局部中晚期直肠癌术前新辅助同期加量IMRT联合术前化疗的Ⅱ期临床研究

目的 观察评估局部中晚期直肠癌术前SIB-IMRT联合1周期卡培他滨诱导化疗联合全直肠系膜切除术治疗方案的可行性、安全性及疗效。方法 2015-2016年入组37例局部中晚期直肠癌患者接受术前放疗,直肠病变及阳性淋巴结给予58.75 Gy分25次,盆腔淋巴引流区给予50.00 Gy分25次,同步卡培他滨化疗。同步放化疗结束后休息1周继续行1周期卡培他滨诱导化疗。同步放化疗结束后6~8周接受直肠癌根治术。研究主要终点为pCR,次要终点为TN降期率、保肛手术率、不良反应等。结果 37例患者顺利完成术前同步放化疗,32例行手术治疗,4例因症状缓解拒绝手术,1例患者因肛周水肿手术延迟。pCR率为34%(11/32),TN降期率为91%(29/32),R₀切除率为100%,保肛手术率为75%(24/32)。放化疗期间大部分为1、2级急性不良反应,3、4级不良反应共3例。术后并发症为输尿管损伤(1例)和肠梗阻(1例),围手术期内未见死亡。结论 局部中晚期直肠癌行术前SIB-IMRT联合1周期卡培他滨术前化疗及全直肠系膜切除术方案的初步结果表明其近期疗效好、安全可行、急性不良反应轻。     

Efficacy of S-1 vs capecitabine for the treatment of gastric cancer: A meta-analysis

AIM: To rationally evaluate the effect of S-1 vs capecitabine for the treatment of gastric cancer.METHODS: MEDLINE, EMBASE, Cochrane Controlled Trials Register, Google Scholar, and China Journal Full Text Database were accessed to collect clinical randomized controlled trials regarding the effect of S-1 vs capecitabine for the treatment of gastric cancer patients. Statistical analysis was performed by metaanalysis. Four randomized controlled trials met the inclusion criteria.RESULTS: Compared with capecitabine regimens, the 1-year survival rate in gastric cancer patients was 0.80(95%CI: 0.52-1.21, P = 0.29). The overall response rate of S-1 vs capecitabine was 0.94(95%CI: 0.59-1.51, P = 0.93). Compared with capecitabine regimens, the most frequent hematologic toxicities were neutropenia( O R = 0. 9 9, 9 5 % C I : 0. 6 5- 1. 4 9, P = 0. 9 4) a n d thrombocytopenia(OR = 0.72, 95%CI: 0.31-1.67, P = 0.44). The most frequent non-hematologic toxicities included nausea(OR = 0.85, 95%CI: 0.56-1.28, P = 0.43) and hand-foot syndrome(OR = 0.16, 95%CI: 0.10-0.27, P < 0.00001).CONCLUSION: The existing studies suggest that S-1 is not more effective than capecitabine in the treatment of gastric cancer patients, but does exhibit less toxicity with regard to hand-foot syndrome.     

奥沙利铂联合卡培他滨一线治疗晚期肝内胆管癌的临床观察

目的:探讨奥沙利铂联合卡培他滨一线治疗晚期肝内胆管细胞癌的疗效及安全性.方法:16例无法手术的晚期肝内胆管细胞癌患者接受以下化疗,奥沙利铂130 mg/m2,d1;卡培他滨2 000 mg/m2,d1～14,每21天为1个周期(XELOX方案).最多接受6个周期的化疗.结果:16例患者中CR 0例,PR 2例(12.5%),SD 5例(31.2%).PD 9例(56.2%),临床获益率43.7%,中位TTP 2.1个月,中位生存时间7个月.主要毒副作用有骨髓抑制、外周神经毒性、消化道反应、手足综合征,多为1～2度,无治疗相关性死亡.结论:XELOX方案治疗晚期肝内胆管细胞癌有一定近期疗效,耐受性好.     

不同用法多西紫杉醇联合卡培他滨治疗蒽环类失败复发转移性乳腺癌

目的 观察不同多西紫杉醇用法联合卡培他滨治疗葸环类失败复发转移性乳腺癌的疗效和安全性.方法 选择83例蒽环类失败的复发转移性乳腺癌患者,接受多西紫杉醇联合卡培他滨方案治疗,随机分为两组,A组34例:多西紫杉醇37.5 mg/m2静滴第1、8天;卡培他滨950 ms/m2口服,2次/d,第1～14天,每3周为1周期;B组49例:多西紫杉醇75 mg/m2 静滴第1天;卡培他滨950 ms/m2口服,2次/d,第1～14天,每3周为1周期.每周期评价疗效同时记录不良事件.结果 78例患者可评价疗效,完全缓解(CR)8例,部分缓解(PR)43例,有效率(CR+PR)61.4%(51/83).A组有效率61.8%(21/34),B组有效率61.2%(30/49),两组差异无统计学意义(P=0.813).两组共83例患者可评价毒性反应,元严重不良事件导致死亡的患者,粒细胞减少是主要不良反应,Ⅲ/Ⅳ度发生率45.8%(38/83),两组分别为32.4%(11/34)和55.1%(27/49)(P=0.04).结论 不同多西紫杉酵用法联合卡培他滨是治疗蒽环类失败复发转移性乳腺癌的有效方案,其不良反应能够耐受,两组疗效相当,周疗组Ⅲ/Ⅳ度粒细胞减少较少.     

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.     

Ⅲb及Ⅲc期结肠癌辅助化疗后行卡培他滨巩固化疗的临床研究

目的研究一组Ⅲb及Ⅲc期结肠癌术后患者,在辅助化疗后继续行卡培他滨巩固化疗,观察对无病生存率的影响。方法对入组的2005年6月至2008年9月我院收治的22例Ⅲb及Ⅲc结肠癌术后患者,行常规6个月辅助化疗,休息3～6个月之后给予6个周期卡培他滨口服巩固化疗,观察无病生存率及巩固化疗期间的相关不良反应,无病生存率的计算采用Life Tables分析法。结果使用卡培他滨作为Ⅲb及Ⅲc期结肠癌术后巩固化疗十分安全,初步观察复发转移率较低,无病生存率较高,不良反应轻微。结论Ⅲb及Ⅲc结肠癌术后患者接受卡培他滨巩固化疗可能改善无病生存率,值得进一步行大规模的临床研究。     

5-氟尿嘧啶或卡培他滨联合奥沙利铂治疗转移性结直肠癌有效性及安全性的Meta分析

目的比较5-氟尿嘧啶（5-Fu）或卡培他滨联合奥沙利铂治疗转移性结直肠癌的临床疗效和安全性。方法以转移性结直肠癌、奥沙利铂、5-Fu、卡培他滨为检索词,查阅2011年6月前发表的有关5-Fu或卡培他滨联合奥沙利铂治疗转移性结直肠癌的随机对照研究。由2名作者各自独立对入选文献中试验设计、研究对象的特征、研究结果等内容按照预先制订的数据表进行摘录。采用RevMan4．2软件进行统计分析。结果按照筛选标准,共有6篇文献入选,全部研究共计2189例转移性结直肠癌患者。两组患者基本特征均衡可比。临床疗效方面,有效率合并相对危险度（RR）为0．92[95％CI（0．82,1．02）,P=0．121,中位无疾病进展生存时间、中位生存时间合并加权均数差（WMD）分别为-0．19[95％CI（-0．73,0．35）,P=0．49],-1．91[95％CI（-2．53,0．16）,P：0．08],综合分析结果两组间均无优劣。Ⅲ～Ⅳ级毒副作用的比较中,中性粒细胞减少的综合分析显示卡培他滨组的发生率显著低于5-Fu组,合并RR为0．24[95％a（0．11,0．55）,P=0．0007],而手足症状发生率高于5-Fu组,合并RR为2．83[95％a（1．66,4．82）,19=0．0001]。结论5-Fu或卡培他滨联合奥沙利铂治疗转移性结直肠癌疗效无优劣。在Ⅲ～Ⅳ级毒性方面中性粒细胞减少在5-Fu组更易发生,卡培他滨组主要以手足症状为主。     

Neoadjuvant chemoradiotherapy with capecitabine followed by laparoscopic resection in locally advanced tumors of middle and low rectum – Toxicity and complications of the treatment

Aims

The aim of this prospective study is to elucidate feasibility of protocol of neoadjuvant concomitant radiochemotherapy with capecitabine and long course radiotherapy with subsequent laparoscopic rectal resection. We assessed treatment toxicity, downstaging rate, pathological response to the neoadjuvant treatment, surgery complications, rate of conversions and sphincter-preserving surgical procedures, and intraoperative and early postoperative complications too.

Methods

We acquired data of 78 patients from 1 January 2005 to 31 December 2007 with a locally advanced rectal cancer in our study. All patients were indicated for the neoadjuvant concomitant chemoradiotherapy due to locally advanced tumor (T3 or T4) or lymph nodes involvement suspicion (N+). Both radiotherapy (to pelvic region) and chemotherapy (capecitabine) were administered. Rectal tumors were localized within 12 cm from the anocutaneous verge. The average follow-up time was 23.9 months.

Results

All patients completed their treatment according to the planned regimen and dose. The surgery was performed laparoscopicaly within 4–8 weeks following the concomitant chemoradiotherapy – in 17% cases was converted into conventional surgery. Downstaging was achieved in 69% of patients, pathological complete response in 10%, histologically negative lymph nodes were documented in 58% of patients. Grade 3 toxicity of the concomitant chemoradiotherapy was present in 3%; grade 2 in 29% of patients, particularly skin and gastrointestinal form. Intraoperative and early postoperative complications of the surgery were 18%. Re-operation was needed in 5% cases.

Conclusions

We demonstrated safety and low toxicity of the concomitant chemoradiotherapy with capecitabine.     

XELOX双周方案治疗晚期胃肠癌的近期疗效

目的 观察奥沙利铂联合卡培他滨(XELOX)双周方案治疗晚期胃、结直肠癌的临床疗效和不良反应。方法 46例晚期胃、结直肠癌患者应用奥沙利铂85mg/m2,静滴2h,d1;卡培他滨 （900～1000）mg/m2,一日分两次,口服,d1～10;14d为1周期,4周期评价疗效。结果 46例均可评价疗效,CR 4例,PR 24例,RR 65.2％;不良反应主要为I～Ⅱ度血液学毒性,恶心、呕吐,末梢神经异常及手足综合征。结论 奥沙利铂联合卡培他滨(XELOX)双周方案治疗晚期胃、结直肠癌疗效确切,耐受性好,值得临床推广应用。