奥沙利铂联合卡培他滨治疗体力状况削弱的晚期胃癌临床观察

为了评估奥沙利铂联合卡培他滨治疗体力状况削弱的(KPS≤70)晚期胃癌的毒性和疗效,应用奥沙利铂联合卡培他滨治疗21例晚期胃癌患者。奥沙利铂100mg/m2,静脉滴入,持续3h,d1;卡培他滨1650mg/(m2·d),分2次口服,d1~d14;21d为1个周期。患者每2个周期行CT检查以评估疗效,并监控其毒性。结果:所有患者均可评估毒性,21例中有20例可评估疗效。PR6例(30%),SD8例(40%),PD6例(30%),有效率为30·0%。中位进展时间4·5个月,中位生存时间8·3个月。初步研究结果提示:奥沙利铂联合卡培他滨治疗体力状况削弱(KPS≤70)的晚期胃癌有效,且有良好的耐受性。     

卡培他宾治疗晚期肝癌临床观察

目的 探讨卡培他宾在晚期肝癌临床治疗中的疗效。方法 将我科收住的34例肝癌病人随机分为两组：①治疗组：希罗达2000mg／m^2，分2次／d 口服、连用14d，休息7d，为一周期，至少用药二周期以上；②对照组：单纯支持治疗，至少6wk。治疗前后查肝肾功能，血常规，AFP，ECG，CT或MRI、B超等。疗效和不良反应按WHO疗效及不良反应评价标准评价，统计分析方法采用x^2检验，P〈0．05为有统计学意义。结果 治疗组：CR无病例，PR2例，SD10例，PD6例；总有效例数2例，总有效率为11．8％，稳定率58．8％。12例AFP增高中5例下降，下降率为41．7％。生存期最短的为3mo，最长的7mo，中位生存期为5．3mo。希罗达最少为2周期，最多6周期，共40周期。对照组：CR无病例，PR无病例，SD2例，PD15例；总有效率为零，稳定率11．8％。11例AFP增高病人中无AFP下降。生存期最短的为1．5mo，最长的4mo，中位生存期为2．3mo。采用x^2检验，P〈0．05，两组有显著的统计学差异。不良反应，治疗组3例恶心、呕吐，3例中性粒细胞减少，3例出现腹泻，皮肤红肿、脱屑等手足综合征，这些副反应均在1乏级。发生最多的是手足综合症，发生率为：29．4％。结论 本组病例说明希罗达2000mg／d，分二次口服，连用14d，休息7d为一周期，在晚期肝癌中的临床应用是可行、安全而有效的。主要不良反应表现为手足综合症，可以对晚期肝癌进一步推广应用。     

Weekly docetaxel and capecitabine is not effective in the treatment of advanced gastric cancer: a phase II study.

BACKGROUND: Capecitabine and docetaxel have demonstrated preclinical antitumor synergy and activity in advanced gastric cancer. We assessed the clinical activity and the toxicity of weekly docetaxel in combination with capecitabine in untreated patients with advanced gastric cancer. PATIENTS AND METHODS: A total of 38 patients were treated with docetaxel 36 mg/m2 on days 1, 8, and 15 i.v., plus capecitabine, 625 mg/m2 bid per os on days 5 to 18 repeated every 4 weeks. RESULTS: All patients were assessable for response to treatment and for toxicity. Major responses were observed in eight patients (21%), with three patients achieving a CR (7.8%) and five showing a PR (13%). The median time to progression was 5.4 months and the overall survival was 7.7 months. The safety profile of this schedule was acceptable with a low rate of myelossuppression, diarrhoea and hand-foot syndrome. CONCLUSIONS: The combination of docetaxel and capecitabine at the doses and schedule investigated in this study is safe, but does not show significant activity in untreated patients with advanced gastric cancer.     

Short-time infusion of oxaliplatin in combination with capecitabine (XELOX30) as second-line therapy in patients with advanced colorectal cancer after failure to irinotecan and 5-fluorouracil.

BACKGROUND: The efficacy of oxaliplatin combined with capecitabine (XELOX) as second-line therapy in patients with advanced colorectal cancer (ACRC) resistant to irinotecan is not well established. Oxaliplatin induces acute, cold-induced neuropathy in most patients. The incidence is claimed to be infusion rate-dependent and therefore a 2-h infusion is recommended. PATIENTS AND METHODS: For practical and economic reasons, but also for patient's convenience, we performed a phase II study to examine XELOX30 (capecitabine 1000 mg/m2 orally twice daily on days 1-14 and oxaliplatin 130 mg/m2 as a 30 min infusion on day 1) in patients with ACRC resistant to irinotecan. In addition the pharmacokinetics of oxaliplatin was studied. RESULTS: From November 2002 to September 2003, 70 patients with ACRC were treated with XELOX30. Median age was 62 (range 33-74 years) years and median performance status was 1 (range 0-2). The median number of courses was four (range 1-12) and median cumulative dose of oxaliplatin was 530 (range 125-1560) mg/m2. The response rate was 17% (95% CI 10-23), median time to progression (TTP) was 5.4 months (95% CI 4.6-6.4) and median survival 9.5 months (95% CI 8.5-11.2). White blood cell count (WBC) and performance status were significantly correlated to TTP. Neurotoxicity was moderate: grade 1 56%, grade 2 17% and grade 3 6%. Other grade 3 toxicities were nausea/vomiting 9%, diarrhoea 14% and PPE 8%. The maximum blood concentration and total body clearance of oxaliplatin was higher than previously reported in studies examining 2-h infusions, but the volume of distribution and terminal half-life was in close agreement with previous results. CONCLUSION: XELOX30 is a very convenient second-line regimen in ACRC with an activity and safety profile similar to other oxaliplatin schedules.     

草酸铂联合卡培他滨治疗晚期胃癌的近期疗效分析

目的：探讨草酸铂联合卡培他滨治疗晚期胃癌的近期疗效。方法：对32例晚期胃癌采用草酸铂联合卡培他滨方案治疗共76周期。结果：CR6例，PR16例，NC8例和PD2例，总有效率(CR PR)为68．75％(22／32)。中位缓解期8个月，中位生存期12个月，1年生存率为55％；临床受益者共30例(93．75％)。不良反应可耐受，经积极对症治疗后均见好转，无相关死亡出现。无患者因为不良反应中止治疗。结论：草酸铂加卡培他滨方案而组成的OX方案治疗晚期胃癌疗效较好，毒性反应能够耐受，可作为经济状况好的患者的一线方案在更多的病人中应用，以进一步探讨其疗效。     

卡培他滨联合肝动脉栓塞化疗治疗原发性肝癌

目的 :探讨卡培他滨联合经肝动脉栓塞化疗 (TACE)治疗晚期肝癌的有效性。方法 :6 2例不能手术切除的晚期肝癌患者 (TNM分期Ⅱ～Ⅳ )随机分成两组 :①单纯TACE组 30例 ;②卡培他滨联合TACE组 32例 ,在TACE治疗后第 2天 ,口服给药 14天。全部患者随访两年。比较两组患者的中位生存时间 ,死亡患者平均生存时间、一年生存率、二期手术切除率。结果 :卡培他滨联合TACE治疗组患者的中位生存时间为 14 .5个月 ,一年生存率为 75 .0 % ,二期手术切除率 2 5 .0 % ;而单纯TACE组患者的中位生存时间为 6个月 ,一年生存率为 39.3% ,二期手术切除率 6 .7% ,两组比较有显著差异 (P <0 .0 5 )。结论 :卡培他滨联合TACE治疗晚期原发性肝癌患者的疗效优于单纯TACE。     

Capecitabine and vinorelbine in elderly patients (> or =65 years) with metastatic breast cancer: a phase I trial (SAKK 25/99).

BACKGROUND: Few chemotherapy regimens are suitable for the treatment of elderly patients with advanced breast cancer. With the aim of finding a regimen with a low burden of subjective non-overlapping toxic effects, vinorelbine and capecitabine were chosen to be investigated in a phase I dose-finding study. PATIENTS AND METHODS: Thirty-six patients with advanced breast cancer were stratified for the presence of bone and non-bone involvement and treated at four dose levels from capecitabine 800 mg/m2 orally days 1-14 and vinorelbine 20 mg/m2 intravenously days 1 and 8, to capecitabine 1250 mg/m2 orally days 1-14 and vinorelbine 25 mg/m2 intravenously days 1 and 8, for a maximum of six cycles. None of the patients had received prior chemotherapy for metastatic/advanced disease. Fifty-three per cent of patients with bone metastases and 67% of patients without bone metastases had visceral disease. The median age was 70 years for the 15 with bone involvement patients and 73 years for the 21 without bone involvement patients. RESULTS: Twenty-eight patients were fully evaluable for hematological dose-limiting toxicity (DLT), and all patients for other DLTs and for antitumor activity. One DLT with grade 3 venous thrombosis at dose level 2 and two dose-limiting neutropenia events at level 3 occurred in patients without bone involvement. Two dose-limiting neutropenia events were observed at dose level 2 for patients with bone involvement. Thus, the recommended dose was defined at level 1 (capecitabine 1000 mg/m2 days 1-14 and vinorelbine 20 mg/m2 days 1 and 8) for patients with bone involvement. For patients without bone involvement, the recommended dose was at level 2 (capecitabine 1250 mg/m2 days 1-14 and vinorelbine 20 mg/m2 days 1 and 8). For patients without bone involvement the overall response rate was 48% and the time to progression (TTP) was 4.5 months [95% confidence interval (CI) 3.3-6.9]. For patients with bone involvement the overall response rate was 53% and TTP was 5.3 months (95% CI 2.7-7.8). CONCLUSIONS: This regimen of capecitabine and vinorelbine is well tolerated and effective in elderly patients with metastatic breast cancer. Toxicity was mainly hematological and was observed at a lower dose in patients with bone involvement. A phase II study with the two different dose levels for elderly patients with and without bone involvement is currently being conducted.     

Front-line treatment of inoperable or metastatic pancreatic cancer with gemcitabine and capecitabine: an intergroup, multicenter, phase II study.

PURPOSE: To evaluate the efficacy and toxicity of gemcitabine (GEM) combined with capecitabine (CAP) in untreated patients with inoperable or metastatic pancreatic cancer. PATIENTS AND METHODS: Fifty-three patients with pancreatic cancer (85% stage IV) were enrolled. Patients were treated with GEM 1000 mg/m2 on days 1 and 8 and CAP 1300 mg/m2 per day PO (per os), divided into two equal doses on days 1-14, in 21-day cycles. RESULTS: In an-intention-to-treat analysis, 10 (18.9%) objective partial responses were achieved (95% confidence interval 8.33% to 29.4%). Twenty-two (42%) patients had stable disease and 15 (28%) had progressive disease. The median response time was 3 months (range 1.5-7.0) and the median time to tumor progression was 6.5 months (range 3.5-15.5). Median overall survival time was 8 months (range 1.0-15.5) and 1-year survival was 34.8%. Pain improvement during treatment was observed in 23 of 43 (53%) patients, and eight of 18 (44%) patients who had been receiving opioids discontinued their use. Weight gain was observed in 12 of 33 (36%) patients. Grade 3 anemia occurred in five (9%) patients and grade 3-4 thrombocytopenia occurred in three (6%). Grade 3-4 neutropenia occurred in 13 (25%) and five (9%) patients, respectively, and two (4%) developed febrile neutropenia. Non-hematological toxicity was mild. CONCLUSION: In patients with pancreatic cancer, the combination of GEM with CAP is an active and well tolerated regimen that merits further evaluation in prospective randomized studies.     

XELOX与FLO方案治疗晚期胃癌的近期疗效及毒副反应比较

目的比较奥沙利铂联合卡培他滨方案(XELOX)与奥沙利铂联合5-FU/LV(FLO)方案治疗的晚期胃癌的近期疗效和毒副反应。方法通过查阅病例资料回顾分析2007年5月～2009年4月期间该科收治的62例采用XELOX和FLO化疗方案治疗的晚期胃癌,其中奥沙利铂联合卡培他滨(XELOX)A组33例,奥沙利铂联合5-FU/LV(FLO组)B组29例。结果 A组总有效率48.48%,疾病进展时间5.92个月,B组为44.83%和5.70个月,两组之间差异无统计学意义;A组中性粒细胞减少发生率15.2%,明显低于B组48.3%(P=0.006<0.01);A组神经毒性发生率15.2%明显低于B组58.6%(P=0.000<0.01);A组的手足综合症发生率(48.5%)明显高于B组13.8%(P=0.006<0.01),大多数为轻度,主要为I～Ⅱ度。结论 XELOX方案与FLO方案的疗效相近,但XELOX方案毒副反应较轻、耐受性良好、临床使用方便等优点。     

卡培他滨单药一线治疗Ⅱa期老年乳腺癌的临床研究

目的:观察卡培他滨单药一线治疗Ⅱa期老年乳腺癌的临床疗效和不良反应。方法:2002年6月至2005年6月本院收治的71例Ⅱa期老年乳腺癌,患者术后分别行卡培他滨单药口服化疗(X组)及CEF方案化疗(CEF组)。结果:X组3年和5年总生存率分别为97.06％、94.12％,复发及转移率为5.88％,均与CEF组患者无明显差异(P>0.05)。X组具有口服给药的优势,不良反应以手足综合征为主,发生率82.35％,均可耐受,其胃肠道反应以及骨髓抑制程度等均显著低于CEF组(P<0.01),未有因不良反应减量、中断或放弃化疗者,且无明显化疗恐惧感。结论:对于Ⅱa期老年乳腺癌患者术后采用卡培他滨单药口服化疗疗效可靠,给药方便,不良反应极小,患者对治疗的耐受及依从性佳。