健择联合卡铂治疗31例晚期非小细胞肺癌

[目的]评价健择联合卡铂治疗Ⅲb～Ⅳ期非小细胞肺癌(NSCLC)的疗效和安全性.[方法]31例NSCLC患者联用健择1000mg/m2d1,8,卡铂AUC5 d1,每21～28天为一周期,治疗8周后评价疗效及不良反应.[结果]31例患者中无CR,PR12例,其中Ⅲb期8例,Ⅳ期4例,有效率(RR)38.7%.Ⅲ～Ⅳ度白细胞下降9例(29%),Ⅲ～Ⅳ度血小板下降10例(32.2%),未出现Ⅲ～Ⅳ度恶心,呕吐.[结论]健择联合卡铂是治疗晚期NSCLC的有效药物,使用安全,耐受性好.     

健择联合顺铂治疗老年晚期非小细胞肺癌患者的临床疗效观察

为了观察健择联合顺铂治疗老年(≥60岁)晚期(Ⅲ期及Ⅳ期)非小细胞肺癌(NSCLC)的疗效和毒副反应,探索适于老年人NSCLC的治疗方案。将48例患者分为治疗与观察两组,治疗组23例,d1、d8。健择1200mg/m2,静脉滴入,d1、d8;给予顺铂100mg/m2,静脉滴入,d1、d8。28d为1个周期。对照组25例采用单纯支持对症治疗。治疗组完全缓解(CR)4例,部分缓解(PR)7例,稳定(SD)8例,进展(PD)4例,有效率47·8%;对照组完全缓解(CR)0例,部分缓解(PR)2例,有效率8·0%,两组经统计学比较,差异有统计学意义,P<0·05。治疗组毒副反应有白细胞下降和血小板减少。初步研究的结果提示,健择联合顺铂治疗老年晚期NSCLC疗效较高,毒性可耐受。     

健择联合顺铂治疗晚期非小细胞肺癌的临床研究

目的　观察健择 (gemcitabine)联合顺铂治疗晚期非小细胞肺癌的疗效及毒性反应。方法　经病理细胞学证实的 46例晚期非小细胞肺癌患者采用健择 +顺铂方案 :健择 10 0 0mg/m2 ,第 1,8天 ;顺铂 80mg/m2 ,第 1天或分 3d应用 ,2 1d为 1个周期。结果　完全缓解 (CR) 1例 ,部分缓解 (PR) 2 0例 ,稳定 (SD) 19例 ,进展 (PD) 6例 ,总有效率 45.7%。初治 2 4例中 ,CR +PR 14例 ,有效率58.3 % ;复治 2 2例中 ,CR +PR 7例 ,有效率 3 1.8% ,两组差异有显著性 (P <0 .0 5)。毒副反应以白细胞及血小板下降为常见 ,但均可耐受。结论　健择联合顺铂对晚期非小细胞肺癌有较好疗效 ,毒副反应可以耐受     

健择联合顺铂治疗老年晚期非小细胞肺癌患者的临床疗效观察

为了观察健择联合顺铂治疗老年（≥60岁）晚期（Ⅲ期及Ⅳ期）非小细胞肺癌（NSCLC）的疗效和毒副反应,探索适于老年人NSCLC的治疗方案.将48例患者分为治疗与观察两组,治疗组23例,d1、d8.健择1 200 mg/m^2,静脉滴入,d1、d8;给予顺铂100 mg/m^2,静脉滴入,d1、d8.28 d为1个周期.对照组25例采用单纯支持对症治疗.治疗组完全缓解（CR）4例,部分缓解（PR）7例,稳定（SD）8例,进展（PD）4例,有效率47.8%;对照组完全缓解（CR）0例,部分缓解（PR）2例,有效率8.0%,两组经统计学比较,差异有统计学意义,P＜0.05.治疗组毒副反应有白细胞下降和血小板减少.初步研究的结果提示,健择联合顺铂治疗老年晚期NSCLC疗效较高,毒性可耐受.     

健择联合顺铂治疗晚期非小细胞肺癌的疗效观察

目的评价健择（GEM）联合顺铂（DDP）治疗晚期非小细胞肺癌（NSCLC）近期疗效及毒副反应。方法对64例不能手术的非小细胞肺癌患者采用健择联合顺铂化疗。健择1000mg／m^2，d1.8，顺铂20mg／m^2，d2-6，21天为一周期，完成2周期评价疗效，观察毒副反应。结果总有效率（CR＋PR）42．2％，主要毒性作用是骨髓抑制和胃肠道反应。结论健择联合顺铂治疗晚期NSCLC疗效较好，毒性作用可耐受。骨髓抑制是其剂量限制性毒性。     

健择联合顺铂治疗晚期非小细胞肺癌疗效观察

目的:评价健择(GEM)联合顺铂(DDP)治疗晚期非小细胞肺癌(NSCLC)的疗效和毒副反应。方法:收集NSCLC患者38例给予GP方案化疗,GEM1000mg/m2iv d1,8;DDP80mg/m2iv d1,28天为一周期,应用2周期后评价疗效。结果:全组有效率46.9%,无CR病例,鳞癌和腺癌有效率分别为44.0%和46.1%,初治、复治有效率分别为46.9%、33.3%,Ⅲ、Ⅳ期有效率为47.6%、41.2%。毒副反应主要为白细胞下降68.4%,其次为消化道症状为42.1%。结论:GP方案治疗NSCLC疗效较好,毒副反应轻。     

健择在难治性非霍奇金淋巴瘤治疗中的应用研究

 目的　观察健择联合顺铂、强的松治疗难治性非霍奇金淋巴瘤的近期疗效。方法　健择10 0 0mg/m2 ,静滴 ,d1,8;顺铂 2 5mg/m2 ,静滴 ,d1～ 3 ;强的松 6 0mg/m2 ,口服 ,d1～ 5。以 3～ 4周为 1周期 ,每例患者至少连用 3个周期。结果　全组 10例病人中 ,CR 2例 ,PR 5例 ,总有效率 70 %。 4例具有B类症状患者中 ,2例症状消失 ,1例明显改善 ,1例无改善。毒副反应主要是轻度的胃肠道反应和少数患者出现Ⅲ级以上骨髓抑制。结论　健择联合顺铂、强的松治疗难治性非霍奇金淋巴瘤有较好的近期疗效 ,其毒副反应可耐受 ,是值得临床进一步验证的补救性化疗方案。     

GP方案治疗晚期非小细胞肺癌的临床观察

目的:观察健择 顺铂治疗晚期非小细胞肺癌(non-small cell lung cancer, NSCLC)的近期疗效.方法:自2000年6月到2005年6月,对60例晚期(Ⅲb期或Ⅳ期) NSCLC采用健择(GEM 1.0g/m2·d第1、8天)联合顺铂(CDDP 30mg/m2·d第1、2、3天)的方案化疗,21天重复,治疗两个周期后评价临床疗效.结果:60例患者中,2例CR,13例PR,26例SD,19例PD,总有效率为(CR PR)25.0%;鳞癌有效率35.3%,腺癌有效率23.1%;Ⅲb期有效率41.7%,Ⅳ期有效率22.2%,中位疾病进展时间(TTP)4.7月,1年生存率28.3%,中位生存时间9.2个月,主要毒副反应为骨髓抑制,其中白细胞下降至Ⅲ、Ⅳ度者达35.0%,血小板下降至Ⅲ、Ⅳ度者为10.0%,恶心呕吐发生程度达Ⅲ、Ⅳ度者为25.0%.结论:GP方案治疗晚期NSCLC临床效果较好,副作用较轻,适合晚期NSCLC患者使用.     

吉西他滨联合顺铂治疗47例老年晚期非小细胞肺癌

[目的]观察吉西他滨（商品名健择）联合顺铂治疗老年晚期非小细胞肺癌（NSCLC）的近期疗效、毒副反应。[方法]健择（GEM）1000mg/m2静滴30min,d1,8;顺铂30mg/m2,静滴d1～3;21d为一个周期。完成2个周期以上评价疗效。[结果]47例老年晚期NSCLC患者共行化疗189个周期,全组总有效率38.3%。（全组42例均可评价,有效率为38.3%）。主要毒副反应为胃肠反应（Ⅲ～Ⅳ度为23.4%）和血液学毒性（Ⅲ～Ⅳ度白细胞下降率为27.7%,Ⅲ～Ⅳ度血小板下降率为14.9%）。[结论]健择联合顺铂治疗老年人非小细胞肺癌,有效率高,毒副反应轻,可以耐受。     

健择联合奥沙利铂治疗老年中晚期非小细胞肺癌的临床研究

目的 观察健择联合奥沙利铂治疗老年中晚期非小细胞肺癌的临床疗效及毒副反应.方法 50例老年中晚期非小细胞肺癌采用健择、奥沙利铂联合方案化疗:健择1 000 mg/m2静脉滴注,d1,8,奥沙利铂 100 mg/m2静脉滴注,d121 d为1周期.采用 WHO 疗效及毒副反应评价标准,完成治疗2个周期以上的患者进行临床疗效及毒副反应评估.结果 可评价疗效50例,有效(RR)率42%(21/50),其中完全缓解(CR)5例,部分缓解(PR)16例.稳定(SD)23例.进展(PD)6例.缓解期为1.5-12个月,中位缓解期为7个月.生存期为4-19个月,中位生存期为10个月,1年生存率48%(24/50).50例共化疗121个周期,主要毒副反应为骨髓抑制9例(18%)、贫血6例(12%)、血小板减少7例(14%);非血液毒性反应较轻,主要表现为胃肠道反应7例(14%).结论 健择联合奥沙利铂方案治疗老年中晚期非小细胞肺癌的疗效较好,毒副反应较轻,患者的耐受性好.     

卡铂联合吉西他滨每周给药治疗晚期非小细胞肺癌的临床疗效观察

目的:评价每周应用卡铂与吉西他滨治疗晚期非小细胞肺癌(NSCLC)的疗效及安全性。方法:52名未接受过化疗治疗的,所患NSCLC体积可测定的患者被纳入。患者接受吉西他滨（1 000mg/m2 d1,8)及卡铂（AUC=2 d1,8)治疗,每三周为一个化疗疗程。结果:缓解率为33%（17/52)。疾病进展时间为17.2周,中位生存时间43.6周。1年生存率42.3%。主要毒副反应为血液系统毒性:3级或4级中性粒细胞减少(35%)及血小板减少(29%)。无其他严重毒副反应。结论:一线应用卡铂联合吉西他滨每周给药治疗晚期NSCLC,耐受性好,有较好临床效果。     

吉西他滨/卡铂和吉西他滨/顺铂方案治疗晚期非小细胞肺癌的疗效比较

目的 观察吉西他滨／卡铂（GCarb）和吉西他滨／顺铂（GCis）治疗晚期非小细胞肺癌（NSCLC）的疗效和毒副反应。方法 经病理和细胞学证实的40例晚期NSCLC患者随机分为两组。GCarb组给予吉西他滨1000mg/m^2静脉滴注，第1、8天；卡铂AUC4－6静脉滴注，第1天。GCis组给予吉西他滨1000mg/m^2静脉滴注，第1、8天，顺铂30－40mg/m^2静脉滴注，第1－3天。两组均21天为一周期，连续使用2－3周期评价疗效和毒副反应。结果 GCarb组有效率为65％，GCis组为60％，两组疗效无显著性差异（P＞0.5）。两组毒副反应依次为骨髓抑制、胃肠道反应、脱发和皮疹。GCarb组胃肠道反应低于GCis组（P＜0.05）。结论 GCarb和GCis均可作为NSCLC的一线治疗方案。     

吉西他滨联合铂类治疗64例晚期非小细胞肺癌临床疗效研究

目的:比较吉西他滨(gemcitabine)联合顺铂(cisplatin)、卡铂(carboplatin)和奥沙利铂(oxaliplatin)三种化疗方案对晚期非小细胞肺癌(NSCLC)的疗效和毒性反应。方法:经病理和细胞学证实的64例晚期NSCLC患者随机分为吉西他滨 顺铂(gemcitabine cisplatin,Gcis)、吉西他滨 卡铂(gemcitabine carbopl-atin,Gcarb)和吉西他滨 奥沙利铂(gemcitabine oxaliplatin,GLOHP)三组。三组均选用吉西他滨1000mg/m2静脉滴注第1、8天。GCis组:顺铂70mg/m2静脉滴注,第1天;GCarb组:卡铂AUC4～6(初治6,复治4～5),静脉滴注,第1天;GLOHP组:奥沙利铂LOHP130mg/m2静脉滴注,第1天。三组均21天为一周期,连续使用2～3周期评价疗效和毒副反应。结果:Gcis、Gcarb、GLOHP三种方案治疗晚期非小细胞肺癌的有效率分别为52.38%(11/21)、50.00%(10/20)和60.87%(14/23)(P>0.05)。三种方案毒副反应主要为可耐受的骨髓抑制、消化道反应、脱发和外周神经毒性等。结论:吉西他滨联合三种不同铂类的化疗方案均为治疗晚期非小细胞肺癌较为安全有效的化疗方案。     

Rational drug sequencing of paclitaxel, gemcitabine and carboplatin in patients with untreated stage IV and select stage IIIB non-small cell lung cancer

INTRODUCTION: To conduct a phase II study evaluating the efficacy of rationally sequenced paclitaxel, gemcitabine, and carboplatin in patients with stage IV or select stage IIIB non-small cell lung cancer (NSCLC). METHODS: Patients with select stages IIIB (pleural effusion) and IV NSCLC with an ECOG performance status of 0-1 and no prior chemotherapy for their disease were eligible to participate. Treatment was delivered as follows: paclitaxel at 70 mg/m2 followed by gemcitabine at 300 mg/m2 on day 1, with carboplatin (AUC 5) on day 2 of a 28-day cycle. Response was assessed after every two cycles of therapy. The primary endpoint of this trial was response rate, with secondary endpoints of time to progression and 1 year overall survival. RESULTS: Twenty patients were enrolled on protocol, one of whom never received chemotherapy. The median number of cycles delivered was 3 (range 0-8). A partial response rate of 42% (8/19; 95% CI: 20-67%) and a stable disease rate of 11% (2/19; 95% CI: 1-33%) were observed. The median overall survival time was 9.6 months (95% CI: 4.6-16.6), with a 1 year overall survival rate of 42.1% (95% CI: 24.9-71.3%). Eight patients (42%) stopped treatment due to toxicity. CONCLUSION: Paclitaxel followed by gemcitabine and then carboplatin is an active, albeit complex, regimen in the treatment of patients with advanced NSCLC with insufficient advantage to justify continuation of this regimen.     

Does chemotherapy have a role as palliative therapy for unfit or elderly patients with non-small-cell lung cancer?

Elderly patients and younger "unfit" patients with poor Eastern Cooperative Oncology Group (ECOG) performance status (PS) (> or = 2) suffering from advanced non-small-cell lung cancer (NSCLC) are two different populations--both of which require palliative treatments. Elderly patients frequently experience progressive decline of organ function and multiple comorbidities, which need to be considered when choosing therapy. ECOG 1594 showed that advanced NSCLC patients with an ECOG PS of 2 did not tolerate platinum-based chemotherapy (cisplatin/paclitaxel, carboplatin/paclitaxel, cisplatin/docetaxel, carboplatin/paclitaxel). These data confirm that treatments designed specifically for this patient subset are needed. Single-agent chemotherapy seems to be a reasonable approach, and non-platinum-based combination chemotherapy should also be investigated. The oncology community has become increasingly aware of the magnitude of the problem of cancer in the elderly. More than 30% of lung cancers arise in patients > or = 70 years old. Elderly patients tolerate chemotherapy poorly, according to the few published papers, and are not considered eligible for aggressive cisplatin-based chemotherapy in clinical practice. A phase III randomized trial (ELVIS [Elderly Lung Cancer Vinorelbine Italian Study]) demonstrated survival and quality-of-life benefits with single-agent vinorelbine versus best supportive care. Among the newer drugs, gemcitabine has demonstrated activity and low toxicity in phase II studies. With this background, we performed a randomized, multicenter phase III trial (MILES [Multicenter Italian Lung Cancer in the Elderly Study]) in 707 advanced NSCLC elderly patients. The MILES study compared single-agent chemotherapy with vinorelbine or gemcitabine versus polychemotherapy with gemcitabine plus vinorelbine. Results showed no benefit in response rate, time to progression, survival, and quality of life for the combination. Single-agent chemotherapy remains the standard treatment approach for elderly NSCLC patients with advanced disease.     

A phase II study of carboplatin plus gemcitabine in advanced non-small-cell lung cancer (NSCLC): a hoosier oncology group study

The purpose of this study was to evaluate the toxicity and determine the response rate, duration of remission, and survival using gemcitabine plus carboplatin in non-small cell lung cancer (NSCLC). This was a phase II study of gemcitabine and carboplatin in chemotherapy-naive patients with advanced NSCLC and Karnofsky Performance Status of at least 80. Gemcitabine was administered intravenously at 1,000 mg/m2 weekly for 3 weeks followed by 1 week rest. Carboplatin was administered immediately after gemcitabine at an area under the curve (AUC) of 5 given intravenously on day 1 of an every-4-week cycle. Seven patients were entered in the study and five were evaluable for toxicity. The median age of patients was 68 years (range, 52-72). The protocol was prematurely terminated because of severe and unexpected hematologic toxicity. Grade 3-4 thrombocytopenia was observed in four of the first five patients. These toxicities were all observed with the first course of chemotherapy. There were no objective responses seen. Median survival time was 130 days. Carboplatin plus gemcitabine was a logical combination. However, because of the severe thrombocytopenia associated with this regimen, we do not recommend this two-drug combination in the dose and schedule used in this study.     

Gemcitabine and carboplatin in patients with locally advanced or metastatic non-small cell lung cancer: a prospective phase II study

PURPOSE: The primary objective of this phase II study was to determine the tumor remission rates in previously untreated patients with advanced or metastatic non-small cell lung cancer (stage IIIB and IV), after treatment with gemcitabine plus carboplatin. Secondary objectives of this study were to determine toxicity, median survival and progression free survival in the same patient population treated with gemcitabine plus carboplatin. PATIENTS AND METHODS: Chemonaive patients with histological or cytological diagnosis of stage IIIB or IV NSCLC and Karnofsky performance status >/=60 received gemcitabine 1000 mg/m(2) over 30 min on days 1 and 8 and carboplatin AUC 5.0 over 30 min on day 1 after the gemcitabine infusion. Treatment cycles were repeated every 21 days for a maximum of six cycles, or until disease progression or unacceptable toxicity occurred. RESULTS: Of the 60 patients qualified for efficacy analysis, five achieved complete remissions, 15 partial remissions and 33 had stable disease, for an overall objective response rate (CR+PR) of 33.3% (95% CI, 21.7-46.7%). Four patients had progressive disease. The predominant toxicity was hematologic, with grade 3/4 leucopoenia being most common (35% patients). The median duration of response was 5 months, median time to progression was 6 months and median survival was 9 months with 80% of patients censored. CONCLUSION: Gemcitabine plus carboplatin is an effective and well tolerated treatment for advanced NSCLC.     

Combination of carboplatin and gemcitabine is a safe and feasible regimen in adjuvant therapy for stage II and IIIA NSCLC

BACKGROUND: Recently, several randomized trials have shown that postoperative adjuvant treatment improves survival among patients with completely resected non-small cell lung cancer (NSCLC). Platinum-based chemotherapy has been reported to be effective for patients with postoperative stage II to IIIA. PATIENTS AND METHODS: In the present study, 5 patients with completely resected stage IIB and IIIA received carboplatin AUC 4 on day 1 and gemcitabine 1,000 mg/m(2) on days 1 and 8 every 3 weeks for six cycles as adjuvant chemotherapy. RESULTS: No early or toxic deaths were observed. All patients were administered 6 cycles completely and safely. Three patients had grade 3 neutropenia and three had grade 2 thrombocytopenia. One patient had grade 3 neutropenia on day 8 in the 2nd and 3rd cycle, and the medications were postponed for a week. Non-hematological toxicity including alopecia and neuropathy were not found. CONCLUSION: In the present study, the combination of carboplatin and gemcitabine has been a safe and feasible regimen in adjuvant therapy for stage II and IIIA NSCLC.     

A novel triplet regimen with paclitaxel, carboplatin and gemcitabine (PACCAGE) as induction chemotherapy for locally advanced unresectable non small cell lung cancer (NSCLC)

Phase II study of 3 cycles of triplet induction chemotherapy (response, toxicity) followed by radiotherapy in locally advanced non small cell lung cancer (NSCLC). BACKGROUND: Patients with locally advanced inoperable non-small cell lung cancer are currently treated with concomitant or sequential chemotherapy and radiotherapy. However, the outcome of existing treatment modalities is unsatisfactory. Development of new strategies including more efficient systemic chemotherapy is warranted. OBJECTIVE: To study the antitumour activity and toxicity of a triplet combination of paclitaxel, carboplatin and gemcitabine as induction chemotherapy before radiotherapy, in locally advanced NSCLC and to evaluate time to progression and survival. METHODS: Three cycles of paclitaxel (175 mg/m(2) by 3h infusion on day 1), carboplatin (AUC 5mg/(mlmin) by IV bolus on day 1) and gemcitabine (1000 mg/m(2) by IV bolus on day 1 and 8) were administered every 3 weeks in reasonably fit patients. Fractionated radiotherapy with curative intent was initiated 4 weeks after the last chemotherapy administration. Toxicity was assessed weekly during cycle 1 and on day 1 and 8 in cycles 2 and 3. Response evaluation was performed at the end of cycle 3. RESULTS: Forty-eight patients (20 stage IIIA and 28 stage IIIB) received a total of 134 cycles of chemotherapy. Forty-two patients received the intended 3 cycles. Thirty patients obtained an objective response (1 complete and 29 partial response) or 62.5% on the intent to treat analysis (95% confidence interval: 49-76%). None of the responders became eligible for surgery. The median time to progression and survival for all patients was 10.1 and 15.7 month, respectively. A significant difference was observed in survival parameters between stage IIIA and stage IIIB patients. Haematological toxicity grade 3/4, mainly neutropenia and thrombocytopenia, was most prominent on day 15 of the treatment cycles. Haematological support by means of recombinant erythropoietin, red blood cell or platelet transfusion, filgrastim administration or a combination was needed in 21 patients. None of the patients discontinued chemotherapy because of haematotoxicity. Grade 3/4 non-haematological toxicity leading to chemotherapy withdrawal occurred early during induction (2 and 1 in cycles 1 and 2, respectively). CONCLUSION: Three cycles of the novel triplet combination of paclitaxel, carboplatin and gemcitabine (PACCAGE) is an active and feasible induction regimen for patients with locally advanced inoperable NSCLC. Neutropenia and to a lesser extent thrombocytopenia represent the main haematological toxicity. Whether this triplet regimen can improve outcome when compared to specific cisplatin doublet regimens should be evaluated in a phase III study.