Semrau Sabine, Bier Anette, Thierbach Ulrike, Virchow Christian, Ketterer Peter, Klautke Gunther, Fietkau Rainer
Department of Radiotherapy, University of Rostock, Rostock, Germany.
Strahlenther Onkol. 2007 Jan;183(1):30-5. doi: 10.1007/s00066-007-1593-5.
Although poor-risk patients represent no minority in inoperable non-small cell lung cancer (NSCLC), there is little experience with concurrent radiochemotherapy (RCT) in this group. Here, the authors report on the feasibility and efficacy of RCT with vinorelbine plus carboplatin or cisplatin in NSCLC patients with comorbidities and poor general health or advanced age.
A total of 66 patients (ten women, 56 men, median age 68 years) with inoperable NSCLC and an increased risk of treatment side effects (WHO performance score of 2-3; cardiac, pulmonary or renal failure or extensive weight loss before treatment, or an age of 71-78 years) were treated with vinorelbine 12.5 mg/m(2) on days 1, 8, 15, 29, 36, and 43 in combination with either carboplatin 70 mg/m(2) (n = 59) or cisplatin 20 mg/m(2) (n = 7) on days 1-5 and 29-33 in addition to receiving conventional fractionated radiotherapy with doses of up to 63 Gy (90% isodose).
62 of 66 patients (94%) reached the 90% level of the prescribed radiation dose, and 41/66 patient (62%) received at least two cycles of the platinum compound and four cycles of vinorelbine. The following hematologic side effects (CTC classification [Common Toxicity Criteria]) were observed: grade 3 (12%) and grade 4 (15%) thrombocytopenia, grade 3 (38%) and grade 4 (4%) leukocytopenia, and anemia requiring transfusion (26%). Other side effects (CTC) included grade 3 (3%) and grade 4 (2%) esophagitis and grade 3 pneumonitis (3%). The response rates were as follows: complete remission 18%, partial remission 56%, stable disease 21%, and progressive disease 5%. The cumulative survival rates were 53%, 24%, and 8% at 12 months, 24 months, and 5 years, respectively.
After including a larger group of patients than in 2003 and following the patients for several years, the authors determine that concurrent RCT consisting of vinorelbine plus a platinum compound and conventional fractionated radiotherapy can be carried out with manageable toxicity, even in this negatively selected population of patients. Their survival rates were comparable to those achieved in other studies with simultaneous RCT.
尽管预后不良的患者在不可切除的非小细胞肺癌(NSCLC)患者中并非少数,但针对这一群体进行同步放化疗(RCT)的经验却很少。在此,作者报告了长春瑞滨联合卡铂或顺铂同步放化疗在合并症、一般健康状况差或高龄的NSCLC患者中的可行性和疗效。
共有66例不可切除的NSCLC患者(10例女性,56例男性,中位年龄68岁),其治疗副作用风险增加(世界卫生组织体能状态评分为2 - 3分;治疗前存在心脏、肺部或肾衰竭或体重显著减轻,或年龄在71 - 78岁之间),在第1、8、15、29、36和43天接受12.5mg/m²长春瑞滨治疗,同时在第l - 5天和29 - 33天联合卡铂70mg/m²(n = 59)或顺铂20mg/m²(n = 7),此外还接受剂量高达63Gy(90%等剂量线)的常规分割放疗。
66例患者中有62例(94%)达到规定放疗剂量的90%水平,41/66例患者(62%)接受了至少两个周期的铂类化合物和四个周期的长春瑞滨治疗。观察到以下血液学副作用(CTC分类[常见毒性标准]):3级(12%)和4级(15%)血小板减少,3级(38%)和4级(4%)白细胞减少,以及需要输血的贫血(26%)。其他副作用(CTC)包括3级(3%)和4级(2%)食管炎以及3级肺炎(3%)。缓解率如下:完全缓解18%,部分缓解56%,疾病稳定21%,疾病进展5%。12个月、24个月和5年的累积生存率分别为53%、24%和8%。
在纳入了比2003年更大的患者群体并对患者进行数年随访之后,作者确定,即使在这个经过负面筛选的患者群体中,由长春瑞滨加铂类化合物和常规分割放疗组成的同步放化疗也可以在可控制的毒性下进行。其生存率与其他同步放化疗研究的结果相当。