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宫颈癌及其他晚期盆腔恶性肿瘤同步放化疗的I期试验

Phase I trial of concomitant chemoradiotherapy for cervical cancer and other advanced pelvic malignancies.

作者信息

Mundt A J, Rotmensch J, Waggoner S, Quiet C, Fleming G

机构信息

Department of Radiation and Cellular Oncology, University of Chicago Hospitals,Chicago, Illinois, 60637, USA.

出版信息

Gynecol Oncol. 1999 Jan;72(1):45-50. doi: 10.1006/gyno.1998.5212.

DOI:10.1006/gyno.1998.5212
PMID:9889028
Abstract

Purpose. The aim of this study was to determine the feasibility and toxicity of concomitant hydroxyurea (HU) and escalating doses of 5-fluorouracil (5-FU) in locally advanced cervical cancer and other pelvic malignancies undergoing radiation therapy (RT). Methods. Treatment consisted of 5-FU, HU, and pelvic RT delivered in an alternate-week fashion. 5-FU was administered as a continuous intravenous infusion at a starting dose of 600 mg/m2/day and was escalated to 1000 mg/m2/day in cohorts of three patients. The HU dose was 500 mg twice daily. Chemoradiotherapy was administered on a 5-day cycle. Following a 9-day rest, the cycle was repeated until the completion of the pelvic RT. Results. Twenty-one patients (18 cervix, 1 bladder, 1 vagina, 1 ovary) were enrolled. 5-FU escalation to 1000 mg/m2/day was well tolerated. No patients developed grade 3-4 hematologic toxicity. Grade 2 leukopenia was noted in 3 patients (14.3%). Grade 3 mucositis, diarrhea, and dermatitis occurred in 10, 10, and 5% of patients, respectively. None of the 99 treatment cycles were delayed secondary to acute toxicity. The overall response rate in the 18 cervical cancer patients was 89% (78% complete, 11% partial). Conclusions. Concomitant continuous infusion 5-FU, twice daily HU, and pelvic RT delivered in an alternate-week fashion is well tolerated. Further study is necessary to evaluate the therapeutic efficacy of this regimen in patients with advanced cervical and other pelvic malignancies.

摘要

目的。本研究的目的是确定在接受放射治疗(RT)的局部晚期宫颈癌和其他盆腔恶性肿瘤患者中,同时使用羟基脲(HU)和递增剂量的5-氟尿嘧啶(5-FU)的可行性和毒性。方法。治疗包括以隔周方式给予5-FU、HU和盆腔放疗。5-FU以持续静脉输注给药,起始剂量为600 mg/m²/天,并在每组3例患者中递增至1000 mg/m²/天。HU剂量为每日两次,每次500 mg。放化疗以5天为一个周期进行。休息9天后,重复该周期直至盆腔放疗完成。结果。共纳入21例患者(18例宫颈癌、1例膀胱癌、1例阴道癌、1例卵巢癌)。5-FU递增至1000 mg/m²/天耐受性良好。没有患者出现3-4级血液学毒性。3例患者(14.3%)出现2级白细胞减少。3级黏膜炎、腹泻和皮炎分别发生在10%、10%和5%的患者中。99个治疗周期均未因急性毒性而延迟。18例宫颈癌患者的总缓解率为89%(78%完全缓解,11%部分缓解)。结论。以隔周方式同时进行5-FU持续静脉输注、每日两次HU给药和盆腔放疗耐受性良好。有必要进一步研究评估该方案对晚期宫颈癌和其他盆腔恶性肿瘤患者的治疗效果。

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