The current status of docetaxel for advanced non-small cell lung cancer

Docetaxel is an active single agent in both first- and second-line therapy of patients with advanced non-small cell lung cancer (NSCLC). Randomized trials versus best supportive care have documented an improvement in overall survival for docetaxel therapy in both settings. Docetaxel also produced a significant 1-year survival rate improvement when compared with vinorelbine or ifosfamide as second-line therapy. Docetaxel has been extensively investigated in phase I/II studies in combination with cisplatin, carboplatin, irinotecan and gemcitabine. Substantial activity has been demonstrated. In a randomized phase II trial comparing docetaxel plus cisplatin with docetaxel plus gemcitabine, the efficacy of the two regimens was almost identical (response rates 32 and 34%; 1-year survival rates 42 and 38%). However, the combination of docetaxel with gemcitabine was associated with significantly less grade III/IV neutropenia, diarrhea and nausea/vomiting. Three drug regimens combining docetaxel with, for example, gemcitabine and carboplatin or with ifosfamide and cisplatin, are producing very high response rates in phase II trials. Whether three-drug combinations including docetaxel will result in an improved outcome for patients with advanced NSCLC remains to be determined.     

New options in the treatment of non-small cell lung cancer

The options for treating non-small cell lung cancer (NSCLC) were expanded by the introduction of the taxanes. As a single agent, docetaxel produced response rates ranging from 15 to 22% in evaluable patients in the second-line setting, with median duration of responses ranging from 5.6 to 7.5 months. To confirm the results observed in the phase II studies, a phase III trial was conducted. Three-hundred and seventy-three patients with advanced NSCLC who had failed prior platinum-based chemotherapy were randomized to receive docetaxel 100 mg/m2, docetaxel 75 mg/m2 or a reference arm consisting of vinorelbine or ifosfamide. Efficacy, safety and quality of life (using the Lung Cancer Symptom Scale) were assessed. Data from this study are forthcoming and may confirm the benefits provided by the inclusion of docetaxel in the second-line treatment of NSCLC. Docetaxel is also an active single agent in the first-line setting, with response rates ranging from 24 to 38% in evaluable patients, with a median survival of 6-13 months. Based on the single-agent activity, it was logical to evaluate the efficacy of docetaxel in combination with other active agents. As such, docetaxel has been studied in with numerous other agents such as vinorelbine, gemcitabine, platinums, etc. Notably cisplatin and carboplatin has shown promising rates of response and response duration in phase II trials. These combinations have now entered randomized phase III study.     

Docetaxel: an update of its use in advanced breast cancer

Docetaxel, a semisynthetic member of the taxoid class of antineoplastic agents, is effective in the treatment of patients with advanced (locally advanced or metastatic) breast cancer. Reported objective response rates for docetaxel 100 mg/m2 ranged from 54 to 69% and 53 to 82% as first-line monotherapy or combination therapy, respectively. Objective response rates of 23 to 65% and 30 to 81% have been reported for docetaxel as second-line monotherapy or combination therapy, respectively. In Japanese studies, second-line docetaxel 60 mg/m2 produced objective response rates of 42 to 55%. At the recommended dose of 100 mg/m2 given as a 1-hour intravenous (i.v.) infusion every 3 weeks, docetaxel had significantly greater efficacy than doxorubicin, mitomycin plus vinblastine and methotrexate plus fluorouracil, and similar efficacy to fluorouracil plus vinorelbine in pretreated patients with advanced breast cancer. In chemotherapy-naive patients, first-line combined therapy with docetaxel and doxorubicin had significantly greater efficacy than doxorubicin plus cyclophosphamide. Promising results have been achieved in phase I/II trials of a weekly regimen of docetaxel (generally 30 to 45 mg/m2). Preliminary data indicate a potential role for docetaxel in the neoadjuvant therapy of early breast cancer. The major dose-limiting adverse event associated with docetaxel is neutropenia. Although other adverse events are common, the tolerability profile of docetaxel is generally acceptable in the majority of patients, particularly in comparison with other antineoplastic regimens. Conclusions: Although no single standard regimen has been identified as optimal for the treatment of advanced breast cancer, phase III trials have shown that docetaxel has improved efficacy over doxorubicin alone (considered one of the current gold standards), methotrexate/fluorouracil and mitomycin/vinblastine in second-line therapy. In combination with doxorubicin, docetaxel has demonstrated better efficacy than doxorubicin/cyclophosphamide in first-line therapy. These results provide a basis for therapy choice in advanced breast cancer. Clinical trials comparing docetaxel monotherapy versus paclitaxel monotherapy and versus docetaxel combination therapy are warranted. The role of docetaxel in the adjuvant and neoadjuvant treatment of early breast cancer is being evaluated.     

Docetaxel (taxotere) in the treatment of non-small cell lung cancer

Docetaxel is a new semi-synthetic anticancer agent derived from bacatin III of the needles of the European yew Taxus baccata. Docetaxel has a novel mechanism of action since it binds to tubulin inducing its polymerization and promoting stable microtubule formation. Several differences exist between docetaxel and paclitaxel: (i) broader activity of docetaxel against freshly explanted human tumors than paclitaxel; (ii) a 2-fold higher affinity than paclitaxel; (iii) 2.5-fold more potent than paclitaxel as an inhibitor of cell replication and (iv) docetaxel acts at the S-phase whereas paclitaxel at the G(2)/M phases of the cell cycle. Preclinical and phase II studies revealed that docetaxel is active against NSCLC. In chemotherapy-na ve patients with NSCLC response rates ranged from 19% to 54% with a median duration of survival ranging from 6.3 months to 11 months, and 1-year survival ranging from 21% to 71%. Docetaxel as single agent provided a survival as well as a clinical benefit over BSC in untreated patients with NSCLC. Docetaxel has been efficiently combined with cisplatin (ORR 33%-46%), carboplatin (ORR 30%-48%), vinorelbine (ORR 20%-51%), gemcitabine (ORR 37%-47%), with a median survival ranging from 5-14 months. A preliminary analysis of a multicenter randomized trial comparing docetaxel/CDDP with docetaxel/gemcitabine revealed that the two regimens had comparable activity in terms, of response rates, duration of response, TTP and overall survival; however, the docetaxel/gemcitabine combination has a most favourable toxicity profile compared to docetaxel/CDDP. Docetaxel has also demonstrated radiosensitizing properties and encouraging results have been achieved in combination with irradiation. Finally, docetaxel has shown an important activity in previously-treated patients with NSCLC with ORR ranging from 16% to 25% with a median survival ranging from 7.2 months to 10.5 months. Randomized trials revealed that second-line docetaxel confers a survival benefit over either BSC or ifosfamide/vinorelbine in pretreated patients with NSCLC.     

Chemotherapy for advanced non-small-cell lung cancer patients with poor performance

Previous studies have recommended single-agent chemotherapy as an important alternative for non-small-cell lung cancer (NSCLC) patients with old age or poor performance. The authors of the evaluated article have evaluated three treatment strategies within the Intergroupe Francophone de Cancérologie Thoracique (IFCT-0301 study) as a Phase II trial. All strategies started with single-agent chemotherapy in chemotherapy-naive NSCLC patients with performance status (PS) 2 or 3. The three agents used for initial therapy in this study were gefitinib, gemcitabine and docetaxel. All three agents showed similar median progression-free survival values. Docetaxel was associated with higher response rates but also higher rates of adverse events. In subgroup analysis, patients with PS 3 did not benefit from monotherapy. This study suggests that monotherapy is still an option for NSCLC patients with PS 2; but, the study was not powered to favor one agent out of the three. In addition, because the study population did not undergo EGF receptor mutation analysis, it may not reflect the therapeutic impact of EGF receptor inhibitors, which can be tolerable in patients of poor performance.     

Vinorelbine: a review of its use in elderly patients with advanced non-small cell lung cancer

Vinorelbine is a semisynthetic vinca alkaloid that is effective as monotherapy in elderly patients with advanced non-small cell lung cancer (NSCLC). In the large comparative Elderly Lung Cancer Vinorelbine Italian Study (ELVIS), patients receiving vinorelbine monotherapy achieved an objective response rate of 19.7%. The median survival time and the 1-year survival rate were significantly higher in recipients of vinorelbine plus best supportive care than in recipients of best supportive care alone. Vinorelbine recipients generally scored better than recipients of best supportive care on quality-of-life (QOL) functioning scales and experienced significantly fewer lung cancer-related symptoms; however, QOL scores were worse with vinorelbine for parameters relating to drug tolerability. Comparative phase III trials investigating the efficacy of combination therapy with vinorelbine and other agents specifically in elderly patients with advanced NSCLC have been conducted only for the combination of vinorelbine and gemcitabine [the Southern Italy Cooperative Oncology Group (SICOG) trial and the Multicenter Italian Lung Cancer in the Elderly Study (MILES)]. Objective response rates for vinorelbine/gemcitabine combination therapy in these phase III trials were 22 and 20%, respectively. The SICOG trial was closed early when an interim analysis demonstrated a significant survival advantage for combination therapy with vinorelbine plus gemcitabine over vinorelbine monotherapy. However, a survival advantage for combination therapy versus vinorelbine monotherapy was not demonstrated in the larger MILES trial. The main adverse effect of vinorelbine monotherapy in the elderly is myelosuppression. Adverse events associated with most antineoplastic agents, such as mild alopecia, nausea, vomiting and mucositis, were reported in clinical trials; however, these events were rarely severe. Mild-to-moderate neurotoxicity, including constipation (presumably from autonomic neuropathy), was also reported. The addition of gemcitabine to vinorelbine increased the incidence of both haematological and nonhaematological adverse events. However, there was no significant increase in the incidence of life-threatening toxicity. Vinorelbine as a single agent is effective in elderly patients with NSCLC and is associated with improved survival and at least a trend towards improved QOL parameters compared with best supportive care alone. Vinorelbine was associated with a generally manageable tolerability profile. The benefit of adding gemcitabine to vinorelbine for the treatment of NSCLC in the elderly is equivocal; improved survival was reported in one comparative trial, but not in another larger one. Vinorelbine is an effective and well tolerated palliative treatment option for elderly patients with advanced NSCLC.     

Phase II study of weekly docetaxel and cisplatin in patients with non-small cell lung cancer

We conducted a phase II study to examine the efficacy and safety of weekly docetaxel and cisplatin in the treatment of advanced non-small cell lung cancer (NSCLC). Forty chemotherapy-naive patients (10 with stage IIIB and 30 with stage IV NSCLC) with an Eastern Cooperative Oncology Group performance status of 0-2 and adequate organ functions were enrolled. Chemotherapy consisted of cisplatin (80 mg/m2) on day 1, and docetaxel (35 mg/m2) on days 1, 8 and 15, delivered in 4-week cycles consisting of three weekly treatments followed by 1 week of rest. There were 18 partial responses, with an overall response rate of 45% (95% confidence interval 29.6-60.4%) in 40 treated patients. The median survival period was 19.9 months, median progression-free survival was 5.5 months and 1-year survival rate was 69.4%. Hematologic toxicities were mild and included grade 3 or 4 neutropenia in 37.5%. There were no severe infections or septic deaths. Non-hematologic toxicities were generally mild. Grade 3 or 4 transaminase elevations were observed in two patients. Grade 3 events included two cases each of vomiting, and one case each of hypokalemia, diarrhea and creatinine elevations. Weekly docetaxel and cisplatin is an effective and safe combination in the treatment of patients with advanced NSCLC.     

吉非替尼单药一线治疗晚期非小细胞肺癌临床研究

目的评价吉非替尼单药一线治疗在未经化疗的Ⅳ期非小细胞肺癌(NSCLC)患者中的有效性和耐受性。方法23例经组织学或细胞学确诊的未经化疗的Ⅳ期NSCLC患者,予以吉非替尼单药250mg/d口服,直到疾病进展或因严重不良反应不能耐受治疗。2月后评价疗效与不良反应,并随访1年生存率。结果客观有效率为26%,疾病控制率为61%;不良反应轻微,主要是皮疹、乏力、腹泻和肝功能异常。无间质性肺疾病(ILD)发生。1年生存率为58%。结论研究证实了吉非替尼单药一线治疗晚期NSCLC有效并具有良好的耐受性。     

国产多西紫杉醇联合顺铂在晚期非小细胞肺癌中的应用

目的观察国产多西紫杉醇联合顺铂治疗晚期非小细胞肺癌(non-small cell lung cancer,NSCLC)的近期疗效和不良反应。方法采用DP方案化疗:多帕菲75mg/m2,静脉滴注,第1天;顺铂75mg/m2,静脉滴注,第1天;21d为1个周期。至少使用2个周期评价疗效。结果70例中CR2例,PR29例,SD36例,PD3例,总有效率为44.3%。中位TTP6.3个月,中位生存期10.1个月,1年生存率38.6%。不良反应主要为骨髓抑制、脱发和消化系统反应,骨髓抑制为剂量限制性毒性,其中白细胞减少占75.7%。结论国产多西紫杉醇联合顺铂治疗晚期NSCLC近期疗效较好,毒不良反应较轻,值得临床进一步推广应用。     

多西他赛联合卡铂一线治疗晚期非小细胞肺癌的临床观察

目的观察多西他赛(docetaxel)联用卡铂(carboplatin)对晚期非小细胞肺癌一线治疗的疗效和毒性反应。方法晚期非小细胞肺癌患者共31例,多西他赛用量75 mg/m2,第1天静脉滴注,卡铂AUC=5 mg.mL-1.min-1,第1天静脉滴注。21~28 d为1个疗程,每例患者至少接受2个疗程治疗。结果31例患者均可评价疗效,无完全缓解病例(CR),11例获部分缓解(PR),16例稳定(SD),4例疾病进展(PD),总有效率为35.5%(11/31),其中位疾病进展时间为4.5个月,中位生存时间10.2个月(3~20个月),1年生存率为45.1%,毒性反应主要有骨髓抑制、恶心、呕吐和腹泻以及白细胞下降导致的发热等。大部分患者为Ⅰ、Ⅱ度反应,患者耐受良好。结论多西他赛联合卡铂是一种对晚期非小细胞肺癌有效的治疗方法,毒性反应轻,临床使用安全。     

Phase II, open-label, randomized study (SIGN) of single-agent gefitinib (IRESSA) or docetaxel as second-line therapy in patients with advanced (stage IIIb or IV) non-small-cell lung cancer

Our objective was to evaluate gefitinib (IRESSA), an epidermal growth factor receptor tyrosine kinase inhibitor, versus docetaxel as second-line monotherapy for advanced non-small-cell lung cancer (NSCLC). SIGN (Second-line Indication of Gefitinib in NSCLC; code 1839IL/0503) was a multicenter, randomized, parallel-group, open-label, phase II trial that investigated oral gefitinib (250 mg/day) or i.v. docetaxel (75 mg/m2 every 3 weeks) in patients with advanced NSCLC who had previously received one chemotherapy regimen. The primary objective was assessment of symptom improvement (using the FACT-L Lung Cancer Subscale). Secondary objectives included quality of life (FACT-L total score), response rate (using RECIST), overall survival and safety. This trial recruited 141 patients (68 to gefitinib and 73 to docetaxel) who received treatment for a median duration of 3.0 (gefitinib) and 2.8 (docetaxel) months. Similar efficacy was observed with gefitinib and docetaxel, 36.8 and 26.0% symptom improvement rates, 33.8 and 26.0% quality-of-life improvement rates, 13.2 and 13.7% objective response rates, and 7.5 and 7.1 months median overall survival, respectively. Fewer drug-related adverse events were observed with gefitinib compared with docetaxel (all grades: 51.5 versus 78.9%; Common Toxicity Criteria grade 3/4: 8.8 versus 25.4%). There were no withdrawals or deaths due to drug-related adverse events with gefitinib, while three patients withdrew and three died due to adverse events in the docetaxel group that were possibly drug related. We conclude efficacy with gefitinib was similar to docetaxel, but with a more favorable tolerability profile, in the second-line treatment of advanced NSCLC. These results support further investigation of gefitinib in this disease setting.     

Phase II trial of docetaxel with dexamethasone premedication in patients with advanced non-small cell lung cancer: the Canadian experience

We performed a Phase II trial to evaluate the activity and tolerability of docetaxel as a single agent in the treatment of advanced non-small cell lung cancer (NSCLC). Forty-four patients with metastatic and/or locally advanced NSCLC received i.v. docetaxel 100 mg/m2 every 3 weeks for a median of 4 (range 1-11) cycles. All patients received premedication with oral dexamethasone 8 mg twice daily for 5 days starting the day before chemotherapy. Seven partial responses were observed among 35 evaluable patients, and the overall response rate was 20% (95% CI 8-37). The median response duration was 5 months, median survival time was 10 months and the estimated 1-year survival rate was 42%. Treatment was generally well tolerated. Febrile neutropenia occurred in 10 patients (23%); neutropenic infection occurred in 4 patients, and led to 2 toxic deaths (both patients had borderline exclusion criteria). The corticosteroid premedication effectively reduced the overall incidence (34%) and severity (4% severe) of fluid retention, and delayed the median time to onset from cycle 4 to cycle 7. This study shows the promising efficacy of docetaxel as monotherapy in advanced NSCLC, and combination chemotherapy regimens incorporating docetaxel are now being evaluated in this clinical setting.     

Docetaxel-ifosfamide combination chemotherapy in patients with metastatic hormone-refractory prostate cancer: a phase I pharmacokinetic study

This phase I study was designed to evaluate the activity toxicity and pharmacokinetics of docetaxel combined with ifosfamide in the treatment of hormone-refractory prostate cancer. Ten patients received a median of 4.6 treatment cycles. Docetaxel was administered at a dose of 40 mg/m2 in a 1-hour infusion followed by ifosfamide 3,000 mg/m2 in a 24-hour infusion every 3 weeks. The optimal sequence of chemotherapeutic agents was investigated by reversing the order of administration in the second cycle and by collecting a total of six pharmacokinetic blood samples per cycle from all patients during the first and second cycles. The sequence of administration did not influence the pharmacokinetics of docetaxel. Prostate-specific antigen (PSA) responses were observed in four out of nine patients, with a PSA response rate of 44.4% (complete response + partial response). The treatment was well tolerated. No grade IV toxicities were recorded and grade III leucopenia resulted in dose-reductions in 6 cycles (13.3%). The pharmacokinetic parameters of docetaxel were similar in both sequences. Our recommendation for further phase II studies is ifosfamide followed by low-dose docetaxel. Further phase II efficacy studies are warranted.     

奥沙利铂加多西紫杉醇与奥沙利铂加长春瑞宾治疗43例老年晚期NSCLC的对照研究

目的评价奥沙利铂加多西紫杉醇与奥沙利铂加长春瑞宾方案治疗晚期非小细胞肺癌的临床疗效和安全性。方法可评价疗效的NSCLC患者以1：1比例随机分为治疗组与对照组。奥沙利铂联合多西紫杉醇组（治疗组）23例,奥沙利铂联合长春瑞宾组（对照组）20例。治疗组为多西紫杉醇75mg/m^2,静脉滴注2h,第1天;奥沙利铂（OXA）200mg/m^2,静脉滴注2h,第2天。每3周重复一次,行3周期（9周）治疗后判定临床效果。对照组为长春瑞滨25mg/m^2静脉推注,第1、8天;奥沙利铂用法同治疗组。结果治疗组总有效率（RR）为56.52%（13/23）;对照组总有效率（RR）为55%（11/20）。治疗组和对照组两组患者临床疗效和各项生活质量评分差异无统计学意义（P≥0.05）。治疗组恶心呕吐反应以及血红蛋白下降均较对照组轻。未出现治疗相关性死亡。结论奥沙利铂加多西紫杉醇治疗晚期非小细胞肺癌患者临床疗效高,不良反应轻微。     

异环磷酰胺联合长春瑞滨治疗晚期非小细胞肺癌疗效分析

目的 研究异环磷酰胺（IFO）联合长春瑞滨（NVB）的非铂类方案治疗非小细胞肺癌的疗效、毒性以找到一种临床上更有效方案。方法 107例晚期非小细胞肺癌患者，采用IFO1．5g／m^2静脉滴d1～d4，NVB25mg／m^2静脉滴d1、d8，每3周重复，至少用2个周期。结果 完全缓解3例，部分缓解48例，有效率47．7％；中位生存期10．3个月，1年生存率42％，2年生存率12．3％；主要的毒副反应为血液毒性，白细胞下降83．2％，其中Ⅲ～Ⅳ度37．4％；恶心呕吐24．3％。结论 该方案是治疗晚期非小细胞肺癌较好的方案，毒副反应能耐受，是理想的值得临床首选的非铂类方案。     

Phase II study of docetaxel alternating with cisplatin in chemotherapy-naïve patients with advanced non-small cell lung cancer

The objective of this study was to evaluate a regimen of full doses of docetaxel and cisplatin, using an alternating schedule, as first-line therapy for patients with inoperable non-small cell lung cancer (NSCLC). The standard concomitant schedule does not allow full doses of both drugs to be administered. We wanted to see if there was an advantage to be gained by administering full doses of both docetaxel and cisplatin, using a different schedule. Docetaxel 100 mg/m2 was given once every 6 weeks from week 1 and cisplatin (120 mg/m2 for two doses and 100 mg/m2 thereafter) once every 6 weeks from week 4, for six cycles (three docetaxel and three cisplatin). Thirty-six of the 44 patients enrolled were evaluable for efficacy. Forty-eight percent of the patients had good (KPS 90-100%) performance status. A median of five cycles was administered, for which no dose reductions were necessary. There were 13 of 36 partial responses (36%; 95% CI 21-54%) and 15 of 36 patients achieved stable disease (42%). The median duration of response was 10.5 months, the median time to progression was 4.5 months and the median survival was 9 months. The 1 and 2 year survival rates were 39 and 16%, respectively. The most frequent grade 3-4 toxicities were nausea (23% of patients), vomiting (18%) and neutropenia (77%). Infections were also common, but not severe. The alternating schedule produced response, toxicity and survival figures that compared favorable with those using the concomitant schedule. This study could serve as a model for future studies of non-cisplatin-containing regimens, in which full doses of docetaxel could alternate with full doses of other new agents active against NSCLC.     

Docetaxel: a review of its use in metastatic breast cancer

Docetaxel (Taxotere), a cytotoxic taxane, is an antimicrotubule agent effective in the treatment of patients with breast cancer. The clinical profile of docetaxel as an effective cytotoxic agent in the treatment of metastatic breast cancer is well established. As yet, no single standard regimen has been identified as optimal for the treatment of patients with metastatic breast cancer after failure of prior chemotherapy. However, the efficacy of docetaxel monotherapy administered every 3 weeks as a 1-hour infusion is similar to or better than that of doxorubicin, paclitaxel and fluorouracil plus vinorelbine, and better than that of methotrexate plus fluorouracil or mitomycin plus vinblastine. Although docetaxel is associated with neutropenia and other adverse events, its overall tolerability profile is generally acceptable in the majority of patients. Docetaxel, therefore, is an effective option in the treatment of patients with metastatic breast cancer after failure of prior chemotherapy.     

Advanced Non-Small Cell Lung Carcinoma: The Emerging Role of Docetaxel

The treatment of advanced non-small cell lung carcinoma(NSCLC) has improved greatly over the past decade. With theadvent of new agents, in particular taxanes, gemcitabine, vinorelbine,and topoisomerase I inhibitors, response rates have improved from15–20% to 25–35%, with commensurate improvement in median and one year survival rates to 8–10 months and 35–45%, respectively. These improvements have proven statistically significant in multiple studies [1–4].Docetaxel, either alone or in combination with platinols, hasshown particular promise; and, in some arenas, it has become a standard component of our therapeutic armamentarium. We will review the preclinical data and single agent activity of docetaxel in treatment-naïve and previously treated NSCLC patients, its activityin combination with cisplatin and carboplatin, as well as othernew agents, and finally focus on ongoing studies evaluating itsrole in locally advanced disease.     

多西他赛联合奥沙利铂同步化放疗治疗局部晚期非小细胞肺癌临床观察

目的 观察多西他赛联合奥沙利铂同步化、放疗治疗局部晚期非小细胞肺癌（NSCLC）的临床疗效和不良反应.方法 72例Ⅲ期NSCLC患者采用抽签法分为2组：治疗组35例进行同期放化疗,化疗在放疗开始时同期进行,用药多西他赛75 mg/m2第1天静脉滴注;奥沙利铂130 mg/m2第2天静脉滴注.21 d为1个周期,共2个周期.放疗采用X线三维适形放疗,2 Gy/次,5 次/周,总剂量60～70 Gy/30～50次,6～7周内完成.对照组37例只行三维适形放疗,具体剂量、分割方式同治疗组.治疗完成后评价疗效和不良反应.结果 治疗组总有效率80.0%,完全缓解率22.9%;对照组总有效率56.8%,完全缓解率10.8%,2组间总有效率差异有统计学意义（x2=5.77,P＜0.05）.治疗组1、2年生存率分别为68.6%、42.9%,对照组分别为40.5%、18.9%.治疗组肿瘤进展时间平均为10.2个月,单纯放疗组为4.5个月（x2=6.34,P＜0.05）.经对症治疗后均顺利完成,治疗过程无治疗相关死亡.结论 多西他赛联合奥沙利铂同期放疗可以提高晚期非小细胞肺癌的近期疗效和远期生存率,是一种安全有效的综合治疗手段.     

长春瑞滨单药与联合铂类一线治疗老年晚期非小细胞肺癌临床观察

目的观察长春瑞滨单药和长春瑞滨联合顺铂一线治疗老年晚期非小细胞肺癌的疗效和毒性反应。方法 44例晚期非小细胞肺癌,其中21例予长春瑞滨25mg/m2,第1.8天给药,每21天为1周期,23例予长春瑞滨联合顺铂,长春瑞滨25mg/m2,第1,8天,顺铂25mg/m2第1～3天,随访至进展后患者死亡。结果单药组CR、PR、SD、PD、总有效率,1年生存率分别为0%,28.6%,38.1%,33.3%,37.5%和43.6%。联合组CR、PR、SD、PD、总有效率,1年生存率分别为4.3%,26.0%,34.8%,30.1%和47.5%。两者之间无统计学差异;不良反应以粒细胞减少,消化道反应,口腔黏膜炎为主,两者之间对比差异有统计学意义(P<0.05)。结论应用单药长春瑞滨一线治疗老年晚期非小细胞肺癌不仅疗效与长春瑞滨联合顺铂方案大致相同且患者有良好的耐受性,因不良反应稍多,因引起重视。