Cisplatin, radiation, and adjuvant hysterectomy compared with radiation and adjuvant hysterectomy for bulky stage IB cervical carcinoma

Cisplatin, radiation, and adjuvant hysterectomy compared with radiation and adjuvant hysterectomy for bulky stage IB cervical carcinoma
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DOI:
10.1056/nejm199904153401503
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发表时间:
1999-04-15
影响因子:
158.5
通讯作者:
Gersell, D
Gersell, D
中科院分区:
医学1区
文献类型:
--
作者:
Keys, HM;Bundy, BN;Gersell, D

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背景:体积较大的IB期宫颈癌比较小的I期宫颈癌预后更差。对于妇科肿瘤组,我们进行了一项试验,以确定在放疗期间每周输注顺铂是否能改善大块型IB期宫颈癌患者的无进展和总生存率。方法将大块型IB期宫颈癌(肿瘤直径大于或等于4厘米)的女性随机分配到接受放射治疗或联合顺铂治疗(每平方米体表面积40 mg,每周1次,最多6次;每周最大剂量,70 mg),所有患者随后辅以子宫切除术。在计算机断层扫描或淋巴管造影术中有淋巴结病证据的女性不符合条件,除非组织学分析显示没有淋巴结受累。A点(宫颈旁)和B点(盆壁)盆腔外和腔内照射累积剂量分别为75GY和55GY。结果183名接受顺铂联合放疗和化疗的妇女与186名单纯接受放射治疗的妇女相比,疾病进展和死亡的相对风险分别为0.51(95%可信区间,0.34~0.75)和0.54(95%可信区间,0.34~0.86)。两组无进展生存率比较,差异均有统计学意义(P
Background Bulky stage IB cervical cancers have a poorer prognosis than smaller stage I cervical cancers. For the Gynecologic Oncology Group, we conducted a trial to determine whether weekly infusions of cisplatin during radiotherapy improve progression-free and overall survival among patients with bulky stage IB cervical cancer.Methods Women with bulky stage IB cervical cancers (tumor, greater than or equal to 4 cm in diameter) were randomly assigned to receive radiotherapy alone or in combination with cisplatin (40 mg per square meter of body-surface area once a week for up to six doses; maximal weekly dose, 70 mg),followed in all patients by adjuvant hysterectomy. Women with evidence of lymphadenopathy on computed tomographic scanning or lymphangiography were ineligible unless histologic analysis showed that there was no lymph-node involvement. The cumulative dose of external pelvic and intracavitary radiation was 75 Gy to point A (cervical parametrium) and 55 Gy to point B (pelvic wall). Cisplatin was given during external radiotherapy, and adjuvant hysterectomy was performed three to six weeks later.Results The relative risks of progression of disease and death among the 183 women assigned to receive radiotherapy and chemotherapy with cisplatin, as compared with the 186 women assigned to receive radiotherapy alone, were 0.51 (95 percent confidence interval, 0.34 to 0.75) and 0.54 (95 percent confidence interval, 0.34 to 0.86), respectively. The rates of both progression-free survival (P