Alternating weekly administration of paclitaxel and gemcitabine: a phase II study in patients with advanced non-small-cell lung cancer

Background We sought to evaluate toxicity and efficacy of an alternating week schedule of paclitaxel and gemcitabine in patients with advanced non-small-cell lung cancer (NSCLC).Methods Patients (n=27, mean age 56 years, range 27–73 years) received paclitaxel (100 mg/m² i.v. infusion over 1 h) on days 1 and 15 alternating with gemcitabine (1000 mg/m²) on days 8 and 22 of a 36-day cycle. Responses were evaluated after three cycles, and after the proposed six cycles.Results In total, 116 cycles were administered (mean 4.25 cycles per patient). Haematological toxicity was slight: febrile neutropenia (n=1) and neutropenia grade III–IV (n=5). Non-haematological toxicities included arthromyalgia grade II (n=6) and neurotoxicity grade III (n=1). Objective response was 29%, stable disease 25% and disease progression 46%. Median duration of response was 8 months (95% CI 5–11 months), median progression-free survival was 7 months (95% CI 4–11 months), median overall survival was 13 months (95% CI 7–17 months) and survival at 1 year was 52%.Conclusions A regimen of alternating weekly paclitaxel and gemcitabine is feasible in patients with advanced NSCLC, showing a lower toxicity profile compared with other platinum-based combinations, which makes this novel scheme attractive for these patients.     

吉西他滨加卡铂与紫杉醇加卡铂治疗晚期非小细胞肺癌临床对比研究

目的　观察吉西他滨 (GEM )加卡铂 (CBP)与紫杉醇 (TAX)加卡铂治疗晚期非小细胞肺癌的疗效及毒副反应。方法　将经病理组织学或细胞学证实的 64例晚期非小细胞肺癌患者 ,随机分为GC组 30例和TC组 34例 ,分别给予GEM +CBP及TAX +CBP治疗 ,2 8天为一个周期 ,均治疗 2周期以上。结果　GC组总有效率为 5 3.3% ,TC组总有效率为 5 8.8% (P >0 .0 5 )。毒副反应以白细胞降低、胃肠道反应和周围神经炎为主 ,TC组的发生率显著高于GC组 (P <0 .0 5 ) ,但均可耐受。结论　吉西他滨加卡铂与紫杉醇加卡铂治疗晚期非小细胞肺癌均有较好的近期疗效 ,患者耐受性好 ,而吉西他滨组的毒副反应更轻 ,临床应用更安全。     

Single-agent gemcitabine in patients with resistant small-cell lung cancer

Objective:This study was conducted to assess the activity and toxicity of gemcitabine in patients with resistant small-cell lung cancer (SCLC). Patients and methods:Forty-one patients with limited- or extensive-stage SCLC, who were previously treated with at least one chemotherapeutic regimen and progressed during or within three months of finishing the last regimen, were treated with 1000 mg/m² gemcitabine on days 1, 8, and 15 of a four-week cycle. Results:Thirty-eight patients were evaluable for response. Five partial and no complete responses were seen, for an overall response rate of 13% (95% confidence interval (CI): 6%–27%). Time to progression varied from 4 to 20 weeks, with a median of 8 weeks. Median survival was 17 weeks (range 4–84 weeks). Hematological toxicity mainly consisted of NCI–CTC grade 3 thrombocytopenia (29% of patients) and, to a lesser extent, grade 3 leukopenia (18% of patients). Non-hematological toxicity was mild, with nausea being the most commonly reported event. Conclusions:Gemcitabine has modest activity in patients with resistant SCLC. There is some non-cross resistance to most agents against SCLC.     

吉西他滨联合顺铂治疗晚期非小细胞肺癌临床研究

目的：观察吉西他滨联合顺铂治疗晚期非小细胞肺癌的疗效及毒副反应。方法：经病理组织学或细胞学证实的43例晚期非小细胞肺癌患者给予吉西他滨1000mg/m2静滴,第1,8,15天,顺铂30mg/m2静滴,第1－3天,28天为一周期,或吉西他滨1200mg/m2静滴,第1,8天,顺铂30mg/m2静滴,第1－3天,21天为一周期,结果：全组CR1例,PR20例,SD13例,PD9例,总有效率48．8％,初治病例有效率为62．5％,复治病例为31．6％,两组间差异具有显著性（P＜0．05）,毒副反应以白细胞及血小板下降为常见,但均可耐受,结论：吉西他滨联合顺铂治疗晚期非小细胞肺癌具有较好的疗效。毒性可以耐受。     

吉西他滨联合长春瑞滨治疗晚期非小细胞肺癌的临床研究

目的:观察吉西他滨联合长春瑞滨治疗晚期非小细胞肺癌(NSCLC)的临床疗效及毒副反应。方法:38例初治NSCLC给予吉西他滨1000mg/m2,d1、d8,静脉滴注30分钟,长春瑞滨25mg/m2,d1、d8,静脉推注,21d为1个周期,至少治疗2个周期。结果:全组38例均可评价,无CR,PR13例,总有效率(CR PR)34·2%(13/38),SD31·6%(12/38),PD21·1%(8/38),中位生存期为11个月,疾病进展时间为5·9个月;1年生存率及2年生存率分别为44·7%(17/38)和23·7%(9/38)。血液学毒性反应主要是Ⅰ~Ⅱ度白细胞下降占73·7%(28/38),Ⅲ~Ⅳ度白细胞下降占10·5%(4/38),Ⅰ~Ⅱ度血红蛋白及血小板下降分别占26·3%(10/38)和31·6%(12/38),非血液毒性包括食欲减退、Ⅰ~Ⅱ度恶心及呕吐、局部静脉炎等,所有不良反应经对症处理及支持治疗后均恢复正常。结论:吉西他滨联合长春瑞滨组成GN方案对于晚期NSCLC疗效较好,毒副反应可耐受,值得临床推广。     

A multicenter phase II study of carboplatin and paclitaxel with a biweekly schedule in patients with advanced non-small-cell lung cancer: Kyushu thoracic oncology group trial

Purpose: This multicenter phase II study was conducted to investigate the efficacy and safety of carboplatin in combination with paclitaxel administered according to a biweekly schedule as a first-line chemotherapy for advanced non-small-cell lung cancer (NSCLC). Patients and methods: Eligibility criteria included histologically or cytologically confirmed NSCLC (stage IIIb or IV), no prior treatment, and measurable or evaluable disease. Paclitaxel (140 mg/m²) was administered intravenously on day 1, in combination with carboplatin at an area under the concentration time curve (AUC) of 3, every 2 weeks. Results: Seventy-four patients (45 men) with a median age of 62 years (range 40–74) and a median ECOG performance status of 1 (range 0–2) were enrolled. The response rate was 35.1% [95% confidence interval (CI): 24.4–47.1%], with 26 partial responses. The median survival was 357 days, and the median time to progression was 218 days. Toxicity was generally mild; National Cancer Institute-Common Toxicity Criteria (NCI-CTC) grades 3 and 4 neutropenia was observeded in 50.0% of the patients, and grades 3 and 4 nausea/vomiting in 4.1%. Conclusions: Biweekly carboplatin combined with paclitaxel demonstrated anti-tumor activity in advanced NSCLC, with response and survival rates similar to those of carboplatin combined with paclitaxel administered every 3 weeks but with a more favorable toxicity profile, and the present data indicate that the regimen is suitable for use on an outpatient basis.     

Phase II trial of gemcitabine and irinotecan in previously treated patients with small-cell lung cancer

Purpose To investigate the activity of gemcitabine combined with irinotecan in patients with relapsed small cell lung cancer (SCLC). Patients and methods SCLC patients who had experienced treatment failure with one prior chemotherapy were eligible. Patients were required to have a performance status of 0–2 and adequate organ function. Treatment consisted of gemcitabine (1,000 mg/m²) and irinotecan (150 mg/m²) on days 1 and 15 of a 28 day cycle. Results Thirty-one patients were enrolled and 30 patients received protocol treatment (10 had refractory disease and 20 had sensitive disease). The median age was 64 years, and the median performance status was one. An objective response was obtained in 36.7% (95% CI: 17.3.1–56.0%) of the patients. The median overall survival time was 14.4 months, and the 1 year survival rate was 51%. The chief grade 3/4 toxicities included neutropenia (42%), thrombocytopenia (3%), diarrhea (9%), and liver dysfunction (3%). The only grade 4 toxicities were one case of grade 4 neutropenia (3.3%) and one case of grade 4 thrombocytopenia (3.3%). Conclusion Gemcitabine plus irinotecan is an active regimen that seems to be well-tolerated by patients with previously treated SCLC.     

Paclitaxel and gemcitabine, as first-line chemotherapy, combined with trastuzumab in patients with advanced breast cancer: a phase II study conducted by the Hellenic Cooperative Oncology Group (HeCOG)

Purpose: Advanced breast cancer (ABC) is an incurable disease. Standard first-line treatment for patients with HER-2/neu overexpressing tumors includes the combination of the humanized monoclonal antibody trastuzumab with chemotherapy, mainly paclitaxel. This combination is the first to demonstrate a survival advantage in this group of patients. To improve on these results, we investigated a triplet, paclitaxel-gemcitabine-trastuzumab (TGH), in a phase II study. Patients and Methods: Patients with ABC were accrued to the study. Treatment consisted of paclitaxel 80 mg/m²/week, gemcitabine 1000 mg/m² every 2 weeks, and trastuzumab 4 mg/kg loading dose and then 2 mg/kg/week. Patients were treated on study for a total of 12 weeks. Response evaluation was performed at the end of the 12 weeks. Continuation of treatment beyond the 12 weeks was left to the discretion of the investigator. Primary study endpoint was response. Toxicity assessment and survival were secondary endpoints. Results: Between November 2000 and May 2002, 40 patients were accrued and 32 patients completed all 12 weeks of therapy. One patient died of septic shock during therapy. Grade III and IV neutropenia was seen in 12.5% of cases each. Grade III anemia was seen in two patients, and grade III and IV thrombocytopenia in three and two patients, respectively. Both paclitaxel and gemcitabine were delivered at 86% of the planned dose intensity. Six patients achieved a complete response (CR) and 15 a partial response for an overall response rate of 52.5%. An additional 25% demonstrated stable disease and 20% progressive disease. Median duration of response was 14 months. All six patients who achieved CR are still in CR for 6 to 19 months. After a median follow up of 12.2 months, 19 patients have progressed and 7 have died. Median time to progression is 13.7 months, whereas median survival has not been reached. Conclusion: TGH is a well-tolerated and effective regimen for the first-line treatment of ABC. Randomized comparison between paclitaxel, trastuzumab, and triplets are warranted.     

健择、顺铂联合治疗Ⅲ和Ⅳ期非小细胞肺癌

目的　观察健择与顺铂联合化疗方案治疗非小细胞肺癌(NSCLC)的临床疗效和毒性反应。方法　12例入选者均为Ⅲ期(41.7%)和Ⅳ期(58.3%)NSCLC患者,且未接受过其它化疗和放疗。28天为一疗程,第1、8、15天静脉滴注健择1000mg/m2,第1天加用顺铂100mg/m2。结果　11例可评价患者中6例(54.5%)获部分缓解,总有效率为54.5%。主要的副反应是血液学毒性,WHOCTC的Ⅲ、Ⅳ度中性粒细胞减少发生率为33.3%(4/12),Ⅲ、Ⅳ度血小板减少的发生率为41.7%(5/12)。非血液学毒性皆轻度并可耐受。因毒性反应减少健择用量和停药比率为15.2%。经随访,3例存活,8例死亡。中位存活8个月。结论　健择与顺铂联合化疗方案治疗NSCLC有较好疗效。患者临床症状及生活质量明显改善,且有较好的耐受性,该治疗尤其适合老年患者。     

Phase I-II study of gemcitabine and paclitaxel in pretreated patients with stage IIIB-IV non-small cell lung cancer

Gemcitabine and paclitaxel are among the most active new agents in non-small cell lung cancer (NSCLC) and are worth considering for second-line chemotherapy. In this phase I–II study, we combined gemcitabine and paclitaxel for second-line treatment of advanced NSCLC. Gemcitabine doses were kept fixed at 1000 mg/m² on day 1 and 8, and paclitaxel doses were escalated from 90 mg/m² on day 1 of the 21-day cycle. Thirty-seven patients were treated at six different dose levels. Grade 4 neutropenia was dose-limiting toxicity (DLT), since it occurred in two out of six patients treated at paclitaxel 240 mg/m²; the paclitaxel dose level just below (210 mg/m²) was selected for phase II evaluation. Non-hematologic toxicity was mild. One complete response (CR) (3%) and 13 partial responses (PR) (36%) were observed in 36 evaluable patients for an overall response rate of 39% (95% C.I., 23–57%). Median duration of response was 35 weeks (range, 8–102). All of the observed objective responses occurred in the 19 patients who had previously responded to the first-line therapy. Median survival was 40 weeks (range, 8–108 weeks). The combination of gemcitabine and paclitaxel is a feasible, well-tolerated, and active scheme for second-line treatment of advanced NSCLC; further evaluation, at least in selected patients, such as those previously responding to first-line chemotherapy, is definitely warranted.     

吉西他滨治疗高龄晚期非小细胞肺癌

目的:观察吉西他滨治疗高龄晚期非小细胞肺癌的疗效,并与同期单纯支持治疗的患者比较,以探讨高龄晚期非小细胞肺癌的治疗方案。方法:吉西他滨组21例,采用吉西他滨单药化疗,剂量为1250mg/m2,静脉滴注,第1、8天用药,每21天为1周期,共4周期。对照组23例不用任何化疗,单纯支持对症治疗。结果:吉西他滨组总有效率为28.6%,其中PR6例,SD12例,PD3例。对照组无CR和PR者。吉西他滨组中位缓解期6.3个月。吉西他滨组和对照组中位肿瘤进展时间分别为5.8和2.6个月,中位生存时间分别为12.8和4.6个月(P<0.01);1年生存率分别为46.6%和9.2%(P<0.01)。吉西他滨组KPS、体重增加和临床症状改善情况均显著高于对照组(P<0.01)。毒副反应方面吉西他滨组12例(57.1%)出现Ⅰ、Ⅱ级血小板减少,7例(33.3%)出现Ⅰ、Ⅱ级白细胞下降,未见Ⅲ、Ⅳ级毒性反应。少数患者血红蛋白下降Ⅰ度,恶心呕吐Ⅰ/Ⅱ度。结论:吉西他滨单药治疗高龄晚期非小细胞肺癌是安全有效的。     

Second-line chemotherapy with weekly paclitaxel and gemcitabine in patients with small-cell lung cancer pretreated with platinum and etoposide: a single institution phase II trial

Purpose: The safety and efficacy of a combined regimen of weekly paclitaxel and gemcitabine was tested in patients with refractory and sensitive small-cell lung cancer (SCLC). Methods: Treatment consisted of paclitaxel 80 mg/m² on days 1, 8, 15 and gemcitabine 1,000 mg/m² on days 1 and 8 every 3 weeks. Of the 31 patients enrolled, 10 had refractory and 21 had sensitive disease. Objective responses occurred in 8 patients (26%), including 2 out of 10 patients with refractory- and 6 out of 21 patients with sensitive SCLC. Median time to progression and median survival were 9.4 and 32 weeks, respectively. Results: The schedule was very well tolerated, with grade 3–4 thrombocytopenia in 26% of the patients, grade 3 neutropenia in 26%, grade 3–4 asthenia in 13% and grade 1–2 sensory neuropathy in 32%. Conclusion: To conclude, this weekly schedule of paclitaxel and gemcitabine was found to have moderate activity in platinum-etoposide pretreated SCLC patients and a favorable toxicity profile.     

Phase II study of gemcitabine and carboplatin in patients with advanced non-small-cell lung cancer

Purpose To evaluate the efficacy and safety of gemcitabine in combination with carboplatin at standard rate or fixed dose rate infusion in patients with advanced non-small-cell lung cancer (NSCLC). Patients and methods In this prospective study, patients with chemonaive advanced NSCLC were randomized to receive gemcitabine at a standard rate (gemcitabine 1,200 mg/m² over 30 min, the standard arm) or a fixed dose rate (gemcitabine 1,200 mg/m² over 120 min, the FDR arm) on days 1 and 8 every 3 week cycle. In both treatment arms, carboplatin at AUC of 5 was administered over 4 h following gemcitabine on day 1 of each cycle. Results From November 2003 to June 2005, a total of 42 patients, in which 7 (17%) patients had stage III_B disease and 35 (83%) had stage IV disease, were enrolled into this study. All patients were included in efficacy and toxicity assessment. No patient had a complete response. Seven (33%) patients in the standard arm and 10 (48%) in the FDR arm had a partial response. The median time to progression and median overall survival time in the standard arm was 5.4 months (95% CI, 3.8–7 months) and 11.5 months (95% CI, 8.2–14.8 months), respectively, while in the FDR arm was 6.5 (95% CI, 4.4–8.6 months) months, 12.0 months (95% CI, 11.3–12.7 months), respectively. The most frequently reported grade 3 or 4 hematological toxicities were thrombocytopenia (38% patients in the standard arm and 43% in the FDR arm) and neutropenia (24% in the standard arm and 33% in the FDR arm). Although hematological toxicity occurred in a little higher percent of patients in the FDR arm than in the standard arm, there were no discernible differences by statistical analysis in both treatment arms (P > 0.05). And significant nonhematologic toxicities were infrequent and tolerable in both arms. No significant difference existed also (P > 0.05). Conclusion In this phase II study, gemcitabine in combination with carboplatin either at standard rate or fixed dose rate infusion was clinically effective and well tolerated in patients with advanced NSCLC.     

Three-week schedule of irinotecan plus cisplatin in patients with previously untreated extensive-stage small-cell lung cancer

Irinotecan and cisplatin demonstrated promising outcomes in extensive-stage small-cell lung cancer. According to the dosage and schedule of irinotecan, efficacy and toxicity profiles showed subtle differences. This study was designed to evaluate efficacy and toxicity of 3-week schedule of irinotecan/cisplatin in patients with previously untreated extensive-stage small-cell lung cancer. The primary objective was to evaluate response rate and secondary objectives were overall survival and progression-free survival. Patients with previously untreated extensive-stage small-cell lung cancer were enrolled. Irinotecan 65 mg m-2 was administered on days 1 and 8 and cisplatin 60 mg m-2 on day 1. Treatment was repeated every 3 weeks. Seven out of 54 patients (13.0%) had complete response, and partial response was observed in 33 (61.1%). The overall response rate was 74.1% (95% CI; 62.0-82.2%). Stable disease was observed in eight (14.8%) and no progressive disease was observed. After a median follow-up duration of 28.7 months, the median overall survival and progressive-free survival were 13.6 and 6.5 months, respectively. Major grade 3/4 toxicities were neutropenia (50.0%), anorexia (42.6%), diarrhoea (29.6%), fatigue (29.6%) and vomiting (13.0%). There was one treatment-related death owing to pneumonia. Three-week schedule of irinotecan/cisplatin showed effective antitumour activity and moderate toxicities in patients with previously untreated extensive-stage small-cell lung cancer.     

A triplet chemotherapy with cisplatin, docetaxel and gemcitabine in patients with advanced non-small-cell lung cancer: a phase I/II study

Purpose We conducted a phase I/II study of triplet chemotherapy consisting of cisplatin (CDDP), docetaxel (DCT) and gemcitabine (GEM) in patients with advanced non-small-cell lung cancer (NSCLC). Methods Fifty-three untreated patients with stage IIIB or IV NSCLC were enrolled. All drugs were given on days 1 and 8. The doses of CDDP and DCT were fixed at 40 mg/m² and 30 mg/m², respectively. In the phase I portion, a dose escalation study of GEM with starting dose of 400 mg/m² was conducted and primary objective in the phase II portion was response rate. Results The maximally tolerated dose (MTD) and recommended dose (RD) of GEM were determined as 800 mg/m² because grade 3 non-hematological toxicity (liver damage, diarrhea, and fatigue) developed in three of nine patients evaluated at that dose level. In pharmacokinetic analysis, C _max and AUC of dFdC and dFdU were increased along with the dose escalation of GEM. However, no relationship between pharmacokinetic parameters and toxicity or response was observed. Objective response rate was 34% and median survival time was 11.7 months. Though major toxicity was myelosuppression, there were no life-threatening toxicities. Conclusion These results indicate that this triplet chemotherapy is feasible and effective in patients with advanced NSCLC.     

A phase I combination chemotherapy study of biweekly paclitaxel and S-1 administration in patients with advanced gastric cancer

The aim of the current study was to determine the maximum tolerated dose (MTD) and the dose limiting toxicity (DLT) of a combination of paclitaxel and S-1 in patients with advanced gastric cancer. Fifteen patients were enrolled. The dose for S-1 was set at 80 mg/m²/day (days 1–14), while the dose for paclitaxel increased by 10 mg/m² for every three patients, with a starting dose of 100 mg/m² and was given biweekly on day 1 and 15. There was no severe toxicity (grade 4) recorded in patients receiving up to 120 mg/m² of paclitaxel. Leukopenia/neutrophilia with grade 1 to 3 occurred in six patients up to level 3. At 130 mg/m² of paclitaxel, grade 4 leukocytopenia and neutropenia events and grade 3 diarrhea developed in one out of three patients. One patient in another group of three patients that were enrolled at level 3, developed grade 4 granulocytopenia with fever (a body temperature higher than 38°C) and grade 3 leukocytopenia. Eight patients, out of a total of 15, showed a partial response, resulting in an objective response rate of 53%. Five patients received gastrectomy. Median survival time was 428 days and the 1 year survival rate was 53%. Biweekly paclitaxel/S-1 combination chemotherapy could be safely used for the treatment of advanced gastric cancer. The recommended doses for a phase II study with paclitaxel and S-1 are 120 mg/m² and 80 mg/m², respectively.     

吉西他滨联合奥沙利铂或顺铂治疗老年人晚期非小细胞肺癌的随机对照临床研究

背景与目的化疗可延长患者生存期，改善生活质量，是治疗晚期非小细胞肺癌的主要方法。对于70岁及以上的老年晚期非小细胞肺癌患者，治疗的毒副反应和治疗耐受性尤其重要。本研究的目的是观察比较吉西他滨联合奥沙利铂和吉西他滨联合顺铂治疗70岁及以上老年人晚期非小细胞肺癌的疗效和毒副反应。方法42例患者按随机表法分为GO组20例（吉西他滨1000mg／m^2，第1、8天；奥沙利铂65mg／m^2，第1、8天）和GP组22例（吉西他滨1000mg／m^2，第1、8天；顺铂30mg／m^2，第1～3天），28天为一周期，均治疗2周期以上。结果GO组CR1例，PR10例，SD7例，PD2例，有效率为55．0％；中位生存期为11．2月，1年生存率为45％。GP组PR9例，SD10例，PD3例，有效率为40．9％；中位生存期为11．8月，1年生存率为50％。两组有效率、中位生存期和1年生存率比较均无显著性差异（P均〉0．05）。毒副反应以白细胞降低和胃肠道反应为主，GP组Ⅲ＋Ⅳ度白细胞下降发生率和恶心呕吐发生率均显著高于GO组（17．4％VS4．8％，20．7％VS3．6％，P均〈0．05），GP组Ⅰ＋Ⅱ度脱发和肾功能异常发生率均显著高于GO组（43．5％ vs 10．7％，14．1％ vs 2．4％，P均〈0．05）。结论对于70岁及以上老年人晚期非小细胞肺癌，吉西他滨加奥沙利铂方案有较好的近期疗效，毒副反应轻，治疗耐受性好，临床应用更安全。     

A phase II study of biweekly paclitaxel (P) and gemcitabine (G), followed by maintenance weekly paclitaxel in elderly patients with advanced non-small cell lung cancer (NSCLC)

BACKGROUND: This phase II study was conducted to evaluate the efficacy and safety of a novel combination of paclitaxel (P) and gemcitabine (G) in an every 2 weeks schedule followed by weekly paclitaxel (P) as first-line treatment in elderly patients with locally advanced or metastatic NSCLC. METHODS: Elderly patients (> or =65 years of age) with 1997 TNM stage IIIB (pleural effusion)/stage IV NSCLC, performance status (PS) of 0-2 and normal organ function were eligible. Therapy consisted of P at 150 mg/m(2) and G at 2000 mg/m(2) administered every 2 weeks for 3 cycles followed, in progression-free patients, by P at 80 mg/m(2) every week for 6 consecutive weeks every 8 weeks for 2 cycles. RESULTS: Fifty-three eligible patients were enrolled: M/F 51/2; stage IIIB/IV 8/45; PS 0, 40%, PS 1 51%, PS 2 9%; median age, 73 years (range 67-82). The overall response rate was 32% (95% confidence interval [CI]: 19-45). The median overall survival was 7 months (95% CI: 5-9); the median progression-free survival was 5 months (95% CI: 3-6); and the 1- and 2-year survivals were 28.3% and 10.1%, respectively. Both phases of the treatment protocol were well tolerated. CONCLUSIONS: Biweekly P/G followed by weekly P is well tolerated and active as first-line therapy for elderly NSCLC patients.     

Belotecan, new camptothecin analogue, is active in patients with small-cell lung cancer: results of a multicenter early phase II study.

BACKGROUND: Belotecan (Camtobell, Chong Keun Dang Corp, Seoul, Korea; CKD602) is a new camptothecin analogue. This study aimed to investigate the safety and efficacy of single-agent belotecan for small-cell lung cancer (SCLC). PATIENTS AND METHODS: Twenty-seven patients with chemotherapy-naive or chemosensitive SCLC were treated with belotecan 0.5 mg/m(2)/day on days 1-5 of a 3-week cycle. All 27 patients were assessable for toxicity, and 21 patients assessable for response. RESULTS: Nine patients (42.9%) showed objective tumor responses including one complete response; seven (63.6%) in 11 chemotherapy-naive patients; and two (20.0%) in 10 chemosensitive patients. With a median follow-up of 5 years, median progression-free and survival time for chemotherapy-naive patients were 4.8 months and 11.9 months, respectively, while the corresponding values for chemosensitive patients were 3.3 months and 10.5 months, respectively. The most common toxicity was neutropenia. CONCLUSION: Belotecan was active in SCLC patients as a single agent, warranting further investigations of belotecan in combination with platinum or other active agents.     

吉西他滨联合顺铂3周方案治疗非小细胞肺癌

目的：观察吉西他滨（健择）联合顺铂（GP方案）对晚期非小细胞肺癌的疗效。方法：自1999年6月-2001年11月，对26例晚期非小细胞肺癌采用21天GP方案治疗。结果：26例病例中，无GR、PR11例，SD12例，PD3例，总有效率CR PR为42.3％（11/26）。中位生存期（MST）为9.3个月。Ⅲ-Ⅳ度白细胞下降占23.1％（6/26）。结论：治疗晚期非小细胞肺癌，吉西他滨联合顺铂21天方案是有效、经济和安全的。