Are patients with Hodgkin lymphoma and high-grade non-Hodgkin lymphoma in clinical therapy optimization protocols representative of these groups of patients in Germany?
Annals of oncology : official journal of the European Society for Medical Oncology / ESMO, 21 (10):
2045–2051 (2010)Abstract
BACKGROUND\r\nImprovement of lymphoma therapy is largely driven by clinical therapy optimization protocols (TOPs). It is unclear, however, whether the patients treated in clinical TOP are representative for all patients.\r\nPATIENTS AND METHODS\r\nTOP participants were compared with nonstudy patients in a population-based approach. The study included patients with Hodgkin lymphoma (HL) and high-grade non-Hodgkin lymphoma (hgNHL). Incident cases (N = 743) were ascertained in a large population-based epidemiologic survey. Each patient's status with respect to exclusion criteria of the pertinent TOP was abstracted from primary data sources. TOP participants were identified on the basis of the trial databases. Baseline characteristics and risk factor prevalence were compared between nonstudy and TOP patients.\r\nRESULTS\r\nEligible for the respective TOPs were 64.1\% of all incident HL patients and 29.6\% of all hgNHL patients in the population. Main exclusion criterion was age (HL: 15.2\%; hgNHL: 27.4\%). Only 71 HL patients (23.0\%) and 11 hgNHL patients (3.4\%) had actually been enrolled in the respective TOPs.\r\nCONCLUSIONS\r\nTOP participants do not represent all patients with hgNHL and HL in the population. TOP inclusion criteria caused considerable selection among the participants. Further investigation is required to clarify possible limitations for the application of the outcomes observed in TOP patients for all patients with these diseases.