吉西他滨和顺铂联合重组人血管内皮抑制素治疗晚期非小细胞肺癌临床观察

目的评价吉西他滨和顺铂联合重组人血管内皮抑制素（恩度）治疗晚期非小细胞肺癌的疗效和安全性。方法 38例病理确诊的晚期非小细胞肺癌患者给予吉西他滨和顺铂联合恩度治疗,吉西他滨1000mg/m2,第1,8天,顺铂75mg/m2,第2天,恩度注射液7.5mg/m2加入500ml生理盐水中,滴注时间3～4小时,第1～14日,每21天为一周期。结果 38例患者入组,部分缓解13例,疾病稳定17例,疾病进展8例,客观有效率为34.2%,疾病控制率为78.9%。本组中位无进展生存期为4.6个月,95%CI为2.600～6.600个月,中位生存期为13.5个月,95%CI为9.599～17.401个月,1年生存率42.1%。结论吉西他滨和顺铂联合恩度治疗晚期非小细胞肺癌,有较好的疗效和安全性,具有较好临床应用前景。     

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.     

Cisplatin plus gemcitabine on days 1 and 4 every 21 days for solid tumors: Result of a dose-intensity study

Summary Background: Three and 4-week cisplatin-gemcitabine schedules have shown similar dose-intensity (DI) and activity in non-small-cell lung cancer (NSCLC). The 3-week schedule is generally preferred because it enables better treatment compliance. To improve DI and compliance further, we delivered gemcitabine plus cisplatin over 4 days every 21 days. Methods: Patients with any stage NSCLC or epithelial neoplasms and an ECOG PS ≤2 were given gemcitabine 1000 mg/m² on days 1 and 4 plus cisplatin 70 mg/m² on day 2 of a 21-day cycle. Minimax design was used and a received DI for gemcitabine of ≥580 mg/m²/wk was considered successful. Results: Thirty-nine patients (34 NSCLC, 5 epithelial neoplasias) were enrolled. SWOG grade 3–4 neutropenia and thrombocytopenia were observed in 17.9% and 12.8% of patients, respectively. Nonhematological toxicity was minimal. Twenty-eight (18%) of 158 cycles required dose modifications and/or delays. Twenty-five patients received a gemcitabine dose intensity of ≥580 mg/m²/wk. The received DIs were 601.8 mg/m²/wk for gemcitabine and 21.0 for cisplatin, with a relative DIs of 90.3% and 90.1%, respectively. The response rate of 27 evaluable patients with NSCLC was 44% (95% confidence interval [CI], 25.3 to 62.7%). Conclusions: The shorter schedule of gemcitabine on days 1 and 4 plus cisplatin on day 2 produces an effective DI and a toxicity profile comparable to that of weekly regimens.     

替吉奥和吉西他滨分别联合顺铂一线治疗EGFR野生型的晚期非小细胞肺癌的临床观察

目的:比较替吉奥联合顺铂方案和吉西他滨联合顺铂方案一线治疗表皮生长因子受体(EGFR)基因野生型的晚期非小细胞肺癌的疗效和安全性。方法:选取2010年7月-2011年12月收治的68例符合入组标准的EGFR基因野生型的晚期非小细胞肺癌患者,将其随机分为2组,观察组采用替吉奥联合顺铂方案进行一线化疗;对照组采用吉西他滨联合顺铂方案进行一线化疗。比较2组患者的近期疗效、无进展生存期和不良反应。结果:替吉奥联合顺铂组(观察组)和吉西他滨联合顺铂组(对照组)的总有效率分别为41.2%和38.2%,差异无统计学意义(P>0.05);中位无进展生存期分别为5.4个月和5.1个月,差异无统计学意义(P=0.088);不良反应中替吉奥组的血小板降低发生率(11.8%)低于吉西他滨组,差异有统计学意义(P<0.05)。结论:替吉奥联合顺铂方案一线治疗EGFR基因野生型的晚期非小细胞肺癌具有较好疗效,且不良反应较轻。     

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.     

Gemcitabine and vinorelbine (GV) versus cisplatin, gemcitabine and vinorelbine (CGV) as first-line treatment in advanced non small cell lung cancer: Results of a prospective randomized phase II study

The objective of this study was to assess whether adding cisplatin to gemcitabine/vinorelbine combination improves the clinical outcome in patients with non-small-cell lung cancer (NSCLC). Chemotherapy-na?ve patients with advanced NSCLC; age < or = 75 years: Karnofsky performance status > or = 60%, and with adequate hematological, renal and hepatic function, were randomized into 2 treatment groups to receive Gemcitabine 1250 mg/m2 + vinorelbine 30 mg/m2 (GV group), or cisplatin 50 mg/m2 + gemcitabine 1000 mg/m2 + vinorelbine 25 mg/m2 (CGV group). All drugs were administered on days 1 and 8 every three weeks: From September 1999 to March 2003, 114 patients were enrolled. No statistically significant difference was observed in GV vs CGV group in objective response (37 versus 47%, respectively; P = 0.5), median time to progression (5 versus 5.8 months; P = 0.6), overall survival (9 versus 10 months; P = 0.9) and 1-year survival (26 versus 28%; P = 0.9). Conversely, toxicities were significantly higher for CGV, including grade 3-4 neutropenia (24 versus 45%); neutropenic fever (4 versus 14%, including one toxic death); grade 3-4 thrombocytopenia (2 versus 14%); and grade 3-4 emesis (2 versus 14%). Our results suggest that the combination of gemcitabine and vinorelbine is less toxic than three-drug combination with cisplatin while showing similar efficacy.     

Combined treatment in advanced stages (IIIb-IV) of non-small cell lung cancer

Chemotherapy regimens based on platinum represent the reference standards in Non-Small Cell Lung Cancer (NSCLC) and when it is associated with radiotherapy and/or surgery (combined treatment) it improves survival of patients. Aim of this study was to estimate the efficacy of chemotherapy, based on high-dose epirubicin plus cisplatin, associated with surgery and/or radiotherapy. Twenty-four inoperable NSCLC patients (15 pts in stage IIIb and 9 in stage IV) were treated with epirubicin (120 mg/m2) plus cisplatin (60 mg/m2), every three weeks for at least 3 cycles up to a maximum of 6. A total of 109 treatment cycles (epirubicin plus cisplatin) were administered and two of 24 patients achieved full response (CR), 9 showed partial response (PR), for an overall response rate of 45.8%, 8 patients (33.4%) achieved stable disease (SD) and 5 (20.8%) progressive disease (PD). Leukopenia aroses in 81.9% of the cycles, anaemia in 36.6% and thrombocytopenia in 14%. After chemotherapy, nausea/vomiting was present in 33.3% of patients, while in a small number of cases there were also mucositis, diarrhea, fever, phlebitis, transaminase increase and electrocardiographic anomalies. Upon entry, at the end of therapy patients underwent restaging (CT, bronchoscopy, bone scintiscan) to evaluate the possibility of surgical resection; 15 out of 24 patients completed treatment with radiotherapy (40-60 Gy) and then were re-evaluated for surgery. Five patients underwent complete surgical resection of the neoplasia (4 after chemotherapy and one after radiotherapy). After 1 year survival was 66.6% for all patients. Combined treatment in advanced NSCLC showed a good response and survival after 1 year.     

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。     

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。     

The current status of docetaxel for advanced non-small cell lung cancer

Docetaxel is an active single agent in both first- and second-line therapy of patients with advanced non-small cell lung cancer (NSCLC). Randomized trials versus best supportive care have documented an improvement in overall survival for docetaxel therapy in both settings. Docetaxel also produced a significant 1-year survival rate improvement when compared with vinorelbine or ifosfamide as second-line therapy. Docetaxel has been extensively investigated in phase I/II studies in combination with cisplatin, carboplatin, irinotecan and gemcitabine. Substantial activity has been demonstrated. In a randomized phase II trial comparing docetaxel plus cisplatin with docetaxel plus gemcitabine, the efficacy of the two regimens was almost identical (response rates 32 and 34%; 1-year survival rates 42 and 38%). However, the combination of docetaxel with gemcitabine was associated with significantly less grade III/IV neutropenia, diarrhea and nausea/vomiting. Three drug regimens combining docetaxel with, for example, gemcitabine and carboplatin or with ifosfamide and cisplatin, are producing very high response rates in phase II trials. Whether three-drug combinations including docetaxel will result in an improved outcome for patients with advanced NSCLC remains to be determined.     

培美曲塞或吉西他滨联合顺铂治疗晚期非小细胞肺癌的比较研究

目的比较培美曲塞或吉西他滨联合顺铂治疗晚期非小细胞肺癌(NSCLC)的疗效及不良反应。方法选择晚期NSCLC患者50例,随机分为培美曲塞加顺铂组(PC组)和吉西他滨加顺铂组(GC组)各25例。PC组给予培美曲塞500mg/m2,第1天,GC组吉西他滨1000mg/m2,第1、8天,两组均给予顺铂30mg,第2～4天,均为21d一个周期。结果培美曲塞加顺铂组和吉西他滨加顺铂组有效率分别为48%和44%,两组之间有效率无统计学意义(P>0.05)。PC组粒细胞减少的发生率小于GC组。结论 PC方案治疗晚期非小细胞肺癌的疗效与GC方案的疗效相当,但毒副作用明显减少,可以作为一线治疗方案。     

Paclitaxel: a pharmacoeconomic review of its use in non-small cell lung cancer.

A number of first-line chemotherapy options for patients with advanced non-small cell lung cancer (NSCLC) are advocated in treatment guidelines and/or by various clinical investigators. Platinum-based chemotherapy has clearly demonstrated efficacy in patients with advanced NSCLC and is generally recommended as first-line therapy, although there is increasing interest in the use of non-platinum chemotherapy regimens. Among the platinum-based combinations currently used in clinical practice are regimens such as cisplatin or carboplatin combined with paclitaxel, vinorelbine, gemcitabine, docetaxel or irinotecan. The particular combinations employed may vary between institutions and geographical regions. Several pharmacoeconomic analyses have been conducted on paclitaxel in NSCLC and most have focused on its use in combination with cisplatin. In terms of clinical efficacy, paclitaxel-cisplatin combinations achieved significantly higher response rates than teniposide plus cisplatin or etoposide plus cisplatin (previously thought to be among the more effective regimens available) in two large randomised trials. One of these studies showed a survival advantage for paclitaxel plus cisplatin [with or without a granulocyte colony-stimulating factor (G-CSF)] compared with etoposide plus cisplatin. A Canadian cost-effectiveness analysis incorporated data from one of the large randomised comparative trials and showed that the incremental cost per life-year saved for outpatient administration of paclitaxel plus cisplatin versus etoposide plus cisplatin was $US 22181 (30619 Canadian dollars; $Can) [1997 costs]. A European analysis incorporated data from the other large randomised study and showed slightly higher costs per responder for paclitaxel plus cisplatin than for teniposide plus cisplatin in The Netherlands ($US 30769 vs $US 29592) and Spain ($US 19 923 vs $US 19724) but lower costs per responder in Belgium ($US 22852 vs $US 25000) and France ($US28 080 vs $US 34747) [1995/96 costs]. In other cost-effectiveness analyses, paclitaxel plus cisplatin was associated with a cost per life-year saved relative to best supportive care of approximately $US 10000 in a US study (year of costing not reported) or $US 11200 in a Canadian analysis ($Can 15400; 1995 costs). Results were less favourable when combining paclitaxel with carboplatin instead of cisplatin and particularly when G-CSF was added to paclitaxel plus cisplatin. The Canadian study incorporated the concept of extended dominance in a threshold analysis and ranked paclitaxel plus cisplatin first among several comparator regimens (including vinorelbine plus cisplatin) when the threshold level was $Can 75000 ($US 54526) per life-year saved or per quality-adjusted life-year gained (1995 values). CONCLUSION: Current treatment guidelines for advanced NSCLC recognise paclitaxel-platinum combinations as one of the first-line chemotherapy treatment options. In two large head-to-head comparative clinical trials, paclitaxel plus cisplatin was associated with significantly greater response rates than cisplatin in combination with either teniposide or etoposide, and a survival advantage was shown for paclitaxel plus cisplatin (with or without G-CSF) over etoposide plus cisplatin. There are limitations to the currently available pharmacoeconomic data and further economic analyses of paclitaxel-carboplatin regimens are warranted, as this combination is widely used in NSCLC and appears to have some clinical advantages over paclitaxel plus cisplatin in terms of ease of administration and tolerability profile. Nevertheless, results of various cost-effectiveness studies support the use of paclitaxel-platinum combinations, particularly paclitaxel plus cisplatin, as a first-line chemotherapy treatment option in patients with advanced NSCLC.     

Pharmacokinetic evaluation of gemcitabine hydrochloride for the treatment of cervical cancer

INTRODUCTION: Cervical cancer is the third most prevalent cancer in females worldwide. When advanced, the disease requires primary radiation concurrent with chemotherapy. However, chemotherapy alone is the standard treatment for recurrent/persistent/metastatic disease. AREAS COVERED: Areas covered in this review include the treatment of advanced cervical cancer with gemcitabine as radiosensitizer, either alone or in combination with cisplatin. The use of gemcitabine for recurrent/persistent/metastatic cervical cancer is also reviewed. EXPERT OPINION: Statistically significantly better survival rates are achieved with cisplatin doublets against cisplatin alone, in the management of recurrent/persistent/metastatic cervical cancer. The choice of the cisplatin doublet with paclitaxel, vinorelbine, gemcitabine and topotecan arms should be based on physician preference, pre-existing morbidity and patient-related factors. In advanced disease, a recently reported Phase III trial establishes the novel regimen of concurrent gemcitabine plus cisplatin and external radiation, followed by brachytherapy and two adjuvant 21-day cycles of gemcitabine plus cisplatin, as significantly improving survival outcomes when compared with the current standard of care. The increased acute toxicity of this regimen is clear; however, this should not deter its incorporation into clinical practice, in that the toxicity is predictable and manageable; nevertheless, the occurrence of late toxicity and survival at longer follow-up time are reasonable concerns in this regimen.     

Phase I-II trial of low-dose gemcitabine in prolonged infusion and cisplatin for advanced non-small cell lung cancer

After monotherapy with gemcitabine in low dose in long infusion, promising results in a variety of advanced chemoresistant tumors have been reported. In a previous phase I trial on heavily pre-treated patients, maximum tolerated dose (MTD) of gemcitabine in a 6 h infusion was 250 mg/m. The objective of our phase I-II trial was to test the combination of gemcitabine in a 6-h infusion and cisplatin in the treatment of advanced non-small cell lung cancer (NSCLC). Eligible patients were chemonaive, had locally advanced or metastatic NSCLC, Eastern Oncology Cooperative Oncology Group performance status 0-2 and normal organ function. Treatment consisted of gemcitabine in a 6-h infusion on days 1 and 8, and cisplatin at 75 mg/m on day 2 of a 3-week cycle. During phase I of the trial, the dose of gemcitabine was escalated from 130 to 170, 210 and 250 mg/m. After establishing dose-limiting toxicity (DLT) and MTD of the combination, the trial continued as phase II. Altogether, 61 patients were enrolled, of whom 54 had stage IV disease. In phase I of the trial, groups of six, seven, eight and eight patients were treated at the four dose levels of gemcitabine. In phase II, the remaining 32 patients all received gemcitabine at 250 mg/m. Serious toxicity included a patient with grade 5 ventricular arrhythmia and another with grade 4 cerebrovascular ischemia; four patients had grade 3 anemia. Reversible thrombocytosis with platelets over 500 was recorded in 32 patients; 42 patients had grade 2 alopecia. In general, tolerance to this treatment was good. One patient had complete response and 27 had partial responses, for a 28 of 61 (46%) response rate. Median progression-free survival, median survival and 1-year survival were 6 months, 9.5 months and 40%, respectively. We conclude that this treatment has an acceptable, yet distinct, toxicity profile; routine thromboprophylaxis is recommended. In our population of chemonaive patients, no DLT has been encountered. Due to the remarkable response rate, further research is warranted.     

替吉奥联合吉西他滨与单药吉西他滨治疗进展期胰腺癌的疗效比较

目的 评价吉西他滨单药以及与替吉奥联合治疗局部晚期或转移性胰腺癌的有效率、临床受益反应（评价指标包括患者的疼痛强度、止痛药物消耗量、体力状况评分和体重变化）、生存时间和不良反应。方法 回顾性分析2009年1月至2011年10月收治的62例晚期胰腺癌患者,分为吉西他滨单药组（30例）和吉西他滨＋替吉奥联合组（32例）。单药组：吉西他滨1 000 mg·m-2、第1,8天,静脉滴注30 min,每3周重复。联合组：吉西他滨用法同单药组,替吉奥口服2次·d-1,第1~14天,每3周重复。结果 62例患者均可评价客观疗效,可评价临床受益反应者56例（单药组27例,联合组29例）。单药组和联合组有效率分别为23.3％和31.3％（P〈0.05）,临床受益率分别为59.2%和72.4%（P〉0.05）。2组6个月生存率分别为60.0%和68.7%（P〉0.05）,1年生存率分别为26.6%和31.2%（P〉0.05）。中位无疾病进展时间（PFS）分别为3.9个月和5.4个月（P〈0.05）,中位总生存时间分别为7.8个月和9.1个月（P〉0.05）。2组不良反应比较差异无统计学意义（P〉0.05）。结论 吉西他滨联合替吉奥与单药吉西他滨治疗晚期胰腺癌安全有效,前者有效率优于后者。在延长生存期方面也显示出一定的优势,但该差异无统计学意义。     

吉西他滨联合顺铂治疗多药耐药的晚期乳腺癌的临床观察

目的观察吉西他滨联合顺铂方案治疗蒽环类及紫杉类耐药晚期乳腺癌的疗效与安全性。方法2007年1月～2008年4月以吉西他滨联合顺铂方案治疗蒽环类及紫杉类耐药晚期乳腺癌15例,吉西他滨1000 mg.m-2静滴,第1、8天,顺铂25 mg.m-2,静脉滴注,第1～3天;每21 d为一周期,至少治疗2周期。结果全组患者均可评价疗效,其中完全缓解（CR）1例（6.7%）,部分缓解（PR）6例（40.0%）,稳定（SD）5例（33.3%）,进展（PD）3例（20.0%）,总有效率（ORR）46.7%,TTP6.4月,MST13.2月;Ⅲ～Ⅳ度毒性反应分别为血小板减少20.0%,白细胞减少26.7%,恶心或呕吐13.3%。结论吉西他滨和顺铂联合方案治疗蒽环类及紫杉类耐药晚期乳腺癌的疗效较好,使用方便,毒性反应较轻,是蒽环类及紫杉类耐药晚期乳腺癌的有效解救治疗方案。     

A randomized phase II study of recombinant human endostatin plus gemcitabine/cisplatin compared with gemcitabine/cisplatin alone as first-line therapy in advanced non-small-cell lung cancer

Purpose Studies indicate that recombinant human endostatin (rh-endostatin) can inhibit tumor endothelial cell proliferation, angiogenesis, and tumor growth. This study assessed the efficacy of the combination of standard gemcitabine plus cisplatin chemotherapy with rh-endostatin in patients with non-small-cell lung cancer (NSCLC). Patients and Methods Chemotherapy-naive patients with stage IIIB to IV NSCLC were randomly (1:1) assigned to receive gemcitabine/cisplatin chemotherapy alone or with 7.5 mg/ m² of intravenously rh-endostatin on days 1 to 14 of each 3-week cycle. The primary end point was objective response rate (ORR). Results Baseline characteristics were similar between treatment arms. The best ORRs for rh-endostatin arm (n = 33) and chemotherapy-alone arm were 37.5% (95% CI: 21.3 to 47.2%) and 28.6% (95% CI: 19.8 to 37.6%), respectively. Median survival was 12.4 months in the rh-endostatin arm and 9.8 months in the chemotherapy-alone arm, and 1-year survival was 51.6% and 38.7%, respectively. Mild palpitions, diarrhea, and liver dysfunction were the most common rh-endostatin-related adverse events. Grade 3/4 hematological toxicities were all reported similar for patients in the two arms. Conclusion The addition of rh-endostatin to gemcitabine plus cisplatin chemotherapy for first-line treatment of NSCLC improves objective response and may improve survival.     

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。