泽菲联合顺铂治疗中晚期非小细胞肺癌近期疗效观察

目的评价泽菲(吉西他滨,GEM)联合顺铂(DDP)(GP方案)对中晚期非小细胞肺癌(NSCLC)的疗效、临床受益情况和毒副作用。方法42例中晚期非小细胞肺癌,初治31例,复治11例,以GP方案化疗,每例持续2～3个周期,共102个周期。结果42例化疗患者,有效率(CR+PR)达52.4%(22/42),稳定(SD)者占35.7(15/42)%,进展(PD)者占11.9%(5/42)。毒副反应:Ⅲ～Ⅳ度白细胞减少者为30.9%,Ⅲ～Ⅳ度血小板减少者为14.2%,Ⅲ～Ⅳ度血红蛋白降低者为11.9%。结论GEM联合DDP治疗中晚期非小细胞肺癌有较好疗效,毒副反应轻,易耐受。     

吉西他滨联合奥沙利铂方案治疗晚期胆囊癌与胆管癌临床观察

目的观察吉西他滨联合奥沙利铂方案治疗晚期胆囊癌和胆管癌临床疗效和毒副作用。方法16例晚期胆囊癌和胆管癌患者,应用吉西他滨联合奥沙利铂方案化疗,即吉西他滨1000mg／m^2,第1、第8天应用,奥沙利铂100mg／m^2,第1天。每21天重复,直至出现不可耐受的副作用或肿瘤进展。结果16例均可以进行疗效评价,CR1例,PR6例,SD6例,PD3例,总有效率43．7％。中位生存期为12．8个月。不良反应主要为骨髓抑制、外周神经炎等。结论吉西他滨联合奥沙利铂方案治疗晚期胆囊癌和胆管癌近期疗效较好,不良反应有可以耐受性。可作为晚期胆囊癌和胆管癌的治疗选择。     

低剂量吉西他滨联合顺铂治疗老年晚期非小细胞肺癌的临床观察

目的观察低剂量吉西他滨联合顺铂治疗老年晚期非小细胞肺癌的疗效及毒副反应。方法国产吉西他滨800mg／m2,静脉滴注30min,第1、8天;顺铂14mg／m2,第1～5天,3周重复,治疗32例70岁以上的晚期非小细胞肺癌患者。结果32例患者共化疗108周期,完全缓解0,部分缓解17例（53．1％,17／32）,稳定8例（25％,8／32）,进展7例（21．9％,7／32）,总有效率53．1％,疾病控制率（CR＋PR＋SO）78．1％,中位疾病进展时问5．2个月,中位生存期11．6个月。毒副作用主要为粒细胞减少、血小板下降、贫血、乏力。均可耐受。结论低剂量吉西他滨联合顺铂治疗老年晚期非小细胞肺癌的疗效肯定且患者耐受性较好。     

吉西他滨联合长春瑞滨用于转移性鼻咽癌二线治疗的临床观察

目的评价吉西他滨联合长春瑞滨二线治疗晚期鼻咽癌的近期疗效和毒性反应。方法 38例均为含顺铂方案一线化疗失败的晚期鼻咽癌患者,接受吉西他滨联合长春瑞滨方案治疗,吉西他滨1000mg/m2静脉滴注30min,d1、d8,长春瑞滨25mg/m2静脉推注,d1、d8,每21d重复一次。结果 38例共完成167个周期的治疗,中位数4周期,范围2~6周期,均可评价疗效,其中CR5例,PR20例,SD9例,PD4例,客观有效率(CR+PR)65.8%,中位缓解时间5.6个月。中位疾病进展时间6.2个月,中位生存期16.2个月;1年生存率65.8%,2年生存率44.7%。不良反应主要为Ⅰ~Ⅱ度骨髓抑制、末梢神经毒性及胃肠道反应。结论吉西他滨联合长春瑞滨二线治疗转移性鼻咽癌患者,初步观察疗效可,毒副作用可耐受,值得临床进一步研究。     

长春瑞滨联合顺铂治疗蒽环及紫杉类耐药的晚期转移性乳腺癌

目的观察长春瑞滨联合顺铂方案（NP方案）治疗蒽环和紫杉类耐药的晚期转移性乳腺癌的疗效和安全性。方法20例蒽环类和紫杉类方案治疗失败的晚期转移性乳腺癌患者接受：长春瑞滨25mg／m2,静脉滴注,第1天和第8天;顺铂75mg／m2,静脉滴注,第1天,或25mg／m2,静脉滴注,第l一3天;每3周重复。每例患者至少化疗2个周期,每2个疗程评价1次。结果总有效率（CR＋PR）50％,其中CR2例（10％）,PR8例（40％）,SD4例（20％）,PD6例（30％）。中位随访时间6个月（4-18个月）,16例存活,4例死亡。中位疾病进展时间5个月（3～15个月）;中位总生存期8个月（4-18个月）,1年生存率为60％。主要不良反应为骨髓抑制和消化道反应,Ⅲ-Ⅳ度消化道反应、白细胞下降和血小板下降分别为25％、65％和10％。结论NP方案治疗蒽环类和紫杉类治疗失败的晚期转移性乳腺癌患者疗效可靠且可耐受,可以考虑作为难治性乳腺癌的解救方案。     

吉西他滨联合顺铂治疗晚期非小细胞肺癌临床观察

目的观察吉西他滨联合顺铂治疗晚期非小细胞肺癌的近期疗效及毒副反应。方法吉西他滨1．2／m^2,第一、八天;顺铂25mg／m^2,第二～四天,21天为1周期,两周期以上评价疗效。结果可评价疗效43例,其中CR1例,PR19例,NC20例,PD3例,总有效率CR PR46．5％。主要毒副反应为骨髓抑制、恶心、呕吐。结论吉西他滨联合DDP治疗晚期非小细胞肺癌疗效高,毒副反应轻,可以作为治疗晚期非小细胞肺癌的一线治疗方案。     

Phase II trial of gemcitabine as prolonged infusion in metastatic breast cancer.

Gemcitabine is an active agent in the treatment of metastatic breast cancer. The phosphorylation of gemcitabine into the active gemcitabine triphosphate (dFdCTP) is catalyzed by deoxycytidine kinase. This enzyme is saturated at plasma concentrations achieved after an infusion over 30 min. Therefore accumulation of higher intracellular dFdCTP concentrations, which may result in an enhanced antineoplastic activity, cannot be achieved by higher dosage, but only by prolonged infusion time. In a previous phase I trial the maximum tolerated dose of gemcitabine given as a 6 h i.v. infusion was 250 mg/m2. The objective of this phase II trial was to determine the efficacy and safety of gemcitabine as prolonged infusion in patients with metastatic breast cancer. Twenty patients [median age 50.4 years, range 35-63 years; performance status EORTC 0 (17 patients), 1 (two patients), 2 (one patient)] with metastatic breast cancer were treated with 250 mg/m2 gemcitabine as infusion over 6 h on days 1, 8 and 15 q3 weeks for up to six courses (median 3.9 courses). Treatment was first line for four patients, second line for five patients and third line or higher for 11 patients. Metastatic sites were liver in 14 patients, bone in 12 patients, lung in eight patients and lymph nodes in nine patients. Nine patients presented two metastatic sites, three patients three and five patients four. All patients were evaluable for response and toxicity. One patient (5%) achieved a complete remission (CR) and four patients (20%) a partial remission (PR) (one patient with CR of visceral metastases but stable bone metastases), for an overall response rate of 25% (five of 20). In addition, six patients (30%) had stable disease and nine (45%) failed to respond to the treatment. Time to progression ranged from 2 to 23 months with a median of 6.3 months. Hematologic toxicity was mild with leukopenia grade 3 in only three patients (15%) and no grade 3 thrombocytopenia. Moderate elevations of liver enzymes (three patients grade 3), nausea and vomiting (two patients grade 2), and mild alopecia were observed, but only one patient had to be withdrawn due to toxicity. In conclusion gemcitabine as prolonged infusion is an effective treatment in metastatic breast cancer. Toxicity, especially myelosuppression, is surprisingly mild. Therefore, gemcitabine seems to be ideal for combination therapies.     

国产吉西他滨联合顺铂治疗晚期非小细胞肺癌的临床观察

目的 观察国产吉西他滨(GEM)联合顺铂(DDP)治疗晚期非小细胞肺癌的近期疗效、毒副反应、中位生存期及耐受性.方法 国产吉西他滨1 000 mg·m-2,静脉滴注30 min,第1、8 天;顺铂60～70 mg·m-2,静脉滴注,分3～ 4 d应用,28 d为一个周期,治疗39 例晚期非小细胞肺癌患者.结果 39 ...     

替吉奥联合顺铂一线治疗晚期非小细胞肺癌的疗效观察

目的观察替吉奥联合顺铂一线治疗晚期非小细胞肺癌的有效性和安全性。方法 44例晚期非小细胞肺癌患者一线接受替吉奥(根据体表面积调整剂量:40～60mg,口服bid,d1～14),联合顺铂(25mg/m2静滴qd,d1～3)化疗。结果化疗客观有效率(CR+PR)为22.7%,疾病控制率(CR+PR+SD)为72.7%。1年生存率为53.5%,中位PFS为5.3个月(95%CI,5.091～5.509)。化疗后常见的毒副作用为口腔黏膜炎及神经毒性,而严重的骨髓抑制发生率较低。结论替吉奥联合顺铂治疗晚期非小细胞肺癌的疗效确切,耐受性良好,给药途径方便,为晚期非小细胞肺癌的治疗提供了一种新的选择。     

Efficacy and toxicity of bendamustine in patients with relapsed low-grade non-Hodgkin's lymphomas

Low-grade non-Hodgkin's lymphomas (NHL) are very sensitive to a broad range of chemotherapeutic and biological agents. Relapses, however, occur even after aggressive cytostatic combinations in first-line therapy. Therefore, effective and well-tolerated salvage therapies are very important. In this single-institution trial, the efficacy and toxicity of bendamustine in the treatment of relapsed low-grade NHL was investigated. Fifty-eight patients with low-grade NHL pretreated with different cytostatic regimens were included. All patients received bendamustine at 120 mg/m(2) as a 1-h infusion on 2 consecutive days. The treatment was repeated every 3 weeks until complete remission (CR), partial remission (PR) or stable disease (SD) was confirmed on two consecutive cycles. Efficacy and toxicity were evaluated in 52 patients: CR was induced in 11%, PR in 62% and SD in another 10% of the patients. No response to treatment was seen in 17%. The median duration of remission was 16 months and the median survival time was 36 months. Side effects were generally mild, and restricted to myelosuppression, gastrointestinal toxicity and allergic reactions. Bendamustine proved to be very effective and was well tolerated in pretreated patients with relapsed or primary resistant low-grade NHL.     

重组人血管内皮抑制素联合GP方案治疗晚期非小细胞肺癌37例临床观察

目的观察重组人血管内皮抑制素（恩度）联合GP方案治疗晚期非小细胞肺癌（NSCLC）的疗效和毒副反应。方法经病理学或细胞学检查证实的37例晚期NSCLC患者,包括鳞癌21例,腺癌16例。吉西他滨1000mg／m^2,静脉滴注,第1、8天;顺铂80mg／m^2,静脉滴注,分3d给予;恩度15mg／d,静脉滴注,第1～14天,21d为1个周期。每例患者至少完成2个周期。根据WHO疗效评定及毒副反应分级标准,观察其近期疗效、疾病进展时间及毒副反应。结果37例晚期NSCLC患者中,CR1例,PR15例,SD14例,PD7例,总有效率（CR＋PR）43．2％。中位疾病进展时间为5．2个月。毒副反应主要为血液学、消化道毒性,Ⅲ-Ⅳ度中性粒细胞减少占32．4％,Ⅲ-Ⅳ度血小板减少占20．5％,未见与化疗相关的死亡。结论恩度联合GP方案治疗晚期NSCLC近期客观疗效较高,安全性好。     

重组人血管内皮抑制素联合GP方案治疗晚期非小细胞肺癌37例临床观察

目的 观察重组人血管内皮抑制素(恩度)联合GP方案治疗晚期非小细胞肺癌(NSCLC)的疗效和毒副反应.方法 经病理学或细胞学检查证实的37例晚期NSCLC患者,包括鳞癌21例,腺癌16例.吉西他滨1 000 mg/m2,静脉滴注,第1、8天;顺铂80 mg/m2,静脉滴注,分3 d给予;恩度15 mg/d,静脉滴注,第1～14天,21 d为1个周期.每例患者至少完成2个周期.根据WHO疗效评定及毒副反应分级标准,观察其近期疗效、疾病进展时间及毒副反应.结果 37例晚期NSCLC患者中,CR 1例,PR 15例,SD 14例,PD 7例,总有效率(CR+PR)43.2%.中位疾病进展时间为5.2个月.毒副反应主要为血液学、消化道毒性,Ⅲ～Ⅳ度中性粒细胞减少占32.4%,Ⅲ～Ⅳ度血小板减少占20.5%,未见与化疗相关的死亡.结论 恩度联合GP方案治疗晚期NSCLC近期客观疗效较高,安全性好.     

吉西他滨联合顺铂治疗晚期非小细胞肺癌45例临床观察

目的观察吉西他滨联合顺铂方案治疗晚期非小细胞肺癌的近期疗效与不良反应。方法采用GP方案治疗晚期NSCLC45例：吉西他滨1．0／m2,第1、8天,静脉滴注;顺铂25mg／m2,第1～3天,静脉滴注,21d为1个周期,至少治疗2个周期。结果可评价疗效45例,完全缓解（CR）1例（2．2％）,部分缓解（PR）20例（44．4％）,稳定（SD）15例（33．3％）,进展（PD）9例（20％）。总有效率（CR＋PR）46．7％（21／45）,肿瘤控制率（CR＋PR＋SD）80％（36／45）。中位生存期11．8个月。不良反应主要为可耐受的骨髓抑制、恶心呕吐、脱发为常见、无化疗相关死亡。结论吉西他滨与顺铂联合方案疗效较好,不良反应较轻可耐受,是晚期NSCLC的有效治疗方案。     

伊立替康联合顺铂用于初治小细胞肺癌的临床观察

目的观察伊立替康（CPT-11）联合顺铂（DDP）治疗初治小细胞肺癌的临床疗效和安全性。方法34例小细胞肺癌患者,采用CTP—1165mg／m2,静滴,第1、8天;DDP25mg／m2,静滴;第1～3d。21d为1个周期,至少完成2个周期后评价疗效和不良反应。结果34例患者中CR5例,PR21例,总有效率RR76．5％,无进展生存期（PFS）5．4个月。主要毒副反应为血液学毒性和消化道反应,仅3例出现III度腹泻。结论CPT-11联合DDP一线治疗小细胞肺癌是安全及有效的,毒性可耐受,迟发性腹泻是可以控制的。     

Induction chemotherapy with docetaxel, cisplatin, fluorouracil and l-leucovorin for locally advanced head and neck cancers: a modified regimen for Japanese patients

Combination chemotherapy with docetaxel (T), cisplatin (P), fluorouracil (5-FU) and leucovorin has been reported to have major activity against squamous cell carcinoma of the head and neck (SCCHN) administered as a 4-day (TPFL4) or 5-day (TPFL5) regimen. The purpose of this study was to evaluate the efficacy and toxicity of a modified TPFL regimen (m-TPFL) for locally advanced SCCHN, consisting of a modified dosage with docetaxel, cisplatin, 5-FU and l-leucovorin (l-LV) designed for Japanese patients. Organ preservation of the primary tumor site was also assessed. Thirty-four Japanese patients with locally advanced SCCHN were eligible. Docetaxel was administered as a 1-h i.v. infusion at 48 mg/m2 on day 1; cisplatin, 24 mg/m2/day; 5-FU, 560 mg/m2/day and l-LV, 125 mg/body/day were delivered on days 1-4 by continuous i.v. infusion. This regimen was administered every 28 days. Patients who achieved a complete response (CR) after induction chemotherapy underwent radiation therapy alone. Ninety-one cycles were administered. The main hematological toxicity was neutropenia, classified as grade III or IV in 18.7% of cycles. The most common non-hematologic toxicities included anorexia, stomatitis and alopecia. The clinical overall response rate to m-TPFL was 88.2%, with 58.8% CRs and 29.4% partial responses. After definitive locoregional therapy, 25 of 34 patients were disease-free with preserved primary tumor site anatomy. Overall and progression-free survival rates at the 2-year follow-up are 92.8 and 75.3%, respectively. Our m-TPFL regimen designed for Japanese patients yielded excellent response rates with an acceptable toxicity profile in good-performance-status patients.     

白蛋白结合型紫杉醇联合吉西他滨治疗局部进展期胰腺癌的疗效观察

目的评估白蛋白结合型紫杉醇联合吉西他滨治疗局部进展期胰腺癌的有效性及安全性。方法20例经病理确诊不能手术的局部进展期胰腺癌患者,给予白蛋白结合型紫杉醇+吉西他滨方案化疗:白蛋白结合型紫杉醇125 mg/m~2,吉西他滨1 000 mg/m~2,d1、d8给药,21 d重复1次。结果所有患者均进行疗效评价,其中完全缓解(CR)2例,部分缓解(PR)6例,疾病稳定(SD)9例,疾病进展(PD)3例。客观有效率(ORR):40%,疾病控制率(DCR):85%。中位无进展生存期(mPFS)和中位生存期(mOS)分别为5.5个月和10.3个月,1年生存率为40%。所有患者均未发生因不能耐受不良反应而停止治疗及治疗相关性死亡。其中主要的不良反应为:骨髓抑制、脱发、恶心呕吐、乏力、周围神经毒性。结论白蛋白结合型紫杉醇联合吉西他滨治疗局部进展期胰腺癌具有良好的有效性及安全性。     

多西紫杉醇联合顺铂治疗晚期胃癌临床观察

目的：评价多西紫杉醇（Doeetaxel）联合顺铂化疗方案，治疗晚期胃癌的临床疗效和毒性反应。方法：对30例晚期胃癌患者用多西紫杉醇联合顺铂化疗方案治疗78周期。结果：可评价疗效者30例，无完全缓解（CR）、部分缓解（PR）者10例（33．3％），稳定（SD）15例（50．0％），进展（PD）5例（16．7％），总有效率（CR＋PR）33．3％。临床受益率73．3％。肿瘤中位进展期5．6个月，中位生存期9．7个月。主要不良反应：WBC减少27例（90.0％），脱发26例（86．7％），恶心、呕吐22例（73．3％）等，无治疗相关性死亡。结论：多西紫杉醇联合顺铂化疗方案治疗晚期胃癌患者有效，临床缓解率较高，不良反应可耐受，可作为难治或复发的晚期胃癌的治疗方案。     

替吉奥单药治疗老年晚期非小细胞肺癌的临床观察

目的观察替吉奥单药治疗老年晚期非小细胞肿瘤（NSCLC）患者的疗效及不良反应。方法对31例II—IB—IV期老年NSCLC患者应用替吉奥（S－1）单药化疗[60mg／（m2·d）,口服1～14d）21d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31例患者中,完全缓解（CR）0例,部分缓解（PR）10例,稳定（sD）13例,进展（PD）8例,有效（CR＋PR）率为：32．3％;临床受益（CR＋PR＋SD）率为：74．2％。中位无疾病进展生存（PFS）期为5．1个月。中位生存（0s）期为7．8个月,1年生存率为30．6％。患者不良反应主要表现为白细胞减少为主的骨髓抑制,白细胞减少I—II度发生率为38．7％（12／31）,III—IV度为6．5％（2／31）。血小板减少I—II。发生率为19．3％（6／31）,III。为3．2％（1／31）无IV度减少发生。结论采用替吉奥弹药治疗老年晚期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。     

吉西他滨加卡培他滨治疗复发转移性乳腺癌的临床观察

目的观察吉西他滨加卡培他滨治疗复发转移性乳腺癌近期疗效。方法吉西他滨加卡培他滨治疗27例复发转移性乳腺癌,同时观察其毒副作用。结果完全缓解1例,部分缓解18例,稳定5例,进展3例,总有效率为70．4％。主要毒副作用为手足综合症、骨髓抑制。结论吉西他滨联合卡培他滨治疗蒽环类耐药的复发转移性乳腺癌疗效较好,不良反应可以耐受。     

Primary chemotherapy with gemcitabine, liposomal doxorubicin and docetaxel in patients with locally advanced breast cancer: results of a phase I trial

The primary objective was to determine the optimal doses for gemcitabine (prolonged infusion), liposomal doxorubicin (Myocet) and docetaxel as primary (neoadjuvant) chemotherapy for locally advanced breast cancer. Secondary objectives included evaluation of the safety and efficacy of the regimen. Patients (n=19) with histologically confirmed stage II or III breast cancer were treated with liposomal doxorubicin (50-60 mg/m2) and docetaxel (60-75 mg/m2) on day 1, and gemcitabine as 4-h infusion (350-400 mg/m2) on day 4. Treatment was repeated every 3 weeks for a maximum of 6 cycles. The maximum tolerated doses were gemcitabine 350 mg/m2, liposomal doxorubicin 60 mg/m2 and docetaxel 75 mg/m2. Dose-limiting toxicities were stomatitis, diarrhea and infection. The predominant hematologic toxicity was mild-to-moderate myelosuppression with grade 3/4 neutropenia in 20% of cycles. Non-hematologic toxicity was generally mild, with no grade 4 toxicities being observed. Predominant non-hematologic toxicity was stomatitis, which occurred in 95% of patients. Grade 3 toxicities were reported for stomatitis, nausea, diarrhea, infection and constipation. No cases of cardiac, renal, pulmonary or neurotoxicity were observed. The clinical response rate was 83% and histologically confirmed, clinically complete remissions occurred in two patients (11%). We conclude that the combination of gemcitabine (prolonged infusion), liposomal doxorubicin and docetaxel is safe and highly effective in patients with locally advanced breast cancer as defined by maximum tolerated doses. The evaluated schedule is suitable for phase II studies.