重组人血管内皮抑素联合卡培他滨、草酸铂治疗结肠癌肝转移的临床观察

目的：评价重组人血管内皮抑素（恩度）联合卡培他滨、草酸铂治疗结肠癌肝转移的有效性和安全性。方法：经临床明确诊断的结肠癌肝转移患者１６例,均接受恩度联合卡培他滨、草酸铂的治疗。恩度３０ｍｇ加生理盐水５００ｍｌ匀速缓慢静脉滴注,ｄ１～ｄ１４,间歇１４天,重复给药;草酸铂２００ｍｇ加５％葡萄糖水５００ｍｌ静脉滴注,ｄ１;卡培他滨每日３０００ｍｇ分早、中、晚３次口服,ｄ１～ｄ１４,休息１４天。２８天为１周期。以ＲＥＣＩＳＴ标准评价近期疗效,以ＮＣＩＣＴＣ３.０评价毒性反应。结果：１６例患者均可评价客观疗效和毒副反应。共完成４０个周期,平均为２５个周期,获得ＣＲ３例,ＰＲ５例,ＳＤ３例,ＰＤ５例。客观有效率（ＲＲ）５０.０％（８／１６）,疾病控制率（ＤＣＲ）６８８％（１１／１６）,３、４级毒性主要与化疗药物有关,白细胞减少４例,血小板减少１例,恶心呕吐４例。结论：恩度联合卡培他滨、草酸铂治疗结肠癌肝转移的疗效较好,毒性低,安全可靠。     

Biweekly oxaliplatin combined with oral capecitabine (OXXEL regimen) as first-line treatment of metastatic colorectal cancer patients: a Southern Italy Cooperative Oncology Group phase II study

Oxaliplatin 100 mg/m² iv on day 1, and capecitabine 1,000 mg/m² orally bid from day 1 (evening) to day 11 (morning) were administered every 2 weeks (OXXEL regimen) to 38 patients as first-line treatment for metastatic colorectal carcinoma. A total of 318 cycles were administered, with a median of 8 (range, 4–12) cycles per patient. Response rate (RR) was 45% (95% confidence interval (CI), 29%–62%), with 7 complete responses and 10 partial responses; furthermore, 12 patients showed a stable disease, so that a disease control was achieved in 29 (76%) patients. RR was greater among patients with performance status 0 (52%), without weight loss (52%), younger than 65 years (50%), and previously unexposed to adjuvant chemotherapy (48%), while no correlation was found with the actually delivered oxaliplatin dose intensity. Overall, haematological side effects were negligible, with no case of grade 4 toxicity, and only one patient suffering from an episode of grade 3 neutropenic fever. Severe anaemia occurred in 4 (11%) patients, and grade 3 neuropathy affected 9 (24%) patients. Median progression-free survival was 7.9 (95% CI, 6.2–9.6) months, and median overall survival has not been reached yet. In conclusion, the OXXEL regimen resulted safe and active, and it deserves further evaluation in metastatic colorectal cancer patients.     

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。     

Xelox方案联合沙利度胺治疗胃癌术后淋巴结转移的近期疗效

目的探讨奥沙利铂、卡培他滨联合沙利度胺治疗胃癌手术后淋巴结转移的近期疗效。方法50例胃癌手术后淋巴结转移患者采用奥沙利铂,卡培他滨联合沙利度胺方案治疗共189个周期。结果完全缓解（CR）4例,部分缓解（PR）28例,无变化（NC）13例和进展（PD）5例,总有效率（CR＋PR）为64%（32/50）。中位缓解期6.2个月,中位生存期12.3个月,1年生存率为60.5%,临床受益者共45例（90%）。毒副反应可耐受,无患者因为毒副反应终止治疗,无相关死亡出现。结论奥沙利铂,卡培他滨联合沙利度胺方案治疗胃癌手术后淋巴结转移疗效较好,毒副反应能够耐受,可作为一线方案在胃癌手术后淋巴结转移的患者中应用。     

卡培他滨单药用于一线治疗后复发乳腺癌疗效观察

目的:探讨卡堵他滨单药1线治疗后复发晚期乳腺癌的近期疗效.方法:全组27例1线治疗后复发的乳腺癌,卡培他滨2500 mg/(m2·d),分早晚2次口服,连服14天,21天为1个周期,治疗至少2个周期后评价疗效及不良反应.结果:24例可评价疗效,全组无完全缓解(CR),部份缓解(PR)7例(29.1%),稳定(SD)10例(41.8%),进展(PD)7例(29.1%),总有效率为29.1%.主要的不良反应为手足综合征(54.1%)、恶心呕吐(29.1%).结论:卡培他滨对经蒽环类、紫杉类等药物治疗后复发的晚期乳腺癌仍有较好疗效,且不良反应小,耐受性好,可作为复发的晚期乳腺癌的二线治疗方案.     

卡培他滨联合奥沙利铂对胃癌患者多项血清因子水平的影响

目的:探讨卡培他滨联合奥沙利铂对胃癌患者多项血清因子水平的影响。方法:选取2008年3月～2009年12月于我院进行治疗的80例胃癌患者为研究对象,将其随机分为A组(卡培他滨联合奥沙利铂组)40例和B组(氟尿嘧啶联合奥沙利铂组)40例,同时选取40例健康志愿者为对照组(C组)。记录所有患者的治疗效果及治疗前后的血清溶性细胞间黏附分子-1(sI-CAM-1)、一氧化氮(NO)、志愿者血管内皮细胞生长因子(VEGF)、白细胞介素-2(IL-2)、肿瘤坏死因子-α(TNF-α)和白细胞介素-6(IL-6)的水平。结果:治疗前A、B组的血清sICAM-1、NO、VEGF、IL-2、TNF-α和IL-6水平均显著高于C组(P<0.05),治疗后A组的治疗效果优于B组,且A组的血清sICAM-1、NO、VEGF、IL-2、TNF-α和IL-6的水平均低于B组,差异有统计学意义(P<0.05或P<0.01)。结论:卡培他滨联合奥沙利铂对胃癌患者多项血清因子水平的影响较大,效果明显。     

Assessment of Tolerability,Response and Complications of Concurrent Chemoradiation With Capecitabine and Cisplatin in Muscle-Invasive Bladder Cancer; A Single Arm Study

PurposeTo evaluate the feasibility, tolerance and efficacy of cisplatin+capecitabine as a proposed combination in concurrent chemoradiotherapy for patients with muscle-invasive bladder cancer (MIBC).MethodsMIBC patients with stage T2-T4aN0M0 participated in this single-arm clinical trial. After maximal TURBT, 66Gy/33 daily fractions of radiation were administered with concurrent chemotherapy of cisplatin (35 mg/m²) and capecitabine (625 mg/m²). The primary endpoint was treatment tolerability, defined as receiving capecitabine+cisplatin combination for at least 5 weeks during radiation therapy. The secondary endpoints included complete response (CR) and acute toxicity rates.ResultsThis study included 19 MIBC patients from 2018 to 2019. Eighteen patients (94.7%, 95%CI: 75.4-99.0) completed the planned treatment course. Only one patient (5.26%, 95%CI: 0.9-24.6) discontinued the treatment due to grade-3 GI toxicity. Among those who completed the treatment, CR was seen in 12 patients (66.7%, 95% CI = 44.4-88.9) with no grade ≥ 3 toxicities. The most common grade-2 side effects during therapy were renal complications (57.9%), and the only grade-2 complication after therapy was urinary-related (11.1%). The median follow-up was 31 months and the median overall survival (OS) was 31 months. The 2-year OS was 78% (95% CI 58.4-97.6), Cystectomy-free survival was 61% (95% CI: 37.5-84.5), and the median OS after recurrence was 13 months. Distant metastases were the first type of recurrence in most patients with a recurrence, which occurred in 7 (36.8%) patients. Median metastasis-free survival (MFS) was 30 months, and 2-year MFS was 66% (95% CI:45-87).ConclusionThe promising tolerability rate seen with concurrent cisplatin+capecitabine in this study was comparable to the available literature. Thus, this combination concurrently with radiation warrants further studies in the context of chemoradiotherapy of MIBC.     

Pharmacokinetic and pharmacodynamic comparison of fluoropyrimidine derivatives, capecitabine and 5′-deoxy-5-fluorouridine (5′-DFUR)

Purpose Capecitabine is a three-step prodrug that was rationally designed to be a more effective and safer alternative to its intermediate metabolite, 5-deoxy-5-fluorouridine (5-DFUR). We compared the pharmacokinetics/pharmacodynamics of these drugs in metastatic breast cancer patients.Methods Six patients received oral capecitabine at 1657 mg/m² twice daily and 17 received 5-DFUR at 400 mg three times daily. Both drugs were administered for 21 days followed by a 7-day rest.Results Median daily 5-DFUR AUC was significantly higher for capecitabine than for 5-DFUR (81.1 vs 32.6 mmol h/l; P=0.01). Following treatment with 5-DFUR, the median AUC and C_max of 5-DFUR tended to be higher in patients with a partial response (3.83 g h/ml and 4.88 g/ml) and stable disease (6.46 g h/ml and 4.96 g/ml) than in those with disease progression (2.53 g h/ml and 1.36 g/ml). The AUC and C_max of 5-DFUR was significantly related to overall survival.Conclusions These results support the superiority of capecitabine over 5-DFUR.     

长春瑞滨联合卡培他滨治疗转移性乳腺癌30例临床观察

目的观察长春瑞滨联合卡培他滨对蒽环类药物治疗后无效或复发的转移性乳腺癌的疗效.方法转移性乳腺癌患者30例,长春瑞滨20 mg/m2第1天和第8天静脉滴注,卡培他滨每天1 250 mg/m2,分早晚两次服用,连续服用2周,3周为一个周期.结果 CR 1例(33.3%),PR 7例(23.3%),MR 7例(23.3%),SD 7例(23.3%),PD 8例(26.7%),有效率达49.9%,中位缓解期4.6个月(2～13个月).常见的不良反应为骨髓抑制、胃肠道反应、手足综合征、神经毒性等.结论长春瑞滨联合卡培他滨对蒽环类药物治疗后失败的转移性乳腺癌有较好的疗效,毒性可以耐受.     

Preoperative concomitant boost intensity-modulated radiotherapy with oral capecitabine in locally advanced mid-low rectal cancer: A phase II trial

Purpose

We aimed to assess the safety and efficacy of preoperative intensity-modulated radiotherapy (IMRT) with oral capecitabine in patients with locally advanced mid-low rectal cancer using a concomitant boost technique.

Materials and methods

Patients with resectable locally advanced mid-low rectal cancer (node-negative ?T3 or any node-positive tumor) were eligible. The eligible patients received IMRT to 2 dose levels simultaneously (50.6 and 41.8 Gy in 22 fractions) with concurrent capecitabine 825 mg/m² twice daily 5 days/week. The primary end point included toxicity, postoperative complication, and pathological complete response rate (ypCR). The secondary endpoints included local recurrence rate, progression-free survival (PFS), and overall survival (OS).

Results

Sixty-three eligible patients were enrolled; five patients did not undergo surgery. Of the 58 patients evaluable for pathologic response, the ypCR rate was 31.0% (95% CI 19.1-42.9). Grade 3 toxicities included diarrhea (9.5%), radiation dermatitis (3.2%), and neutropenia (1.6%). There was no Grade 4 toxicity reported. Four (6.9%) patients developed postoperative complications. Two-year local recurrence rate, PFS, and OS were 5.7%, 90.5%, and 96.0%, respectively.

Conclusions

The design of preoperative concurrent boost IMRT with oral capecitabine could achieve high rate of ypCR with an acceptable toxicity profile.