Randomised study of radical surgery versus radiotherapy for stage Ib-IIa cervical cancer
Randomised study of radical surgery versus radiotherapy for stage Ib-IIa cervical cancer
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DOI：
10.1016/s0140-6736(97)02250-2
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发表时间：
1997-08-23
期刊：
影响因子：
168.9
通讯作者：
Mangioni, C
中科院分区：
文献类型：
--
作者：
Landoni, F;Maneo, A;Mangioni, C
背景tb期和IIa期宫颈癌可通过根治性手术或放射治疗治愈。这两种手术同样有效，但相关发病率和并发症类型不同。在这个前瞻性随机试验的放射治疗与手术，我们的目的是评估5年的生存率和并发症和复发率和模式与每个treatment.Methods之间，1986年9月，1991年12月，469名妇女与新诊断的Ib期和IIa期宫颈癌被称为我们的研究所。343例符合条件的患者被随机分配：172例接受手术，171例接受根治性放疗。对于手术分期pT 2b或更高、安全宫颈基质小于3 mm、切穿或阳性淋巴结的女性，术后给予辅助放疗。主要结果指标为5年生存率和并发症发生率。生存率和复发的分析是通过意向治疗和并发症的分析是通过治疗delivered.Findings 170例手术组和167例放疗组被纳入意向治疗分析;预定治疗分别交付给169和158名妇女。114例宫颈直径≤ 4 cm的患者中有62例接受了辅助治疗，55例宫颈直径> 4 cm的患者中有46例接受了辅助治疗。在中位随访87个月（范围57-120）后，手术组和放疗组的5年总生存率和无病生存率相同（两组分别为83%和74%）。86名女性出现复发性疾病：手术组42名（25%），放疗组44名（26%）。单变量和多变量分析中影响生存率的重要因素为：宫颈直径、阳性淋巴管造影和腺癌组织类型。48例（28%）手术组患者出现严重发病率，而19例（12%）放疗组患者出现严重发病率（p=0.0004）。解释就总体或无病生存率而言，早期宫颈癌没有治疗选择。手术加放疗的并发症最多，尤其是泌尿系并发症。每个患者的最佳治疗应考虑临床因素，如绝经状态，年龄，医学疾病，组织学类型和宫颈直径，以产生最佳的治疗效果，并发症最少。
Background Stage tb and Ila 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.Methods Between September, 1986, and December, 1991, 469 women with newly diagnosed stage Ib and Ila 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.Findings 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 lymphanglography, and adeno-carcinomatous histotype. 48 (28%) surgery-group patients had severe morbidity compared with 19 (12%) radiotherapy-group patients (p=0.0004).Interpretation 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.