Effects of a combined physical and psychosocial intervention program for childhood cancer patients on quality of life and psychosocial functioning: results of the QLIM randomized clinical trial.

OBJECTIVE: Although survival rates in childhood cancer have improved, prevention and reduction of late effects remain important. This study evaluates the effects of a combined physical exercise and psychosocial intervention on health-related quality of life (HrQoL) and psychosocial functioning in childhood cancer patients. METHODS: In this multicenter randomized controlled trial, cancer patients (aged 8-18 years) and their parents filled in questionnaires on HrQoL, depressive symptoms, behavioral problems, and self-esteem. Measurements were conducted at baseline, shortly after the 12-week intervention period and 12 months after baseline. Generalized estimating equations analyses were performed to assess short-term and long-term psychosocial effects. RESULTS: Of the 174 eligible patients, 68 (39.1%) participated. The intervention group consisted of 30 participants at baseline [mean age 13.0 (SD 3.0) years; 53% male], 26 at short-term and 22 at long-term follow-up. The 'care as usual' control group consisted of 38 participants at baseline [mean age 12.6 (SD 3.1) years; 53% male], 33 at short-term and 31 at long-term follow-up. Overall, the intervention did not improve psychosocial functioning and HrQoL. According to parent-proxy reports, the intervention leads to a greater improvement on pain-related HrQoL on both the short (ß = 13.4; 95% CI: 3.0; 23.8) and long term (ß = 13.0; 95% CI: 1.6; 24.4) and to greater improvement on procedural anxiety immediately after the intervention (ß = 12.6; 95% CI: 1.9; 23.3). CONCLUSION: A combined physical and psychosocial training for children with cancer did not have effects on HrQoL or psychosocial functioning, with exception of modest positive effects on parent-reported pain and procedural anxiety Copyright © 2015 John Wiley & Sons, Ltd.

Nivolumab plus Brentuximab vedotin +/- bendamustine combination therapy: a safe and effective treatment in pediatric recurrent and refractory classical Hodgkin lymphoma.

Introduction: Classical Hodgkin lymphoma (cHL) is the most common pediatric lymphoma. Approximately 10% of patients develop refractory or recurrent disease. These patients are treated with intensive chemotherapy followed by consolidation with radiotherapy or high-dose chemotherapy and autologous stem cell reinfusion. Although this treatment is effective, it comes at the cost of severe long-term adverse events, such as reduced fertility and an increased risk of secondary cancers. Recently, promising results of inducing remission with the immune checkpoint inhibitor nivolumab (targeting PD-1) and the anti-CD30 antibody-drug conjugate Brentuximab vedotin (BV) +/- bendamustine were published. Methods: Here we describe a cohort of 10 relapsed and refractory pediatric cHL patients treated with nivolumab + BV +/- bendamustine to induce remission prior to consolidation with standard treatment. Results and discussion: All patients achieved complete remission prior to consolidation treatment and are in ongoing complete remission with a median follow-up of 25 months (range: 12 to 42 months) after end-of-treatment. Only one adverse event of CTCAE grade 3 or higher due to nivolumab + BV was identified. Based on these results we conclude that immunotherapy with nivolumab + BV +/- bendamustine is an effective and safe treatment to induce remission in pediatric R/R cHL patients prior to standard consolidation treatment. We propose to evaluate this treatment further to study putative long-term toxicity and the possibility to reduce the intensity of consolidation treatment.

No efficacy for silicone gel sheeting in prevention of abnormal scar formation in children with cancer: a randomized controlled trial.

BACKGROUND: Placement of a totally implantable venous access device in children with cancer often leads to hypertrophic scars after its removal. This study investigates whether the use of silicone gel sheets has a beneficial effect on scar outcome in children with cancer. METHODS: In a three-arm randomized controlled trial, the effects of use of silicone gel sheets for 2 and 6 months were assessed and compared with no intervention in children with cancer after removal of the totally implantable venous access device. Silicone gel sheets were first administered 14 days after surgery. The 1-year follow-up included measurements at seven time points. Next to scar size assessment, the modified Vancouver Scar Scale was used to assess scar outcome. RESULTS: Thirty-six children participated. For hypertrophy, no significant differences were found between the two intervention groups and the control group. However, at 1-year follow-up, the 2-month application group showed significantly smaller scars compared with the group receiving silicone gel sheet treatment for 6 months (p = 0.04), but not when compared with the control group (p = 0.22). Longitudinal multilevel analyses could not confirm these findings and showed no significant intervention effects on both outcomes. CONCLUSIONS: This study provides no strong evidence to support the use of silicone gel sheets after totally implantable venous access device removal in children with cancer. There seems to be a small benefit for scar width with application for 2 months. However, for hypertrophy, the scar outcome shows no significant difference between the control group and the 2-month and 6-month treatment groups.