National Cancer Institute, Centro di Riferimento Oncologico, Gynecologic Oncology Unit, Via Franco Gallini 2, 33081 Aviano (PN), Italy.
Eur J Surg Oncol. 2011 May;37(5):442-7. doi: 10.1016/j.ejso.2011.02.011.
The goal of this study was to determine the rational of radical surgery with intra-operative high-dose radiotherapy after chemoradiation (RT-CT) in extra cervical locally advanced cervical cancer (LACC) patients.
Between 2000 and 2007, 42 LACC (stage IIA bulky-IVA) patients were treated at the Gynecologic Oncology Unit of the C.R.O. of Aviano in a Phase II Clinical Trial. Radiotherapy was administered to the whole pelvic region (50.4 Gy in 28 fractions) in combination with cisplatin (60 mg/mq) plus 5FU (750 mg/mq for 4 days) on first and fifth week of RT. Radical surgery with Intra-Operative Radiation Therapy (IORT) was performed 6-8 weeks after the end of RT-CT treatment.
After RT-CT, 35/42 patients (83%) underwent radical surgery and IORT treatment. At pathologic examination 8/35 (23%) patients showed complete response, while the rest (27/35) had residual disease either microscopic (17/27) or gross (10/27). The 5-year disease free survival (DFS) and the 5-year overall survival (OS) were 46% and 49% respectively. There were significant better DFS and OS when residual tumor was absent or limited to the cervix, respectively 78% versus 16% and 81% versus 20% (p < 0.001). All recurrences occurred within 24 months from treatment.
RT-CT followed by surgery and IORT in LACC patients seems to be active in a subgroup of patients with pathological complete response to treatment or partial response with residual tumor limited to the cervix.
本研究的目的是确定在接受放化疗（RT-CT）后，对局部晚期宫颈癌（LACC）患者进行根治性手术和术中高剂量放疗的合理性。
在 2000 年至 2007 年间，42 名 LACC（IIA 期大块-IVA 期）患者在阿维亚诺的 C.R.O.妇科肿瘤学组进行了一项 II 期临床试验。对整个骨盆区域进行放疗（50.4 Gy，28 个分次），同时在 RT 的第一和第五周给予顺铂（60 mg/mq）和 5FU（750 mg/mq，4 天）。在 RT-CT 治疗结束后 6-8 周，进行根治性手术和术中放疗（IORT）。
在 RT-CT 后，35/42 名（83%）患者接受了根治性手术和 IORT 治疗。在病理检查中，8/35（23%）患者显示完全缓解，而其余 27/35（27%）患者有显微镜下（17/27）或大体（10/27）残留病变。5 年无病生存率（DFS）和 5 年总生存率（OS）分别为 46%和 49%。当残留肿瘤不存在或局限于宫颈时，DFS 和 OS 显著更好，分别为 78%对 16%和 81%对 20%（p<0.001）。所有复发均发生在治疗后 24 个月内。
在 LACC 患者中，RT-CT 后手术和 IORT 似乎对治疗后病理完全缓解或残留肿瘤局限于宫颈的部分缓解的亚组患者有效。
