Randomized comparison of fluorouracil plus cisplatin versus hydroxyurea as an adjunct to radiation therapy in stage IIB-IVA carcinoma of the cervix with negative para-aortic lymph nodes: A Gynecologic Oncology Group and Southwest Oncology Group Study
Randomized comparison of fluorouracil plus cisplatin versus hydroxyurea as an adjunct to radiation therapy in stage IIB-IVA carcinoma of the cervix with negative para-aortic lymph nodes: A Gynecologic Oncology Group and Southwest Oncology Group Study
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DOI：
10.1200/jco.1999.17.5.1339
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发表时间：
1999-05-01
影响因子：
45.3
通讯作者：
Liao, SY
中科院分区：
文献类型：
--
作者：
Whitney, CW;Sause, W;Liao, SY
目的：1986 年，妇科肿瘤学组 (GOG) 启动了一项方案，比较初级放射治疗 (RT) 加羟基脲 (HU) 与放射加氟尿嘧啶 (5-FU) 和顺铂 (CF) 的治疗方案，用于治疗局部晚期宫颈癌患者。目标是确定较好的放化疗方案并量化相对毒性。方法：所有患者均患有活检证实的宫颈浸润性鳞状细胞癌、腺癌或腺鳞癌，患者接受了标准临床分期研究，发现其肿瘤为国际妇产科联合会分期 IIB、Ill 或 IVA。进入时需要阴性细胞学冲洗液和主动脉旁淋巴结。患者被随机分配接受标准全盆腔 PT 联合 5-FU 输注和推注 CF 或相同 PT 加口服 HU。 结果：在 388 名随机分配的患者中，368 名符合条件；其中 368 名符合条件。 177 人被随机分配至 CF，191 人被随机分配至 HU。两种方案的不良反应主要是血液学或胃肠道反应。严重或危及生命的白细胞减少症在 HU 组 (24%) 中比 CF 组 (4%) 更常见。无进展生存期 (PFS) 的差异具有统计学意义，有利于 CF 组 (P =.033)。两个治疗组的进展部位没有显着差异。随机接受 CF 的患者的生存率显着提高 (P = 0.018)。 结论：这项研究表明，对于局部晚期宫颈癌患者，5-FU 和 CF 与 PT 的组合为患者提供了比 HU 更好的 PFS 和总生存率，并且毒性可控。 J 临床肿瘤杂志 17：1339-1348。 (C) 1999 年，美国临床肿瘤学会。
Purpose: In 1986, a protocol comparing primary radiation therapy (RT) plus hydroxyurea (HU) to irradiation plus fluorouracil (5-FU) and cisplatin (CF) was activated by the Gynecologic Oncology Group (GOG) for the treatment of patients with locally advanced cervical carcinoma. The goals were to determine the superior chemoradiation regimen and to quantitate the relative toxicities.Methods: All patients had biopsy-proven invasive squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix, Patients underwent standard clinical staging studies and their tumors were found to be International federation of Gynaecology and Obstetrics stages IIB, ill, or IVA. Negative cytologic washings and para-aortic lymph nodes were required for entry. Patients were randomized to receive either standard whole pelvic PT with concurrent 5-FU infusion and bolus CF or the same PT plus oral HU.Results: Of 388 randomized patients, 368 were eligible; 177 were randomized to CF and 191 to HU. Adverse effects were predominantly hematologic or gastrointestinal in both regimens. Severe or life-threatening leukopenia was more common in the HU group (24%) than in the CF group (4%). The difference in progression-free survival (PFS) was statistically significant in favor of the CF group (P =.033). The sites of progression in the two treatment groups were not substantially different. Survival was significantly better for the patients randomized to CF (P =.018).Conclusion: This study demonstrates that for patients with locally advanced carcinoma of the cervix, the combination of 5-FU and CF with PT offers patients better PFS and overall survival than HU, and with manageable toxicity. J Clin Oncol 17:1339-1348. (C) 1999 by American Society of Clinical Oncology.