Ettinger David S, Berkey Brian A, Abrams Ross A, Fontanesi James, Machtay Mitchell, Duncan Philip J, Curran Walter J, Movsas Benjamin, Byhardt Roger W
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD 21231-1000, USA.
J Clin Oncol. 2005 Aug 1;23(22):4991-8. doi: 10.1200/JCO.2005.00.414. Epub 2005 Jun 6.
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).
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.
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%.
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.
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。
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。
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%。
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。