0
selected
-
1.
A supportive care intervention for people with metastatic melanoma being treated with immunotherapy: a pilot study assessing feasibility, perceived benefit, and acceptability.
Lacey, J, Lomax, AJ, McNeil, C, Marthick, M, Levy, D, Kao, S, Nielsen, T, Dhillon, HM
Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer. 2019;(4):1497-1507
Abstract
INTRODUCTION Increasing numbers of metastatic melanoma (MM) patients are receiving immunotherapy treatment, including pembrolizumab, and the impact on their well-being is underexplored. OBJECTIVES To assess the feasibility of a multimodal supportive care program to MM patients being treated with pembrolizumab. METHODS This pre-post-test feasibility cohort study recruited MM participants treated with pembrolizumab: (i) supportive care intervention with usual care and (ii) usual care. The intervention comprised comprehensive medical assessment by supportive care physician (SCP), exercise physiologist (EP), and dietitian then a tailored supportive care program. Programs included exercise, dietary advice, non-invasive complementary therapies, and psychology consultation. Outcome measures included adherence, patient-reported symptoms, anxiety and depression, and toxicity. Descriptive data are reported. RESULTS We recruited 28 participants: 13 intervention and 15 control; three did not complete the study. Most were male, with median age 66 (range 42-85) years. All intervention participants completed baseline assessments with SCP, EP, and dietitian. Two missed follow-up with EP or dietitian. Symptoms most troubling at baseline were as follows: fatigue (n = 6), sleep (n = 6), general aches and pains (n = 5), and memory (n = 4). All intervention participants were prescribed 16 exercise sessions; 8 (50%) completed all; overall exercise adherence was 85%. Integrative therapies were accessed by 85% (11) participants. Immunotherapy-related adverse event rates were low and SCP consultation identified symptoms not captured by CTCAE 4.0. CONCLUSIONS A holistic supportive care intervention tailored to individual needs is feasible. The symptom burden in MM patients was low. Further investigation of the intervention is warranted, focused on populations with higher symptom burden to improve outcomes.
-
2.
An open-label, prospective pilot clinical study of denosumab for severe hyperparathyroidism in patients with low bone mass undergoing dialysis.
Chen, CL, Chen, NC, Hsu, CY, Chou, KJ, Lee, PT, Fang, HC, Renn, JH
The Journal of clinical endocrinology and metabolism. 2014;(7):2426-32
Abstract
CONTEXT Denosumab is widely used for bone diseases with increased bone resorption. Its effectiveness in patients with severe secondary hyperparathyroidism on dialysis is unclear. OBJECTIVE This study aimed to evaluate the efficacy and safety of denosumab in patients with severe secondary hyperparathyroidism who are on dialysis. DESIGN This 6-month prospective, open-labeled study evaluated 12 patients (five women, seven men; mean age 53.5 ± 3.8 y). All had intact PTH (iPTH; > 1000 pg/mL), low bone mass (T-score < -1.0 SD), and bone pain and were poor surgical candidates. Serum calcium, phosphorus, alkaline phosphatase (AP), and iPTH levels were assessed at baseline and every month thereafter. Vertebral spine x-rays and bone mineral densities (BMDs) (lumbar spine and femoral neck) were assessed at the start and end of the study. All patients received denosumab (60 mg), calcitriol, phosphate binders, and dialysate calcium that were adjusted according to the biochemistry data. RESULTS The BMD increased in both the femoral neck (mean increase 23.7% ± 4.0%) and lumbar spine (17.1% ± 2.6%) after 6 months. In the first month, most patients had increased iPTH levels, which dramatically decreased from 1702.1 ± 181.9 to 518.8 ± 126.8 pg/mL by the end of the study after increasing the calcitriol dose. All patients had significant decreases in AP, calcium × phosphorus, and bone pain. Changes in femoral neck BMD correlated only with AP and iPTH levels. CONCLUSIONS Denosumab is effective in restoring bone mass and reducing bone pain in patients on dialysis with secondary hyperparathyroidism. It also allows for a more aggressive use of calcitriol to control hyperparathyroidism.
-
3.
Change of retinal nerve fiber layer thickness in various retinal diseases treated with multiple intravitreal antivascular endothelial growth factor.
Shin, HJ, Shin, KC, Chung, H, Kim, HC
Investigative ophthalmology & visual science. 2014;(4):2403-11
Abstract
PURPOSE To investigate the effect of multiple intravitreal injection of anti-VEGF on the retinal nerve fiber layer (RNFL) in AMD, diabetes mellitus retinopathy (DMR), and retinal vein occlusion (RVO). METHODS In this retrospective controlled case series, we reviewed the AMD, DMR, and RVO patients who received more than three anti-VEGF injections (injection group: 148 eyes). Patients without treatment were included as a control group (noninjection group: 183 eyes). RNFL thickness was measured by SD-OCT. Also, correlation between RNFL change and associated factors, including intraocular pressure (IOP), injection times, and severity of retinal ischemia, were analyzed using multivariate logistic regression. RESULTS RNFL thickness (μm) had not changed in AMD, but it decreased from 100.0 to 97.1, and from 101.1 to 98.0 in injection groups of DMR and RVO, respectively, as well as the noninjection group. However, decreased RNFL thickness of the injection groups was not significantly different from those of the noninjection groups. Severity of retinal ischemia was associated with decreased RNFL thickness (odds ratio: 4.667). However, number of injections and IOP-related variables had no association with RNFL change. CONCLUSIONS Multiple intravitreal injections of anti-VEGF did not lead to significant change in RNFL thickness in wet AMD, DMR, and RVO patients. Furthermore, IOP fluctuations and number of injections did not appear to adversely affect RNFL thickness. Decreased RNFL thickness associated with severity of retinal ischemia in the DMR and RVO patients suggests that inner retinal ischemia itself could be a cause of RNFL loss rather than anti-VEGF effect.
-
4.
Intravitreal bevacizumab for the treatment of nonarteritic anterior ischemic optic neuropathy: a prospective trial.
Rootman, DB, Gill, HS, Margolin, EA
Eye (London, England). 2013;(4):538-44
-
-
Free full text
-
Abstract
PURPOSE There is currently no accepted treatment for Nonarteritic Anterior Ischemic Optic Neuropathy (NAION). One new therapeutic approach involves decreasing optic nerve edema with intravitreal bevacizumab in order to resolve a proposed compartment syndrome. METHODS In this non-randomized controlled clinical trial, 1.25 mg intravitreal bevacizumab was compared with natural history. Patients were examined at baseline, 1, 3, and 6 months with a full neuro-ophthalmic exam, automated perimetry, and optic nerve optical coherence tomography (OCT) measurements. The primary outcome measure was change in mean deviation on Humphrey visual field testing. Secondary outcome measures were change in visual acuity and optic nerve OCT thickness. Incidence and type of complications were also recorded. RESULTS Twenty-five patients were enrolled (17 treatment and 8 control). There was no significant effect of treatment on the primary outcome measure of mean deviation score (P=0.4). There was similarly no effect of group assignment on the secondary outcome measures of change in mean Early Treatment Diabetic Retinopathy Study letters (P=0.33) or nerve fiber layer thickness on OCT (P=0.11). In the bevacizumab group, there was one case of a corneal abrasion and two cases of recurrent NAION. No other complications were noted. CONCLUSIONS We found no difference between bevacizumab and natural history for change in visual field, visual acuity, or optic nerve OCT thickness. Based on the current evidence we would not recommend the use of intravitreal bevacizumab to treat patients with the new onset of NAION.
-
5.
Topical vitamin K1 may not be effective in preventing acneiform rash during cetuximab treatment in patients with metastatic colorectal cancer.
Jo, JC, Hong, YS, Kim, KP, Lee, JL, Kim, HJ, Lee, MW, Lim, SB, Yu, CS, Kim, JC, Kim, JH, et al
European journal of dermatology : EJD. 2013;(1):77-82
Abstract
BACKGROUND Several studies have described the efficacy of topical vitamin K1 cream in the prevention and treatment of acneiform rash during cetuximab treatment. OBJECTIVES An interventional study with a historical control was conducted to investigate the efficacy of vitamin K1 cream for acneiform rash associated with cetuximab. METHODS For the historical control, data were collected from 40 patients with metastatic colorectal cancer who had participated in a previous clinical trial of cetuximab plus irinotecan. The experimental group consisted of 61 patients who were instructed to prophylactically apply topical vitamin K1 cream beginning on the first day of cetuximab treatment. The incidence, severity, and time to occurrence of acneiform rash were compared between groups. RESULTS The incidence of grade≥2 acneiform rash after 4 weeks of cetuximab treatment was 42.5% in the historical control group and 55.5% in the experimental group. The median time to grade≥2 rash in the experimental group was 4 weeks compared to 6 weeks in the historical control group (p=0.340). By multivariate analysis, male gender was the only independent risk factor for grade 2 or worse acneiform rash (HR=2.49; 95% CI, 1.27-4.88; p=0.007). Prophylactic application of topical vitamin K1 cream did not decrease the risk of acneiform rash (HR=1.33; 95% CI, 0.57-3.10; p=0.507). CONCLUSIONS The prophylactic application of topical vitamin K1 cream did not translate into clinically meaningful benefit in terms of reducing acneiform rash in patients with metastatic colorectal cancer treated with cetuximab.
-
6.
[Colorectal cancer -- cetuximab: will the hypomagnesemia treatment have future success].
Zeitschrift fur Gastroenterologie. 2013;(8):712