Underrepresentation in Clinical Trials of Elderly With CLL
Clinical studies addressing the issue of treatment of elderly/unfit CLL patients are lacking. Common reasons for the exclusion of older CLL patients from clinical trials are concomitant diseases, lack of social and home care support, difficulties with access to care and, less frequently, arbitrary decision of the treating physician. Often, a combination of these factors determines relevant selection biases thus preventing the applicability of results obtained from clinical trials to the management of single patients.
To the best of the authors' knowledge, only two Phase III trials were conducted in elderly/unfit CLL patients. The first one is the GCLLSG CLL5 that addressed the efficacy and safety profile of chlorambucil versus fludarabine. The second is the ongoing GCLLSG CLL11 randomized three-arm study investigating the safety and efficacy profile of GA101 plus chlorambucil compared with rituximab plus chlorambucil or chlorambucil alone in nearly 800 previously untreated patients with CLL and coexisting medical conditions. Although Roche recently announced a potential advantage of adding GA101 to chlorambucil, until new options are available in the day-to-day practice, the authors suggest offering patients ineligible for FCR but still suitable for a chemoimmunotherapy approach the chance to participate in clinical trials.
Expert Rev Hematol. 2013;6(4):441-449. © 2013 Expert Reviews Ltd.