Neoadjuvant chemotherapy in cervical carcinoma stage IIB: a randomized controlled trial

Neoadjuvant chemotherapy in cervical carcinoma stage IIB: a randomized controlled trial
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IIB期宫颈癌新辅助化疗:一项随机对照试验

DOI:
10.1046/j.1525-1438.1998.09862.x
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发表时间:
1998
影响因子:
4.8
通讯作者:
Di Paola
Di Paola
中科院分区:
医学3区
文献类型:
--
作者:
Sardi;Sananes;Giaroli;Bermúdez;Ferreira;Soderini;Snaidas;Guardado;Anchezar;C. Ortiz;Di Paola

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Sardi JE,Sananes CE,Giaroli AA,Aldez A,Ferreira MH,Soderini AH,Snaidas L,Guardado N,Anchezar P,Ortiz OC,di保拉GR.宫颈癌IIB期新辅助化疗:一项随机对照试验。国际妇科癌症杂志。1998; 8:441-450. 本研究的目的是确定新辅助化疗(Nch)的可行性和作用,在Wertheim Meigs手术(S)和常规放疗(RT)之前在IIB期宫颈癌中使用。 295例患者随机分为4组:对照组(N = 73)接受全盆放疗50戈伊+A点放疗35-40戈伊,一次或两次,对照组(N = 75)接受S +全盆放疗50戈伊,对照组(N = 71)接受Nch +放疗。第四组(N = 76)采用Nch + S + RT方案,VBP方案为长春新碱1 mg/m2第1天,博莱霉素25 mg/m2第1 ~ 3天,顺铂50 mg/m2第1天,间隔10天,共3个疗程。年龄、肿瘤体积、宫旁受累或对Nch的反应无差异。根据Kaplan-Meier表和log-rank检验计算无病生存率(DFS)和总生存率(OS)。术后7年随访,Nch + S组总生存率(65%)与RT组(48%)比较,差异有统计学意义(P < 0.05)。在两个Nch组中,未观察到3级或4级毒性,化疗应答者的OS在统计学上更好。Nch + S是可行的,没有3级或4级毒性。它是传统放射治疗的替代治疗,OS增加。
Sardi JE, Sananes CE, Giaroli AA, Bermudez A, Ferreira MH, Soderini AH, Snaidas L, Guardado N, Anchezar P, Ortiz OC, di Paola GR. Neoadjuvant chemotherapy in cervical carcinoma stage IIB: a randomized controlled trial. Int J Gynecol Cancer. 1998; 8: 441–450. The aim of this study was to determine the feasibility and role of neoadjuvant chemotherapy (Nch), used before Wertheim Meigs operation (S) and conventional radiotherapy (RT) in Stage IIB cervical carcinoma. Two hundred ninety-five patients were randomized into four groups: first control group (N = 73) received RT of 50 Gy to whole pelvis + 35–40 Gy to point A, in one or two brachytherapy applications; the second control group received (N = 75) S + adjuvant RT to whole pelvis (50 Gy) the third group (N = 71) received Nch + RT; the fourth group received (N = 76) Nch + S + RT. The VBP scheme was used (3 courses of vincristine 1 mg/m2 on day 1, bleomycin 25 mg/m2 on days 1 to 3, and cisplatinum 50 mg/m2 on day 1, at 10 day intervals). No differences were found regarding age, tumor volume, parametrial involvement or response to Nch. Disease-free survival (DFS) and overall survival (OS) rates were calculated according to Kaplan-Meier tables and log-rank test. After seven years follow-up, statistically significant differences were found in OS between Nch + S (65%) and RT (48%, P 5 cm from 36% in RT to 66% in Nch + RT (P < 0.05). In both Nch groups no grades 3 or 4 toxicity was observed and OS was statistically better in chemotherapy responders. Nch + S is feasible, with no grades 3 or 4 toxicity. It is an alternative treatment to conventional radiation therapy with an increase in OS.
DOI: 10.3109/02841868809090333
发表时间: 1988-01-01
期刊: ACTA ONCOLOGICA
影响因子: 3.1
作者:
WITHERS, HR;TAYLOR, JMG;MACIEJEWSKI, B
通讯作者: MACIEJEWSKI, B