A randomised evaluation of low-dose cytosine arabinoside plus lenalidomide versus single-agent low-dose cytosine arabinoside in older patients with acute myeloid leukaemia: Results from the LI-1 trial.

Improving outcomes for older patients with acute myeloid leukaemia remains an unmet need. As part of the LI-1 trial, we evaluated lenalidomide (LEN) in combination with low-dose cytosine arabinoside (LDAC) in patients aged >60 years unfit for intensive therapy and compared this to LDAC alone. Two hundred and two patients, randomised 1:1, were evaluable. Overall response rate (CR + CRi) was higher for LDAC + LEN versus LDAC (26% and 13.7% respectively p = 0.031). However, there was no difference in overall survival between the arms (14% and 11.5% at 2 years for LDAC + LEN and LDAC respectively). The addition of LEN was associated with increased toxicity and supportive care requirements.

A randomised evaluation of low-dose Ara-C plus pegylated recombinant arginase BCT-100 versus low dose Ara-C in older unfit patients with acute myeloid leukaemia: Results from the LI-1 trial.

The survival of acute myeloid leukaemia (AML) patients aged over 60 has been suboptimal historically, whether they are treated using hypomethylating agents, low-dose cytarabine (LDAC) or venetoclax-based regimens. Progress is being made, however, for subgroups with favourable molecular or cytogenetic findings. Arginine metabolism plays a key role in AML pathophysiology. We report the only randomised study of LDAC with recombinant arginase BCT-100 versus LDAC alone in older AML patients unsuitable for intensive therapy. Eighty-three patients were randomised to the study. An overall response rate was seen in 19.5% (all complete remission [CR]) and 15% (7.5% each in CR and CR without evidence of adequate count recovery [CRi]) of patients in the LDAC+BCT-100 and LDAC arms respectively (odds ratio 0.73, confidence interval 0.23-2.33; p = 0.592). No significant difference in overall or median survival between treatment arms was seen. The addition of BCT-100 to LDAC was well tolerated.

Beliefs about Emotions, Depression, Anxiety and Fatigue: A Mediational Analysis.

BACKGROUND: Beliefs that it is unacceptable to experience or express negative emotions have been found to be associated with various clinical problems. It is unclear how such beliefs, which could be viewed as a form of unhelpful perfectionism about emotions, may contribute to symptomatology. AIMS: This study investigated two hypotheses: a) greater endorsement of beliefs about the unacceptability of negative emotions will be associated with greater emotional avoidance and lower levels of support-seeking and self-compassion; b) these beliefs about emotions will be associated with higher levels of symptoms of depression, anxiety and fatigue and that this relationship will be mediated by social support-seeking, emotional avoidance and self-compassion. METHOD: Online questionnaires were completed by 451 community participants. Mediational analyses were undertaken to investigate emotional avoidance, social support-seeking and self-compassion as mediators of the relationship between beliefs about emotions and symptoms of depression, anxiety and fatigue. RESULTS: Beliefs about the unacceptability of negative emotions were significantly associated with more emotional avoidance and less self-compassion and support-seeking. The relationships between beliefs about emotions and depression, anxiety and fatigue were significantly mediated by self-compassion and emotional avoidance but not social support-seeking. CONCLUSIONS: Future research should investigate whether interventions that pay particular attention to emotional avoidance and self-compassion, such as mindfulness-based therapy or modified forms of CBT, may be beneficial in reducing distress and fatigue associated with beliefs about the unacceptability of negative emotions.