吉西他滨联合卡培他滨治疗复发转移性乳腺癌的临床观察

在我国,乳腺癌近年来发病率呈明显上升趋势,并已成为导致妇女死亡的主要肿瘤,含有蒽环类的联合化疗方案广泛用于乳腺癌的一线治疗或辅助治疗。此外,活性较高的紫杉类药物现已逐渐用于早期的辅助治疗,但对于紫杉类药物治疗后出现复发的病例,目前尚无公认的替代治疗方案。针对晚期复发转移性乳腺癌,给予正确的化疗、内分泌治疗、放疗等综合手段治疗可达到姑息性治疗的目的,提高患者的生活质量。其中化疗方案的选择是整个治疗中一个重要的环节。[第一段]     

吉西他滨联合卡培他滨治疗复发转移乳腺癌的疗效观察

目的 探讨吉西他滨联合卡培他滨治疗复发转移乳腺癌的疗效及不良反应。方法 选取50例复发转移的乳腺癌患者,给予吉西他滨联合卡培他滨方案化疗,吉西他滨 1 000 mg/m²,静脉滴注,d1、d8;卡培他滨 1 250 mg/m²,口服,2次/d,d1~14,休息1周,21 d为1个周期。2个周期后评价疗效,每个周期评价不良反应。结果 50例患者经4个周期规范化疗后,完全缓解（CR）4例、部分缓解（PR）25例、稳定（SD）11例、进展（PD）10例,治疗有效率为58%,临床获益率为80%。主要不良反应为骨髓抑制、胃肠道反应及手足综合征。 结论 吉西他滨联合卡培他滨治疗复发转移乳腺癌的疗效肯定,不良反应可耐受。     

吉西他滨联合卡培他滨治疗耐药转移性乳腺癌的临床观察

目的探讨吉西他滨和卡培他滨联合化疗治疗蒽环类和(或)紫杉类耐药的转移性乳腺癌的近期疗效和不良反应。方法 2008年3月至2011年3月应用吉西他滨联合卡培他滨治疗转移性乳腺癌38例,每3周为1个周期,所有患者均评估毒性,对至少用过2个周期化疗的患者评估疗效。结果 CR 3例,PR 13例,SD 14例,PD 8例,有效率(CR+PR)为42.1%(16/38),临床获益率(CR+PR+SD)为78.9%(30/38)。主要不良反应为骨髓抑制、手足综合征、胃肠道反应。Ⅲ～Ⅳ度的骨髓抑制发生率低,手足综合征及消化道反应以Ⅰ～Ⅱ度为主。结论吉西他滨联合卡培他滨对蒽环类和(或)紫杉类耐药的转移性乳腺癌有较好的治疗效果,且不良反应可以耐受。     

吉西他滨联合卡培他滨治疗耐药转移性乳腺癌的临床观察

近年来,我国的乳腺癌发病率呈逐年上升趋势,已经成为肿瘤导致妇女死亡的最主要原因。晚期乳腺癌患者平均生存时间仅18～30个月,药物治疗是晚期乳腺癌治疗的主要手段。含蒽环类的联合化疗方案已广泛用于乳腺癌的一线治疗。此外,抗癌活性较高的紫杉类药物,近年也逐渐用于早期的辅助治疗。但临床上仍有20％-30％的乳腺癌患者对其发生耐药,对于这类患者目前尚无公认的标准替代方案。     

吉西他滨联合卡培他滨治疗耐药转移性乳腺癌56例临床分析

为了评估吉西他滨(GEM)和卡培他滨(CAP)3周联合化疗方案在蒽环类和(或)紫杉类耐药的转移性乳腺癌(MBC)患者中的有效性和毒性,对56例既往用过蒽环类和紫杉类的MBC患者给予GEM1000mg/m2,静脉滴入30min,d1、d8;CAP2000mg/m2,分2次口服,d1～d14,每3周为1个周期。所有患者均评估毒性,至少用过2个周期的患者评估疗效。结果:56例患者共完成196个周期化疗,中位化疗周期数为3.5个周期。完全缓解4例,部分缓解22例,稳定18例,进展12例,有效率为46.4%(26/56)。最常见的毒副反应为骨髓抑制和手足综合征。初步研究结果提示,GEM和CAP联合化疗方案在既往接受过蒽环类和紫杉类药物的MBC患者中是安全有效的,血液学和非血液学毒性都可耐受。     

吉西他滨联合卡培他滨治疗胰腺肿瘤1例

胰腺癌是消化系统常见的恶性肿瘤之一,因其病程短,进展快,治疗效果差,5年生存率仅为5%～10%。绝大多数胰腺癌在诊断时已是晚期或已有远处转移,因此,姑息性的全身化疗有助于可以改善患者的生活质量并延长生存时间。现将我科收治的1例应用吉西他滨联合卡培他滨治疗老年胰腺癌患者的诊疗情况报告如下。     

吉西他滨联合卡培他滨治疗耐药性乳腺癌近期疗效观察

目的:对蒽环类和(或)紫杉类耐药性乳腺癌尚无标准解救方案.本研究探讨既往接受过蒽环类和或紫杉类药物治疗失败的晚期乳腺癌患者,使用吉西他滨联合卡培他滨方案治疗的疗效和不良反应.方法:23例患者入选,均给予吉西他滨1000mg/m2,静脉滴注,第1、8天;卡培他滨2000mg/m2,分2次口服,第1-14天;每3周为1周期,至少应用2周期,评价临床疗效和不良反应,并进行随访.结果:23例患者中完全缓解1例,部分缓解11例,总有效率52.2%.主要不良反应为骨髓毒性及手足综合症,均较轻.结论:吉西他滨联合卡培他滨方案治疗蒽环类和(或)紫杉类耐药晚期乳腺癌有较好的近期疗效,不良反应小,值得临床选择应用.     

吉西他滨联合卡培他滨治疗耐药性乳腺癌近期疗效观察

目的：对蒽环类和（或）紫杉类耐药性乳腺癌尚无标准解救方案.本研究探讨既往接受过蒽环类和或紫杉类药物治疗失败的晚期乳腺癌患者,使用吉西他滨联合卡培他滨方案治疗的疗效和不良反应.方法：23例患者入选,均给予吉西他滨1000mg/m2,静脉滴注,第1、8天;卡培他滨2000mg/m2,分2次口服,第1-14天;每3周为1周期,至少应用2周期,评价临床疗效和不良反应,并进行随访.结果：23例患者中完全缓解1例,部分缓解11例,总有效率52.2%.主要不良反应为骨髓毒性及手足综合症,均较轻.结论：吉西他滨联合卡培他滨方案治疗蒽环类和（或）紫杉类耐药晚期乳腺癌有较好的近期疗效,不良反应小,值得临床选择应用.     

卡培他滨联合长春瑞滨治疗复发转移性乳腺癌的临床观察

目的　观察卡培他滨（ＣＡＰ）联合长春瑞滨（ＮＶＢ）治疗复发转移性乳腺癌的近期疗效和毒副反应。方法　卡培他滨２ ５００ｍｇ／ｍ^２,分２次口服。连续服用２周;长春瑞滨２５ｍｇ／ｍ^２,ｄ１、ｄ８快速静脉滴入。３周为１周期。至少治疗２个周期。结果　３６例患者可评价疗效和毒副反应,完全缓解（ＣＲ）４例,部分缓解（ＰＲ）１３例,病情稳定（ＳＤ）１０例,病情进展（ＰＤ）９例,总有效率（ＣＲ＋ＰＲ）为４７.２％,疾病控制率（ＣＲ＋ＰＲ＋ＳＤ）为７５.０％。主要毒副反应为骨髓抑制及手足综合征,其次为胃肠道反应及脉管炎,均可以耐受。结论　ＣＡＰ联合ＮＶＢ治疗复发转移性乳腺癌有较好的疗效,尤其是对蒽环类及紫杉类治疗失败的患者疗效显著,且耐受性好,并发症轻。     

吉西他滨联合卡培他滨治疗难治性乳腺癌的临床观察

目的观察吉西他滨联合卡培他滨（GX方案）治疗术后复发的乳腺癌患者的疗效和不良反应。方法50例患者分别接受GX方案化疗3～6个周期,按世界卫生组织（WHO）标准评价疗效及不良反应。结果50例患者均可评价,其中完全缓解（CR）4例（8．0％）,部分缓解（PR）22例（44．0％）,稳定（SD）18例（36．0％）,进展（PD）6例（12．0％）。中位肿瘤进展时间（mTTP）为8．3个月（95％CI：6．55—10．89）,中位总生存时间（mOS）为18．0个月（95％CI：14．34～21．98）。主要不良反应为骨髓抑制和皮疹。结论GX方案治疗晚期乳腺癌安全有效,不良反应较轻,值得临床推广应用。     

Capecitabine combined with gemcitabine (CapGem) as first-line treatment in patients with advanced/metastatic biliary tract carcinoma

BACKGROUND: Biliary tract carcinoma is an aggressive cancer, with median survival rarely exceeding 6 months. There is currently no established palliative standard of care. A Phase II trial was conducted to study a combination of oral capecitabine and gemcitabine (CapGem) as first-line therapy in patients with advanced and/or metastatic biliary carcinoma. METHODS: Patients with unresectable or metastatic intrahepatic or extrahepatic biliary duct carcinoma and gallbladder carcinoma were enrolled. Eligible patients had histologically or cytologically confirmed, measurable adenocarcinoma and had not received prior therapy with capecitabine or gemcitabine. Treatment consisted of intravenous (i.v.) gemcitabine (1000 mg/m(2) on Days 1 and 8) plus oral capecitabine (650 mg/m(2) twice daily on Days 1-14) every 3 weeks for up to 6 cycles. Tumor response, survival, and safety were determined. RESULTS: A total of 44 patients were evaluable. Primary tumor sites were: intrahepatic (n = 14) and extrahepatic biliary duct (n = 16); gallbladder (n = 7); and ampulla (n = 7). Fourteen (32%) patients had a partial response and 15 (34%) patients had stable disease. Median time to disease progression and overall survival were 6.0 (range, 3.8-8.1) and 14 (range, 11.4-16.6) months, respectively. The 1-year survival rate was 58%. No Grade 4 adverse events were seen. Transient Grade 3 neutropenia/thrombocytopenia and manageable (almost invariably Grade 2) nausea, diarrhea, and hand-foot syndrome were the most common adverse events. CONCLUSIONS: CapGem is an active and well tolerated first-line combination chemotherapy regimen for patients with advanced/metastatic biliary tract carcinoma that offers a convenient home-based therapy.     

Gemcitabine improves survival in patients with recurrent or metastatic nasopharyngeal carcinoma

For decades, the selection of chemotherapeutic regimens for the treatment of recurrent or metastatic nasopharyn-geal carcinoma has been mainly empirical. To our knowledge, there is no phase 3 trial that has been conducted to determine the optimal treatment for these patients before our publication. Recently, we published an article inThe Lancet entitled “Gemcitabine plus cisplatin versus lfuorouracil plus cisplatin in recurrent or metastatic nasopharyngeal carcinoma: a multicentre, randomised, open-label, phase 3 trial.” The results of our study indicate that gemcitabine plus cisplatin could improve the survival of patients with recurrent or metastatic nasopharyngeal carcinoma com-pared with conventional lfuorouracil plus cisplatin.     

希罗达联合长春瑞宾二线治疗紫杉类及蒽环类失败复发转移性乳腺癌的疗效观察

目的观察希罗达联合长春瑞宾二线治疗复发转移乳腺癌的临床效果及不良反应发生情况。方法选择32例乳腺癌复发转移性患者,于第1、8天静脉滴注长春瑞宾25mg／m2;早晚2次口服希罗达2000mg／（m2·d）,连用2周,休息1周为1个周期。所有患者均行2个以上周期的治疗。结果32例患者中,5例完全缓解（CR）,12例部分缓解（PR）,11例病情稳定（SD）,4例病情进展（PD）,总有效率53．12％,临床获益患者（CR＋PR＋SD）28例（87．5％）。患者不良反应为恶心、呕吐、皮肤色素沉着、厌食、手足综合征和疲劳等,小部分患者有头晕、口腔炎、胸闷和腹泻发生,偶见谷丙转氨酶、胆红素轻度升高者,其中轻一中度白细胞下降及贫血者占36．4％。结论对紫杉类及蒽环类治疗失败的复发转移乳腺癌患者,希罗达联合长春瑞宾作为二线治疗方案治疗效果肯定,且不良反应轻,患者能耐受。     

Gemcitabine alone or combined with cisplatin in relapsed or refractory multiple myeloma

Gemcitabine is a pyrimidine nucleoside analog with antitumor activity against solid tumor malignancies and leukemia. We evaluated its activity as a single agent and combining it with cisplatin in relapsed-refractory multiple myeloma (MM). Sixteen patients with advanced MM received intravenous gemcitabine 1250 mg/mq (days 1, 8 and 15) as a single agent for a total of 3 monthly courses. The responders received another three courses, and the non-responders received three courses of gemcitabine 1000 mg/mq (days 1, 8 and 15) plus cisplatin 80 mg/mq (day 1). No grade 4 hematological toxicity was seen after gemcitabine treatment, whereas > or = 3 grade neutropenia and thrombocytopenia were seen in 21 and 13% of the gemcitabine-cisplatin infusions, respectively. Non-hematological toxicity was negligible for both the regimens. After three courses of gemcitabine as a single agent, th e response rate was 31% (1 complete response, 1 partial response and 3 minimal response). Eight patients (50%) achieved stable disease and 3 (19%) had disease progression. Ten patients received gemcitabine-cisplatin and were evaluable for the response. Two patients progressed, four maintained stable disease whereas four patients, unresponsive to gemcitabine, obtained a response (3 partial response and 1 minimal response). With a median follow-up of 13 months (range 8-17.5), 7 patients (44%) died, 5 (31%) had disease progression, 1 (6%) relapsed, 1 was still in partial response (+11 months) and 2 (13%) had a stable disease. Median time to treatment failure (TTF) was 8 months (CI95%: 7.6-8.4) and median overall survival (OS) was 16 months (CI95%: 10-22). These results showed that gemcitabine and gemcitabine-cisplatin were feasible regimens and well tolerated in advanced relapsed-refractory MM. The response rates, the TTF and OS were similar to other salvage chemotherapy regimens; nevertheless, the quality of response was modest particularly after gemcitabine alone. Better results might be obtained combining gemcitabine with other chemotherapy compounds or with biologically based therapies.     

A phase II trial of S-1 and cisplatin in patients with metastatic or relapsed biliary tract cancer.

BACKGROUND: Optimal chemotherapy for advanced biliary tract cancer (BTC) is yet to be defined. We carried out this study to evaluate the efficacy and toxicity of combination chemotherapy with S-1 and cisplatin in metastatic or relapsed BTC. PATIENTS AND METHODS: Patients with pathologically proven BTC were eligible. The chemotherapy regimen consisted of S-1 (40 mg/m(2) p.o. b.i.d. from D1-14) and cisplatin (60 mg/m(2) on D1), repeated every 3 weeks. RESULTS: Fifty-one BTC patients (metastatic:relapsed = 37:14, Gall-bladder:intrahepatic bile ducts:extrahepatic bile ducts = 16:25:10) were enrolled from January 2005 to December 2006. Median age was 57 years (range, 31-71) and most patients had a good performance status. The overall response rate was 30% [95% confidence interval (CI), 17.3-42.7] and complete response was observed in two patients (4%), partial response in 13 (26%), stable disease in 21 (42%), and progressive disease in 9 (18%). With a median follow-up of 12.4 months, the median time to progression was 4.8 months (95% CI, 3.3-6.3) and median overall survival was 8.7 months (95% CI, 6.0-11.4). Major toxic effects were grade 3/4 neutropenia (8.9% of all cycles) and febrile neutropenia was observed in six cycles (2.7% of all cycles). CONCLUSION: Combination chemotherapy with S-1 and cisplatin was a moderately effective outpatient-based regimen in BTC patients. Toxic effects were moderate but manageable.     

Gemcitabine in patients with relapsed or cisplatin-refractory testicular cancer.

PURPOSE: Despite generally high cure rates in patients with metastatic testicular germ cell tumors, patients with incomplete response to cisplatin-based first-line therapy or with relapsed disease after high-dose salvage chemotherapy have a very poor prognosis. This phase II study evaluates the use of gemcitabine in patients with intensively pretreated or cisplatin-refractory testicular germ cell cancers. PATIENTS AND METHODS: Thirty-five patients (median age, 33 years) were enrolled; 31 patients were fully assessable. All patients had metastatic nonseminomatous germ cell tumors; eight patients had extragonadal primary tumors. Twenty patients (63%) had lung metastases, and 12 patients (39%) had liver metastases. The median number of prior cisplatin-based chemotherapy cycles was seven; 22 patients (71%) had received high-dose chemotherapy with autologous stem-cell transplantation, and 19 patients (61%) had received treatment with paclitaxel. Seventeen patients (54%) were considered refractory or absolutely refractory to chemotherapy. RESULTS: Six of 31 assessable patients (19%) responded favorably to gemcitabine, 11 patients (35%) displayed no change, and 14 patients (45%) had disease progression. The median time to treatment failure was 4 months (range, 2 to 9+ months), and the median survival was 6 months (range, 2 to 23 months). Patients received a median of six gemcitabine applications. Ten patients (32%) required dose reductions, mainly owing to hematologic toxicity. Grade 3/4 granulocytopenia occurred in four patients (13%) and grade 3/4 thrombocytopenia in seven patients (22%). One case of severe sepsis was observed. CONCLUSION: Gemcitabine displays antitumor activity in intensively pretreated and refractory germ cell tumors. Responses were observed in approximately 20% of patients, including three of 22 patients after previous high-dose chemotherapy and one of four patients with mediastinal tumors. Gemcitabine may be a reasonable palliative option for intensively pretreated patients and should be further investigated to define its role in the risk-adapted treatment strategies for germ cell tumors.     

GEMOX方案联合重组人血管内皮抑素一线治疗晚期胆系肿瘤的初步观察

目的 观察吉西他滨（GEM）、奥沙利铂（OXA）联合重组人血管内皮抑素（恩度）一线治疗晚期胆系肿瘤（BTCs）的疗效及安全性。方法 回顾性分析2009年1月至2013年8月ⅣB期BTCs患者 48例,分为联合组（n=20）和单纯化疗组（n=28）。联合组：吉西他滨1000mg／m2静滴,d1、d8;奥沙利铂 100mg／m2 静滴 d2,3周为1周期;恩度 15mg 静滴 d1～d14,3周为1周期。单纯化疗组仅给予GEMOX方案化疗,剂量与使用方法同联合组。2个周期后按照RECIST11标准评价近期疗效,参考KPS变化评价生活质量（QoL）,根据NCI CTC30标准评价不良反应,并观察疾病进展时间（TTP）和总生存时间（OS）。结果 联合组获CR 1例、PR 3例、SD 12例、PD 4例,有效率（RR）为200％,疾病控制率（DCR）为80.0％;中位TTP为8.6个月,中位OS为14.0个月;QoL改善稳定率为80.0％。单纯化疗组获CR 1例、PR 5例、SD 15例、PD 7例,RR 为21.5％,DCR 为75.0％;中位TTP为 6.0个月,中位OS 为10.0个月; QoL改善稳定率为71.4％。两组中位TTP和OS的差异有统计学意义（P＜0.05）。两组最常见的不良反应为骨髓抑制,其他不良反应包括恶心呕吐、肝功能损害、外周神经炎、皮肤过敏反应等,以1～2级为主,两组比较差异无统计学意义（P＞0.05）。化疗联合恩度组仅2例出现心电图T波改变,1例出现房性早搏,1例出现轻度血压升高。结论 GEMOX联合恩度方案一线治疗转移性BTCs疗效较好,可以改善或稳定QoL,延长生存时间,且耐受性较好,值得临床推广使用和进一步深入观察。     

Gemcitabine in the treatment of relapsed or refractory non-Hodgkin's lymphoma

OBJECTIVE: To evaluate the efficacy and drug-related toxicity of combined gemcitabine, cisplatin, and prednisone for the treatment of patients with relapsed or refractory aggressive non-Hodgkin's lymphoma (NHL). METHODS: Fifteen patients with histologically confirmed relapsed or refractory aggressive NHL were included in this study. Gemcitabine was given on D1, 8 of a three to four weeks schedule at a dose of 1000 mg/m(2) intravenously over 30 minutes for no less than three cycles, and cisplatin was given on D1-3 at a dose of 25 mg/m(2). Prednisone was taken orally on D1-5 at a dose of 60 mg/m(2). RESULTS: Of 15 patients, 11 patients (73.3%) showed responses: 5 patients (33.3%) giving complete response and 6 patients (40.0%) partial response. Four patients' symptoms disappeared, and 1 in 6 patients was alleviated of type B symptoms. Drug-related toxic effects of chemotherapy were mild gastrointestinal reactions in most patients and severe bone marrow depression in very few patients. CONCLUSION: The present combination of gemcitabine, cisplatin, prednisone possesses moderate short-term efficacy, acceptable toxicity, and alleviation of suffering related to the disease. This protocol is worthy to be warranted as salvage for relapsed or refractory aggressive NHL.     

Gemcitabine for relapsed or resistant lymphoma

Background:Gemcitabine therapy has not been widely assessed inthe treatment of hematological malignancies. We have examined the efficacy andsafety of gemcitabine in patients with relapsed or resistant lymphoma. Patients and methods:Gemcitabine (1 g/m²) was givenweekly for 7 consecutive weeks, followed by a week off treatment. The drug wasthen given for 3 consecutive weeks, followed by a week off treatment; thisregimen was continued until disease progression or drug intolerance. Fifteenpatients have enrolled. Most have been extensively pre-treated for advanceddiffuse large-cell or mantle-cell lymphoma. Results:The drug was well tolerated; no patient sufferedtreatment-related sepsis, hemorrhage or death. Non-hematopoietic toxicity ledto discontinuation of gemcitabine therapy in two patients. Dose reductions ordelays were required for about two-thirds of treatments. Of 13 evaluablepatients, one had a complete response, 3 a partial response, 3 stable disease,and 6 disease progression. After 6 infusions of gemcitabine, a patient withadvanced Hodgkin's disease has had a complete remission lasting 21 months. Conclusions:Gemcitabine has substantial activity and acceptabletoxicity in heavily pre-treated patients with advanced lymphoma. Further studyis warranted.