Quoix E, Finkelstein H, Wolkove N, Kreisman H
J Clin Oncol. 1986 Sep;4(9):1314-20. doi: 10.1200/JCO.1986.4.9.1314.
During a 27-month period, 215 new cases of lung cancer were diagnosed at five McGill University hospitals. Only 44 patients (20%) so diagnosed were treated on available chemotherapy protocols. Six categories were used to define reasons for nonparticipation. The most important were medical reasons (MRs), 46%; non-medical reasons (NMRs), 20%; and physician preference (PP), 16%. The three remaining categories, representing 18% of exclusions, were death before diagnosis (DBD), surgical treatment (S), and a miscellaneous group (M). Median survival of patients on and off protocol was 10 and 7 months, respectively. Patients with limited disease treated off protocol for NMR and those treated with surgery did better than patients on protocol. Patients with extensive disease not enrolled because of MR did worse, and those excluded because of PP did better than patients treated on protocol. The implication of these findings for other cancer studies is that analysis of chemotherapy trials often represents treatment results in a small proportion of all patients with a given neoplasm. As such, caution must be exercised when extrapolating results to the group as a whole. We suggest that complete demographic data, including proportion of patients participating and reasons for exclusion, be included in all chemotherapeutic trial reports.
在27个月的时间里，麦吉尔大学的五家医院诊断出215例新肺癌病例。在这些确诊病例中，只有44名患者（20%）按照现有的化疗方案接受了治疗。用六个类别来定义未参与治疗的原因。最重要的原因是医学原因（MRs），占46%；非医学原因（NMRs），占20%；以及医生偏好（PP），占16%。其余三个类别占排除病例的18%，分别是诊断前死亡（DBD）、手术治疗（S）和其他类别（M）。接受和未接受治疗方案的患者的中位生存期分别为10个月和7个月。因非医学原因未接受治疗方案的局限性疾病患者以及接受手术治疗的患者比接受治疗方案的患者情况更好。因医学原因未纳入研究的广泛性疾病患者情况更差，而因医生偏好被排除的患者比接受治疗方案的患者情况更好。这些研究结果对其他癌症研究的启示是，化疗试验的分析往往只代表了所有特定肿瘤患者中一小部分人的治疗结果。因此，在将结果外推至整个群体时必须谨慎。我们建议在所有化疗试验报告中纳入完整的人口统计学数据，包括参与患者的比例和排除原因。
