Phase II study of neoadjuvant chemotherapy with irinotecan hydrochloride and nedaplatin followed by radical hysterectomy for bulky stage Ib2 to IIb, cervical squamous cell carcinoma: Japanese Gynecologic Oncology Group study (JGOG 1065).

Phase II study of neoadjuvant chemotherapy with irinotecan hydrochloride and nedaplatin followed by radical hysterectomy for bulky stage Ib2 to IIb, cervical squamous cell carcinoma: Japanese Gynecologic Oncology Group study (JGOG 1065).
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使用盐酸伊立替康和奈达铂进行新辅助化疗,然后进行根治性子宫切除术治疗 Ib2 至 IIb 期宫颈鳞状细胞癌的 II 期研究:日本妇科肿瘤小组研究 (JGOG 1065)。

DOI:
10.3892/or.2012.1814
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发表时间:
2012
期刊:
影响因子:
4.2
通讯作者:
K. Takizawa
K. Takizawa
中科院分区:
医学3区
文献类型:
--
作者:
S. Yamaguchi;R. Nishimura;N. Yaegashi;K. Kiguchi;T. Sugiyama;T. Kita;K. Kubushiro;K. Kokawa;M. Hiura;K. Mizutani;Kaichiro Yamamoto;K. Takizawa

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伊立替康新辅助化疗的疗效及不良反应 盐酸奈达铂和奈达铂在大体积Ib 2期患者中进行了评价, 子宫颈鳞状细胞癌。合格性包括接受以下治疗的患者: 伊立替康(60 mg/m2)第1天和第8天,奈达铂(80 mg/m2)第1天, 21-日周期化疗1-3个疗程后行根治性子宫切除术。 68例患者入组。66人被纳入全面分析 集年龄22-71岁,中位年龄47岁,18例FIGO分期为Ib 2 IIa型10例,IIb型38例。NAC后行根治性子宫切除术 63例(95.5%)。新来港儿童接受的课程数目为1/13 43例中有2例,10例中有3例。反应率,主要终点, 研究中,CR 2例,PR 48例,SD 12例,PD 0例,NE 4例)。 缓解所需的平均治疗疗程数为1.42(1个疗程 30例中19例2个疗程,1例3个疗程。年级发生率 3或4例血液学毒性为:中性粒细胞减少72.2%,白细胞减少16.7%,贫血 13.6%,血小板减少7.6%,发热性中性粒细胞减少1.5%,丙氨酸升高 谷草转氨酶1.5%。3级或4级非血液学 毒副反应:腹泻6.1%,恶心3%,厌食1.5%,呕吐 1.5%,发热1.5%,过敏反应1.5%,肠梗阻1.5%和膀胱阴道瘘 百分之一点五伊立替康联合奈达铂新辅助化疗是一种有效的治疗方法。 对于Ib 2至IIb期巨大鳞状细胞癌患者, 子宫颈细胞癌
The efficacy and adverse events of neoadjuvant chemotherapy with irinotecan hydrochloride and nedaplatin were evaluated in patients with bulky stage Ib2 to IIb cervical squamous cell carcinoma. Eligibility included patients who received irinotecan (60 mg/m2) on days 1 and 8 and nedaplatin (80 mg/m2) on day 1 of a 21-day cycle. After 1-3 courses of chemotherapy, radical hysterectomy was performed. Sixty-eight patients were enrolled. Sixty-six were included in the full analysis set. Their median age was 47 years (range 22-71), the FIGO stage was Ib2 in 18 patients, IIa in 10, and IIb in 38. Radical hysterectomy was performed after NAC in 63 patients (95.5%). The number of administered courses of NAC was 1 in 13 patients, 2 in 43, and 3 in 10. The response rate, the primary endpoint of this study, was 75.8% (CR in 2 patients, PR in 48, SD in 12, PD in 0, and NE in 4). The mean number of treatment courses required for a response was 1.42 (1 course in 30 patients, 2 courses in 19, and 3 courses in 1). The incidences of grade 3 or 4 hematological toxicities were: neutropenia 72.2%, leukopenia 16.7%, anemia 13.6%, thrombocytopenia 7.6%, febrile neutropenia 1.5%, and elevations of alanine aminotransferase and aspartate aminotransferase 1.5%. Grade 3 or 4 non-hematologic toxicities were as follows: diarrhea 6.1%, nausea 3%, anorexia 1.5%, vomiting 1.5%, fever 1.5%, allergic reactions 1.5%, ileus 1.5% and vesicovaginal fistula 1.5%. Neoadjuvant chemotherapy with irinotecan and nedaplatin was an effective and well-tolerated treatment for patients with bulky stage Ib2 to IIb squamous cell carcinoma of the uterine cervix.
DOI: 10.1016/j.ygyno.2007.04.007
发表时间: 2007-08-01
影响因子: 4.7
作者:
Eddy, Gary L.;Bundy, Brian N.;O'Connor, Dennis
通讯作者: O'Connor, Dennis