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 trial of amrubicin and carboplatin in patients with sensitive or refractory relapsed small-cell lung cancer

Amrubicin is a novel, totally synthesized anthracycline derivative, and has antitumor activity against several human tumor xenografts. The combination of amrubicin with platinum derivative showed additive effect against a human small-cell lung cancer (SCLC) cell line. Until now, the combination of amrubicin plus carboplatin has not been studied in patients with previously treated SCLC. Therefore, we examined the safety and efficacy of the combination of amrubicin plus carboplatin in patients with sensitive or refractory relapsed SCLC. Patients with previously treated SCLC were eligible if they had a performance status of 2 or less, were 75 years or younger, and had adequate organ function. Twenty-five patients were enrolled (21 men and 4 women; median age, 65 years; age range 55-73 years). Patients received the combination of amrubicin (30 mg/m² on days 1-3) plus carboplatin (with a target area under the concentration-versus-time curve of 4 mg min/ml using the Calvert formula on day 1) every 3 weeks. The overall response rate was 36.0% (95% confidence interval [CI], 18.0-57.5%). Response rates differed significantly between patients with sensitive relapse (58.3%; 95% CI, 27.7-84.8%) and those with refractory relapse (15.4%; 95% CI, 1.9-15.4%; p = 0.03). The median survival time (MST) from the start of this treatment was 7 months (range: 1-42 months); the MST of patients with sensitive relapse (10 months) was significantly longer than that of patients with refractory relapse (5 months: p = 0.004). The median progression-free survival (PFS) time was 3 months (range: 1-14 months): the median PFS time of patients with sensitive relapse (5 months) was significantly longer than that of patients with refractory relapse (2 months; p = 0.01). The most frequent grade 3-4 toxicity was myelosuppression, especially neutropenia, which developed in 88% of patients. Grade 3-4 thrombocytopenia developed in 44% of patients, and anemia developed in 56%. Nonhematologic toxicities were generally mild to moderately severe and temporary. None of the patients had cardiotoxicity. In conclusion, this therapy is effective and well tolerated for previously treated SCLC.     

Phase II study of weekly chemotherapy with paclitaxel and gemcitabine as second-line treatment for advanced non-small cell lung cancer after treatment with platinum-based chemotherapy

Purpose We evaluated the tolerability and activity of the combination of weekly paclitaxel (PTX) and gemcitabine (GEM) in second-line treatment of advanced non-small cell lung cancer (NSCLC) after treatment with platinum-based chemotherapy. Patients and methods PTX (100 mg/m²) and GEM (1,000 mg/m²) were administered to patients with previous treated NSCLC on days 1 and 8 every 3 weeks. Results A total of 40 patients (performance status 0/1/2, 7/27/6 pts) were enrolled. The response rate was 32.5% (95% confidence interval: 18.0–47.0%). The median survival time was 41.7 weeks (95% confidence interval: 28.5–54.7 weeks). The median time to disease progression was 19 weeks. Hematological toxicities (grade 3 or 4) observed included neutropenia in 60%, anemia in 15%, and thrombocytopenia in 12.5% of patients. Non-hematological toxicities were mild, with the exception of grade 3 diarrhea, pneumonitis, and rash in one patient each. There were no deaths due to toxicity. Conclusion The combination of weekly PTX and GEM is a feasible, well-tolerated, and active means of second-line treatment of advanced NSCLC.     

EFFECT OF NEOADJUVANT CHEMOTHERAPY USING PACLITAXEL COMBINED WITH CARBOPLATIN ON ADVANCED NON-SMALL CELL LUNG CANCER

Objeetive： To assess the therapeutic effectiveness of preoperative neoadjuvant chemotherapy using a combination of paclitaxel and carboplatin on local advanced non-small cell lung cancer （NSCLC）. Methods： Twenty-five patients with advanced NSCLC were treated with paclitaxel and carboplatin for 2 to 4 cycles before undergoing tumor resection and then postoperative chemotherapy/radiotherapy therapy for 2 to 4 cycles. Results： Following neoadjuvant chemotherapy, the most prominent side-effect was bone marrow restraint. The overall response rate of preoperative chemotherapy was 56%. The mean survival time was 26.5 months, with 1-, 2- and 5-year survival rates of 55%, 25%, and 16%, respectively. All NSCLC patients survived the perioperative period. Conclusion： Preoperative neoadjuvant chemotherapy combining paclitaxel and carboplatin produced minimal side-effect while increasing the probability that advanced NSCLC patients would be able to undergo surgery thus improving their prognosis.     

Phase I study of vinorelbine and paclitaxel in small-cell lung cancer

Background: Vinorelbine and paclitaxel interfere with mitotic spindle function through different mechanisms of action. Both of the drugs show antitumor activity in small-cell lung cancer when used as single agents; furthermore, in vitro and in vivo studies have shown a synergistic activity between the two drugs. Patients and methods: Patients with small-cell lung cancer no longer amenable to conventional treatment were entered into a phase I study in which vinorelbine was given at a fixed dose of 30 mg/m² by 15-min intravenous infusion, whereas paclitaxel was given by 3-h infusion starting 1 h after vinorelbine at an initial dose of 90 mg/m², which was subsequently escalated by 30-mg/m² steps. Cycles were repeated every 21 days. Results: Grade 3 neutropenia was observed only in three patients treated at the fifty dose level. Thrombocytopenia never reached grade 3. Neurotoxicity was considered dose-limiting, since grade 3 peripheral neuropathy occurred in three of five patients treated at the fifth dose level (paclitaxel 210 mg/m²). Other side effects were generally mild. The overall response rate in 22 evaluable patients was 32% (95% CI 13–51%); in particular, 1 complete response (4.5%) and 6 partial responses (27.3%) were observed. The maximally tolerated doses recommended for phase II studies are 180 mg/m² for paclitaxel and 30 mg/m² for vinorelbine. The observed myelosuppression was less severe than anticipated on the basis of the effects of each drug alone. Conclusions: The promising activity of this drug combination warrants a phase II study in untreated patients with extensive-stage small-cell lung cancer. Received: 9 February 1997 / Accepted: 9 June 1997     

紫杉醇加卡铂方案治疗晚期非小细胞肺癌

目的：探讨紫杉醇加卡铂联合化疗方案对晚期非小细胞肺癌的疗效和毒性反应,方法：78例晚期非小细胞肺癌患者应用国产紫杉醇150mg/m2加卡铂300mg/m2联合方案化疗。结果：58例初治者和20例复治者近期有效率分别为56．9％（33／58）和35％（7／20）,总有效率51．3％（40／78）,有4例（5．1％）获CR。中位生存期9．0个月,1年生存率为33．3％（26／78）,主要不良反应为骨髓抑制及关节或肌肉酸痛。结论：杉醇加卡铂对晚期非小细胞肺癌有较好疗效,不良反应可以耐受。     

Phase II trial of combination chemotherapy with cisplatin, carboplatin and etoposide in stage IIIB and IV small-cell lung cancer

Purpose: A phase II trial combining cisplatin, carboplatin and etoposide was conducted in previously untreated patients with stage IIIB and IV small-cell lung cancer, in an attempt to increase response rates and prolong survival. Methods: Previously untreated patients with small-cell lung cancer, with measurable disease, aged ≤ 72 years, performance status ≤ 2, and adequate hematologic, hepatic and renal function were enrolled in the study. They were treated with 80 mg/m² cisplatin on day 1, 100 mg/m² carboplatin on days 2, 3 and 8, and 50 mg/m² etoposide on days 1, 2, 3 and 8. Results: A total of 46 patients (20 with stage IIIB and 26 with stage IV disease) were enrolled in the study. A total of 186 courses of chemotherapy were given, and the dose was reduced in 27 courses (15%). The chemotherapy was repeated for four or more courses in 30 patients. There were 10 complete responses and 32 partial responses, for a total response rate of 91% (95% confidence interval, 79% to 98%). The median survival time and 2-year survival rates were 18 months and 22% for stage IIIB disease, and 14 months and 15% for stage IV disease. Major side effects were hematologic: leukopenia, anemia, and thrombocytopenia of grade 3 or more occurred in 48%, 46%, and 43% of patients, respectively. Conclusions: The three-drug regimen of cisplatin, carboplatin and etoposide is feasible and active against small-cell lung cancer. Received: 21 May 1997 / Accepted: 11 September 1997     

Phase II trial of the combination of carboplatin and irinotecan in elderly patients with small-cell lung cancer

Aim

The aim of the present phase II study was to assess the antitumour activity and safety of the combination of irinotecan and carboplatin in elderly patients with small-cell lung cancer (SCLC).

Material and methods

Patients with previously untreated SCLC were eligible if they had a performance status of 0-2, were 70 years or older, and had adequate organ function. Patients were treated with carboplatin at an area under the plasma concentration versus time curve of 5 min/ml on day 1 and with irinotecan at 50 mg/m² on days 1 and 8 every 3 weeks.

Results

Thirty patients (26 men and 4 women; median age, 76 years; age range, 70-86 years) were enrolled. Eight patients had limited disease (LD) and 22 patients had extensive disease (ED). The overall response rate was 83.3% (95% confidence interval: 65.3-94.4%). Response rates did not differ significantly between patients with LD (87.5%) and those with ED (81.8%; p = 0.71). The median survival time was 14 months overall and was significantly longer in patients with LD (26 months) than in patients with ED (11 months; p = 0.025). The median progression free survival time was 6 months overall and was significantly longer in patients with LD (12 months) than in patients with ED (6 months; p = 0.016). Grade 3-4 toxicities included neutropenia in 83% of patients, thrombocytopenia in 47%, anaemia in 60%, infection in 23%, and diarrhoea in 20%. There were no treatment-related deaths.

Conclusions

This chemotherapy is safe and effective for elderly patients with SCLC.     

Phase II study of weekly irinotecan and carboplatin for refractory or relapsed small-cell lung cancer

We designed a phase II study of weekly irinotecan (CPT-11) and carboplatin for refractory or relapsed small cell lung cancer (SCLC) and assessed the response rate, survival, and toxicity. Twenty-nine patients with refractory or relapsed SCLC were entered onto the trial. The median time off chemotherapy was 3.5 months (range: 0.8-12.9). Patients were treated at 4-week intervals using CPT-11 (50 mg/m(2) intravenously on days 1, 8 and 15) plus carboplatin (AUC = 2 mg/ml min, intravenously on days 1, 8, 15). All patients were assessable for toxicity and survival; 28 patients were assessable for response. There were nine partial responses (PRs). Overall response rate was 31.0% (95% CI: 15.3-50.8%). The median time to progression was 3.5 months. Median survival time was 6.1 months. Major toxicity was myelosuppression. Grade 3 to 4 neutropenia and thrombocytopenia occurred in 52 and 21% of patients, respectively. Grade 3-4 diarrhea was observed in 7%. There was one treatment-related death due to febrile neutropenia and sepsis. This combination of CPT-11 and carboplatin seems to be active second-line regimen with acceptable toxicity against small cell lung cancer.     

泰素联合卡铂化疗和同步放疗治疗局部晚期非小细胞的肺癌Ⅰ期？…

目的 评价泰素联合卡铂化疗和同步放疗在局部晚期非小细胞肺癌治疗中的疗效和毒性反应。方法 自１９９６年７月至１９９８年６月,１５例不能手术的初治局部晚期非小细胞肺癌患者行泰素联合卡铂化疗和同步放疗。ⅢＡ期７例（４７％）,ⅢＢ期８例（５３％）;鳞癌１４例（９３％）,腺癌１例（７％）。在放疗开始的第１天、第１５天和第２９天分别给予泰素４０ｍｇ／ｍ＾２（静滴１小时）和卡铂１５０ｍｇ／ｍ＾２,放疗总剂量为６     

Phase II study of irinotecan and carboplatin in patients with the refractory or relapsed small cell lung cancer

We examined the safety and efficacy of the combination of irinotecan plus carboplatin in patients with refractory or relapsed small cell lung cancer (SCLC). Patients with previously treated SCLC were eligible. Patients were treated every 3 weeks with carboplatin (with a target area under the concentration versus time curve of 5 mg min/ml using the Calvert formula on day 1) plus irinotecan (50 mg/m² on days 1 and 8). From May 2000 to January 2002, 24 patients were eligible. None of the 22 patients achieved a complete response, but 15 achieved a partial response with an overall response rate of 68.2% (95% confidence interval, 45.1–86.1%). In 13 patients with sensitive disease, the response rate was 92.3% (95% confidence interval, 64.0–99.8%). The median survival time (MST) was 194 days (range 27–605 days). The MST did not differ significantly between patients with sensitive disease (245 days) and those with refractory disease (194 days, P=0.88). One patient died of treatment-related sepsis. Grade 3–4 hematologic toxicities included leukopenia in 58% of patients, neutropenia in 63%, thrombocytopenia in 58%, and anemia in 67%. Grade 3 diarrhea developed in 21% of patients and grade 3–4 infection in 13%. No patients had grade 4 diarrhea or grade 3–4 nausea and vomiting. This regimen is effective and well tolerated in patients with relapsed or refractory SCLC. However, the search for even more active regimens should be continued.     

Ⅲ期非小细胞肺癌放疗加紫杉醇卡铂同步化疗的临床试验结果

目的探讨放疗结合紫杉醇或（和）卡铂同步化疗局部晚期非小细胞肺癌的副反应和疗效.方法41例Ⅲ期非小细胞肺癌患者（Ⅲa期17例,Ⅲb期24例）接受DT60～70Gy放疗,疗中给予45 mg/m^2紫杉醇（13例）或合用卡铂AUC=2（28例）,1次/周给药,共4～6周,放化疗在同一天开始进行.结果37例患者完成了60～72Gy放疗,2例放疗总量54Gy,2例56Gy.38例完成了4～6周化疗,3例完成了2周化疗.≥3级骨髓抑制2例,3级放射性食管炎4例,≥2级放射性肺炎6例,3级黏膜炎1例.全组总有效率（CR＋PR）78%.中位随访期17.2个月,中位生存期16.5个月,1、2、3年生存率分别为69%、34%和34%.放疗剂量＞66Gy与≤66Gy的中位生存期分别为13.2、36.8个月（P=0.027）.中位无局部复发生存期57.8个月,1、2年无局部复发生存率分别为85%、85%.失败原因照射野内复发4例,照射野外1例,照射野内＋野外1例,癌性胸水2例,远处转移12例.结论紫杉醇或（和）卡铂同步放化疗局部晚期非小细胞肺癌患者副反应可接受,具有较好的近期和远期疗效,失败原因主要为远处转移.放疗剂量高者疗效较好.     

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。     

紫杉醇联合卡铂治疗晚期非小细胞肺癌临床分析

目的:探讨紫杉醇联合卡铂治疗晚期非小细胞肺癌的疗效及毒性。方法:对34例应用紫杉醇联合卡铂治疗的晚期非小细胞肺癌患者进行分析。结果:紫杉醇联合卡铂的总有效率为41.2%,其中鳞癌有效率为36.4%,腺癌有效率为47.3%。中位生存期为12.3个月,1年生存率为43.5%。主要的毒副反应为肌肉酸痛及骨髓抑制,绝大多数患者耐受性良好。结论:紫杉醇和卡铂联合治疗非小细胞癌是一种安全、有效、值得临床推广应用的化疗方案。     

周剂量紫杉醇联合异环磷酰胺治疗晚期非小细胞肺癌23例

目的　评价周剂量紫杉醇与异环磷酰胺联合化疗治疗晚期非小细胞肺癌的疗效和安全性。方法　紫杉醇 5 0～ 65mg/m2 静脉滴注 ,第 1、8、15天 ,异环磷酰胺 1.3 g/m2 静脉注射 ,第 2～ 4天。每 2 8天重复 ,2～ 3周期为一疗程。使用紫杉醇前常规给予抗过敏等处理 ,异环磷酰胺使用后第 0、4、8小时给予美安解毒。结果　本组完全缓解 1例 ,部分缓解 8例 ,稳定 11例 ,进展 3例 ,总有效率为 3 9.1% ( 9/2 3 ) ,临床受益率为 87.0 % ( 2 0 /2 3 )。化疗后KPS评分显著提高 (P <0 .0 1)。随防 2 0例 ,中位生存期为 8.9月 ,1年生存率为40 % ( 8/2 0 )。全组毒性反应主要为血液学毒性和消化道反应 ,其中白细胞降低发生率为 69.6% ( 16/2 3 ) ,恶心呕吐发生率为 47.8% ( 11/2 3 )。结论　周剂量紫杉醇 +异环磷酰胺联合化疗对晚期非小细胞肺癌有较好的疗效 ,不良反应可耐受 ,安全性高 ,可在临床上推广应用。     

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.     

Optimal doses of paclitaxel and carboplatin combination chemotherapy for ovarian cancer: a phase I modified continual reassessment method study

Background. A multicenter, phase I study of combination therapy with paclitaxel and carboplatin for epithelial ovarian cancer was conducted to determine the safety and recommended dosages for Japanese women. Methods. Paclitaxel was administered intravenously over a 3-h period, followed by carboplatin administered intravenously over a 1.5-h period. A modified continual reassessment method (mCRM) was used in two treatment arms to establish the maximum tolerated dose (MTD) and recommended doses of the combination. In group A, the dose of paclitaxel (175 mg/m²) was constant and the dose of carboplatin was increased from 4 to 7 in terms of the target area under the plasma concentration-versus-time curve (AUC). In group B, the dose of carboplatin was constant (AUC 6) and paclitaxel was administered at two dose levels (160 and 175 mg/m²). In both groups, the carboplatin dose was limited to a maximum of 800 mg/body for each administration. Results. Because the calculated probability of toxicity was greatest at a dose of paclitaxel 175 mg/m² and carboplatin AUC 7, this dose was designated the MTD in group A. Based on this result, treatment in group B was initiated at doses of paclitaxel of 160 mg/m² and carboplatin AUC 6. While the dose of paclitaxel was escalated to 175 mg/m², the safety of the combination was confirmed. The most frequent adverse effect was neutropenia, which resolved promptly with the appropriate use of granulocyte-colony stimulating factor (G-CSF). No other severe hematologic or nonhematologic toxicities were observed. Conclusions. Our study demonstrated that the recommended dose for this combination regimen should be paclitaxel 175 mg/m² plus carboplatin AUC 6 (maximum dose, 800 mg/body). Received: March 5, 2001 / Accepted: September 6, 2001     

Front-line paclitaxel and topotecan chemotherapy in advanced or metastatic non-small-cell lung cancer: a phase II trial

Purpose: Based on previous experience, we combined topotecan with paclitaxel (weekly administration) in patients with non-small-cell lung cancer (NSCLC). Our primary objective was to determine the response rate and survival and our secondary objective, the safety of the regimen. Methods: From October 2003, until March 2005, 45 patients all with histologically or cytologically confirmed NSCLC were enrolled. All patients were chemotherapy and radiotherapy naive. Both agents were infused on day 1 of every week once for three consecutive weeks, every 28 days. Three infusions were considered as one course. The treatment plan was to give three courses (nine infusions) and then to evaluate the response. Topotecan (1.75 mg/m²) was infused for 30 min and paclitaxel (70 mg/m²) for 90 min; these doses had been established as the maximum tolerated dose in a previous phase I–II trial. Results: Eighteen/45 (40%) patients responded, 2 (4.4%) complete responses and 16 (35.6%) partial responses. Twenty-one (46.7%) patients had stable disease, and 6 (13.3%) disease progression. The median duration of response was 8 months and median time to tumor progression 9 months. Grade 3 and 4 neutropenia was observed in two patients (in these two patients, the dose of both drugs was reduced by 25% and G-CSF was given), grade 4 thrombocytopenia in one patient and grade 4 anemia in one patient. Conclusion: This novel combination of topotecan–paclitaxel in a weekly administration rendered a 40% response rate, with very low toxicity in stages IIIA, IIIB and IV NSCLC patients.     

A phase II study of weekly paclitaxel and carboplatin in previously untreated patients with advanced non-small-cell lung cancer

Purpose: Both paclitaxel (P) and carboplatin (C) have a significant activity in non-small cell lung cancer (NSCLC). Weekly administration of P is active, is dose intense, and has a favorable toxicity profile. To evaluate the efficacy and toxicity of weekly P and C in advanced-stage NSCLC, we initiated this phase II study in patients with advanced NSCLC (III B with pleural effusion and stage IV). Patients and Methods: Eligible patients were treated with paclitaxel 100 mg/m² intravenously (iv) over 1 h followed by carboplatin AUC 2 iv over 30 min. This treatment was administered weekly for 3 of every 4 wk until disease progression or intolerable toxicities. Results: Of the 30 patients enrolled in the study, one patient did not meet the eligibility criteria. Of the remaining 29 patients, 6 did not complete at least two cycles of treatment and hence were not assessable for response. The overall response rate was 43.5% (10/23) (all partial responses). An additional 43.5% had stable disease. The median time to progression was 162 d and the median duration of response was 169 d. Overall survival at 1 yr on intent-to-treat analyses was 44% and median survival was 10.8 mo. We observed the following grade 3/4 toxicities: hypersensitivity to paclitaxel (13%), hypersensitivity to carboplatin (3%), neutropenia (31%), thrombocytopenia (7%); 31% experienced grade 1 neuropathy and 17% experienced grade 2 neuropathy. Conclusions: We conclude that weekly paclitaxel and carboplatin is active and very well tolerated in patients with advanced NSCLC.     

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.