卡培他滨单药与联合化疗治疗老年女性晚期乳腺癌的临床研究

[目的]观察老年女性晚期乳腺癌应用卡培他滨单药与联合化疗疗效与耐受性的差别。[方法]65岁以上晚期老年女性乳腺癌患者分为卡培他滨单药组34例和联合化疗组23例，单药组给予卡培他滨1250mg/m^2，每日2次，服2周停1周：联合化疗组给予下列二联药物，如紫杉醇135mg／m^2（d1）、多西他赛75mg／m^2（d1）、长春瑞滨25mg/m^2（d1.8）、吉西他滨800mg／m^2（d1.8）或卡培他滨800mg／m^2，每日2次，单药组与联合化疗组完成疗程数分别为4．2±0．9和2．5±0．7。[结果]卡培他滨单药组和联合化疗组有效率（CR＋PR）分别为28．2％和31．8％，TTP分别为7．7±2．1个月和8．2±1.8个月，总生存期分别为13．7±3．9个月和15．0±4．5个月。联合化疗组3／4度毒性反应明显，如白细胞降低（P=0．03）、G—CSF支持治疗增加（P=0．0009）和乏力（P=0．005）等，卡培他滨单药组3度手足综合征比联合组略多（P=0．07）。[结论]卡培他滨单药对老年女性晚期乳腺癌疗效与耐受性好。     

吉西他滨联合长春瑞滨治疗蒽环类／紫杉类耐药晚期乳腺癌24例

[目的]观察国产吉西他滨联合长春瑞滨方案治疗蒽环类和／或紫杉类治疗失败的晚期乳腺癌的近期疗效与毒副反应。[方法]对接受蒽环类和,或紫杉类药物治疗病情进展的24例乳腺癌患者,采用国产吉西他滨联合长春瑞滨方案治疗：吉西他滨1000mg／m^2,静脉滴注30min,d1、d8;长春瑞滨25mg／m^2,静脉推注,d1、d8;每21d重复一次．至少2个周期评价疗效。[结果]全组24例患者均可评价疗效,其中CR2例（8.33％）,PR9例（37.50％）,SD8例（33．33％）。PD5例（20．83％）;客观有效率（CR＋PR）45．83％,临床受益率（CR＋PR＋SD）79．16％;中位疾病进展时间（TTP）6．8个月;中位生存期（MST）17．1个月。主要毒副反应为骨髓抑制和胃肠道反应,但均可耐受。[结论]吉西他滨联合长春瑞滨方案治疗蒽环类和／或紫杉类药物治疗失败的晚期乳腺癌患者,疗效确切,其毒副作用患者可以耐受．值得临床进一步研究.     

吉西他滨单药治疗老年晚期非小细胞肺癌46例

[目的]观察吉西他滨单药治疗老年晚期非小细胞肺癌（NSCLC）的临床疗效和毒性反应。[方法]46例Ⅲ～Ⅳ期NSCLC患者均经病理组织学或细胞学检查确诊。国产吉西他滨（泽菲）1000mg/m2,静滴,d1、8,每3～4周重复,2个周期后CT评价疗效。[结果]46例患者均可评价疗效,无CR,PR12例,有效率26.0%,中位生存期7.1个月,中位疾病进展时间（TTP）6.2个月,1年生存率32.5%。主要的毒副反应为白细胞及血小板降低,均可耐受。[结论]吉西他滨单药治疗老年晚期NSCLC疗效确切,可明显改善患者生存质量,延长生存时间,毒副反应轻。     

Sorafenib联合化疗治疗进展期肾癌Ⅱ期临床研究

[目的]探讨Sorafenib联合吉西他滨、5-Fu治疗晚期肾细胞癌的疗效及安全性。[方法]入组转移性肾细胞癌患者19例，其中既往细胞因子治疗失败者15例。化疗方案采用吉西他滨1g／m^2，d1.8,5-Fu 400mg／m^2静脉推注d1，随后5-Fu 2．1g／m^2 46h化疗泵泵入，每4周为1个周期。同时Sorafenib治疗，400mg／次，口服，2次／d，持续使用至疾病进展或出现不可耐受的毒副反应。[结果]19例患者均可评价疗效。客观有效率37％（7／19），临床受益率79％（15／19）。6个月的PFS百分比为37％（7／19），并且该7例患者目前均无疾病进展。常见毒副作用为Ⅲ-Ⅳ度的骨髓抑制、Ⅱ度以上的手足综合征、Ⅱ度以上的胃肠道反应、Ⅱ度以上的皮疹、Ⅰ-Ⅱ度脱发、Ⅰ-Ⅱ度高血压。[结论]研究提示Sorafenib联合吉西他滨．5-Fu治疗晚期肾细胞癌表现出了较好的疗效和一定的安全性。     

单药多西他赛周方案治疗老年晚期非小细胞肺癌65例

[目的]评价单药多西他赛周方案治疗老年晚期非小细胞肺癌（NSCLC）的临床疗效和毒副作用。[方法]2000年10月～2006年3月收治的65例年龄63～82岁老年晚期NSCLC患者应用单药多西他赛周方案化疗，剂量为35mg／（m^2·W），连用3周，休息1周，治疗有效者最多接受16周治疗或至疾病进展。[结果]65例患者共接受503周多西他赛化疗，PR19例，有效率29．2％；稳定26例，占40％。1年生存率32．4％，2年生存率8．6％。主要毒副作用轻微。[结论]单药多西他赛周方案治疗老年晚期NSCLC耐受性良好，安全有效。     

吉西他滨联合卡铂-线治疗晚期非小细胞肺癌疗效观察

目的：观察吉西他滨（泽菲）联合卡铂治疗Ⅲb或Ⅳ期初治非小细胞肺癌（NSCLC）的疗效和毒副作用。方法：初治的Ⅲb或Ⅳ期NSCLC 46例，采用吉西他滨（洋菲）1200mg／m^2，d1、d8，静滴；卡铂AUC=5，d1，静滴，21天为1个周期。结果：46例患者中，无CR病例，PR21例，SD20例，PD5例，客观有效率（CR＋PR）为45．65％，中位生存期11．8个月，1年生存率35%（16／46），中位肿瘤进展时间7个月：毒副作用主要为中性粒细胞和血小板减少：结论：吉西他滨联合卡铂一线治疗晚期NSCLC有效率较高，有生存优势，毒副作用可耐受。     

吉西他滨联合顺铂与联合多西紫杉醇治疗非小细胞肺癌的随机对照研究

目的含铂类方案目前是治疗晚期非小细胞肺癌（NSCLC）的标准方案，但其严重的毒副反应促使人们寻找新的替代方案，本研究探讨用吉西他滨联合多西紫杉醇与吉西他滨联合顺铂方案治疗晚期NSCLC的疗效、生存率及毒副反应。方法对62例经病理或细胞学证实的晚期NSCLC的初治患者给予联合化疗，随机分为GT（吉西他滨联合多西紫杉醇）组与GP（吉西他滨联合顺铂）组，两组病例具有可比性，GT组31例，吉西他滨1000mg／m^2，静脉滴注，d1,8，多西紫杉醇（艾素）75mg／m^2加入生理盐水200mL中静脉滴注1h，d1；GP组31例，吉西他滨1000mg／m^2，静脉滴注，d1,8，顺铂25mg/m^2，静脉滴注，d1-3，21d为1个周期，每例治疗不超过6个周期。结果GT组患者总有效率为35．4％，1年生存率为76．2％，中位生存期18．6个月，中位TTP4．9个月，中位PFS3．0个月；GP组患者总有效率为32．2％，1年生存率为67．8％，中位生存期为14．6个月，中位4．4个月，中位PFS3．0个月。两组间有效率、1年生存率、中位生存期差异无统计学意义。最常见的毒副反应为恶心呕吐，GT和GP组的Ⅲ＋Ⅳ度反应发生率分别为3．2％和54．8％，差异有统计学意义（P〈0．05），其余毒副反应轻微，可耐受。结论吉西他滨联合多西紫杉醇与吉西他滨联合顺铂相比疗效相似，但毒副反应轻，安全可行，耐受性好，中位生存期、1年生存率及生活质量以吉西他滨联合多西紫杉醇的非铂方案较好，值得临床推荐应用。     

吉西他滨联合顺铂对蒽环类及紫杉类耐药的晚期乳腺癌的治疗

[目的]观察吉西他滨联合顺铂治疗耐蒽环类及紫杉类晚期乳腺癌的疗效及毒性反应。[方法]34例对蒽环类及紫杉类耐药的晚期乳腺癌患者，接受吉西他滨1000mg／m^2，静脉滴注，第1、8天；顺铂30mg／m^2，静脉滴注，第1～3天；21天为1个周期。[结果]全组病例共完成116个周期，巾位周期数为4个；1例（2．94％）完全缓解，15例（44．12％）部分缓解，12例（35．92％）病灶稳定，6例（17．85％）病灶进展，总有效率为47．10％。中位疾病进展时间为6个月．中位生存期为12．5个月；主要毒副反应为骨髓抑制及胃肠道反应。[结论]吉两他滨联合顺铂治疗耐蒽环类及紫杉类的晚期乳腺癌疗效较好，毒副反应较轻，可作为蒽环类及紫杉类治疗失败的晚期乳腺癌的解救方案。     

吉西他滨单药治疗老年晚期非小细胞肺癌患者36例

 【摘要】　目的　观察吉西他滨单药治疗老年晚期非小细胞肺癌（NSCLC）患者的疗效及不良反应。方法　对36例ⅢB～Ⅳ期老年NSCLC患者应用吉西他滨单药化疗（1000 mg／m2,第1、8天静脉滴注）,21 d为1个周期。2个周期后分别按实体瘤疗效评价标准（RECIST）和美国国立癌症研究所（NCI）常见毒性反应标准评价不良反应,同时评估生活质量改善指标。结果　本组36例患者中,完全缓解（CR）0例,部分缓解（PR）10例,稳定（SD）15例,进展（PD）11例,有效（CR+PR）率为27.8 %,临床受益 （CR+PR+SD）率为69.4 %。中位无进展生存（PFS）期为5.1个月,中位总生存（OS）期为7.8个月,1年生存率为30.6 %（11／36）。患者不良反应主要表现为以白细胞和血小板减少为主的骨髓抑制,白细胞减少Ⅰ～Ⅱ度发生率为44.4 %（16／36）,Ⅲ～Ⅳ度11.1 %（4／36）;血小板减少Ⅰ～Ⅱ度发生率为38.9 %（14／36）,Ⅲ度2.8 %（1／36）,无Ⅳ度减少发生。结论　采用吉西他滨单药治疗老年晚期NSCLC患者疗效好、不良反应轻、安全,可作为老年晚期NSCLC患者的一线治疗方案。     

吉西他滨联合奥沙利铂治疗晚期非小细胞肺癌的临床研究

目的：观察吉西他滨联合奥沙利铂治疗晚期非小细胞肺癌（NSCLC）的疗效、毒副作用、中位疾病无进展生存、中位生存期、生存率、生活质量。方法：58例经病理组织学证实的晚期非小细胞肺癌患者给予奥沙利铂130mg／m^2第8天静脉输注；吉西他滨800—1200mg／m^2第1，8天静脉输注。21天为1个周期，完成2—4周期治疗后评价疗效。结果：全组患者可评价56例，无完全缓解，部分缓解（PR）12例（21．4％），稳定（SD）30例（53．6％），进展（PD）14例（25％），总有效率21．4％，疾病控制率（PR＋SD）75％，中位疾病无进展生存7个月，中位生存期15．1个月，1年生存率59．17％，2年生存率32．16％。主要毒副反应为骨髓抑制和神经毒性。结论：吉西他滨联合奥沙利铂方案治疗晚期非小细胞肺癌有一定疗效，可延长生存期，毒副反应可耐受，生存质量下降不明显。     

Experience with Impedance Phlebography Compared with Venography

Venography is a particularly reliable method for the diagnosis of deep venous thrombosis but is not suitable as a screening test. Impedance phlebography represents another attempt to discover a simple, non-invasive and reliable method of detecting deep venous thrombosis. It does not, however, meet these criteria.     

Compliance with guidelines and correlation with outcome in patients with advanced germ-cell tumours

PurposeTo evaluate prior compliance with guidelines in patients treated with salvage chemotherapy for advanced germ-cell tumours (GCT).Patients and methodsData concerning the initial management of patients requiring salvage chemotherapy for GCT at Institut Gustave Roussy between 2000 and 2010 were obtained and correlated with recommendations for treatment. Criteria of non-compliance were defined based on guidelines. Compliance with guidelines, predictive factors for non-compliance and the impact on outcome were analysed.ResultsAmong 82 patients treated in the salvage setting, guidelines to initial treatment were followed in only 41 cases (50%). The most common non-compliance criteria were non-adherence to the planned dose (16%), an inappropriate interval between first-line chemotherapy cycles (16%), the lack of post-chemotherapy surgery (16%) and a long interval to post-chemotherapy surgery (48%). Compliance with standard care was better in cancer centres than in other hospitals (private or public) (Odd Ratio (OR): 6.9, P = 0.001). A poor-risk status according to the International Germ Cell Cancer Collaborative Group (IGCCCG) was also predictive of compliance in univariate but not in multivariate analysis. No significant difference in outcome after salvage chemotherapy was observed. Patients relapsing after non-compliant first-line therapy tended to be more easily salvaged, which is consistent with the fact that their initial treatment was inadequate. Some of these relapses were therefore probably not due to true biologically refractory disease.ConclusionGuidelines for first-line treatment are adhered to in only half the patients requiring salvage chemotherapy. As the only predictive factor for non-compliance was the treating centre, centralisation of patients with GCT in well-trained hospitals should be recommended.     

Treatment with methylnaltrexone is associated with increased survival in patients with advanced cancer

BackgroundMethylnaltrexone (MNTX), a peripherally acting μ-opioid receptor (MOR) antagonist, is FDA-approved for treatment of opioid-induced constipation (OIC). Preclinical data suggest that MOR activation can play a role in cancer progression and can be a target for anticancer therapy.Patients and methodsPooled data from advanced end-stage cancer patients with OIC, despite laxatives, treated in two randomized (phase III and IV), placebo-controlled trials with MNTX were analyzed for overall survival (OS) in an unplanned post hoc analysis. MNTX or placebo was given subcutaneously during the double-blinded phase, which was followed by the open-label phase, allowing MNTX treatment irrespective of initial randomization.ResultsIn two randomized, controlled trials, 229 cancer patients were randomized to MNTX (117, 51%) or placebo (112, 49%). Distribution of patients' characteristics and major tumor types did not significantly differ between arms. Treatment with MNTX compared with placebo [76 days, 95% confidence interval (CI) 43–109 versus 56 days, 95% CI 43–69; P = 0.033] and response (laxation) to treatment compared with no response (118 days, 95% CI 59–177 versus 55 days, 95% CI 40–70; P < 0.001) had a longer median OS, despite 56 (50%) of 112 patients ultimately crossing over from placebo to MNTX. Multivariable analysis demonstrated that response to therapy [hazard ratio (HR) 0.47, 95% CI 0.29–0.76; P = 0.002) and albumin ≥3.5 (HR 0.46, 95% CI 0.30–0.69; P < 0.001) were independent prognostic factors for increased OS. Of interest, there was no difference in OS between MNTX and placebo in 134 patients with advanced illness other than cancer treated in these randomized studies (P = 0.88).ConclusionThis unplanned post hoc analysis of two randomized trials demonstrates that treatment with MNTX and, even more so, response to MNTX are associated with increased OS, which supports the preclinical hypothesis that MOR can play a role in cancer progression. Targeting MOR with MNTX warrants further investigation in cancer therapy.Clinical trials numberNCT00401362, NCT00672477.     

Living with secondary breast cancer: coping with an uncertain future with unmet needs

JOHNSTON S.R.D. (2010) European Journal of Cancer Care 19 , 561–563 Living with secondary breast cancer: coping with an uncertain future with unmet needs     

奥沙利铂联合羟基喜树碱治疗晚期胃癌临床分析

背景与目的体外及体内的临床研究显示,奥沙利铂(L-OHP)对多种肿瘤有显著抑制作用并与绝大多数抗癌药物具有相加或协同细胞毒作用.本文旨在观察L-OHP联合羟基喜树碱(HCPT)治疗晚期胃癌的近期疗效和患者耐受性,并与传统的化疗方案进行对比.方法采用非随机的分组方法将43例晚期胃癌患者分为L-OHP+HCPT方案组(治疗组)与Vp-16+CF+5-FU(ELF)方案组(对照组),其中男性28例,女性15例,中位年龄59岁,KPS评分≥60,观察两组的近期疗效和患者耐受性.结果治疗组24例有效率58.3%(14/24),对照组19例有效率42.1%(8/19).治疗组有效率高于对照组,两组差异有显著性(P<0.05).两组不良反应主要是骨髓抑制、恶心、呕吐、口腔炎、周围神经炎、静脉炎、脱发等,均在Ⅰ、Ⅱ度范围内.结论L-OHP联合HCPT方案治疗晚期胃癌疗效较好,不良反应可以耐受.     

Varicella-Zoster Virus Prophylaxis with Low-Dose Acyclovir in Patients with Multiple Myeloma Treated with Bortezomib

BackgroundVaricella-zoster virus (VZV) reactivation is a common complication in patients with multiple myeloma (MM) treated with bortezomib, with an incidence rate of 10%-60%. The aim of our study was to analyze the effect of acyclovir prophylaxis in this patient population.Patients and MethodsWe studied 98 consecutive patients with relapsed MM treated with bortezomib. Bortezomib 1.3 mg/m² was given on days 1, 4, 8, and 11 of a 21-day cycle. At first, patients did not receive any VZV prophylaxis, but because of the high incidence of VZV reactivation, VZV prophylaxis with acyclovir was implemented subsequently.ResultsA total of 11 patients treated with bortezomib did not have any VZV prophylaxis, and 4 of these 11 patients (36%) developed VZV reactivation in the form of herpes zoster. No VZV reactivations were observed in the 32 patients who received acyclovir 400 mg 3 times daily or the 55 patients who received acyclovir in a dose reduced to 400 mg once daily during bortezomib treatment.ConclusionVaricellazoster virus reactivation is a common and serious adverse effect of bortezomib treatment. Acyclovir 400 mg once daily is sufficient to protect from VZV reactivation in patients with MM treated with bortezomib.     

Costs associated with complications are lower with capecitabine than with 5‐fluorouracil in patients with colorectal cancer

BACKGROUND:

Capecitabine, an oral alternative to 5‐fluorouracil (5‐FU) in patients with colorectal cancer (CRC), has equal clinical efficacy and a favorable safety profile; however, its use may be limited because of unit cost concerns. In this study, the authors measured the cost of chemotherapy‐related complications during treatment with capecitabine‐ and 5‐FU–based regimens.

METHODS:

Patients with CRC who received at least 1 administration of capecitabine or 5‐FU during 2004 and 2005 were identified from the Thomson MarketScan research databases. Monthly frequency and cost for 23 complications were recorded. Logistic regression was used to predict complication probability. General linear models were used to predict monthly complication cost and total monthly expenditure.

RESULTS:

In total, 4973 patients with CRC met the inclusion criteria for this analysis. Although the most frequently observed complications were the same between capecitabine and 5‐FU (nausea and vomiting, infection, anemia, neutropenia, diarrhea), each was observed with greater frequency in 5‐FU–based regimens. The mean predicted monthly complication cost was significantly higher (by 136%) with 5‐FU monotherapy than with capecitabine monotherapy (difference, $601; 95% confidence interval [95% CI], $469‐$737). In addition, the mean predicted monthly complication cost for 5‐FU+oxaliplatin was higher than the cost with capecitabine plus oxaliplatin (difference, $1165; 95% CI, $892‐$1595). When acquisition, administration, and complication costs were taken into consideration, there were no significant differences in the total cost between capecitabine regimens and 5‐FU regimens.

CONCLUSIONS:

Capecitabine compared well with 5‐FU–based therapy in patients with CRC and was associated with lower complication rates and associated costs. Cancer 2009. © 2009 American Cancer Society.