动态浊度法测定多西他赛注射液中细菌内毒素的含量

目的:建立测定多西他赛注射液中细菌内毒素含量的方法。方法:采用动态浊度法。确立细菌内毒素检查的标准曲线及稀释倍数,通过测定供试液中外加内毒素的回收率进行干扰试验,确定样品检测浓度线性范围,并定量测定样品中的细菌内毒素。结果:内毒素检测浓度线性范围为0.03125～2.0EU·mL-1(r=-0.9999);样品在稀释12～96倍时对试验无干扰作用;细菌内毒素回收率为50%～200%;3批样品的内毒素定量测定结果符合规定。结论:动态浊度法可用于多西他赛注射液中细菌内毒素的定量检测。     

多西他赛联合卡培他滨治疗复发转移性乳腺癌的疗效及对CEA、CA199的影响

目的探讨多西他赛联合卡培他滨治疗复发转移性乳腺癌的疗效及对CEA、CA199的影响。方法选取74例复发转移性乳腺癌患者,随机将其分为治疗组和对照组,各37例。对照组采用卡培他滨进行治疗,治疗组采用多西他赛联合卡培他滨治疗。对比两组患者的临床治疗效果。结果治疗组的总有效率和疾病控制率均均明显高于对照组(P<0.05);治疗组的血小板减少、WBC减少、脱发发生率明显低于对照组(P<0.05);两组患者治疗后的血清CEA、CA199水平均明显较治疗前低(P<0.05),但治疗组的血清CEA、CA199水平明显低于对照组(P<0.05)。结论多西他赛联合卡培他滨治疗复发转移性乳腺癌效果显著,可以提高临床疗效,降低不良反应发生率和血清CEA、CA199水平,值得在临床中应用推广。     

Response and Prognosis of Docetaxel and Cyclophosphamide as Neoadjuvant Chemotherapy in ER+ HER2− Breast Cancer: A Prospective Phase II Study

BackgroundAlthough a docetaxel and cyclophosphomide (TC) regimen without anthracycline as adjuvant therapy became one of the standard regimens especially for ER-positive (ER⁺)/human epidermal growth factor receptor 2-negative (HER2⁻) primary breast cancer, the efficacy of TC as neoadjuvant chemotherapy (NAC) is not known. We conducted the prospective trial to assess the efficacy of a TC regimen in the neoadjuvant setting for stage II to III ER⁺/HER2⁻ primary breast cancer.Patients and MethodsA TC regimen that included 75 mg/m² of docetaxel and 600 mg/m² of cyclophosphamide for 4 cycles every 3 weeks was administered as NAC. Primary endpoints are the rate of clinical response (clinical partial response and clinical complete response) and pathologic complete response; secondary endpoints are the disease-free survival and overall survival rates.ResultsThirty (71.4%) of 42 tumors had clinical response. No patient achieved pathologic complete response. At the median follow-up period of 105.2 months (range, 12.1-119.7 months), the disease-free survival rate was 81.6%, and the distant disease-free survival rate was 86.8%. In terms of survival, only 1 patient died during the study period. The overall survival rate was 97.4% during the study period. Patients who developed distant recurrence had a trend to have progesterone receptor-negative or weakly positive compared with those who did not develop any recurrence (85.7% vs. 45.2%; P = .05).ConclusionsOur prospective study showed that a TC regimen as NAC achieved a high clinical response rate in stage II to III ER⁺/HER2⁻ breast cancer. A TC regimen without anthracycline as NAC might be one of the options for patients with ER⁺/HER2⁻ breast cancer without high-risk factors including progesterone receptor negativity.     

扶正化瘀消癌汤和多西紫杉醇对老年宫颈癌复发患者生活质量及预后的影响

目的探讨扶正化瘀消癌汤联合多西紫杉醇对老年宫颈癌复发患者生活质量及预后的影响。方法选取2018年6月至2019年12月间沈阳红十字会医院收治的128例老年宫颈癌复发患者,采用随机数字表法分为观察组62例和对照组66例,对照组患者采用多西紫杉醇化疗治疗,观察组患者在此基础上联合扶正化瘀消癌汤治疗,比较两组患者治疗前后的生活质量、治疗安全性和生存率。结果治疗后,两组患者各项功能量表评分均升高,且观察组患者均高于对照组,差异均有统计学意义(均P<0.05)。治疗期间,两组患者肝肾功能损害发生率比较,差异无统计学意义(P>0.05),且两组均未出现严重肝肾功能损害病例。观察组患者胃肠道反应和骨髓抑制发生率均低于对照组,但差异无统计学意义(P>0.05)。观察组患者不良反应发生率为33.9%,低于对照组的56.1%,两组比较,差异有统计学意义(P<0.05)。观察组患者1年生存率和2年生存率均高于对照组,两组比较,差异有统计学意义(P<0.05)。结论扶正化瘀消癌汤联合多西紫杉醇能有效提高老年宫颈癌复发患者的生活质量,延长生存时间,提高生存率,缓解化疗不良反应,值得临床推广。     

多西他赛和吉西他滨分别联合顺铂治疗晚期非小细胞肺癌效果比较

目的 比较多西他赛与吉西他滨联合顺铂方案治疗晚期非小细胞肺癌(NSCLC)的临床疗效及不良反应.方法 120例晚期非小细胞肺癌患者完全随机分为2组.多西他赛组60例给予多西他赛37.5 mg/m2,第1、8天;顺铂25 mg/m2,第1～3天.吉西他滨组60例给予吉西他滨1000 mg/m2,第1、8天;顾铂用量同前.化疗每3周重复,每周期评价不良反应,评价疗效并随访生存期.结果 20例患者均可评价疗效和不良反应,2组有效率分别为多西他赛组45.0%(27/60)和吉西他滨组43.3%(26/60),1年生存率分别为45%和43.3%,两组之间有效率和1年生存率均无统计学意义(P＞0.05).不良反应主要为骨髓抑制和肝功能损害[多西他赛组白细胞产减少率为85.0%(51/60),吉西他滨组为78.0%(47/60),2组差异无统计学意义(P＞0.05);2组肝功能损害率分别为33.3%(20/60)、26.7%(16/60),差异有统计学意义(P＜0.05)].结论 多西他赛与吉西他滨联合顺铂方案治疗晚期NSCLC均具有较好的疗效,且两者的疗效相似,不良反应可以耐受,可以作为临床一线治疗.

Abstract：

Objective To compare the efficacy and safety of docetaxel plus cisplatin and gemcitabine plus cisplatin in advanced non-small cell lung cancer (NSCLC). Methods A total of 120 patients with advanced NSCLC were divided into two groups. The patients received docetaxel in docetaxel group. In gemcitabine group the patients received gemcitabine and cisplatin. The treatment schedule was repeated every 3 weeks. The toxicity,quality response and survival rate of life were evaluated after every cycle. Results The response rates of the docetaxel group and the gemcitabine group were 45% and 43.3%,respectively. One-year survival rates in the two groups were 45% and 43.3%,respectively. The response rate,one-year survival time showed no significance (P ＞0.05). The main side effects were myelosupp ression,nausea and vomiting. Conclusion Regimens of DC and GC are both safe and effective in the treatment of advanced stage NSCLC. They can be used as the first regimen of chemotherapy in patients with advanced stage NSCLC.     

三维适形放疗联合多烯紫杉醇治疗局部晚期非小细胞肺癌近期疗效观察

目的 探讨和分析三维适形放疗联合多烯杉醇治疗局部晚期非小细胞肺癌患者的近期疗效.方法 选取接受治疗的局部晚期非小细胞肺癌患者90例,按照随机数字表的方法分为观察组(n=45)和对照组(n=45),观察组患者采用三维适形放疗联合多烯紫杉醇的治疗方法,对照组患者仅采用紫杉醇化疗的方案进行治疗.比较两组患者的治疗总有效率,两组患者的不良反应发生率,两组患者治疗后的生活质量良好率.结果 观察组患者的治疗总有效率高于对照组,差异具有统计学意义(P<0.05);观察组与对照组不良反应发生率比较差异无统计学意义(P>0.05);治疗后,观察组患者的生活质量良好率显著高于对照组(P<0.05).结论 三维适形放疗联合多烯紫杉醇对局部晚期非小细胞肺癌患者的效果显著,提高患者生存质量,值得推广应用.     

Aged patients with metastatic castration resistant prostate cancer: Should we treat with chemotherapy?

Prostate cancer largely affects aged men and as life expectancy continues to increase, it is likely to be a growing burden requiring an adequate management. Aging is a heterogeneous process, thus, to assess the individual state of health when making decisions is essential. Comprehensive geriatric assessment allows a detailed evaluation of the state of health of a specific subject and can modify the therapeutic decision. It is still not commonly used because it is time consuming. Chemotherapy should be administered equally in aged well-fit patients as in the general population as per the SIOG (International society of geriatric oncology) recommendations for geriatric evaluation and treatment in prostate cancer patients. Chemotherapy with docetaxel or cabazitaxel is expected to have an efficacy and toxicity similar to younger patients and they might be considered treatment options for these patients among others. In vulnerable or frail patients, weekly or biweekly docetaxel regimens are acceptable treatment options.     

几丁糖、透明质酸酶治疗多西紫杉醇外渗性大鼠皮肤损伤

背景与目的:多西紫杉醇外渗至周围组织可导致严重皮肤损伤,目前还没有公认的治疗指南.本研究旨在探讨单用或联合局部外涂几丁糖、注射透明质酸酶对多西紫杉醇大鼠外渗性皮肤损伤的疗效.方法:在30只SD大鼠双后肢建立多西紫杉醇血管外渗模型.随机分为6组,分别给局部外涂几丁糖、局部注射透明质酸酶、局部注射透明质酸酶联合外涂几丁糖、局部外涂生理盐水、局部注射生理盐水和不进行任何处理(模型对照组).观察各组大鼠外渗性皮肤损伤发生率、损伤程度和损伤愈合时间.结果:透明质酸酶组和透明质酸酶联合几丁糖组的损伤发生率分别为30%和20%,显著低于几丁糖组、生理盐水外涂组、生理盐水注射组和模型对照组的损伤发生率(90%、100%、90%、100%)(P＜0.05).透明质酸酶组和透明质酸酶联合几丁糖组的损伤愈合时间为(12.00±3.00)天和(9.50±2.12)天,显著短于其它4组(P＜0.01).几丁糖组的损伤愈合时间为(18.33±2.00)天,显著短于生理盐水外涂组[(23.70±2.41)]天和模型对照组[(25.70±2.26)天](P＜0.01).结论:透明质酸酶单独局部注射或联合几丁糖外涂均可减少多西紫杉醇外渗性损伤的发生,缩短损伤愈合时间.单用几丁糖外涂不能防止损伤的发生,却可促进损伤愈合.     

Concurrent and adjuvant docetaxel with three-dimensional conformal radiation therapy plus androgen deprivation for high-risk prostate cancer: Preliminary results of a multicentre phase II trial

Background and purpose

We evaluate the feasibility of concomitant and adjuvant docetaxel combined with three-dimensional conformal radiotherapy (3D-CRT) and androgen deprivation in high-risk prostate carcinomas.

Methods

Fifty men with high-risk localized prostate cancer (16), locally advanced (28) or very high-risk prostate cancer (6) were included. Seventy Gy were delivered on prostate and seminal vesicles in 35 fractions, concurrently with weekly docetaxel (20 mg/m²). Three weeks after the completion of 3D-CRT, docetaxel was given for 3 cycles (60 mg/m²), every 3 weeks. Patients had to receive LHRH agonist during 3 years.

Results

The intent to treat analysis shows that four patients out of 15 stopped prematurely the chemotherapy due to grade 3-4 acute toxicity. In the per protocol analysis, 46 patients completed a full-dose chemoradiation regimen representing 413 cycles: five patients experienced a grade 3 toxicity, and 15 patients experienced a grade 2 toxicity. With a median follow-up of 54 months, the 5-year clinical disease-free survival was 66.72% and the 5-year survival was 92.15%.

Conclusions

3D-CRT with androgen deprivation and concurrent weekly docetaxel, followed by three cycles of adjuvant docetaxel may be considered as feasible in high-risk prostate cancer and deserved to be evaluated in a phase III randomized trial.     

Future scenarios for the treatment of advanced non-small cell lung cancer: focus on taxane-containing regimens

Despite recent progress in the development of new molecularly targeted agents, the chemotherapy regimens considered standard at the end of the last century—that is, two‐drug combinations consisting of either cisplatin or carboplatin plus a third‐generation agent (docetaxel, paclitaxel, gemcitabine, or vinorelbine)—remain the primary treatment option for advanced non‐small cell lung cancer (NSCLC) patients. Most recently, the existing standard of care has been amended to reflect the significant survival advantage of cisplatin–pemetrexed over cisplatin–gemcitabine as first‐line treatment of nonsquamous NSCLC. The addition of a biological drug (bevacizumab, cetuximab) or the use of a single‐agent epidermal growth factor receptor inhibitor may further improve outcomes in selected patients. It has become increasingly clear, primarily through recent meta‐analyses, that although the therapeutic equivalence of any combination of a platinum agent plus either gemcitabine, vinorelbine, docetaxel, or paclitaxel has been long accepted, each regimen has different side effects and therapeutic outcomes that allow clinicians to select the most appropriate treatment for chemotherapy‐naïve patients with stage IIIB/IV NSCLC. In this review, we evaluate the available evidence and explore the role and importance of various modern chemotherapy regimens, with the aim of optimizing treatment selection and combination with biological agents. Emphasis is placed on the role of taxanes (docetaxel versus paclitaxel) in this changing landscape.