以奈达铂为主联合方案治疗非小细胞肺癌的临床观察

目的:观察3种含奈达铂联合化疗方案治疗中晚期非小细胞肺癌(NSCLC)的短期疗效及毒副反应.方法:应用含奈达铂联合化疗方案治疗20例非小细胞肺癌.化疗2周期后按WHO标准进行评价.结果: 入组20例均可以进行疗效评价, 其中完全缓解2例,部分缓解7例,稳定12例,进展1例.总有效率45.0%.毒副作用以骨髓抑制为主,但Ⅰ～Ⅱ度占多数,其中白细胞下降发生率85.0%,Ⅲ～Ⅳ度为35.0%;血小板下降为40.0%,Ⅲ～Ⅳ度为25.0%,经相应处理均可恢复,并不影响下一周期的化疗.未出现严重的肝肾功能损害的现象.胃肠道反应均为Ⅰ～Ⅱ度.结论:以奈达铂为主的3组联合化疗方案经临床初步观察有一定疗效且毒性患者可耐受,但应进一步观察研究奈达铂联合方案对NSCLC的生存率的影响.     

低剂量吉西他滨联合奈达铂治疗晚期非小细胞肺癌疗效观察

目的：探讨低剂量持续静脉滴注吉西他滨联合奈达铂作为晚期非小细胞肺癌的疗效、不良反应、耐受性。方法：对40例晚期非小细胞肺癌患者使用低剂量吉西他滨联合奈达铂方案化疗：吉他西滨250 mg.（m^2）^-1静滴6 h,第1、8天;奈达铂80 mg.（m^2）^-1静滴,第1天,每4周为1疗程;连续使用2个疗程后评价。结果：40例总有效率（CR＋PR）为37.5%;不良反应主要为骨髓抑制（特别是血小板下降）、外周神经毒性,但恶心和呕吐较轻。结论：低剂量持续静脉滴注吉西他滨联合奈达铂是治疗晚期非小细胞肺癌可行的化疗方案之一。     

高效液相色谱法测定注射用卡铂和奈达铂的含量

目的 建立同时测定注射用卡铂和奈达铂的液相测定方法.方法 采用RP-HPLC进行测定.采用Kromasil-NH2柱(4.6mm×250mm,5μm),流动相为0.01 mol·L-1枸橼酸(三乙胺调节pH值至6.0)-乙腈(70∶30),检测波长为210nm,外标法.结果 峰面积与浓度线性关系良好,卡铂和奈达铂的回归方程分别为:y=1E 07x 36454,r=0.9999;y=1E 07x 78792,r=0.9997.两者的回收率和RSD分别为:99.75%(n=9),0.5%;99.82%(n=9),0.47%.结论 该方法操作简便、结果准确、重现性好.     

奈达铂联合低剂量氟尿嘧啶持续静脉输注治疗晚期食管癌

目的观察国产奈达铂（NAP）＋低剂量氟尿嘧啶（5-Fu）持续静脉输注治疗晚期食管癌的疗效和毒副作用。方法晚期食管癌28例接受奈达铂＋5-Fu联合方案化疗,奈达铂30 mg/m^2,第1-3天;5-Fu 250 mg/m^2,持续静脉输注10天,28天为1周期,至少治疗2个周期。结果完全缓解2例,部分缓解11例,稳定10例,进展5例,总有效率46.4%,中位TTP 8.2月。主要毒副作用为骨髓抑制,Ⅲ＋Ⅳ度白细胞下降,血小板下降分别为28.6%,21.4%,胃肠道、肝、肾毒性轻微,多为Ⅰ-Ⅱ度。结论奈达铂联合低剂量氟嘧啶持续静注治疗晚期食管癌,有较好疗效,毒性小,具有临床应用价值。     

紫杉醇联合5-氟尿嘧啶、奈达铂治疗晚期食管癌的临床观察

目的:观察紫杉醇(PTX)联合5-氟尿嘧啶(5-Fu)、奈达铂(NDP)治疗晚期食管癌的近期疗效和不良反应。方法:晚期食管癌患者35例,紫杉醇135~175mg/m2,静脉滴注,第1天;奈达铂80~100mg/m2,加入生理盐水500ml中静滴2h,第2天;5-Fu 500mg/m2,静脉滴注,第1天~第5天;21d为1周期,连用2个周期后评价疗效。结果:全组35例可评价疗效,总有效率60.0%(21/35),完全缓解2例,部分缓解19例,中位生存期为9.7个月(3.5~22个月),中位缓解时间为4.6个月(3~7个月),主要不良反应为骨髓抑制所致的血小板及白细胞减少,消化道反应轻,未发现肝肾功能损害。结论:紫杉醇联合5-氟尿嘧啶、奈达铂治疗晚期食管癌近期疗效高,耐受性好,值得进一步观察应用。     

Combination of nedaplatin and vindesine for treatment of relapsed or refractory non-small-cell lung cancer

Purpose: A phase II study of nedaplatin and vindesine was conducted to evaluate their efficacy and safety for treatment of relapsed or refractory non-small-cell lung cancer (NSCLC). Methods : Between August 1996 and September 1998, 48 patients who had previously received chemotherapy, thoracic radiotherapy, and/or surgery were enrolled in the study. Patients were required to have an Eastern Cooperative Oncology Group performance status of 0 to 2 and an age between 20 and 79 years. Treatment consisted of nedaplatin (80 mg/m², day 1) and vindesine (3 mg/m², days 1 and 8) every 3 to 4 weeks. Results: Of 48 patients, 7 (14.6%) exhibited an objective response. Four (50%) of eight chemotherapy-naive patients had a partial response. However, of the 40 patients who had received prior chemotherapy, a partial response was observed in only 3 (7.5%). At a median follow-up time of 85.1 weeks, the median survival time was 43.6 weeks (95% confidence interval 34.4–52.7) for patients who had received chemotherapy, with a survival rate of 40% at 1 year. Grade 3 or 4 neutropenia occurred in 43 of 48 patients (90%), and neutropenic fever was observed in 3 of the 43 patients, one of whom died of sepsis. Pharmacokinetic and pharmacodynamic analyses of platinum were performed in 43 patients during the first cycle of chemotherapy. Percent reduction in absolute neutrophil count was correlated not only with the area under the plasma ultrafilterable platinum concentration versus time curve (r=0.41, P=0.007) but also with the duration of ultrafilterable platinum concentration above 1 μg/ml (r=0.41, P=0.007). Patients with progressive disease exhibited a shorter duration of ultrafilterable platinum concentration over 1 μg/ml (P=0.046) than those with other responses. Conclusion: A combination of nedaplatin and vindesine was unsatisfactory as second-line chemotherapy for NSCLC, although the combination was well tolerated. The duration of ultrafilterable platinum concentration above 1 μg/ml was an important pharmacokinetic parameter for predicting both chemotherapy-induced neutropenia and treatment outcome. Received: 4 November 1999 / Accepted: 28 April 2000     

奈达铂联合长春瑞滨治疗非小细胞肺癌临床观察

目的观察国产奈达铂(捷佰舒)联合长春瑞滨组成NN方案治疗非小细胞肺癌的疗效和毒副反应。方法32例均经病理组织学或细胞学检查证实的非小细胞肺癌,应用奈达铂80~100mg/m2,d1,长春瑞滨25mg/m2,d1、d8,静脉滴注,21天为1周期,至少2周期。结果32例患者中,CR2例,PR15例,NC9例,PD6例,总有效率(CR PR)53.12%(17/32)。奈达铂主要毒副反应为骨髓抑制(白细胞下降Ⅲ度和Ⅳ度分别为18.75%和12.50%)和胃肠道反应(恶心、呕吐Ⅲ度和Ⅳ度分别为6.25%和0)。结论奈达铂联合长春瑞滨组成的NN方案治疗非小细胞肺癌耐受性好,疗效与第三代化疗方案相当。     

奈达铂联合氟尿嘧啶治疗晚期食管肿瘤的近期疗效观察

目的:探讨奈达铂(NDP)联合氟尿嘧啶(5-FU)组成NF方案治疗晚期食道肿瘤的近期疗效和毒副反应。方法:64例病人随机分为NF方案组和PF方案组各32例,前者接受NDP 5-FU化疗,后者予顺铂(PDD) 5-FU,即PF方案化疗,根据WHO标准评价疗效和毒副反应。结果:NF方案组有效率为56·2%,PF方案组有效率50%;骨髓抑制:NF方案组白细胞减少为56·2%,PF方案组为50%,其中血小板减少在NF方案组为12·5%,而PF方案组为0,胃肠道反应两组发生率分别为25%和50%。结论:奈达铂联合氟尿嘧啶组成的NF方案治疗晚期食道肿瘤毒副作用小,疗效较高,值得临床上进一步推广应用。     

Retrospective analysis of 27 consecutive patients treated with docetaxel/nedaplatin combination therapy as a second-line regimen for advanced esophageal cancer

Background The aim of this study was to evaluate the efficacy and safety of combination therapy with docetaxel and nedaplatin in advanced esophageal cancer as a second-line regimen in an outpatient setting. Methods Twenty-seven consecutive patients with advanced esophageal cancer who received docetaxel/nedaplatin combination therapy as a second-line regimen were retrospectively evaluated. The combination therapy consisted of intravenous administration of docetaxel 30 mg/m² and nedaplatin 40 mg/m² every 2 weeks. Results The patients received a median of 7.4 cycles of treatment (range, 2–25 cycles ). No complete response was observed, and 3 of the 27 patients (11%) achieved partial responses. The disease control rate (partial response + stable disease) was 52%. The median survival time (MST) was 11.4 months. Severe hematological adverse events (grade 3–4) were: neutropenia (n = 10; 37%) and anemia (n = 5; 19%); there was neither febrile neutropenia nor grade 3-4 thrombocytopenia. Furthermore, no severe nonhematological adverse events or treatment-related deaths were observed. Conclusion Combination therapy of docetaxel with nedaplatin was safe and well tolerated; however, the development of more effective therapy is warranted to improve the prognosis of esophageal cancer.     

Complete response to irinotecan hydrochloride and nedaplatin in a patient with advanced ovarian clear cell carcinoma

A 55-year-old multiparous woman was diagnosed with stage IIIc ovarian clear cell carcinoma. Three years after the first surgery and adjuvant chemotherapy with irinotecan hydrochloride and mitomycin C, she developed common iliac lymph node recurrence. Two cycles of chemotherapy with irinotecan hydrochloride and nedaplatin led to a complete response. Surgical resection revealed pathological complete response. The chemosensitivity of ovarian clear cell carcinoma has been reported to be very poor. No standard chemotherapeutic regimens for this carcinoma have been established. The present study is the first report of a pathological complete response in a patient with advanced ovarian clear cell carcinoma. Future studies are needed to confirm the efficacy of this regimen for this carcinoma.