Landoni F, Maneo A, Colombo A, Placa F, Milani R, Perego P, Favini G, Ferri L, Mangioni C
III Clinica Ostetrico Ginecologica, University of Milan, Italy.
Lancet. 1997 Aug 23;350(9077):535-40. doi: 10.1016/S0140-6736(97)02250-2.
Stage Ib and IIa cervical carcinoma can be cured by radical surgery or radiotherapy. These two procedures are equally effective, but differ in associated morbidity and type of complications. In this prospective randomised trial of radiotherapy versus surgery, our aim was to assess the 5-year survival and the rate and pattern of complications and recurrences associated with each treatment.
Between September, 1986, and December, 1991, 469 women with newly diagnosed stage Ib and IIa cervical carcinoma were referred to our institute. 343 eligible patients were randomised: 172 to surgery and 171 to radical radiotherapy. Adjuvant radiotherapy was delivered after surgery for women with surgical stage pT2b or greater, less than 3 mm of safe cervical stroma, cut-through, or positive nodes. The primary outcome measures were 5-year survival and the rate of complications. The analysis of survival and recurrence was by intention to treat and analysis of complications was by treatment delivered.
170 patients in the surgery group and 167 in the radiotherapy group were included in the intention-to-treat analysis; scheduled treatment was delivered to 169 and 158 women, respectively, 62 of 114 women with cervical diameters of 4 cm or smaller and 46 of 55 with diameters larger than 4 cm received adjuvant therapy. After a median follow-up of 87 (range 57-120) months, 5-year overall and disease-free survival were identical in the surgery and radiotherapy groups (83% and 74%, respectively, for both groups), 86 women developed recurrent disease: 42 (25%) in the surgery group and 44 (26%) in the radiotherapy group. Significant factors for survival in univariate and multivariate analyses were: cervical diameter, positive lymphangiography, and adeno-carcinomatous histotype. 48 (28%) surgery-group patients had severe morbidity compared with 19 (12%) radiotherapy-group patients (p = 0.0004).
There is no treatment of choice for early-stage cervical carcinoma in terms of overall or disease-free survival. The combination of surgery and radiotherapy has the worst morbidity, especially urological complications. The optimum therapy for each patient should take account of clinical factors such as menopausal status, age, medical illness, histological type, and cervical diameter to yield the best cure with minimum complications.
Ib期和IIa期宫颈癌可通过根治性手术或放疗治愈。这两种治疗方法效果相当，但相关的发病率和并发症类型有所不同。在这项放疗与手术的前瞻性随机试验中，我们的目的是评估每种治疗方法的5年生存率、并发症发生率以及复发率和复发模式。
1986年9月至1991年12月期间，469例新诊断为Ib期和IIa期宫颈癌的女性被转诊至我院。343例符合条件的患者被随机分组：172例接受手术，171例接受根治性放疗。手术分期为pT2b或更高、宫颈安全基质小于3mm、切缘阳性或淋巴结阳性的女性患者术后接受辅助放疗。主要结局指标为5年生存率和并发症发生率。生存和复发分析采用意向性分析，并发症分析采用实际接受治疗情况分析。
手术组170例患者和放疗组167例患者纳入意向性分析；分别有169例和158例女性接受了计划治疗，114例宫颈直径4cm或更小的女性中有62例、55例直径大于4cm的女性中有46例接受了辅助治疗。中位随访87（57 - 120）个月后，手术组和放疗组的5年总生存率和无病生存率相同（两组均为83%和74%），86例患者出现疾病复发：手术组42例（25%），放疗组44例（26%）。单因素和多因素分析中影响生存的显著因素为：宫颈直径、淋巴管造影阳性和腺癌组织学类型。手术组48例（28%）患者出现严重并发症，而放疗组为19例（12%）（p = 0.0004）。
就总生存率或无病生存率而言，早期宫颈癌没有首选的治疗方法。手术和放疗联合治疗的发病率最高，尤其是泌尿系统并发症。针对每位患者的最佳治疗方案应考虑临床因素，如绝经状态、年龄、内科疾病、组织学类型和宫颈直径，以实现最佳治愈效果并使并发症最少。
