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紫杉醇、依托泊苷和顺铂化疗联合每日两次胸部放疗治疗局限期小细胞肺癌患者的研究:放射肿瘤学组9609 II期研究

Study of paclitaxel, etoposide, and cisplatin chemotherapy combined with twice-daily thoracic radiotherapy for patients with limited-stage small-cell lung cancer: a Radiation Therapy Oncology Group 9609 phase II study.

作者信息

Ettinger David S, Berkey Brian A, Abrams Ross A, Fontanesi James, Machtay Mitchell, Duncan Philip J, Curran Walter J, Movsas Benjamin, Byhardt Roger W

机构信息

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD 21231-1000, USA.

出版信息

J Clin Oncol. 2005 Aug 1;23(22):4991-8. doi: 10.1200/JCO.2005.00.414. Epub 2005 Jun 6.

Abstract

PURPOSE

To determine the response rate, progression-free survival and overall survival, and toxicity of paclitaxel, etoposide, and cisplatin combined with accelerated hyperfractionated thoracic radiotherapy in patients with limited-disease (LD) small-cell lung cancer (SCLC).

PATIENTS AND METHODS

LD-SCLC patients with measurable disease, Karnofsky performance score of > or = 70, and adequate organ function who were previously untreated were eligible for the study. Treatment was as follows. In cycle 1 of chemotherapy, concurrent thoracic radiation therapy was administered. In cycles 2 to 4, chemotherapy was administered alone. In cycle 1, chemotherapy consisted of paclitaxel 135 mg/m(2) intravenous over 3 hours on day 1, etoposide 60 mg/m(2) intravenous on day 1 and 80 mg/m(2) orally on days 2 and 3, and cisplatin 60 mg/m(2) intravenous on day 1. In cycles 2 to 4, the paclitaxel dose was increased to 175 mg/m(2), with the etoposide and cisplatin doses remaining the same as in cycle 1. The thoracic radiation therapy consisted of 1.5 Gy in 30 fractions (total dose, 45 Gy) administered 5 days a week for 3 weeks.

RESULTS

Fifty-five patients were enrolled onto the study, and 53 were assessable. The major toxicities included grade 3 and 4 acute neutropenia (32% and 43%, respectively) and grade 3 and 4 esophagitis (32% and 4%, respectively). Two patients died as a result of therapy (one died of acute respiratory distress syndrome, and one died of sepsis). There was one late fatal pulmonary toxicity. The median survival time was 24.7 months. The 2-year survival rate was 54.7%. The median progression-free survival time was 13 months, with a 2-year progression-free survival rate of 26.4%.

CONCLUSION

Although this therapeutic regimen is effective in the treatment of patients with LD-SCLC, it is unlikely that the three-drug combination with thoracic radiation therapy will improve the survival times compared with the etoposide plus cisplatin chemotherapy regimen with thoracic radiation therapy in LD-SCLC patients.

摘要

目的

确定紫杉醇、依托泊苷和顺铂联合加速超分割胸部放疗对局限期(LD)小细胞肺癌(SCLC)患者的缓解率、无进展生存期和总生存期以及毒性。

患者与方法

可测量病灶、卡氏评分≥70且器官功能良好的既往未接受过治疗的LD-SCLC患者符合本研究条件。治疗如下。在化疗第1周期,同时进行胸部放疗。在第2至4周期,单独进行化疗。在第1周期,化疗方案为第1天静脉滴注紫杉醇135mg/m²,持续3小时,第1天静脉滴注依托泊苷60mg/m²,第2天和第3天口服依托泊苷80mg/m²,第1天静脉滴注顺铂60mg/m²。在第2至4周期,紫杉醇剂量增至175mg/m²,依托泊苷和顺铂剂量与第1周期相同。胸部放疗为每周5天,每次1.5Gy,共30次(总剂量45Gy),持续3周。

结果

55例患者入组本研究,53例可评估。主要毒性包括3级和4级急性中性粒细胞减少(分别为32%和43%)以及3级和4级食管炎(分别为32%和4%)。2例患者死于治疗(1例死于急性呼吸窘迫综合征,1例死于败血症)。有1例晚期致命性肺部毒性。中位生存时间为24.7个月。2年生存率为54.7%。中位无进展生存时间为13个月,2年无进展生存率为26.4%。

结论

尽管该治疗方案对LD-SCLC患者有效,但与依托泊苷加顺铂化疗方案联合胸部放疗相比,三药联合胸部放疗不太可能改善LD-SCLC患者的生存时间。

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