.2 (1999): 177-183.
2. Rotman, Marvin, et al. "A phase III randomized trial of postoperative pelvic irradiation in Stage IB cervical carcinoma with poor prognostic features: follow-up of a gynecologic oncology group study." International Journal of Radiation Oncology* Biology* Physics 65.1 (2006): 169-176.
3. NCCN guildeline
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