Jassem J, Karnicka-Młodkowska H, Drozd-Lula M, Strug A, Pilarska-Machowicz A, Michalski A, Kowal E, Moś-Antkowiak R, Zych J
Radiotherapy Department, Medical Academy, Gdańsk, Poland.
Eur J Cancer. 1992;28(2-3):473-6. doi: 10.1016/s0959-8049(05)80079-6.
The aim of this prospective study was to assess the activity of a combination of vincristine, epirubicin and cyclosphosphamide (VEC) in previously untreated patients with limited small cell lung carcinoma (SCLC) and to delineate the feasibility of dose escalation for epirubicin in this regimen. The chemotherapy schedule included cyclophosphamide, 1000 mg/m2, vincristine, 1 mg/m2 and escalating doses of epirubicin: 50 mg/m2, 70 mg/m2 and 90 mg/m2; respectively in three consecutive groups of patients. Drug cycles were repeated every 3 weeks. 118 patients from eight institutions were enrolled in this study between February 1986 and March 1989. Objective tumour response was observed in 81 of 116 evaluable patients (70%) including 25 patients (22%) who achieved a complete remission. Responding patients received thoracic radiation after the fourth cycle of chemotherapy. The median duration of response was 30 weeks and the median duration of survival was 52 weeks. There were no significant differences in treatment results between the consecutive groups of patients. The regimen was well tolerated for all doses of epirubicin. The main toxicities included alopecia (96%), nausea and vomiting (81%) and leukopenia (44%). Grade 4 haematological toxicity was observed in 3 patients (2.6%). No significant epirubicin dose-dependent side effects, except for mucositis were observed.
这项前瞻性研究的目的是评估长春新碱、表柔比星和环磷酰胺联合方案(VEC)对既往未接受过治疗的局限期小细胞肺癌(SCLC)患者的疗效,并明确该方案中表柔比星剂量递增的可行性。化疗方案包括环磷酰胺1000mg/m²、长春新碱1mg/m²以及递增剂量的表柔比星:50mg/m²、70mg/m²和90mg/m²,分别用于三组连续的患者。每3周重复一个化疗周期。1986年2月至1989年3月期间,来自8个机构的118例患者入组本研究。116例可评估患者中有81例(70%)观察到客观肿瘤反应,其中25例(22%)达到完全缓解。缓解患者在化疗第4周期后接受胸部放疗。中位缓解持续时间为30周,中位生存时间为52周。连续几组患者的治疗结果无显著差异。该方案对所有剂量的表柔比星耐受性良好。主要毒性包括脱发(96%)、恶心和呕吐(81%)以及白细胞减少(44%)。3例患者(2.6%)观察到4级血液学毒性。除黏膜炎外,未观察到显著的表柔比星剂量依赖性副作用。