拓扑替康治疗小细胞肺癌Ⅱ期临床研究

目的：观察围产拓扑替康单药二线治疗复发性小细胞肺癌（small cell lung cancer,SCLC)和与顺铂联合方案治疗初治SCLC的疗效及毒性。方法：采用多中心开放式研究方法,在100例病例中有97例符合人组条件,其中采用拓扑替康单药治疗的复发SCLC38例,用药方法为拓扑替康1．25mg/(m^2.d)连用5天,每3周一疗程;拓扑替康与顺铂联合用于初治SCLC病例59例,顺铂80mg/(m^2.d)d1,拓扑替康1mg/(m^2.d),连用5天,每3周一疗程。结果：拓扑替康单药用于复发SCLC有效率为37．5％,其中CR3．1％,34．4％,与顺铂联合用于初治SCLC细胞缺乏,Ⅲ-Ⅳ度血小板下降31．6％,而联用药组Ⅲ-Ⅳ度中性粒细胞缺乏61．0％,Ⅲ-Ⅳ度血小板下降39．0％,非血液学毒性较轻,结论：拓扑替康是治疗SCLC的有效药物之一,联合顺铂后可提高疗效,拓扑替康的主要毒副反应为血液学毒性。     

拓扑替康治疗小细胞肺癌的临床疗效观察

目的探讨以拓扑替康(Topotecan)为主联合方案治疗小细胞肺癌(SCLC)的疗效及安全性.方法初治和复治患者30例,拓扑替康1.20 mg/(m2*d),静脉滴入30 min,1次/d,连用5 d,21 d为1个周期.2个周期评价疗效,1个周期可评价不良反应.结果在30例患者中,CR 4例,PR 15例,有效率63.3%.主要不良反应为骨髓抑制,非血液学毒性较轻微,一般均可耐受.结论以拓扑替康为主联合化疗方案治疗SCLC有效,可作为SCLC一线或二线用药,局限期疗效优于广泛期.     

拓朴替康治疗小细胞肺癌的临床观察

目的:探讨以拓朴替康联合顺铂方案治疗小细胞肺癌(SCLC)的疗效及安全性.方法:观察组60例,化疗方案为TP(拓朴替康 顺铂).拓朴替康1.20mg/m2/d,静滴30min,每日1次,连用5日;DDP 80mg/m2iv gtt,分3天使用.对照组60例,化疗方案为PE(VP-16 顺铂).VP-16 100mg/m2 iv gtt,d1,3,5;DDP 80mg/m2iv gtt,分3天使用.21天为1周期,2个周期评价疗效,1个周期评价不良反应.结果:观察组CR 8例,PR 30例,有效率63.3%,主要不良反应为血液学毒性,非血液学毒性较轻微,一般均可耐受.对照组CR 6例,PR 34例,有效率66.7%.两组间疗效及不良反应均无显著性差异(P＞0.05).结论:拓朴替康联合顺铂化疗方案治疗SCLC有效,局限期疗效优于广泛期.     

上腔静脉综合征24例近期疗效观察

目的 观察拓扑替康、多西紫杉醇分别联合顺铂治疗肿瘤上腔静脉综合征24例的近期疗效和患者不良反应.方法 小细胞肺癌(SCLC)组:拓扑替康1 mg/m2,静脉滴注,第1天至第5天,顺铂30 mg/m2,静脉滴注,第1天至第3天;非小细胞肺癌(NSCLC)组:多西紫杉醇75 mg/m2,静脉滴注,第1天,顺铂30 mg/m2,静脉滴注,第1天至第3天,每3周重复,连用3个周期后评价疗效.结果 SCLC组,完全缓解(CR)4例,部分缓解(PR)5例,CR率36.4%,总有效率81.9%;NSCLC组CR 5例,PR 6例,CR率38.5%,总有效率84.7%.24例治疗后CR率为37.5%,总有效率为83.3%.两种化疗方案患者的主要不良反应均为骨髓抑制和胃肠道反应.结论 SCLC组选用拓扑替康加顺铂,NSCLC选用多西紫杉醇加顺铂,治疗肺癌并上腔静脉综合征化疗方案安全有效,值得临床进一步研究.     

伊立替康联合顺铂治疗广泛期小细胞肺癌的临床观察

为了观察伊立替康联合顺铂治疗广泛期小细胞肺癌(SCLC)的近期疗效及毒副反应,对28例患者采用伊立替康联合顺铂治疗的方法.伊立替康 60 mg/m2,静脉滴入,d1、d8、d15;顺铂 60 mg/m2 ,静脉滴入,d1.28 d 为1个周期,2个周期后评价疗效. 结果可评价疗效28例,其中CR 6例(21.4%),PR 12例(42.9%),NC 4例(14.3%),PD 6例(21.4%),总有效率为64.3%(18/28).主要毒副反应为腹泻、骨髓抑制、恶心和呕吐.初步结果提示,伊立替康联合顺铂治疗SCLC有明显的疗效,毒副反应可以耐受,可以作为SCLC临床治疗的有效方案之一.     

拓扑替康联合顺铂治疗晚期非小细胞肺癌28例近期疗效观察

目的　观察拓扑替康联合顺铂治疗晚期非小细胞肺癌的近期疗效。方法　拓扑替康 1mg/m2 ,静脉点滴 ,第 1～ 5天 ;PDD 3 0mg/m2 ,静脉点滴 ,第 1～ 3天。每 2 1天为 1个周期 ,连用 2个周期后评价疗效。结果　CR 2例 ,PR 13例 ,总有效率CR PR 5 3 6%。本方案主要的毒副反应是骨髓抑制和胃肠道反应。结论　拓扑替康联合顺铂是一个安全、有效的治疗晚期非小细胞肺癌的临床方案。     

拓扑替康与顺铂联合化疗结合同步放疗治疗晚期食管癌37例疗效观察

目的:观察国产拓扑替康(金喜素)与顺铂联合化疗结合同步放疗治疗晚期食管癌的疗效。方法:拓扑替康0.75mg/m2与顺铂20mg/m2静脉滴注连用5d,21d为1周期,连用至少2周期,结合60Co同步放射治疗食管原发灶及纵隔DT 61Gy/5 W,锁骨上等转移灶DT 60Gy/6W,化疗结束后48h常规使用集落刺激因子G-CSF 150μg/d,连用7~10d,治疗结束后4周评价疗效。结果:37例可评价疗效的患者中,完全缓解(CR)18例,部分缓解(PR)10例,微效(MR)3例,5例无效或进展。总有效率为75.6%(28/37),1年生存率为70.3%(26/37),2年生存率为51.4%(19/37),3年生存率为24.3%(9/37)。主要毒副反应为II~III度骨髓抑制、放射性食管反应、恶心、呕吐、便秘与脱发。结论:拓扑替康(金喜素)与顺铂联合化疗结合同步放疗治疗晚期食管癌的疗效好,毒副作用轻。     

拓扑替康联合顺铂治疗小细胞肺癌的近期疗效

目的　观察拓扑替康加顺铂联合方案对小细胞肺癌的疗效和毒性反应。方法　经病理组织学或细胞学证实的 2 6例小细胞肺癌应用拓扑替康 1.2 5mg/(m2 ·d) ,连用 5天 ,顺铂 2 5mg/(m2 ·d) ,连用 3天 ,2 1天为一周期 ,至少应用 2个周期。结果　全组 2 6例可评价病例中 ,CR 3例 ,PR 11例 ,SD 7例 ,PD 5例 ,总有效率为 5 3.8%。 12例初治患者中 ,CR 2例 ,PR 7例 ,SD 2例 ,PD 1例 ,有效率为 75 .0 % ;14例复治患者中 ,CR 1例 ,PR 4例 ,SD 5例 ,PD 4例 ,有效率为 35 .7%。 5例脑转移患者中 1例获PR。中位生存期 2 7周 ,1年生存率为 38.5 % ( 10 /2 6 )。主要不良反应为骨髓抑制。结论　拓扑替康联合顺铂治疗小细胞肺癌有较好的近期疗效 ,不良反应可耐受     

拓扑替康联合顺铂治疗小细胞肺癌疗效观察

目的:探讨拓扑替康(topotecan,TPT)联合顺铂(DDP)治疗小细胞肺癌(smallcelllungcancer,SCLC)的疗效。方法:35例初治SCLC患者应用TPT1mg/(m2·d),静脉滴入30min;联合DDP20mg/(m2·d),静脉滴入,连用5d,每3周为1个周期,2～3个周期后评价疗效和不良反应。结果:TPT与DDP联合用于初治SCLC有效率为74.3%(26/35),其中CR20.0%(7/35),PR54.3%(19/35)。主要不良反应为骨髓抑制,其中Ⅲ～Ⅳ度中性粒细胞缺乏为54.3%(19/35),Ⅲ～Ⅳ度血小板下降为34.3%(12/35),Ⅲ～Ⅳ度血红蛋白下降为20.0%(7/35),非血液学毒性较轻。结论:TPT联合DDP是治疗SCLC疗效较好方案,主要不良反应为血液学毒性。     

拓扑替康联合顺铂治疗晚期非小细胞肺癌近期疗效观察

目的观察拓扑替康联合顺铂治疗晚期非小细胞肺癌近期疗效及毒性。方法拓扑替康1.2mg/(m2.d),d1~5,顺铂20 mg/(m2.d),d1~5,3周为1周期。结果有效率为51.35%,其中CR 2例,PR 17例;毒副反应主要为骨髓抑制,Ⅲ~Ⅳ度白细胞下降率为40.54%,Ⅲ~Ⅳ度消化道反应为8.11%。结论拓扑替康联合顺铂治疗晚期非小细胞肺癌有效率高,主要毒副反应是骨髓抑制,可以作为治疗晚期非小细胞肺癌常规方案推广。     

拓扑替康和卡铂新辅助化疗结合手术治疗16例小细胞肺癌的临床观察

目的:探讨拓扑替康为主的新辅助化疗和手术治疗小细胞肺癌的临床疗效及特点.方法:从2002年10月至2004年2月对16例小细胞肺癌患者进行术前化疗,拓扑替康1.5mg/(m2·d),连用5天,卡铂400mg/(m2·d),用1天,共化疗2个周期.休息4周后进行手术治疗.结果:化疗后疗效评价为完全缓解1例,部分缓解6例,好转6例,稳定2例,病变进展1例.临床缓解率为43.8%.2例全肺切除,14例肺叶切除加淋巴结清扫术.手术后1年生存率为75.0%,其中4例1年内死亡.结论:拓扑替康加卡铂新辅助化疗后,手术治疗的疗效优于单一方法治疗,患者可以耐受此方案化疗的不良反应,近期疗效肯定,为提高长期生存率提供了条件.     

周剂量多西紫杉醇联合顺铂、氟尿嘧啶二线治疗晚期胃癌32例

[目的]研究周剂量多西紫杉醇（TXT）联合顺铂（DDP）、氟尿嘧啶（5-Fu）持续滴注二线治疗晚期胃癌的疗效和不良反应。[方法]32例晚期胃癌患者接受DCF方案二线化疗：TXT30mg/m2,d1,8,15,DDP25mg/m2,d1～3,5-Fu500mg/m2持续静脉滴注,d1～5,28d为1个周期。至少完成2个周期后评价有效率、不良反应、疾病进展时间（TTP）和总生存时间（OS）。[结果]32例患者均可评价疗效,客观缓解率21.9%（7/32）,中位TTP及OS分别为2.7个月和7.6个月。主要不良反应为骨髓抑制、胃肠道反应和脱发。[结论]周剂量TXT联合DDP、5-Fu持续滴注二线治疗晚期胃癌疗效显著,不良反应可以耐受。     

Cisplatin-topotecan-paclitaxel weekly administration with G-CSF support for ovarian and small-cell lung cancer patients: a dose-finding study.

Purpose: Paclitaxel (PTX) and topotecan (TPT) have shown promising antitumor activity in both ovarian cancer (OC) and small-cell lung cancer (SCLC) patients. This phase I study was aimed at determining the maximum tolerable dose (MTD) of TPT given weekly over 30 min in combination with fixed doses of cisplatin (CDDP) and (PTX), and with G-CSF support.Patients and methods: Forty-four patients with OC (19) or SCLC (25), either chemo-naïve (20) or pretreated (24) received CDDP 40 mg/m2, PTX 85 mg/m2 (one-hour infusion) and escalating TPT doses (starting from 0.75 mg/ m2) in a 30-min infusion in weekly administration. Filgrastim 5 mg/kg was administered on days 3 to 5 of each week.Results: Eight different dose levels were tested for a total of 295 delivered cycles. The dose escalation was interrupted at the TPT dose of 2.50 mg/m2. No toxic deaths occurred in this study. Grade 3 to 4 neutropenia, thrombocytopenia, and anemia occurred in 15 patients (36 cycles), seven patients (15 cycles), and four patients (five cycles), respectively. Severe vomiting and diarrhoea occurred in seven and four patients. Peripheral neuropathy was recorded in 11 patients (42 cycles), but it was never severe. An overall 11 of 19 (58%) OC and 11 of 25 (44%) SCLC patients obtained objective responses. Eight patients showed complete responses (three OC and three SCLC). Among the 20 chemo-naïve patients, 9 of 11 (82%) OC and seven of nine (78%) SCLC responded.Conclusions: The CDDP/TPT/PTX weekly administration with filgrastim support represents a well-tolerated and active therapeutic approach in both chemo-naïve and pretreated OC and SCLC patients. A weekly dose of TPT of 2.25 mg/m2 is recommended for the phase II study.     

奥铂治疗恶性心包积液的临床疗效观察

目的观察奥铂治疗恶性心包积液的临床疗效。方法本组29例,支气管肺癌21例(NSCLC19例,SCLC2例),乳腺癌4例,食管-胃癌4例。随机分组:奥铂治疗组15例,对照组(顺铂)14例。超声引导下心包置管引流,心包腔注入奥铂(治疗组)50~100mg/次或顺铂(对照组)30~50mg/次,5%GS或NS稀释至20~40ml,间歇性给药2~3次。结果奥铂治疗组和对照组的完全缓解率及有效率分别为26.7%、21.4%和73.3%、64.3%(P>0.05)。奥铂治疗组与对照组的疗效差异无显著性,毒副作用轻微,无心脏骤停,心肌、冠状血管损伤等严重并发症。结论奥铂治疗恶性心包积液疗效显著,毒副作用轻。     

DNCE方案治疗复发或难治的侵袭性非霍奇金淋巴瘤

目的 探讨DNCE方案作为二线解救方案治疗复发或难治的侵袭性非霍奇金淋巴瘤(NHL)的有效性和安全性.方法 经病理学或组织学证实的、且一线CHOP方案治疗后进展的侵袭性恶性NHL患者69例,按信封法随机分为DNCE方案组与DICE方案组.其中DICE组37例,采用地塞米松(DXM)20 mg,静脉滴注,d1～d4;异环磷酰胺(IFO)1 S/m2,静脉滴注,d1～d4;Mesna解救400 mg,静脉滴注q8h,d1～d4;顺铂(DDP)25 mg/m2,静脉滴注,d1～d4;依托泊苷(Vp-16)100 ms/m2,静脉滴注,d1～d4.21～28d为1个周期.DNCE组32例,采用DXM、DDP、Vp-16的剂量与DICE方案相同;NVB 25 ms/m2,静脉滴注,d1和d5.21～28d为1个周期.所有患者均完成≥2个周期的化疗.结果 DNCE组中,完全缓解(CR)6例,部分缓解(PR)12例,有效率为56.3%(18/32);DICE组中,CR 4例,PR 13例,有效率为45.9%(17/37).DNCE组的疗效优于DICE组,但两组间差异无统计学意义(P>0.05).DICE组的1、3、5年生存率分别为86.5%、58.3%和42.9%,DNCE组分别为87.5%、63.2%和38.5%,两组间差异无统计学意义(P>0.05).两组主要的不良反应为骨髓抑制和消化道反应,表现为粒细胞、血小板减少及恶心、呕吐等.DNCE组的骨髓毒性轻于DICE组,差异有统计学意义(P<0.05).结论 DNCE方案治疗侵袭性NHL的疗效肯定,骨髓毒性较DICE方案为轻,是侵袭性NHL患者安全有效的解救治疗方案.     

Randomized phase II study comparing topotecan/cisplatin administration for 5 days versus 3 days in the treatment of extensive stage small cell lung cancer (SCLC)

BACKGROUND: Topotecan (T) is an active drug in SCLC. A combination of topotecan with cisplatin (DDP) was suggested to be highly synergistic. This phase II trial was initiated to assess the activity of T/DDP in chemotherapy-naive patients suffering from extensive disease small cell lung cancer (SCLC) and to compare the conventional 5-day regime with an experimental 3-day schedule. PATIENTS AND METHODS: A total of 86 patients were included. Patients were randomized to receive either T 1.0 mg/m2 d 1-5 and DDP 75 mg/m2 d 5 (arm A) or T 1.5 mg/m2 d 1-3 and DDP 75 mg/m2 d 3 (arm B). Six cycles were given at a 3-week interval. RESULTS: Data of 84 evaluable patients (67 males and 17 females) were analysed. All patients had metastatic disease. The best response rate was 61.9% in arm A and 59.5% in arm B. Median overall survival was 8.7 months in arm A and 7.6 months in arm B (p=0.6809). CONCLUSIONS: Combination of T and DDP is active in ED SCLC. Toxicity and median survival were comparable in both arms. Three days treatment seems to be similar to the 5 days regime.     

拓扑替康联合顺铂方案与IEP方案治疗复发性小细胞肺癌的疗效比较

目的：比较拓扑替康联合顺铂方案与IEP方案治疗复发性小细胞肺癌的疗效和不良反应。方法：80例复发性小细胞肺癌中,37例应用拓扑替康-DDP方案（拓扑替康0.75mg/m2,第1-5天静点,DDP25mg/m2,第1-3天静点）;43例应用IEP方案（IFO1.2mg/m2,第1-3天静点,Mesna400mg静注,第0、4、8小时,第1-3天,VP-16100mg,第1-5天静点,DDP25mg/m2,第1-3天静点）。两组的治疗周期为21天,完成2周期后评价疗效及不良反应。结果：拓扑替康组有效率为45.9%（17/37）,IEP组有效率44.2%（19/43）,两组疗效无差异（P〉0.05）,两组不良反应主要表现为：骨髓抑制,白细胞下降IEP方案高于TP方案（55.8%和45.9%）,但两组无显著性差异（P〉0.05）;血小板下降IEP方案高于TP方案（30.2%和13.5%）,两组有显著性差异（P〈0.05）;脱发IEP方案高于TP方案（76.7%和5.4%）,两组有显著性差异（P〈0.01）。结论：拓扑替康联合顺铂方案与IEP方案治疗复发性小细胞肺癌均取得较好疗效,TP方案不良反应较IEP方案轻,两方案不良反应均可以耐受。     

Chemotherapy with concurrent brain and thoracic radiotherapy in brain-only metastases of treatment naive small-cell lung cancer: a phase II study

To study the treatment outcomes of brain-only metastases from small-cell lung cancer (SCLC) at initial diagnose treated by chemotherapy with concurrent brain and thoracic radiotherapy (RT). From Jan 2004 to Jan 2009, 36 treatment-na?ve SCLC patients with brain-only metastases in Sun yat-sen University were enrolled. Treatment contained initial EP chemotherapy with concurrent whole-brain radiotherapy (WBRT). EP regimen consisted of etoposide 100 mg/m(2) IV d1-3, cisplatin 80 mg/m(2) IV d1, repeated every 3 weeks. WBRT with total dose of 30 Gy in 10 fractions was started within 1 week from the beginning of chemotherapy followed by thoracic RT including 2 Gy once daily to a total dose of 60 Gy. Treatment responses were evaluated after 3 cycles of chemotherapy. EP regimen was given totally 6 cycles for no tumor progression. Thirty-four patients were evaluable. All of the 20 CNS symptomatic patients experienced symptoms relief. Objective responses in the brain and primary thoracic lesions were observed in 26 (76.5%, 16CR + 10PR) and 29 (85.3%, 23CR + 6PR) patients, respectively. The median survival time (MST) was 19.2 months, and the 1-and 2-year overall survival rates (OS) were 70.6 and 29.4%, respectively, in all patients. Patients with CR response had the longest MST of 21.9 months and 1-and 2-year OS of 93.8 and 43.8%, respectively. Treatment toxicity profiles were acceptable. The treatment strategy of concurrent chemotherapy with brain and thoracic RT might achieve promising survival outcomes comparable to limited-stage SCLC in initially diagnosed SCLC with brain-only metastases.     

紫杉醇联合顺铂治疗晚期食管癌近期临床观察

目的观察紫杉醇(PTX)加顺铂(DDP)联合化疗治疗晚期食管癌的近期疗效.方法 PTX 175 mg/m2,静脉滴注,第1天;DDP 80 mg/m2,静脉滴注,第1、2天.每21 d为一个周期,连用3周期评价疗效.结果可评价疗效者28例,其中CR 1例(3.5%),PR 19例(67.7%),总有效率为71.4%.毒副反应主要是骨髓抑制和恶心呕吐.结论 PTX DDP治疗晚期食管癌可获得较高疗效, 毒副反应能耐受,可作为晚期食管癌的有效治疗方案,值得进一步研究.