草酸铂联合异长春花碱治疗晚期NSCLC

目的研究草酸铂(Oxaliplatin,LOHP)联合异长春花碱(Vinorelbine,NVB)组成的NO方案治疗晚期非小细胞肺癌(nonsmallcelllungcancer,NSCLC)的近期、远期疗效和毒副反应。方法77例均为晚期NSCLC患者。化疗方案:LOHP130mg/m2,静滴,第1天;NVB25～30mg/m2,静注,第1、8天,3～4周为1周期。结果有效率为33.78%,临床受益反应率77.03%;初治与复治有效率分别为39.29%和16.67%,差异有显著性意义(P<0.05),初治与复治的临床受益反应率差异有非常显著性意义(P<0.01);治疗后中位缓解期为22周;中位生存期为40周;一年生存率为39.19%。主要毒副反应是:Ⅰ～Ⅱ度周围神经炎发生率为44.59%,静脉炎发生率为78.38%,Ⅲ～Ⅳ度恶心/呕吐发生率仅4.05%。结论NO方案治疗晚期NSCLC有较好的近期疗效和远期疗效,组临床受益反应率较高,恶心/呕吐和骨髓抑制轻,可作为晚期NSCLC的一线化疗方案。     

长春瑞滨联合卡培他滨治疗转移性乳腺癌30例临床观察

目的观察长春瑞滨联合卡培他滨对蒽环类药物治疗后无效或复发的转移性乳腺癌的疗效.方法转移性乳腺癌患者30例,长春瑞滨20 mg/m2第1天和第8天静脉滴注,卡培他滨每天1 250 mg/m2,分早晚两次服用,连续服用2周,3周为一个周期.结果 CR 1例(33.3%),PR 7例(23.3%),MR 7例(23.3%),SD 7例(23.3%),PD 8例(26.7%),有效率达49.9%,中位缓解期4.6个月(2～13个月).常见的不良反应为骨髓抑制、胃肠道反应、手足综合征、神经毒性等.结论长春瑞滨联合卡培他滨对蒽环类药物治疗后失败的转移性乳腺癌有较好的疗效,毒性可以耐受.     

A phase II trial of vinorelbine and intensive temozolomide for patients with recurrent or progressive brain metastases

Purpose To investigate the efficacy and safety of the combination of vinorelbine and intensive temozolomide for recurrent or progressive brain metastases from solid tumors. Methods Patients ≥18 years of age and with Karnofsky performance scale (KPS) ≥ 60, adequate organ function and progressive or recurrent brain metastases were eligible. This was a phase II trial with 28-day cycles using temozolomide (150 mg/m², days 1–7 and 15–21) and vinorelbine 25 or 30 mg/m² on days one and eight. The primary endpoint was objective radiographic response. Results Thirty-eight patients (15 men, 23 women) with a median age of 57 years (range, 39–75) and median KPS of 80 were enrolled. The primary tumor sites were lung (n = 20), breast (n = 11), colorectal (n = 2), kidney (n = 2), bladder (n = 1), endometrium (n = 1), head and neck (n = 1). Prior therapies included chemotherapy (97%), whole-brain radiation therapy (79%), brain metastasis resection (53%) and stereotatic radiosurgery (47%). Objective radiographic response rate was 5% (one complete response and one minor response); five patients had stable disease, 29 progressive disease and two patients were not evaluable. Twenty-nine patients (76%) have died and the median follow-up of survivors was six months. Median progression-free and overall survivals were 1.9 and 5 months, respectively. Grade 3/4 toxicities were mainly hematological and two patients discontinued the study due to myelosuppression. Conclusions In this heavily pretreated population of patients with brain metastases, adding vinorelbine and increasing the intensity of temozolomide do not improve response rates compared to previous studies with single-agent temozolomide at standard doses.     

Sequential vinorelbine–capecitabine followed by docetaxel in advanced breast cancer: long-term results of a pilot phase II trial

Purpose To evaluate the response rate of the combination of capecitabine (C) and vinorelbine (V) followed by Docetaxel (D) in the 1st line treatment of advanced and metastatic breast cancer patients. Patients and methods Patients with measurable disease and no prior chemotherapy in advanced disease were eligible. Pts received V 25 mg/m² on day 1 and 8 in combination with C 825 mg/m² twice a day from day 1 to 14 every 3 weeks for four cycles followed by 12 consecutive weeks of D 25 mg/m²/w. Results Between March 2002 and November 2003, 40 patients were enrolled. Median age was 57 years. Of patients, 77.5% of pts had visceral involvement and 32.5% had more than two metastatic sites. In the adjuvant setting, 62.5% received anthracycline and 10% Taxanes. In the intent-to-treat population, an overall objective response was observed in 25 patients (62.5, 95% CI, 45.8–77.27) and stable disease in 5 (12.5%). Median time till progression (TTP) was 12.3 months (range 1.5–48; 95% CI, 10.05–14.54). The median survival was 35.7 months (range 2–47). Reported grade 3–4 toxicities under Navcap were neutropenia (4 pts), anemia (1 pt), thrombopenia (1 pt) and febrile neutropenia (3 pts). Reported grade 3–4 toxicities under weekly Docetaxel were neutropenia (1 pt), thrombopenia (2 pts), leucopenia (1 pt) and anemia (1 pt). Conclusion The sequential use of Navcap followed by weekly Docetaxel demonstrated an interesting efficacy with a prolonged TTP and OS and warrants further evaluation. This study was supported in part by Institut de Recherche Pierre-Fabre and by sanofi-aventis.     

盖诺持续静脉输注治疗非小细胞肺癌（附41例报告）

目的：观察国产长春瑞宾（盖诺）持续120h静脉输注加顺铂（或卡铂）联合治疗晚期非小细胞肺癌（NSCLC）的疗效。方法：盖诺首剂10mg加入NS 40ml中静推,然后将盖诺10mg加入NS 500ml中持续静脉输注24小时,连续5天,共120小时,盖诺总剂量60mg。治疗NSCLC 41例,逻辑性8例,女性13例;肺腺癌31例,鳞癌10例。19例初治,22例复治。结果：CR2例,PR18例,总有效率为48．8％,中位生存期39周,一年生存率为36．6％,中位进展时间21周。剂量限制性毒性为骨髓抑制,白细胞下降为85．1％,其中Ⅲ-Ⅳ度为21．8％（22／101）,血小板和血红蛋白亦有不同程度的下降。结论：盖诺持续120h静脉输注治疗NSCLC有效率高,毒性可以耐受,值得临床进一步研究。     

长春瑞滨和顺铂联合同步放疗治疗局部中晚期非小细胞肺癌的疗效观察

目的评价国产长春瑞滨(盖诺)和顺铂联合同步放疗治疗中晚期非小细胞肺癌的疗效及毒副反应。方法106例Ⅲ期NSCLC患者,分为二组,化放组在放疗的同时及放疗后进行4周期化疗,化疗用药盖诺25mg/m2在每个周期的第1d、第8d静脉滴注给予;顺铂100mg/m2第1d静脉滴注。单放组行单纯放疗。结果化放组有效率71.4%,单放组有效率为42.0%。化放组的有效率明显高于单放组(P<0.05)。化放组和单放组的1、2年生存率分别为77.39%、30.33%和58.65%、15.75%,中位生存时间分别为18个月和13个月,其差异有显著性(P<0.05)。结论盖诺和顺铂联合同步放疗是治疗晚期非小细胞肺癌的安全有效的治疗方法,值得进一步临床研究。     

奥沙利铂联合长春瑞滨治疗晚期非小细胞肺癌临床疗效观察

目的价奥沙利铂联合长春瑞滨治疗晚期非小细胞肺癌的疗效和不良反应。方法化疗方案:长春瑞滨25mg/m2静脉滴注第1、8天,奥沙利铂130mg/m2静脉滴注第2天,3周重复。治疗2个周期后评价疗效。结果全组28例,CR1例(3.5%),PR9例(32.1%),NC8例(28.6%),PD10例(35.7%),总有效率(CR PR)35.7%;中位生存期8.4个月;中位缓解期4.8个月;1年生存率为38.9%。不良反应以骨髓抑制、静脉炎及消化道反应为主。结论沙利铂联合长春瑞滨治疗晚期非小细胞肺癌疗效确切,不良反应轻,值得临床进一步研究。     

Promising new agents in the treatment of non-small cell lung cancer

 A number of new drugs and drug classes have recently become available for clinical testing which demonstrate significant antitumor activity in non-small cell lung cancer. The preclinical rationale, mechanism of action, toxicity profile and results of early trials of paclitaxel, docetaxel, edatrexate, CPT-11, topotecan, vinorelbine and gemcitabine in non-small cell lung cancer are reviewed. Received: 6 January 1995/Accepted: 14 May 1995     

Clinical investigation of isosorbide mononitrate plus vinorelbine and cisplatin in patients with previously untreated advanced stage non–small-cell lung cancer

Objective To investigate the efficacy and safety of isosorbide mononitrate sustained release tables plus vinorelbine and cisplatin in patients with previously untreated advanced stage non–small-cell lung cancer (NSCLC). Methods 110 patients with stage ⅢB-Ⅳ NSCLC were randomly assigned to group A(57 cases) and group B(53 cases). Patients in group A were treated with vinorelbine 25 mg/m² on days 1 and 8 and cisplatin 25 mg/m² on day 2-4, with transdermally applied isosorbide mononitrate sustained release tables (40 mg, daily for 8 days) , and patients in group B were treated with vinorelbine and cisplatin. Response to treatment was assessed by RECIST1.1 and adverse effect was assessed by NCI-CTC（3.0）. Results The response rate in group A (58.2%, 32/55 patients) was significantly higher than that for patients in group B (30.8%, 16/52 patients; χ²=8.120, P=0.004). Median TTP and median OS in group A were longer than those in group B (8.2 v 5.8 months, χ²=10.684, P=0.001; 11.6 v 9.0 months, χ²=11.231, P=0.001). While，patients with squamous carcinoma showed better response to chemotherapy (RR=2.438, 95%CI 1.136-5.231, P=0.022). Adverse effect difference was not significant between group A and group B, except headache. The rate of grade 1 to 2 headache in group A (34.5%; 19 of 55 patients) was significantly higher than that in group B (3.8%; 2 of 52 patients; P<0 .001). Conclusion Use of isosorbide mononitrate sustained release tables combined with vinorelbine and cisplatin may improve overall response, TTP and OS in patients with advanced stage NSCLC.     

Phase I/II Trial of Vinorelbine and Sorafenib in Metastatic Breast Cancer

PurposeWe investigated the efficacy and toxicity of sorafenib, a multikinase inhibitor of vascular endothelial growth factor receptor tyrosine kinase, in combination with vinorelbine therapy in a phase I/II trial in patients with metastatic breast cancer.Patients and MethodsWe enrolled 11 patients in the phase I portion to determine the maximum tolerated dose (MTD) of the combination, followed by 35 extra patients treated at the MTD in phase II. The median age of patients was 54 years old (range, 31-72 years old). Tumors were estrogen receptor and progesterone receptor (ER/PR) positive in 54% (22/54) of patients, and triple negative (ER⁻, PR⁻, HER2⁻) in 41% (17/54) of patients. Of all patients, 22% received sorafenib and vinorelbine as first-line therapy, 37% as second-line therapy, and 41% as third-line therapy.ResultsIn total, 41 patients were treated at the MTD (6 during phase I; 35 in phase II). The observed 44% 4-month progression-free survival rate was similar to the estimated historical rate of 43% with vinorelbine treatment. The combination was tolerated with expected toxicities. Patients treated at the MTD who had received prior bevacizumab treatment received a median of 1.5 cycles (range, 1-10 cycles) compared with a median of 5 cycles (range, 2-12 cycles) for patients without prior bevacizumab treatment.ConclusionFurther evaluation of vinorelbine and sorafenib in bevacizumab-naive patients may be of interest if specific biomarkers guiding patient selection can be identified.