Impact of the Methotrexate Administration Dose on the Need for Intrathecal Treatment in Children and Adolescents With Anaplastic Large-Cell Lymphoma: Results of a Randomized Trial of the EICNHL Group

Purpose To compare the efficacy and safety of two methotrexate doses and administration schedules in children with anaplastic large-cell lymphoma (ALCL). Patients and Methods This randomized trial for children with ALCL was based on the Non-Hodgkin's Lymphoma–Berlin-Frankfurt-Muenster 90 (NHL-BFM90) study protocol and compared six courses of methotrexate 1 g/m2 over 24 hours and an intrathecal injection (IT) followed by folinic acid rescue at 42 hours (MTX1 arm) with six courses of methotrexate 3 g/m2 over 3 hours followed by folinic acid rescue at 24 hours without IT (MTX3 arm). This trial involved most European pediatric/lymphoma study groups and a Japanese group. Results Overall, 352 patients (96% ALK positive) were recruited between 1999 and 2005; 175 were randomly assigned to the MTX1 arm, and 177 were assigned to the MTX3 arm. Ninety-two percent of patients received protocol treatment. Median follow-up time is 3.7 years. Event-free survival (EFS) curves were superimposed with 2-year EFS rates (73.6% and 74.5% in the MTX1 and MTX3 arms, respectively; hazard ratio = 0.98; 91.76% CI, 0.69 to 1.38). Two-year overall survival rates were 90.1% and 94.9% in MTX1 and MTX3, respectively. Only two CNS relapses occurred (both in the MTX1 arm). Toxicity was assessed after 2,050 courses and included grade 4 hematologic toxicity after 79% and 64% of MTX1 and MTX3 courses, respectively (P < .0001); infection after 50% and 32% of courses, respectively (P < .0001); and grade 3 to 4 stomatitis after 21% and 6% of courses, respectively (P < .0001). Conclusion The results of the NHL-BFM90 study were reproduced in this large international trial. The methotrexate schedule of the NHL-BFM90 protocol including IT therapy can be safely replaced by a less toxic schedule of methotrexate 3 g/m2 in a 3-hour infusion without IT therapy

Using the yes/no recognition response pattern to detect memory malingering

Schindler S, Kißler J, Kühl K-P, Hellweg R, Bengner T. Using the yes/no recognition response pattern to detect memory malingering. BMC Psychology. 2013;1(1): 12.Background Detection of feigned neurocognitive deficits is a challenge for neuropsychological assessment. We conducted two studies to examine whether memory malingering is characterized by an elevated proportion of false negatives during yes/no recognition testing and whether this could be a useful measure for assessment. Methods Study 1 examined 51 participants claiming compensation due to mental disorders, 51 patients with affective disorders not claiming compensation and 13 patients with established dementia. Claimants were sub-divided into suspected malingerers (n = 11) and non-malingerers (n = 40) according to the Test of Memory Malingering (TOMM). In study 2, non-clinical participants were instructed to either malinger memory deficits due to depression (n = 20), or to perform normally (n = 20). Results In study 1, suspected malingerers had more false negative responses on the recognition test than all other groups and false negative responding was correlated with Minnesota-Multiphasic Personality Inventory (MMPI) measures of deception. In study 2, using a cut-off score derived from the clinical study, the number of false negative responses on the yes/no recognition test predicted group membership with comparable accuracy as the TOMM, combining both measures yielded the best classification. Upon interview, participants suspected the TOMM more often as a malingering test than the yes/no recognition test. Conclusion Results indicate that many malingers adopt a strategy of exaggerated false negative responding on a yes/no recognition memory test. This differentiates them from both dementia and affective disorder, recommending false negative responses as an efficient and inconspicuous screening measure of memory malingering