Tocilizumab, tacrolimus and methotrexate for the prevention of acute graft-versus-host disease: low incidence of lower gastrointestinal tract disease.

We conducted a phase 2 study in which patients undergoing allogeneic hematopoietic stem cell transplantation received tocilizumab in addition to standard immune suppression with tacrolimus and methotrexate for graft-versus-host disease prophylaxis. Thirty-five patients were enrolled between January 2015 and June 2016. The median age of the cohort was 66 (range: 22-76). All patients received busulfan-based conditioning, and were transplanted with human leukocyte antigen-matched related or matched unrelated bone marrow or peripheral stem cell grafts. The cumulative incidences of grades II-IV and III-IV acute graft-versus-host disease were 14% (95% CI 5-30) and 3% (95% CI 0-11) at day 100, and 17% (95% CI 7-31) and 6% (95% CI 1-16) at day 180, respectively. Notably, there were no cases of graft-versus-host disease of the lower gastrointestinal tract within the first 100 days. A comparison to 130 matched controls who only received tacrolimus and methotrexate demonstrated a lower cumulative incidence of grades II-IV acute graft-versus-host disease (17% versus 45%, P=0.003) and a significant increase in grades II-IV acute graft-versus-host disease-free survival at six months (69% versus 42%, P=0.001) with tocilizumab, tacrolimus and methotrexate, which was the primary endpoint of the study. Immune reconstitution was preserved in patients treated with tocilizumab, tacrolimus and methotrexate, as T-cell and B-cell subsets recovered to near normal levels by 6-12 months post-transplantation. We conclude that tocilizumab has promising activity in preventing acute graft-versus-host disease, particularly in the lower gastrointestinal tract, and warrants examination in a randomized setting.

Prospective trial of a video educational tool for radiation oncology patients.

OBJECTIVES: Prospective assessment of the informational needs of radiation oncology patients and efficacy of an educational video in meeting them. METHODS: Subjects completed baseline self-administered questionnaires and subsequently viewed the patient education video. Post-testing was performed after initiation of therapy and subjects rated their satisfaction with the video, its relevance, and their emotional response. Analyses were performed with respect to patient and disease characteristics. RESULTS: Fifty-three subjects were enrolled and completed both before and after video measures. The mean age of participants was 58 years (range, 33 to 83). Pretreatment, >90% of patients reported specific information needs. One hundred percent of patients watched the video and 77% rated it as highly relevant. High levels of satisfaction (>90%) were reported with video information describing radiation and simulation. Older subjects (58 years and older) found video information significantly more relevant than those younger (55% versus 27%, P = 0.04) and rated greater satisfaction with side effect information (78% versus 41%, P = 0.006). Subjects with breast cancer exhibited a trend towards feeling better informed by the video. CONCLUSIONS: Radiation oncology patients reported informational needs unmet by standard educational measures. High levels of satisfaction were reported with video education. It promoted better understanding of radiotherapy. Older patients found the video to be significantly more relevant and informative.

Routine screening for depression in radiation oncology patients.

PURPOSE: Depression is a debilitating illness with symptoms that overlap those of cancer and radiotherapy. We sought to measure the frequency of depression in adult radiation oncology patients. METHODS AND MATERIALS: The Beck Depression Inventory-II (BDI-II) was incorporated into routine clinical evaluation of patients. Results were analyzed by univariate analysis and multivariate analysis of variance (MANOVA). RESULTS: One hundred twenty-four patients were screened and 19 (15%) endorsed significant depressive symptoms. Of these, levels of depression were: 58% mild, 32% moderate, and 10% severe. Twenty-six percent of the depressed group had a history of previous psychiatric diagnoses and 32% previously had been placed on psychotropic medications. The most frequent somatic symptoms for the entire group were loss of energy (73%) and tiredness or fatigue (69%). All depressed patients endorsed some somatic symptoms, but these alone were insufficient to score in the range of depression. CONCLUSIONS: A simple tool can be administered in the clinic by radiation oncologists to screen for depression. The frequency of depression in our patients was 15%. Somatic symptoms alone were insufficient to score as depressed.

Regulatory oversight, payment policy, and quality improvement in mental health care in nursing homes.

During the past 15 years, federal regulations, survey and inspection programs, and payment policies have presented conflicting incentives and disincentives for the provision of mental health services in nursing homes in the United States. Policies and regulatory measures have reflected the concern that many patients in nursing homes are not receiving the mental health care they need, and, more prominently, the concern that some of the services that are provided seem to be inappropriate or medically unnecessary. Despite evidence that payment policy and regulatory oversight can be used effectively to promote quality improvement, the need for improved access and quality of mental health services in long-term care remains substantial. Recent reports issued by the Surgeon General and by the Institute of Medicine identify a need for refinements in the assessment process, the use of outcomes-based quality measures, and payment policies designed to improve access and quality. These elements must be coordinated to promote humane treatment in nursing homes, including access to medically necessary psychiatric care.