Collette L, Sylvester R J, Stenning S P, Fossa S D, Mead G M, de Wit R, de Mulder P H, Neymark N, Lallemand E, Kaye S B
European Organization for Research and Treatment of Cancer, Data Center, Brussels, Belgium.
J Natl Cancer Inst. 1999 May 19;91(10):839-46. doi: 10.1093/jnci/91.10.839.
Because metastatic nonseminomatous germ cell cancer is a rare but treatable cancer, we have explored whether there is an association between the experience of the treating institution with this disease and the long-term clinical outcome of the patients, particularly patients with a poor prognosis.
We analyzed data on 380 patients treated in one of 49 institutions participating in the European Organization for Research and Treatment of Cancer/ Medical Research Council randomized trial of four cycles of bleomycin-etoposide-cisplatin followed by two cycles of etoposide-cisplatin versus three cycles of bleomycin-vincristine-cisplatin followed by three cycles of etoposide-ifosfamide-cisplatin-bleomycin, both treatment regimens given with or without filgrastim (granulocyte colony-stimulating factor). Institutions were divided into four groups based on the total number of patients entered in the trial. The groups were compared by use of the Cox proportional hazards model stratified for treatment with filgrastim and for patient prognosis as defined by the International Germ Cell Consensus Classification Group. With the use of this classification, only 65 % of the patients had a poor prognosis.
Patients treated in the 26 institutions that entered fewer than five patients into the trial had an overall survival that was statistically significantly worse (two-sided P = .010; hazard ratio = 1.85; 95% confidence interval = 1.16-3.03) than that of patients treated in the 23 institutions that entered five patients or more. Overall survival and failure-free survival were similar among institutions that entered at least five patients. The observed effect may be related to differences in adherence to the chemotherapy protocol and in the frequency and extent of surgery for residual masses, although only the differences in dose intensity achieved statistical significance.
Patients treated in institutions that entered fewer than five patients into the trial appeared to have poorer survival than those treated in institutions that entered a larger number of patients with "poor-prognosis" nonseminoma.
转移性非精原细胞性生殖细胞癌是一种罕见但可治疗的癌症，我们探讨了治疗机构对这种疾病的治疗经验与患者的长期临床结局之间是否存在关联，尤其是预后较差的患者。
我们分析了参与欧洲癌症研究与治疗组织/医学研究理事会随机试验的49家机构中380例患者的数据。该试验比较了四个周期的博来霉素-依托泊苷-顺铂，随后两个周期的依托泊苷-顺铂与三个周期的博来霉素-长春新碱-顺铂，随后三个周期的依托泊苷-异环磷酰胺-顺铂-博来霉素这两种治疗方案，两种治疗方案均联合或不联合非格司亭（粒细胞集落刺激因子）。根据试验中纳入的患者总数，将机构分为四组。使用Cox比例风险模型对两组进行比较，该模型根据非格司亭治疗情况以及国际生殖细胞共识分类组定义的患者预后进行分层。根据该分类，只有65%的患者预后较差。
在试验中纳入患者少于5例的26家机构中接受治疗的患者，其总生存期在统计学上显著差于（双侧P = 0.010；风险比 = 1.85；95%置信区间 = 1.16 - 3.03）在纳入患者5例或更多的23家机构中接受治疗的患者。在纳入至少5例患者的机构中，总生存期和无失败生存期相似。观察到的效应可能与化疗方案的依从性以及残留肿块手术的频率和范围差异有关，尽管只有剂量强度的差异具有统计学意义。
在试验中纳入患者少于5例的机构中接受治疗的患者，其生存期似乎比在纳入更多“预后较差”非精原细胞瘤患者的机构中接受治疗的患者更差。
