Helsing M, Bergman B, Thaning L, Hero U
Department of Oncology, Orebro Medical Centre Hospital, Sweden.
Eur J Cancer. 1998 Jun;34(7):1036-44. doi: 10.1016/s0959-8049(97)10122-8.
The aim of the present trial was to evaluate the effects of chemotherapy on the quality of life and survival of patients with advanced non-small cell lung cancer (NSCLC) (stage IIIB or IV). In a controlled multicentre trial, patients were randomised to receive supportive care only or supportive care plus chemotherapy. Chemotherapy consisted of intravenous (i.v.) carboplatin 300 mg/m2 on day 1 and etoposide 120 mg/m2 orally on days 1-5 every 4 weeks for a maximum of eight courses. Quality of life was measured at randomisation and prior to each treatment course and at corresponding 4-week intervals in the control arm, using the EORTC QLQ-C30 + LC13 questionnaire. 48 patients were randomised (supportive care 26, chemotherapy 22), being eligible for comparative analyses. Another 102 patients, 97 of which received chemotherapy, were subsequently included in the study on an individual treatment preference basis. Data from these patients were used for confirmative purposes. Patients in the chemotherapy group reported better overall physical functioning and symptom control compared with the supportive care group. Group differences were smaller within the psychosocial domain, although trends were seen in favour of the chemotherapy group. No significant differences were seen in favour of the supportive care group, except for hair loss. Median survival times were 29 weeks in the chemotherapy group versus 11 weeks in the supportive care group, and 1-year survival rates were 28% versus 8%. Quality of life and survival outcomes were similar in the randomised and non-randomised patients receiving chemotherapy. No treatment-related deaths occurred. In conclusion, treatment with carboplatin and etoposide can improve both the quality of life and the survival of patients with advanced NSCLC.
本试验的目的是评估化疗对晚期非小细胞肺癌（NSCLC，ⅢB期或Ⅳ期）患者生活质量和生存的影响。在一项对照多中心试验中，患者被随机分为仅接受支持治疗或接受支持治疗加化疗。化疗方案为每4周重复1次，第1天静脉注射卡铂300mg/m²，第1 - 5天口服依托泊苷120mg/m²，最多进行8个疗程。使用欧洲癌症研究与治疗组织（EORTC）的QLQ - C30 + LC13问卷，在随机分组时、每个治疗疗程前以及在对照组相应的4周间隔时测量生活质量。48例患者被随机分组（支持治疗组26例，化疗组22例），符合比较分析条件。另外102例患者随后根据个人治疗偏好纳入研究，其中97例接受了化疗。这些患者的数据用于确证目的。与支持治疗组相比，化疗组患者报告的总体身体功能和症状控制情况更好。心理社会领域的组间差异较小，不过有化疗组更优的趋势。除脱发外，支持治疗组未见明显优势。化疗组的中位生存时间为29周，支持治疗组为11周，1年生存率分别为28%和8%。接受化疗的随机分组患者和非随机分组患者的生活质量和生存结果相似。未发生与治疗相关的死亡。总之，卡铂和依托泊苷治疗可改善晚期NSCLC患者的生活质量和生存情况。
