The aim of this randomized controlled trial was to investigate the effect of a 4-to 6-week multimodal program of exercise, relaxation and psychoeducation on physical capacity, functional performance and quality of life (QOL) in allogeneic hematopoietic cell transplantation (allo-HSCT) adult recipients. In all, 42 patients were randomized to a supervised multimodal intervention or to a control group receiving usual care. The primary end point was on aerobic capacity measured in VO 2 max. Secondary end points were muscle strength, functional performance, physical activity level, QOL, fatigue, psychological well-being and clinical outcomes. The multimodal intervention had a significant effect on physical capacity: VO 2 max (Po0.0001) and muscle strength: chest press (Po0.0001), leg extension (P ¼ 0.0003), right elbow flexor (P ¼ 0.0009), right knee extensor (Po0.0001) and functional performance (stair test) (0.0008). Moreover, the intervention group showed significantly better results for the severity of diarrhea (P ¼ 0.014) and fewer days of total parenteral nutrition (P ¼ 0.019). Longitudinal changes in QOL, fatigue and psychological well-being favored the intervention group, but did not reach statistical significance. Assignment of a multimodal intervention during allo-HSCT did not cause untoward events, sustained aerobic capacity and muscle strength and reduced loss of functional performance during hospitalization.

Studies applying exercise, relaxation training, and psychoeducation have each indicated a positive impact on physical performance and/or psychological factors in patients diagnosed with cancer. We explored the longitudinal effect of a combination of these interventions on treatment-related symptoms in patients undergoing myeloablative allogeneic hematopoietic stem cell transplantation (allo-HSCT). Forty-two patients (18-65 years) were randomized either to an intervention or a control group. The intervention group received standard treatment and care, and a supervised four- to six-week structured exercise program, progressive relaxation, and psychoeducation during hospitalization, one hour per day for five days per week. The control group received standard treatment, care, and physiotherapy. A 24-item symptom assessment questionnaire was completed weekly during hospitalization, and at three and six months after allo-HCST. Through principal component analysis with varimax rotation, individual symptoms were grouped into five symptom clusters: mucositis, cognitive, gastrointestinal, affective, and functional symptom clusters. Then, a subsequent general estimate equation analysis revealed similar longitudinal patterns of intensity in all symptom clusters for intervention and control groups, but in the intervention group, there was an overall significant reduction (P<0.05) in symptom intensity over time for all clusters except the affective symptom cluster. This study provides beginning evidence for the efficacy of an exercise-based multimodal intervention in reducing the intensity of a spectrum of symptoms in this small sample of patients undergoing allo-HSCT.

Substantial physical and functional deconditioning and diminished psychological wellbeing are all potential adverse effects of allogeneic stem cell transplantation (allo-HSCT). The aim of this study was to evaluate the feasibility, safety and benefits (physical and functional capacity) of a 4-6 week supervised and structured mixed-type exercise, progressive relaxation and psychoeducation programme in patients undergoing allo-HSCT. Nineteen patients were randomized to an intervention or a conventional care group (CC) and were tested for physical and functional capacity before admission and upon hospital discharge. In all, 14 patients completed all study requirements (74%) and no adverse reactions that could be attributed to the intervention were observed. At the time of discharge, the intervention group showed significant improvements in several muscle strength scores as compared to the CC group; chest press (P=0.023), leg extension (P=0.007) and isometric right knee flexor (P=0.033). The intervention proved feasible, safe and well tolerated in this small sample of patients undergoing allo-HSCT. An intervention of this type may be a useful strategy for maintaining or improving muscle strength, and minimizing loss of physical and functional capacity in patients undergoing allo-HSCT.

This article summarizes the scientific review of daratumumab that led to regulatory approval in the European Union.

The pharmacokinetics of glycosylated recombinant human granulocyte-macrophage colony-stimulating factor (rhGM-CSF) was studied following intravenous (i.v.) and subcutaneous (s.c.) bolus injection of rhGM-CSF, 8 micrograms kg-1 employing a sensitive radioimmunoassay. After a single i.v. bolus injection, an initial high serum level of rhGM-CSF was observed, followed by a rapid decrease that occurred in two phases with a half-life (t1/2) alpha of 20.0 +/- 5 min and a t1/2 beta of 68.3 +/- 8 min. Following s.c. bolus injection the absorption was more prolonged. Peak serum concentrations did not occur until about 15-20 h, and were followed by a more protracted elimination than by the i.v. route. In all patients the single rhGM-CSF injection led to an increase in peripheral white blood cells (WBC), after a temporary drop of 2-5 h duration. The increase in WBC was of longer duration after s.c. than after i.v. bolus treatment. Since the subcutaneous administration leads to prolonged serum concentration of rhGM-CSF and prolonged increase in peripheral WBC, it seems preferable to i.v. bolus injection, and as effective as continuous i.v. infusion.