Concurrent cisplatin-based radiotherapy and chemotherapy for locally advanced cervical cancer
Concurrent cisplatin-based radiotherapy and chemotherapy for locally advanced cervical cancer
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DOI：
10.1056/nejm199904153401502
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发表时间：
1999-04-15
影响因子：
158.5
通讯作者：
Insalaco, S
中科院分区：
文献类型：
--
作者：
Rose, PG;Bundy, BN;Insalaco, S
背景和方法代表妇科肿瘤组，我们在局部晚期宫颈癌患者中进行了放射治疗联合三种同步化疗方案的随机试验--单独使用顺铂；顺铂、氟尿嘧啶和羟基脲；以及单独使用羟基尿素。研究对象为未经治疗的浸润性鳞状细胞癌、腺鳞状细胞癌或IIB、III或IVA期宫颈腺癌，均未累及腹主动脉旁淋巴结。患者必须有至少3000每立方毫米的白细胞计数，至少10万每立方毫米的血小板计数，血清肌酐水平不高于每分升2毫克(每升177微克摩尔)，以及足够的肝功能。所有患者均按严格的治疗方案接受外照射。患者随机分为3种化疗方案：顺铂40 mg/m2，每周2次，连续6周(组1)；顺铂50 mg/m2，第1、29天；氟尿嘧啶4 g/m2，96小时静脉滴注，第1、29天；羟基尿素2 g/m2，每周2次，共6周；或3 g/m2，每周2次，共6周。中位随访时间为35个月。接受顺铂治疗的两组患者的无进展存活率均高于单独接受羟基尿素治疗的患者(P
Background and Methods On behalf of the Gynecologic Oncology Group, we performed a randomized trial of radiotherapy in combination with three concurrent chemotherapy regimens - cisplatin alone; cisplatin, fluorouracil, and hydroxyurea; and hydroxyurea alone - in patients with locally advanced cervical cancer. Women with primary untreated invasive squamous-cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix of stage IIB, III, or IVA, without involvement of the para-aortic lymph nodes, were enrolled. The patients had to have a leukocyte count of at least 3000 per cubic millimeter, a platelet count of at least 100,000 per cubic millimeter, a serum creatinine level no higher than 2 mg per deciliter (177 mu mol per liter), and adequate hepatic function. All patients received external-beam radiotherapy according to a strict protocol. Patients were randomly assigned to receive one of three chemotherapy regimens: 40 mg of cisplatin per square meter of body-surface area per week for six weeks (group 1); 50 mg of cisplatin per square meter on days 1 and 29, followed by 4 g of fluorouracil per square meter given as a 96-hour infusion on days 1 and 29, and 2 g of oral hydroxyurea per square meter twice weekly for six weeks (group 2); or 3 g of oral hydroxyurea per square meter twice weekly for six weeks (group 3).Results The analysis included 526 women. The median duration of follow-up was 35 months. Both groups that received cisplatin had a higher rate of progression-free survival than the group that received hydroxyurea alone (P