伊立替康联合丝裂霉素C治疗晚期或复发性宫颈鳞状细胞癌的II期研究:JGOG研究

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The efficacy and toxicity of combined therapy with irinotecan(CPT -11)plus mitomycin -C(MMC)were evaluated in patients with advanced or recurrent squamous cell carci-noma (SCC)of the uterine cervix.CPT -11(100mg /m 2 )was administered on days 1,8,and 15b y intravenous(iv)infusion over 90min,while MMC(10mg /m 2 iv)was given on day 1.This regimen was repeated every 28days and at least two courseswere given.A mong 51eligible patients(median age:52years;range:25-72years),2showed complete response(CR)and 24showed PR,for an overall response rate(ORR)of 51.0%(95%confidence interval:36.6-65.3%).In patients without prior chemotherapy,the ORR was 54.8%(38.7-70.2%).Twenty -five patients(Ib2:3,IIb:17,and IIIb:5)re-ceived this regimen as neoadjuvant c hemotherapy and their ORR was 76%(54.9-90.6%).Twentytwo patients were able to undergo radical surgery afte r NAC.The major tox-icity was neutropenia,which was gra de 3-4in 59%of the patients.Grade 3-4thrombocytopen ia and anemia were also seen in 26%of the patients each.The most common nonhematologic toxicitywas diarrh ea(grade 3-4in 12%).CPT -11combined with MMC can be effective against advanced or recurrent SCC of the uterine cervix. The efficacy and toxicity of combined therapy with irinotecan (CPT-11) plus mitomycin -C (MMC) were evaluated in patients with advanced or recurrent squamous cell carci-noma (SCC) of the uterine cervix. CPT-11 ) was administered on days 1,8, and 15b y intravenous (iv) infusion over 90 min while while MMC (10 mg / m 2 iv) was given on day 1. This regimen was repeated every 28 days and at least two courses were given. Among 51 of eligible patients (median age: 52years; range: 25-72years), 2showed complete response (CR) and 24showed PR, for an overall response rate (ORR) of 51.0% (95% confidence interval: 36.6-65.3% Twenty -five patients (Ib2: 3, IIb: 17, and IIIb: 5) re-ceived this regimen as neoadjuvant c hemotherapy and their ORR was 76% (38.7-70.2%) without prior chemotherapy, the ORR was 54.8% 54.9-90.6%). Twentytwo patients were able to undergo radical surgery antef NAC. Major tox-icity was neutropenia, which was gra de 3-4 in 59% of the patients. Grade 3-4 thrombocytopen ia and anemia were also seen in 26% o f the patients each. the most common nonhematologic toxicity was diarrh ea (grade 3-4 in 12%). CPT-11 combined with MMC can be effective against advanced or recurrent SCC of the uterine cervix.
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