三氧化二砷联合吉西他滨及多西他赛治疗晚期转移性骨肉瘤26例临床分析

  目的   探讨三氧化二砷（arsenic trioxide,As₂O₃）联合吉西他滨及多西他赛治疗骨肉瘤肺转移的临床疗效。   方法   收集26例对一线化疗药物耐药的骨肉瘤肺转移患者,男性14例,女性12例,年龄11~62岁,平均31.2岁,所有患者均接受过传统规范化疗后出现肺转移。应用As₂O₃（剂量为10 mg/d,d1~28）联合吉西他滨（剂量为800 mg/m2,d1、d8）及多西他赛（剂量为75 mg/m2,d8）每3周重复给药,每2个化疗疗程复查疗效。   结果   接受化疗的患者总体有效率（CR+PR）为34.6%（9/26）。中位随访时间28.2（1~48）个月,中位总生存期（OS）为16.7个月（95%CI:7.561~18.058）和中位无进展生存期（PFS）为10.3个月（95%CI:6.541~ 8.754）,1、2和4年生存率分别是61.5%、38.4%和15.4%。治疗后最常见的不良反应为骨髓抑制,而常见的非血液学不良反应包括心脏毒性、消化道反应及肝肾功能异常,对症处理后均明显缓解。   结论   As₂O₃联合吉西他滨及多西他赛作为二线化疗药物治疗骨肉瘤肺转移的近期临床疗效较好,且有较好的耐受性。      

不同剂量吉西他滨联合卡铂一线治疗晚期非小细胞肺癌的临床疗效

[目的]比较不同剂量吉西他滨联合卡铂一线治疗晚期非小细胞肺癌的疗效和不良反应。[方法]回顾性分析行一线GC方案化疗的晚期非小细胞肺癌患者,共83例,均接受吉西他滨1250mg/m2（38例）或1000mg/m2（45例）联合卡铂（AUC=5）化疗。Kaplan-Meier法进行生存分析和比较。[结果]吉西他滨高剂量组（1250mg/m2）中位无进展生存期为5.2个月,低剂量组（1000mg/m2）中位无进展生存期为4.8个月（P=0.67）,中位总生存期分别为14.5个月和15.8个月,差异亦无统计学意义（P=0.65）。两组有效率分别为31.6%和35.6%（P=0.70）,疾病控制率分别为78.9%和73.3%（P=0.55）。吉西他滨高剂量组血小板降低比例高于低剂量组。[结论]与1250mg/m2化疗组相比,吉西他滨1000mg/m2联合卡铂一线治疗晚期非小细胞肺癌患者疗效及生存期相当,但不良反应降低。     

恩度联合吉西他滨、多西他赛治疗晚期软组织肉瘤的疗效及安全性

目的:探讨恩度联合吉西他滨、多西他赛(GD)治疗晚期软组织肉瘤的疗效及安全性。方法:选取2013年1月至2016年4月入住我院晚期软组织肉瘤患者49例，随机分为恩度组（恩度联合吉西他滨、多西他赛）和对照组（吉西他滨联合多西他赛），比较两组患者疾病控制率、客观缓解率、不良反应及无进展生存期。结果:恩度组疾病控制率为52.17%，高于对照组的23.08%，经χ2检验差异有统计学意义（P<0.05）；两组客观缓解率分别为17.39%和3.85%，差异无统计学意义（P>0.05）；两组患者Ⅲ、Ⅳ度不良反应差异均无统计学意义（P＞0.05）。恩度组无进展生存期为（4.08±0.70）月，对照组为（2.35±0.29）月，差异有统计学意义（P<0.05）。结论:恩度联合GD方案对晚期软组织肉瘤疗效较GD方案好，患者耐受性好，可考虑应用于晚期软组织肉瘤患者。     

吉西他滨联合多西他赛治疗复发或难治性骨肉瘤的临床观察

目的 观察吉西他滨联合多西他赛治疗复发或难治性骨肉瘤的有效性和安全性。方法 经病理确诊的28例复发或难治性骨肉瘤患者接受吉西他滨联合多西他赛治疗,具体方案为：吉西他滨1000mg／m²,静脉滴注,d1、d8;多西他赛 75mg／m²,静脉滴注,d8,3周为1周期。化疗2个周期后,按照RECIST标准评价客观疗效。每周期按照NCI CTC 3.0分级标准评价药物毒性反应。结果 28例患者均可评价疗效,获PR 1例,SD 8例,PD 19例,有效率（RR）为3.6％（1／28）,疾病控制率（DCR）为32.1％（9／28）;中位无疾病进展时间为6.0周（6～24周）,中位总生存时间为11.0个月（3～26个月）。主要毒副反应为骨髓抑制、胃肠道反应和乏力,未出现严重不良反应。结论 吉西他滨联合多西他赛治疗复发或难治性骨肉瘤具有一定的疗效,安全性高,值得临床推广应用。     

吉西他滨联合多西他赛治疗晚期复发转移性骨肉瘤疗效观察

目的：观察吉西他滨联合多西他赛方案治疗晚期复发转移性骨肉瘤的有效性和安全性。方法：收集2010年1月至2014年12月间我院收治的23例一线化疗失败的出现转移的晚期骨肉瘤患者,行多西他赛（75mg／m2,d1,8）联合吉西他滨（1000mg／m2,d1,8）方案行全身化疗,21天为1周期,如达到 PR 及 SD 的患者继续行原方案化疗2周期。采用 RECIST 标准1．0版评价疗效,化疗2周期后评价疗效及毒副反应,3．0版观察毒副反应。结果：23例患者均完成化疗,可评价疗效。完全缓解（CR）0例,部分缓解（PR）3例,疾病稳定（SD）9例,疾病进展（PD）11例;有效率（RR）为13．0％,疾病控制率（DCR）为52．2％,中位无进展生存时间为8．5个月,中位生存时间为16个月,主要毒副反应为限制性骨髓抑制,没有患者出现肾功能不全和过敏反应,2例出现Ⅳ级中性粒细胞减少及 1例出现Ⅳ级白细胞减少。结论：多西他赛联合吉西他滨方案二线治疗晚期复发转移性骨肉瘤疗效肯定,毒副反应可以接受。     

卡培他滨联合多西他赛或长春瑞滨治疗乳腺癌肝转移的临床观察及疗效分析

  目的  探讨含卡培他滨不同化疗方案治疗乳腺癌肝转移的疗效及不良反应。  方法  收集2000年1月至2011年12月中国医学科学院肿瘤医院收治的163例使用多西他赛/卡培他滨或长春瑞滨/卡培他滨治疗的乳腺癌肝转移患者,回顾性分析临床特点,探讨两种方案的不良反应及疗效。  结果  全组共纳入163例患者,接受多西他赛/卡培他滨治疗109例（66.9%）,长春瑞滨/卡培他滨组54例（33.1%）。多西他赛/卡培他滨组可评价疗效病例中CR 4例、PR 55例、SD 25例、PD 22例,不详3例,客观有效率为54.1%（59/109）,临床获益率77.1%（84/109）;长春瑞滨/卡培他滨组可评价疗效病例中CR 1例、PR 26例、SD 11例、PD 13例,不详3例,客观有效率为50.0%（27/54）,临床获益率为70.4%（38/54）。在3~4级血液学不良反应方面长春瑞滨/卡培他滨组发生率为42.6%（23/54）,3~4级非血液学不良反应主要表现为手足综合征1例（18.9%）、胃肠道反应2例（3.8%）,均高于多西他赛/卡培他滨治疗组。多西他赛/卡培他滨中位无疾病进展时间（progression free survival,PFS）为8个月,中位肝转移后生存（overall survival after liver metastases,LMS）为26个月,中位转移后生存（post metastasis survival,MSR）为30个月;长春瑞滨/卡培他滨组中位PFS为6个月,中位LMS为20个月,中位MSR为28个月。多西他赛联合卡培他滨方案在PFS、LMS以及MSR均较长春瑞滨联合卡培他滨方案延长,但无显著性差异。  结论  含卡培他滨化疗方案应用乳腺癌肝转移治疗耐受性良好,其中多西他赛/卡培他滨方案在疗效和耐受性方面可能优于长春瑞滨/卡培他滨方案。      

立体定向放射治疗联合吉西他滨与吉西他滨单药治疗局部晚期胰腺癌疗效比较

  [摘要]　　　目的 评价立体定向放射治疗联合吉西他滨与吉西他滨单药治疗局部晚期胰腺癌的疗效。方法 对治疗组56例胰腺癌患者行立体定向放射治疗(总剂量4000~4500CGY,10次分割)联合盐酸吉西他滨单药化疗(500mg/m2第1、8天)。对照组50例仅行盐酸吉西他滨单药化疗（500mg/m2第1、8、15天）。结果[给出各项主要数据] 治疗结束2个月CT复查,治疗组及化疗组局部控制率分别为98%、78%（P<0.05）,疼痛控制率分别为67%、17%（P<0.05）。治疗组中位PFS为14个月,较化疗组7.5个月明显延长（P<0.05）。治疗组与化疗组中位生存期分别为15.8、13.2个月（P>0.05）。结论 立体定向放射治疗联合吉西他滨治疗局部晚期胰腺癌较单纯化疗组近期疾病控制率较高,能延长患者无病生存期,显著提高患者的生存质量。     

多西他赛及吉西他滨分别联合顺铂治疗晚期非小细胞肺癌随机对照临床研究

背景与目的: 肺癌是当前世界最常见的恶性肿瘤之一,由于症状隐匿,往往就诊时已是晚期.本研究的目的是为了比较多西他赛及吉西他滨联合顺铂一线治疗晚期非小细胞肺癌的疗效和不良反应.方法: 103例晚期非小细胞肺癌患者随机分为2组.多西他赛组:多西他赛37.5 mg/m2,第一天、第八天,顺铂75 mg/m2,第一天至第三天.吉西他滨组:吉西他滨1 000 mg/m2,第一天、第八天,顺铂用量同前.化疗每3周重复,每周期评价不良反应,生活质量,两周期后评价疗效并随访生存期.结果: 多西他赛组有效率46%,1年生存率48%,3年生存率10%.吉西他滨组有效率43.4%,1年生存率47.2%,3年生存率9.4%(P>0.05).两组主要毒副作用为骨髓抑制、恶心、呕吐.结论: 一线治疗晚期非小细胞肺癌多西他赛和吉西他滨联合顺铂疗效高,生存期长.     

多西他赛或吉西他滨联合替吉奥二线治疗晚期食管鳞癌的临床疗效和安全性分析

目的 比较多西他赛或吉西他滨联合替吉奥二线治疗晚期食管鳞癌的临床疗效和安全性.方法 选取一线紫杉醇联合铂类化疗方案治疗失败或缓解后再进展的晚期食管鳞癌患者61例,根据二线化疗方案不同将患者分为多西他赛组和吉西他滨组,多西他赛组(n=31)给予多西他赛联合替吉奥治疗,吉西他滨组(n=30)给予吉西他滨联合替吉奥治疗.两组患者均每2个周期评价疗效,并对两组患者的疗效、不良反应发生情况、无进展生存情况进行比较.结果 多西他赛组和吉西他滨组患者的有效率(RR)分别为25.806%、16.667%,疾病控制率(DCR)分别为61.290%、56.667%,中位无进展生存期(PFS)分别为4.5个月、4.0个月,差异均无统计学意义(P>0.05).两组患者的主要不良反应均为血液学不良反应和消化道不良反应,经过对症治疗均可缓解,多西他赛组的中性粒细胞减少、血小板减少、乏力及皮疹的发生率低于吉西他滨组(P<0.05).结论 多西他赛或吉西他滨联合替吉奥药物作为二线化疗方案治疗晚期食管鳞癌疗效相当,但多西他赛相较吉西他滨可有效降低化疗不良反应发生率.     

吉西他滨联合多西紫杉醇治疗晚期软组织肉瘤

目的探讨吉西他滨联合多西紫杉醇治疗软组织肉瘤的疗效及毒性反应。方法 89例复发转移的晚期软组织肉瘤患者,采用吉西他滨900mg/m2静脉滴注90min,第1、8天;多西紫杉醇75mg/m2,静脉滴注60min,第8天;3周重复。分析肉瘤及5种组织学亚型患者的近期疗效、生存及影响因素。结果可评价近期疗效的82例患者中2例完全缓解,25例部分缓解,总有效率32.9%;平滑肌肉瘤和恶性纤维组织细胞瘤有效率分别为44.4%和40%,与其他组织学亚型之间差异有显著性（P=0.024）。83例患者可评价生存,1年生存率42.2%,2年生存率16.9%。结论吉西他滨联合多西紫杉醇是治疗复发转移晚期软组织肉瘤的有效方案,不同组织学亚型之间存在敏感性差异,毒性可以耐受。     

Gemcitabine and Docetaxel as a Second-Line Treatment in Advanced Soft Tissue Sarcomas

OBJECTIVE Promising anti-tumor activity in patients with metastatic or unresectable soft tissue sarcomas has been reported with gemcitabine and/or docetaxel.METHODS Forty patients with advanced soft tissue sarcomas refractorv to first-line chemotherapv treatment were enrolled.They received:combination of gemcitabine at dose of 900 mg/m2 on days 1 and 8 and docetaxel at dose of 100 mg/m2 on day 8,and had this regimen repeated every 3 weeks. If the patients had received the Delvic irradiation in advance. aemcitabine dose was reduced to 675 mg/m2 on days 1 and 8 and docetaxel to 75 mg/m2 on day 8,and had it repeated every 3 weeks. RESULTS Gemcitabine/ docetaxel combination was well tolerated by the patients with an overall response of 20%.After median follow-up of 15 months, a median overall survival time was 12 months(95% CI 7.042-16.958)and a median progression free survival time was 6 months(95% CI 5.445-6.545).The most common hematologic toxicity was neutropenia(47.5%)while mucositis was the most common non- hematologic toxicity(45%).The 1-and 2-year survival rates were 50% and 15%,respectively.CONCLUSION This regimen of gemcitabine/docetaxel combination as second-line treatment for the patients with advanced soft tissue sarcomas is effective with acceptable toxicities. These results should be evaluated in a large phase III trial.     

Gemcitabine combined with docetaxel for the treatment of unresectable pancreatic carcinoma

Purpose. To assess the efficacy and toxicity of combination therapy with gemcitabine and docetaxel in patients with unresectable pancreatic carcinoma. Patients and Methods. Thirty-four patients with unresectable stage III, IVA, and IVB pancreatic carcinoma were eligible for this study. The first 18 patients received gemcitabine 800 mg/m² intravenously (IV) on days 1, 8, and 15 and docetaxel 75 mg/m² IV on day 1, repeated every 28 days. Due to a high incidence of myelosuppression in this first group, the treatment schedule was modified in the remaining patients to gemcitabine 1,000 mg/m² IV and docetaxel 40 mg/m² IV on days 1 and 8 of a 21-day schedule. The primary study endpoints were objective response rate and duration of survival. Results. Ten of 33 evaluable patients achieved a partial response, for an overall response rate of 30.3% (95% CI, 16.21%-48.87%). Partial responses noted in the pancreas and a variety of metastatic sites were maintained for 4 to 12 months (median 6 months). Twelve additional patients (36%) experienced stable disease. The median time to progression was 6 months, and median survival was 10.5 months. The toxicity profile of the modified gemcitabine/docetaxel schedule was more favorable than that associated with the initial regimen, particularly with respect to hematologic toxicity. Conclusion. The response and survival data reported here for combination therapy with gemcitabine and docetaxel are encouraging given the poor prognosis associated with unresectable pancreatic cancer. These data suggest that gemcitabine plus docetaxel may be more effective than either agent alone in the treatment of pancreatic cancer and warrants further study.     

Gemcitabine and docetaxel as front-line chemotherapy in patients with carcinoma of an unknown primary site

BACKGROUND: The current study was performed to evaluate the efficacy and toxicity of a noncisplatin-based chemotherapy regimen combining gemcitabine and docetaxel as front-line chemotherapy for patients with carcinoma of an unknown primary site. METHODS: Patients were to receive intravenous gemcitabine at a dose of 1000 mg/m2 over 30 minutes on Days 1 and 8 and docetaxel at a dose of 75 mg/m2 over 1 hour on Day 8 in an outpatient setting. The schedule was repeated every 3 weeks for a maximum of 6 cycles. RESULTS: Thirty-five patients were assessable for response and survival. One complete and 13 partial responses were observed. The overall response rate was 40% (95% confidence interval, 28-52%). The median time to disease progression was 2 months (range, 1-4 months). The median overall survival time was 10 months (range, 0-32 months). Toxicity was reported to be manageable. CONCLUSIONS: The combination of gemcitabine and docetaxel was found to be active in patients with carcinomas of an unknown primary site. However, the overall outcome of these patients remains poor and novel treatment approaches are required.     

Docetaxel versus docetaxel plus gemcitabine as front-line treatment of patients with advanced non-small cell lung cancer: a randomized, multicenter phase III trial

To compare the overall survival (OS) of patients with advanced non-small cell lung (NSCLC) treated with either docetaxel plus gemcitabine or single-agent docetaxel. Chemotherapy-naive patients with advanced/metastatic NSCLC were randomly assigned to receive either DG [n=157; gemcitabine 1100mg/m(2) on days 1 and 8], docetaxel 75mg/m(2) on day 8 or D [n=155; docetaxel 100mg/m(2) on day 1] every 3 weeks. A total of 312 patients were evaluable for toxicity and response. A predefined interim intention-to-treat analysis showed significantly longer median OS (p=0.037) in favor of the DG regimen (9.4 months versus 8.3 months for DG and D regimens, respectively), resulting in the premature termination of the study. The DG regimen was also associated with a significantly higher response rate compared to D (26.8% versus 11.6%, p<0.001). TTP were 3.5 and 2.3 months for the DG and D regimen, respectively (p=0.054). Although there were two treatment-related deaths in the DG arm, the toxicity profiles of the two regimens were comparable. The DG regimen was associated with a significantly better quality of life. The efficacy of the docetaxel plus gemcitabine combination is superior to single-agent docetaxel in chemonaive patients with advanced NSCLC.     

Phase II trial of cisplatin, gemcitabine and treosulfan in patients with metastatic uveal melanoma

Gemcitabine plus treosulfan (GeT) is under investigation in metastatic uveal melanoma. In this phase II trial, cisplatin was added to a GeT regimen to investigate the efficacy and toxicity of two alkylating agents in combination with gemcitabine. Patients received 30 or 40 mg/m of cisplatin, 1000 mg/m of gemcitabine and 3000 mg/m of treosulfan on days 1 and 8. Therapy was repeated on day 29. A maximum of six cycles was administered. Nineteen patients were included in the trial, of whom 17 were evaluable for response. No objective response was observed; seven patients (41%) had stable disease and 10 (59%) progressed. The median progression-free survival of all 19 patients was 3.0 months [95% confidence interval (CI), 1.8-3.1]; the median overall survival was 7.7 months (95% CI, 1.9-13.8). Grade 3 and 4 thrombopenia and leucopenia occurred in eight and nine of the 19 patients, respectively. The addition of cisplatin to the GeT regimen results in excessive haematological toxicity without improvement in efficacy.     

Phase II trial of weekly docetaxel and gemcitabine for previously untreated, advanced non-small cell lung cancer

Docetaxel and gemcitabine combination chemotherapy has been reported to be active against non-small cell lung cancer (NSCLC) and myelosuppression is the most common dose-limiting toxicity. This prospective phase II study was designed to test the hypothesis that better tolerance and increased dose intensity might be achieved if patients are treated with weekly administration schedule. Thirty-five patients with stage IIIB/IV NSCLC and a performance status 0-2 received first-line chemotherapy with docetaxel 35mg/m2 and gemcitabine 600mg/m2 on days 1, 8 and 15. Treatment was repeated every 4 weeks, for up to 4 cycles. In total, 85 chemotherapy cycles were given (median, 2; range, 1-4). Other than the completion of all 4 planned cycles (n=6), the main reasons for treatment discontinuation were toxicity (n=15) and progressive disease (n=14). The most frequently encountered toxic effects were anemia (52% of patients), nausea and vomiting (60%), fatigue (71%) and anorexia (57%). One patient died of bilateral pneumonitis, which developed shortly after the administration of second cycle. Disease control (objective response and stable disease) in the intent-to-treat (ITT) population was achieved in 60% of patients and the overall response rate was 29% (95% CI, 14-44%). With a median follow-up duration of 13 months, the median progression-free survival and overall survival were 2.8 (95% CI, 0.7-4.8) months and 10.6 (95% CI, 7.0-14.3) months, respectively. In conclusion, weekly schedule of docetaxel and gemcitabine has modest activity with acceptable toxicity profile in advanced NSCLC, but as high frequency of early discontinuation occurred does not merit further study with the present regimen.     

Efficacy and toxicity of gemcitabine plus docetaxel combination as a second line therapy for patients with advanced stage soft tissue sarcoma

Purpose: To assess the safety and efficacy of a gemcitabine plus docetaxel regimen as a second line therapy for patients with advanced soft tissue sarcoma (STS) resistant to doxorubicin and ifosfamide-based therapy. Patients and Methods: Medical records of 64 patients with advanced STS who received gemcitabine plus docetaxel regimen as a second line treatment between May 2006 and June 2011 were examined. All patients had been previously treated with doxorubicin plus ifosfamide-based regimen at first line setting. Patients received gemcitabine 900 mg/m2 on days one and eight intravenously over 90 minutes, followed by docetaxel 75 mg/m2 on day eight intravenously over one hour. Cycles were repeated every 3 weeks. Results: The male-to-female ratio was 37/27 and the median age was 44 years (range; 19-67 years). Objective responses were observed in 13 (20.3 %) patients (2 CR, 11 PR) and stable disease in 21 (32.8 %). Total clinical benefit (CR+PR+SD) was observed in 34 (53.1 %). Median overall survival (OS) was 18 months (95% confidence interval (CI):12.1-23.9) and Median time to progression (TTP) was 4.8 months (95% CI: 3.6-6). A total of 243 cycles of chemotherapy were administered. The median number of cycle was 3 (range;1-11). The most common grade 3-4 hematologic toxicity was neutropenia (35.9 %). The most common nonhematologic toxicities consisted of nausea/vomiting (37.5 %), mucositis (32.8 %), peripheral neuropathy (29.7%), and fatigue (26 %). There was no toxicity-related death. Conclusion: The combination of gemcitabine plus docetaxel is an active and tolerable regimen as a second line therapy for patients with advanced soft tissue sarcoma who have failed doxorubicin and ifosfamide-based therapy.     

A phase II study of days 1 and 8 combination of docetaxel plus gemcitabine for the second-line treatment of patients with advanced non-small-cell lung cancer and good performance status

OBJECTIVE: We conducted a phase II trial to evaluate the efficacy and toxicity of a combination consisting of second-line docetaxel and gemcitabine in patients with advanced non-small-cell lung cancer (NSCLC) previously treated with platinum-based chemotherapy. PATIENTS AND METHODS: Eligibility criteria: histologically confirmed advanced NSCLC with progressive disease to platinum-based chemotherapy, ECOG performance status (PS) 0 or 1, and adequate kidney, liver and bone marrow function. Treatment consisted of docetaxel 36 mg/m(2) i.v. over 60 min followed by gemcitabine 1000 mg/m(2) i.v. over 30 min on days 1 and 8 of each 3-week cycle for a planned six cycles or unacceptable toxicity. RESULTS: Of the 52 patients enrolled, 50 were evaluable for response and toxicity. The mean age was 59 years (range 42-79), 46 male and 4 female. Histology subtypes were: adenocarcinoma 26 patients, bronchioloalveolar 1 patient, large cell carcinoma 5 patients, and squamous cell carcinoma 18 patients. Thirty-eight patients had ECOG PS 1 and 12 patients had PS 0. The median number of cycles administered was four (range 2-6). The overall response rate was 28%. The median follow-up was 9 months (range 5-34 months). The median survival time (MST) was 8.2 months (95% CI, 4-12%), and the 1-year survival was 25%. The median progression-free survival was 4.4 months (95% CI, 2-6%). In the Cox regression model, survival was only significantly affected by the PS. The median survival in patients with PS 0 was 17.8 months (95% CI, 18.8-21.8%) compared with a median survival for patients with PS 1 of 6.1 months (95% CI, 4.1-8.2%) (P=0.0057). Toxicity: three patients had grade 3 anemia, three patients had grade 3 thrombocytopenia, four patients had grade 3 neutropenia and only one patient developed grade 4 febrile neutropenia. Non-hematologic toxicity was also mild; the most frequent was asthenia, with grade 3 in eight patients (16%), and one patient with grade 4. CONCLUSION: This regimen of docetaxel in combination with gemcitabine in advanced second-line NSCLC is an active and safe regimen.     

Weekly docetaxel versus docetaxel/gemcitabine in the treatment of elderly or poor performance status patients with advanced nonsmall cell lung cancer: a randomized phase 3 trial of the Minnie Pearl Cancer Research Network

BACKGROUND: The aim of this study was to compare the efficacy of single-agent weekly docetaxel with the combination of docetaxel and gemcitabine in elderly and/or poor performance status patients with advanced nonsmall cell lung cancer (NSCLC). METHODS: Previously untreated patients with stage IIIB/IV NSCLC who were either >65 years old or had an Eastern Cooperative Oncology Group (ECOG) performance status 2 were eligible. Patients were randomized to receive weekly docetaxel (36 mg/m(2)) Days 1, 8, and 15 or docetaxel (30 mg/m(2))/gemcitabine (800 mg/m(2)) Days 1, 8, and 15. Both regimens were repeated on 28-day cycles for 6 cycles or until disease progression. RESULTS: Three hundred fifty patients were randomized, and 345 received treatment. The median age of patients was 74 years; 38% were >75 years old, and 35% had ECOG performance status 2. Intent-to-treat analysis showed median survivals of 5.5 months versus 5.1 months in the groups receiving docetaxel/gemcitabine versus weekly docetaxel, respectively (P = .65). There were no survival differences detected with docetaxel/gemcitabine versus weekly docetaxel in the 223 patients with good performance status (7.2 months vs 8.0 months, respectively) or in the 122 poor performance status patients (3.8 months vs 2.9 months, respectively). Median time-to-progression was longer in patients who received docetaxel/gemcitabine (4.8 months vs 2.9 months; P = .004). Both regimens were generally well tolerated. CONCLUSIONS: Treatment with docetaxel/gemcitabine produced a modest improvement in time-to-progression but had no impact on survival when compared with single-agent weekly docetaxel in this group of patients. Results with both regimens were disappointing, particularly in patients with poor performance status. Improved treatment for these patients will require the introduction of novel, well-tolerated, targeted agents.