A randomized phase III trial in advanced endometrial carcinoma of surgery and volume directed radiation followed by cisplatin and doxorubicin with or without paclitaxel: A Gynecologic Oncology Group study.
A randomized phase III trial in advanced endometrial carcinoma of surgery and volume directed radiation followed by cisplatin and doxorubicin with or without paclitaxel: A Gynecologic Oncology Group study.
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DOI：
10.1016/j.ygyno.2008.11.014
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发表时间：
2009-03
影响因子：
4.7
通讯作者：
Montag, Anthony
中科院分区：
文献类型：
--
作者：
Homesley, Howard D.;Filiaci, Virginia;Gibbons, Susan K.;Long, Harry J.;Cella, David;Spirtos, Nick M.;Morris, Robert T.;DeGeest, Koen;Lee, Roger;Montag, Anthony
在手术减容和骨盆/主动脉旁淋巴结的体积定向照射后，随机比较两种化疗方案治疗晚期子宫内膜癌的无复发生存率（RFS）和毒性。治疗随机分为顺铂[C] （50 mg/m2）和阿霉素[D] （45 mg/m2）加或不加紫杉醇[P] (160 mg/m2) 6个周期。最初在紫杉醇治疗的患者中，2002年5月之后，所有患者每个周期都接受粒细胞生长因子治疗。手术后入组的659名患者中，552名符合条件的患者在放疗后随机接受化疗。Accrual于2003年6月对IV期患者关闭。大约80%的患者完成了6个周期的化疗。3人死于肠道并发症，1人死于肾功能衰竭。血液学不良事件，感觉神经病变和肌痛，在紫杉醇组更频繁和严重（p< 0.01），证实了生活质量评估。36个月时，CD患者存活且无复发的比例为62%，而CDP为64%。复发或死亡风险相对于分期分层的CD组为0.90 （95% CI为0.69至1.17,p=0.21，单尾）。然而，在亚组分析中，CDP与总体残留疾病患者复发或死亡风险降低50%相关（95% CI: 0.26至0.92）。分期、残留疾病、组织学/分级、主动脉旁淋巴结和细胞学阳性、盆腔转移和年龄与RFS显著相关。在手术和放疗后顺铂和阿霉素中加入紫杉醇与RFS的显著改善无关，但与毒性增加有关。
After surgical debulking and volume-directed irradiation of the pelvis/para-aortic lymph nodes, treatment was randomized to compare recurrence-free survival (RFS) and toxicity between two chemotherapy regimens for the treatment of women with advanced stage endometrial carcinoma. Treatment was randomized between 6 cycles of cisplatin [C] (50 mg/m2) and doxorubicin [D] (45 mg/m2) with or without paclitaxel [P] (160 mg/m2). Initially in paclitaxel treated patients and, after May 2002, all patients received granulocyte growth factor with each cycle. Of 659 patients enrolled following surgery, 552 eligible patients were randomized to chemotherapy after irradiation. Accrual closed to Stage IV patients in June, 2003. Approximately 80% completed six cycles of chemotherapy. Three deaths resulted from bowel complications and one death was due to renal failure. Hematologic adverse events, sensory neuropathy and myalgia, were more frequent and severe in the paclitaxel arm (p< 0.01) which was confirmed by Quality of Life assessments. Percentage of patients alive and recurrence-free at 36 months was 62% for CD vs. 64% for CDP. The hazard of recurrence or death relative to the CD arm stratified by stage is 0.90 (95% CI is 0.69 to 1.17, p=0.21, one-tail). However, in subgroup analysis, CDP was associated with a 50% reduction in the risk of recurrence or death among patients with gross residual disease (95% CI: 0.26 to 0.92). Stage, residual disease, histology/grade, positive para-aortic node and cytology, pelvic metastases and age were significantly associated with RFS. The addition of paclitaxel to cisplatin and doxorubicin following surgery and radiation was not associated with a significant improvement in RFS but was associated with increased toxicity.
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DOI：
10.1111/j.1525-1438.2003.13603.x
发表时间：
2003-11-01
影响因子：
4.8
作者：
Calhoun, EA;Welshman, EE;Cella, D
通讯作者：
Cella, D
影响因子：
4.7
作者：
Sutton, G;Axelrod, JH;King, ME
通讯作者：
King, ME
影响因子：
4.7
作者：
GREER, BE;HAMBERGER, AD
通讯作者：
HAMBERGER, AD
影响因子：
4.7
作者：
Lincoln, S;Blessing, JA;Rocereto, TF
通讯作者：
Rocereto, TF
影响因子：
8.8
作者：
Tebeu, PM;Popowski, GY;Major, AL
通讯作者：
Major, AL