吉西他滨、异环磷酰胺和长春瑞滨用于晚期非小细胞肺癌：一项II期研究。

Gemcitabine, ifosfamide and vinorelbine in advanced non-small cell lung cancer: a phase II study.

作者信息

Recchia Francesco, Lombardo Marco, De Filippis Sandro, Rosselli Michele, Rea Silvio

机构信息

Unità operativa di Oncologia, Ospedale Civile di Avezzano, Università degli studi di L'Aquila, Italy.

出版信息

Anticancer Res. 2002 Mar-Apr;22(2B):1321-8.

PMID:12168945

Abstract

BACKGROUND

The objective of this phase II study was to determine the activity and toxicity of gemcitabine, ifosfamide and vinorelbine, in the treatment of patients with advanced non-small cell lung cancer (NSCLC).

PATIENTS AND METHODS

Chemotherapy-naïve patients with unresectable, stage IIIB and stage IV NSCLC, measurable lesions and an Eastern Cooperative Oncology Group (ECOG) performance status < or = 3, were entered into the trial. The treatment consisted of ifosfamide 1500 mg/m2 on days 1 to 3 with vinorelbine 25 mg/m2 and gemcitabine 1000 mg/m2 on days 3 and 8, every 3 weeks.

RESULTS

Fifty-four patients with stage IIIB (24%) and stage IV (76%) were enrolled into the trial. The median age of the patients was 65 years. The performance status was 0-1, 2 and 3 in 48%, 43% and 9% of patients, respectively. The histology was mainly squamous cell carcinoma (52%), which was poorly-differentiated in 30% of patients. All patients, receiving a total of 249 chemotherapy courses, were assessable for response and toxicity on an intent-to-treat basis. Objective responses included complete response in 3 (5.6%) patients (95% CI: 1.1% to 15.3%), partial response in 26 (48.1%) patients (95% CI: 34.3% to 62.2%), giving an overall response rate of 53.7% (95% CI: 39.6% to 674%). Stable disease was observed in 20 (37%) patients (95% CI: 24.3% to 51.2%) and progressive disease in 5 (9.3%) patients (95% CI: 3% to 20.3%). The median time to progression was 8.8 months (range: 2-55+ months). The median overall survival was 13.2 months (range: 2-55+). The 1-year survival rate was 56% for all patients, comprising 78% and 47% for stage IIIB and stage IV patients, respectively (p=0.088). Myelosuppression was the main side-effect with (WHO) grade 3/4 neutropenia and thrombocytopenia in 56% and 13% of the patients, respectively.

CONCLUSION

Our results showed that even patients with a poor performance status may benefit from gemcitabine, ifosfamide and vinorelbine treatment, with acceptable toxicity.

摘要

背景

本II期研究的目的是确定吉西他滨、异环磷酰胺和长春瑞滨治疗晚期非小细胞肺癌（NSCLC）患者的疗效和毒性。

患者与方法

未接受过化疗、不可切除的IIIB期和IV期NSCLC患者，有可测量病灶且东部肿瘤协作组（ECOG）体能状态≤3，进入本试验。治疗方案为第1至3天给予异环磷酰胺1500mg/m²，第3天和第8天给予长春瑞滨25mg/m²及吉西他滨1000mg/m²，每3周重复。

结果

54例IIIB期（24%）和IV期（76%）患者入组试验。患者中位年龄为65岁。体能状态为0 - 1、2和3的患者分别占48%、43%和9%。组织学类型主要为鳞状细胞癌（52%），其中30%为低分化。所有患者共接受249个化疗疗程，基于意向性分析评估疗效和毒性。客观缓解包括3例（5.6%）患者完全缓解（95%CI：1.1%至15.3%），26例（48.1%）患者部分缓解（95%CI：34.3%至62.2%），总缓解率为53.7%（95%CI：39.6%至67.4%）。20例（37%）患者病情稳定（95%CI：24.3%至51.2%），5例（9.3%）患者疾病进展（95%CI：3%至20.3%）。中位疾病进展时间为8.8个月（范围：2 - 55 +个月）。中位总生存期为13.2个月（范围：2 - 55 +）。所有患者1年生存率为56%，IIIB期和IV期患者分别为78%和47%（p = 0.088）。骨髓抑制是主要副作用，56%的患者出现（WHO）3/4级中性粒细胞减少，13%的患者出现3/4级血小板减少。