伊立替康联合卡培他滨二线治疗38例晚期结直肠癌的临床观察

目的:观察伊立替康联合卡培他滨二线治疗晚期结直肠癌的疗效及不良反应.方法:38例晚期结直肠癌患者予以伊立替康200mg/m2,第1天,口服卡培他滨 1000mg/m2一日两次,联用14天,每21天重复,至少治疗2周期.结果:本组患者有效率7.9%(3/38),疾病控制率55.3%(21/38),其中部分缓解(PR)3例,稳定(SD)18例,进展(PD)17例.中位进展时间(TTP)及中位总生存期分别为4月和11月,临床疗效是影响TTP及OS的主要预后因素.3度以上不良反应主要为中性粒细胞减少(18.4%)及腹泻(10.5%).结论:伊立替康联合卡培他滨二线治疗晚期结直肠癌具有良好的疗效与耐受性.     

伊立替康联合卡培他滨二线治疗晚期结直肠癌

目的:观察伊立替康(开普拓,CPT-11)联合卡培他滨(希罗达)治疗一线化疗失败的晚期结直肠癌的疗效及安全性。方法:72例晚期结直肠癌患者,均为经氟脲嘧啶(5-FU)、亚叶酸钙(LV)以及奥沙利铂等药物一线化疗失败者,行CPT-11联合卡培他滨方案治疗,CPT-11180mg/m2,静脉滴注90min,第1天;卡培他滨1250mg/m2,2次/天,第1～14天口服,休息7天,21天为1个疗程,每例患者至少接受4个疗程。按照WHO实体瘤近期客观疗效评定标准进行评价。结果:72例均可评价疗效及不良反应。完全缓解(CR)为0,部分缓解(PR)16例,有效率(RR)22.2%(16/72),稳定(SD)44例,进展(PD)12例。中位疾病进展时间7.6个月(6～28个月),中位生存期12.8个月。不良反应主要为恶心、呕吐、厌食、白细胞减少、脱发和延迟性腹泻,多为Ⅰ～Ⅱ度。结论:伊立替康联合卡培他滨二线治疗晚期结直肠癌,用药方便、疗效肯定,不良反应低,可广泛用于临床。     

伊立替康联合卡培他滨治疗晚期结直肠癌的临床观察

目的观察伊立替康联合卡培他滨治疗晚期结直肠癌的疗效和安全性。方法回顾性分析62例复发或转移性结直肠癌患者,接受伊立替康联合卡培他滨治疗：伊立替康125mg／m^2 d1、d8、d15静脉滴注90min;卡培他滨（希罗达）2500mg/m^2,分早晚2次,第1—14天,每28天重复。治疗至少2个周期,按照WHO标准进行疗效和不良反应评价,并观察至疾病进展时间及总生存期。结果62例患者中,可评价疗效的有59例。其中一线治疗28例,RR42．8％,DCR71．4％,TTP 8．6个月,MST18．8个月;二线治疗31例,RR32．3％,DCR61．2％,TTP 7．2个月,MST13．2个月。不良反应主要为恶心与呕吐、迟发性腹泻、粒细胞减少,多为Ⅰ-Ⅱ度,且一线和二线治疗的不良反应无统计学差异。结论伊立替康联合卡培他滨治疗晚期结直肠癌疗效高,不良反应可耐受,值得扩大样本进一步观察。     

伊立替康联合卡培他滨二线治疗晚期结直肠癌临床观察

目的观察伊立替康联合卡培他滨二线治疗晚期结直肠癌的近期疗效及毒副反应。方法 37例经FOLFOX4、FOLFIRI方案治疗失败的晚期结直肠癌患者采用伊立替康联合卡培他滨方案治疗:伊立替康125 mg.m-2,静滴,d1,8;卡培他滨1 250 mg.m-2,口服,bid,d1～14,21 d为1周期,化疗4周期后评价近期疗效及毒副反应。结果 37例患者中,CR 0例,PR 10例,SD 22例,PD 5例,有效率为27.0%。毒副反应主要是恶心、呕吐及迟发性腹泻,且多为Ⅰ～Ⅱ度。结论伊立替康联合卡培他滨二线治疗晚期结直肠癌近期疗效肯定,毒副反应可耐受。     

伊立替康联合卡培他滨治疗晚期结直肠癌的临床观察

目的：观察伊立替康（CPT-11）联合卡培他滨（Capecitabine,希罗达）治疗晚期结直肠癌的疗效及毒性反应。方法：从2004年2月-2006年5月对晚期结直肠癌采用CPT-11联合卡培他滨方案化疗。入组患者均经病理组织学证实,且有可测量病灶。具体方案为：CPT-11250mg／m^2 iv,d1;希罗达1250mg／m^2 po,bid,d1-d14。21天为1个周期,化疗2个周期后评价疗效及毒性反应。结果：可评价疗效者60例,其中完全缓解（CR）4例,部分缓解（PR）22例,有效率（RR）为43．3％,稳定（SD）28例（46．7％）,进展（PD）6例（10．0％）。临床受益率为83．3％,疼痛缓解率83．3％。肿瘤中位进展时间7．2个月,中位生存期13．8个月。主要毒副反应为迟发性腹泻和中性粒细胞减少,未出现治疗相关性死亡。结论：CPT-11联合卡培他滨方案治疗晚期结直肠癌患者有较好疗效,毒副反应可以接受。     

伊立替康联合卡培他滨二线治疗晚期胃癌的临床观察

目的 观察伊立替康联合卡培他滨二线治疗晚期胃癌的疗效和毒副反应.方法 31例晚期胃癌给予伊立替康180 mg/m2,静脉滴注,d1;卡培他滨1 250 mg/m2,口服,2次/d,d1～14.21 d为1个周期,至少治疗2个周期.结果 29例可评价疗效,其中CR2例,PR 10例,SD 9例,PD 8例,有效率为41.4%(12/29),疾病控制率为72.4%(21/29).常见毒副反应为中性粒细胞减少、迟发性腹泻、恶心、呕吐和手足综合征等,多为Ⅰ～Ⅱ度.结论 伊立替康联合卡培他滨二线治疗晚期胃癌疗效较好,毒副反应可耐受.     

卡培他滨联合伊立替康二线治疗19例晚期结直肠癌

[目的]评价卡培他滨联合伊立替康二线方案治疗晚期结直肠癌(ACRC)的疗效与安全性.[方法]卡培他滨联合伊立替康二线治疗19例晚期结直肠癌,每3周重复,完成4个周期(12周)后判定疗效.[结果]无完全缓解(CR),部分缓解(PR)4例(21.0%),疾病稳定(SD)8例(42.1%),疾病进展(PD)7例(36.8%),有效率(RR)21.0%(4/19),中位疾病进展时间4.2个月,中位生存期19.6个月.19例中不良反应为Ⅲ或Ⅳ度者7例,其中白细胞减少6例(31.6%),乏力1例(5.3%).无化疗相关死亡.[结论]卡培他滨联合伊立替康方案二线治疗晚期结直肠癌疗效高,不良反应可耐受.     

卡培他滨联合伊立替康治疗晚期大肠癌

目的 观察和评价卡培他滨联合伊立替康治疗晚期大肠癌的疗效及毒副反应.方法 回顾性分析2002年4月-2004年5月我院经病理证实的晚期大肠癌32例.伊立替康(CPT-11,艾力)给药剂量按180 mg/m2、d1,静滴90 min,卡培他滨2 000 mg/m2,d1-14.每3周重复,每例至少接受2周期化疗后评价疗效.结果 全组32例均可评价疗效,有效率(CR PR)40.62%(13/32),SD34.38%(11/32), PD 25.00%(8/32),中位生存期(MST)13.2个月,中位疾病进展时间(TTP)7.2个月.治疗相关毒副反应主要为手足综合征和迟发生性腹泻及中性粒细胞减少.Ⅲ～Ⅳ级手足综合征发病率为18.75%,Ⅲ～Ⅳ级迟发性腹泻为6.25%,Ⅲ～Ⅳ级中性粒细胞少为9.18%.结论 卡培他滨联合伊立替康治疗晚期大肠癌疗效肯定,可使大部分患者临床获益,其毒副反应可以耐受.     

伊立替康联合卡培他滨治疗晚期胃癌疗效分析

目的 观察伊立替康联合卡培他滨治疗晚期胃癌的疗效和毒副反应.方法 全组24例胃癌均接受化疔.具体方案:伊立替康180 mg/m<'2>,静脉滴注,d<,1>;卡培他滨1 650 mg/(m<'2>·d),口服,d<,1～5>.14 d为1个周期,4个周期后评价疗效和毒副反应.结果 全组24例中,CR 1例,PR 8例,...     

伊立替康联合卡培他滨治疗转移性结直肠癌疗效观察

目的:探讨伊立替康(CPT-11)联合卡培他滨(capecitabine,Cap)治疗复发转移性结直肠癌的疗效与毒性。方法:26例进展期结直肠癌患者接受卡培他滨口服2000mg/(m2.d),分2次,连服14d;CPT-1160mg/m2,静脉滴入,90min,d1、d8,每3周重复。结果:26例患者用药后均可评价疗效,共完成化疗136个周期,无完全缓解病例,PR8例(29%),SD12例(45%),PD6例(26%),中位疾病进展时间7.2个月,疾病控制率74%;远期疗效:平均疾病缓解时间7.2个月,中位生存时间14.7个月。常见的毒副反应为白细胞降低,胃肠道反应主要为腹泻,手足综合征1例。结论:CPT-11联合卡培他滨治疗晚期转移性结直肠癌疗效好且不良反应可耐受。     

The combination of capecitabine and irinotecan in treating 5-Fluorouracil- and Oxaliplatin-pretreated metastatic colorectal cancer

Purpose Since the combination of capecitabine and irinotecan has successfully been used as a first-line treatment in metastatic colorectal cancer (MCRC), we expected promising results when given as a second-line treatment to metastatic colorectal patients who had been pretreated with 5-Fluorouracil and Oxaliplatin. Methods Thirty-three MCRC patients participated in this study and received an oral dose of 1,000 mg/m² capecitabine twice daily on days 1–14 and a dose of 100 mg/m² irinotecan infused over 90 min on days 1 and 8, every 3 weeks. Results The overall response rate in intent-to-treat was 33.3% (95% CI, 21.5–58.3%), including one complete response (3.0%) and ten partial responses (30.3%); 12 patients (36.4%) had disease stabilization and only 9 (27.3%) progressed. The median time to progression was 6.7 months (95% CI, 4.8–8.6 months). After a median follow-up time of 12 months, nine patients (27.3%) were still alive with metastatic disease. The median response duration for all patients was 6.7 months (95% CI, 3.9–9.5 months) and the median overall survival was 13.4 months (95% CI, 11.0–15.8 months) with a 1-year survival rate of 55.4%. Myelosuppression was commonly observed; NCI-CTC (v 2.0) grade 3/4 neutropenia, however, occurred in eight (24%) patients and grade 3 anemia was seen in one patient (3%). The most common (grade 3/4) non-hematological toxicity was diarrhea (15%) and the other severe grade 3/4 toxicities included nausea/vomiting in one patient (3%), stomatitis in one patient (3%), hand-foot syndrome in one patient (3%). Conclusions The combination of capecitabine and irinotecan is an effective and well-tolerated regimen for second-line treatment of metastatic colorectal cancer. However, further phase III trials are required to clarify its use in the treatment of metastastic colorectal cancer patients who have been pretreated with 5-fluorouracil and oxaliplatin.     

Phase II study of weekly irinotecan (CPT-11) as second-line treatment of patients with advanced colorectal cancer

This phase II trial studied the antitumor effect and toxicity of weekly irinotecan (CPT-11, 125 mg/m² 60 min iv infusion, weekly for 4 wk plus 2 wk rest) as second-line chemotherapy in patients with advanced colorectal cancer (CRC) resistant or refractory to prior 5-fluorouracil (5-FU) therapy. Sixty-nine patients with adenocarcinoma (57% in the colon and 43% in the rectum) were enrolled. The median number of treatment cycles received per patient was 4 (range, 1–6). Overall response rate was 18% (95% CI, 9–26), with 4 complete responses (6%) and 8 partial responses (12%), and a median duration of response of 8.1 mo (95% CI, 4.2–12.1). Stable disease was observed in 19 patients (28%). The median time to disease progression was 5.2 mo (95% CI, 4.3–6.1), and the median overall survival was 13.3 mo (95% CI, 9.8–16.8 months). The toxicity profile was favorable: grade 3/4 delayed diarrhea was observed in 10 patients (14.5%) in one cycle each, and grade 3/4 neutropenia in 6 patients (8.7%) and 6 cycles (3.3%). No febrile neutropenia or infection was documented. Grade 3/4 nausea and vomiting were reported in 1 (1.4%) and 7 patients (10.1%), respectively. In conclusion, this phase II trial showed a response rate and a toxicity profile of weekly CPT-11 in line with the results of prior phase II studies.     

Phase II study of capecitabine and mitomycin C as first-line treatment in patients with advanced colorectal cancer

This study was designed to assess the safety and efficacy of capecitabine and mitomycin C (MMC) in previously untreated patients with advanced colorectal cancer (CRC). Patients received capecitabine 2500 mg m(2) day 1, orally divided in two doses of 1250 mg m(-2) in the morning and evening for 14 days every 21 days and MMC 7 mg m(-2) (maximum total dose 14 mg) as an intravenous bolus every 6 weeks for a total of four courses. The median age was 70 years (range 24-85) and the majority of patients (86.9%) were of performance status 1/2. The most common metastatic site was liver. In all, 84 patients were assessable for response. The overall response rate was 38% (95% CI: 27.7-49.3) and a further 33.3% of patients achieved stable disease over 12 weeks. There was good symptom resolution ranging from 64 to 86%. Grade 3/4 toxicity was as follows: hand-foot syndrome 19.7%; diarrhoea 10%; neutropenia 2.4%; infection 2.3%. Capecitabine and MMC have shown encouraging activity with a favourable toxicity profile, a convenient administration schedule, and could be considered for patients deemed unsuitable for oxaliplatin and irinotecan combinations.     

卡培他滨单药联合重组人血管内皮抑素（恩度）用于老年晚期结直肠癌一线化疗的研究

目的：观察卡培他滨单药联合重组人血管内皮抑素（恩度）方案一线化疗老年晚期结直肠癌的临床疗效。方法：选择2010年1月至2013年1月间收治的86例老年晚期结直肠癌患者,随机分为治疗组和对照组,每组43例。治疗组给予卡培他滨单药联合恩度方案,对照组给予卡培他滨单药方案。比较两组患者治疗后的近期疗效、不良反应及生存率。结果：治疗组患者的有效率（44．2％）明显高于对照组（23．3％）,治疗组患者的临床获益率（83．7％）明显高于对照组（55．8％）,差异有统计学意义（P＜0．05）。治疗组患者的白细胞减少、血小板减少、手足反应、恶心呕吐及腹泻发生率与对照组比较,差异无统计学意义（P＞0．05）。两组患者高血压、心血管等不良事件的发生率比较差异亦无统计学意义（P＞0．05）。治疗组患者的1年生存率和2年生存率均明显高于对照组,差异有统计学意义（P＜0．05）。结论：卡培他滨单药联合恩度方案可提高老年晚期结直肠癌的近期疗效和生存率,不良反应可耐受。     

Phase II study of capecitabine and oxaliplatin as first-line treatment in advanced colorectal cancer.

BACKGROUND: Capecitabine and oxaliplatin are both active anticancer agents in the treatment of patients with advanced colorectal cancer. The aim of this phase II study is to determine the efficacy and tolerability of combining oxaliplatin with capecitabine in the treatment of advanced non-pretreated colorectal cancer. PATIENTS AND METHODS: Forty-three chemotherapy-na?ve patients were enrolled. Capecitabine 2500 mg/m(2)/day was administered orally twice a day continuously for 14 days and oxaliplatin 120 mg/m(2) was administered as a 2-h infusion on day 1, repeated every 3 weeks. RESULTS: Forty-three patients were assessable for toxicity and 39 for clinical activity: the main toxicity was grade 3 or 4 diarrhea, which occurred in 28% of the patients. The response rates were 44% [95% confidence interval (CI), 29.3% to 59.0%] and 48.7% (95% CI 33.0% to 64.4%) (intention-to-treat and per protocol analysis, respectively). The median overall survival was 20 months (95% CI 12-28). CONCLUSIONS: Combining capecitabine and oxaliplatin yields promising activity in advanced colorectal cancer; therefore, the capecitabine dose we utilized is probably too high. The main toxicity is diarrhea, which is manageable with appropriate dose reductions.This combination may be preferable compared to a standard combination with infusional fluorouracil/leucovorin as it is more convenient and practical with similar efficacy. Thus, phase III trials are needed to clarify its role in the treatment of chemotherapy-na?ve advanced colorectal cancer patients.     

Randomised study of sequential versus combination chemotherapy with capecitabine, irinotecan and oxaliplatin in advanced colorectal cancer, an interim safety analysis. A Dutch Colorectal Cancer Group (DCCG) phase III study.

BACKGROUND: Results on overall survival in randomised studies of mono- versus combination chemotherapy in advanced colorectal cancer patients may have been biased by an imbalance in salvage treatments. This is the first randomised study that evaluates sequential versus combination chemotherapy with a fluoropyrimidine, irinotecan and oxaliplatin. PATIENTS AND METHODS: A total of 820 patients were randomised between first-line capecitabine, second-line irinotecan and third-line capecitabine + oxaliplatin (arm A) versus first-line capecitabine + irinotecan, and second-line capecitabine + oxaliplatin (arm B). The primary end point was overall survival. We present the results of an interim analysis on the safety data in the first 400 patients. RESULTS: In first-line the incidence of grade 3-4 diarrhoea, nausea, vomiting and febrile neutropenia was significantly higher in arm B. However, when toxicity over all lines was considered only grade 3 hand-foot syndrome occurred more frequently in arm A (12% versus 6%, respectively, P = 0.041). The incidence of cardiovascular toxicity was low. In two out of five patients with sudden death (one in arm A, four in arm B) cardiovascular risk factors were present. CONCLUSIONS: Both treatment arms had an acceptable safety profile. These data imply that the results on survival will be the major determinant for the selection of either strategy. Capecitabine plus irinotecan appears to be a feasible first-line treatment for patients with advanced colorectal carcinoma.     

多西紫杉醇联合卡培他滨治疗蒽环类药物耐药性晚期乳腺癌的初步临床结果

目的观察多西紫杉醇(docetaxel)联合卡培他滨(capecitabine)治疗蒽环类耐药性晚期乳腺癌的疗效.方法2002年6月～2003年10月,以此方案治疗蒽环类药物耐药的晚期乳腺癌16例.全组化疗共52周期,中位周期数3周期(2～6周期).结果CR 2例,PR 7例,SD 4例,PD 3例,总有效率(CR PR)56.2%.全组中位缓解期5个月(2～14个月).主要剂量毒性为骨髓抑制、胃肠道反应和手足综合征,骨髓抑制以白细胞减少为主,Ⅲ～Ⅳ度白细胞减少发生率为18.7%.结论多西紫杉醇联合卡培他滨对蒽环类药物耐药的转移性乳腺癌有较好的疗效,且毒性可以耐受,可以考虑作为解救化疗方案.     

Phase II study of capecitabine and irinotecan combination chemotherapy in patients with advanced gastric cancer

The present study was conducted to evaluate the efficacy and safety of a combination regimen of capecitabine plus irinotecan in patients with advanced gastric cancer. Patients with previously untreated metastatic or recurrent, measurable gastric cancer received oral capecitabine 1000 mg m(-2) twice daily from day 1 to 14 and intravenous irinotecan 100 mg m(-2) on days 1 and 8, based on a 3-week cycle. Forty-one patients were enrolled in the current study, among whom 38 were assessable for efficacy and 40 assessable for toxicity. Three complete responses and 16 partial responses were confirmed, giving an overall response rate of 46.3%. At a median follow-up of 269 days, the median time to progression and overall survival were 5.1 and 8.6 months, respectively. Grade 3/4 neutropenia occurred in four patients and grade 3 febrile neutropenia was observed in two patients. Grade 3 diarrhoea and grade 2 hand-foot syndrome occurred in six patients and eight patients, respectively. The combination of capecitabine and irinotecan was found to be well tolerated and effective in patients with advanced gastric cancer. Accordingly, this regimen can be regarded as one of first-line treatment options for advanced gastric cancer.