Australia and New Zealand Transplant and Cellular Therapies (ANZTCT) position statement: COVID-19 management in patients with haemopoietic stem cell transplant and chimeric antigen receptor T cell.

Patients with post-haemopoietic stem cell transplant or chimeric antigen receptor T -cell (CAR-T) therapy face a significant risk of morbidity and mortality from coronavirus disease 2019 because of their immunosuppressed state. As case numbers in Australia and New Zealand continue to rise, guidance on management in this high-risk population is needed. Whilst we have learned much from international colleagues who faced high infection rates early in the pandemic, guidance relevant to local health system structures, medication availability and emerging therapies is essential to equip physicians to manage our patients optimally.

Challenges associated with test dose pharmacokinetic predictions of high dose melphalan exposure in patients with multiple myeloma.

AIM: To evaluate the accuracy of melphalan test dose pharmacokinetic (PK) predictions of the subsequent high dose (HDM) area under the concentration-versus-time curve (AUC) and to identify sources of prediction error (PE). METHODS: A prospective multicentre PK study was conducted in 40 myeloma patients of median age 60 (range:35-71) years using a 20 mg/m2 test dose administered 1-3 days prior to HDM (predominantly 180 mg/m2). PK data were collected post the test and high doses to compare predicted versus actual AUCs determined using the trapezoidal rule. Test and high dose infusion concentration, volume and duration and the time from preparation to infusion were compared using the paired Wilcoxin rank sign test. The impact of Melphalan administration parameters on PE was evaluated using the Mann-Whitney test. The predictive capacity of a previously published population PK (PopPK) model was also examined. RESULTS: Predicted HDM AUC was within 15% of the observed values in only 63% of patients when analysed using the trapezoidal rule and 70% of patients using PopPK. Test dose infusion concentration, volume, duration and time from preparation to infusion were significantly lower than for HDM (p < 0.005). Test dose administration within 15 min of reconstitution (n = 5) was associated with significantly lower PE than administration times of 16-60 min (n = 22), p < 0.05. Test and HDM infusion concentrations were lower in patients with large PE (> ± 15%), but the differences were not significant (p = 0.078, 0.228, respectively). CONCLUSION: Test dose PK has the potential to predict subsequent HDM exposure to achieve a target AUC once melphalan administration parameters are optimised to account for stability issues in the formulation.

Australia and New Zealand Transplant and Cellular Therapies COVID-19 vaccination consensus position statement.

Australia and New Zealand have achieved excellent community control of COVID-19 infection. In light of the imminent COVID-19 vaccination roll out in both countries, representatives of all adult and paediatric allogeneic bone marrow transplant and cellular therapy (TCT) centres as well as representatives from autologous transplant only centres in Australia and New Zealand collaborated with infectious diseases specialists with expertise in TCT on this consensus position statement regarding COVID-19 vaccination in TCT patients in Australia and New Zealand. It is our recommendation that TCT patients, should have expedited access to high-efficacy COVID-19 vaccines given that these patients are at high risk of morbidity and mortality from COVID-19 infection. We also recommend prioritising vaccination of TCT healthcare workers and household members of TCT patients. Vaccination should not replace other public health measures in TCT patients given the effectiveness of COVID-19 vaccination in TCT patients is unknown. Furthermore, given the limited available data, prospective collection of safety and efficacy data of COVID-19 vaccination in this patient group is a priority.

Predictors of quality of life in allogeneic hematopoietic stem cell transplantation survivors.

OBJECTIVES: To establish the demographic, medical, transplant, and lifestyle factors that impact Quality of Life (QoL) in long-term survivors of allogeneic Hematopoietic Stem Cell Transplantation (allo-HSCT). DESIGN: Cross-sectional study utilizing self-report measures. SAMPLE/METHODS: In this cross-sectional study of 441 adult survivors of allo-HSCT, participants completed questionnaires assessing QoL, psychological, social, demographic, and clinical variables. FINDINGS: Factors associated with improved QoL post-allo-HSCT included time since transplant, female gender, attendance at outpatient appointments, health screening uptake, exercise, and resumption of travel. Factors significantly associated with impaired QoL included chronic morbidities (GVHD), taking psychotropic medication, failure to resume sexual activity (in men), male gender, psychological distress, low income or decline in work status, transition to non-physical work, and necessity for post-allo-HSCT care from various health professionals. IMPLICATIONS FOR PSYCHOSOCIAL PROVIDERS: Identification of survivors more likely to experience a reduced QoL following allo-HSCT may enable the targeting of health services to the most vulnerable, and the development of interventions and resources. The data from this study led to the development of HSCT Long-Term Follow Up Clinical Guidelines in New South Wales.

Australasian Trends in Allogeneic Stem Cell Transplantation for Myelofibrosis in the Molecular Era: A Retrospective Analysis from the Australasian Bone Marrow Transplant Recipient Registry.

To review the updated trends of national practice and outcomes in transplantation to treat myelofibrosis (MF), we retrospectively evaluated 142 patients who underwent allogeneic hematopoietic stem cell transplantation (allo-HSCT) for primary (n = 94) or secondary (n = 48) MF at an Australian/New Zealand transplantation center between 2006 and 2017. The median duration of follow-up was 51.8 months (range, 3.1 to 148 months). The median age at allo-HSCT was 56 years (range, 26 to 69 years). Fifty-two percent of the patients had HLA-identical sibling donors, and 45% had matched unrelated donors (UD). Conditioning regimens were predominantly reduced intensity (83%). Before transplantation, 16% of the patients had undergone splenectomy or splenic irradiation, and 38% (n = 54) received JAK inhibitor therapy. JAK2 mutation testing was performed in 66.9% of the patients, whereas other mutations (CALR, MPL, ASXL1, SRSF2, U2AF1Q57, EZH2, and IDH1/2) were rarely tested (1.4% to 8.4%). Only 4.2% of patients had next-generation sequencing mutation analysis. The median time to neutrophil engraftment was 19 days (range, 10 to 43 days), and the median time to platelet engraftment was 27 days (range, 13 to 230 days). The cumulative incidence of grade II-IV acute graft-versus-host disease (aGVHD) was 21.4% at 100 days, and that of extensive chronic GVHD (cGVHD) at 5 years was 18.1%. Overall survival (OS) was 67% at 1 year and 57% at 5 years. GVHD-free, relapse-free survival was 54% at 1 year and 42% at 5 years. The cumulative incidence of nonrelapse mortality (NRM) was 16% at 100 days and 25% at 1 year. In multivariate analysis, age ≥65 years and use of an UD were identified as significant unfavorable risk factors for OS and NRM. Use of an UD increased the incidence of aGVHD, whereas administration of antithymocyte globulin/alemtuzumab lowered the risk of both aGVHD and cGVHD. Pretransplantation splenectomy/splenic irradiation had a positive influence on time to engraftment. There have been no improvements in the outcomes of allo-HSCT for MF in Australasia over the last decade, with a low uptake of molecular genomic technology due to limited access to funding.

Unrelated Donor Transplant Recipients Given Thymoglobuline Have Superior GRFS When Compared to Matched Related Donor Recipients Undergoing Transplantation without ATG.

Recipients of allogeneic hematopoietic stem cell transplantation (HSCT) from unrelated donors (URDs) and mismatched related donors (MMRDs) typically have a higher incidence of acute and chronic graft-versus-host disease (GVHD) compared with matched related donors (MRDs). Anti-T-cell globulins (ATGs) are often used to reduce GVHD in these recipients. We report the outcomes of 211 adult peripheral blood stem cell transplant recipients with myeloid malignancies who received a standardized transplant protocol, in which ATG (Thymoglobuline 4.5 mg/kg) was administered to recipients of URD and MMRD (n = 147) but not MRD (n = 64) transplant. For all patients, incidence of acute GVHD grades 2 to 4 was 21.4%, and chronic GVHD was 35.0%. Two-year overall survival was 63.2% (95% confidence interval, 55.8% to 71.5%), relapse-free survival was 55.3% (47.4% to 64.6%), and GVHD-free, relapse-free survival (GRFS) was 30.7% (23.2% to 40.8%). There were no differences between recipients of MRDs and other donors in relapse, nonrelapse mortality, and overall and relapse-free survival. However, compared with MRD, recipients from URDs and MMRDs had reduced moderate to severe chronic GVHD (10.4% versus 30.1%, P= .002), less chronic GVHD requiring systemic therapy (19.4% versus 38.9%, P = .006), and superior 2-year GRFS (35.5% versus 20.0%, P = .003). In this retrospective review of nonrandomized transplant groups, outcomes of HSCT performed using an URD with ATG during conditioning were superior to transplant from an MRD without ATG. The addition of Thymoglobuline to conditioning in HSCT from MRD should be further examined in prospective trials.

Clinical experience with new formulation SUBA®-itraconazole for prophylaxis in patients undergoing stem cell transplantation or treatment for haematological malignancies.

BACKGROUND: SUper BioAvailability-itraconazole (SUBA®-itraconazole) was introduced into Australia in April 2014 as a substitute for standard itraconazole on the basis of improved bioavailability, tolerance and interpatient variability. Shortly after its introduction, our centre converted to the novel formulation for mould prophylaxis in patients undergoing allogeneic HSCT, autologous HSCT or treatment for haematological malignancies with an intermediate/high risk of invasive fungal infection (IFI). METHODS: A single-institution, investigator-initiated retrospective cohort study was conducted between June 2016 and April 2018 to assess therapeutic drug concentrations, safety and tolerability of a standard prophylactic dose of SUBA®-itraconazole. RESULTS: A total of 74 patients were assessed across 98 admissions with 178 measured itraconazole trough concentrations. The median duration of prophylaxis was 15.5 (1-59) days. No significant correlation was identified between trough concentrations and patient demographics including gender and weight. Drug concentrations were reduced by gastric acid suppression and diarrhoea. Therapeutic itraconazole trough concentrations (≥0.5 mg/L) were achieved at a median of 7 (95% CI = 6-8) days, with 87% of patients achieving therapeutic concentrations at day 14 (expected steady-state). One (1%) proven/probable IFI and 5 (5%) possible breakthrough IFIs were identified. Although adverse events were experienced by 42% of the cohort, only a single event was directly attributable to SUBA®-itraconazole, resulting in change of prophylactic agent. CONCLUSIONS: SUBA®-itraconazole achieved rapid therapeutic trough concentrations, was associated with low rates of IFI and was well tolerated in the study population. This formulation should be considered a realistic and safe first-line agent for the prevention of IFIs in those undergoing HSCT and intermediate/high-risk therapy for haematological malignancies.

A survey of infectious diseases and vaccination uptake in long-term hematopoietic stem cell transplant survivors in Australia.

BACKGROUND: This cross-sectional survey aimed to establish the prevalence of infectious diseases and vaccination uptake in long-term allogeneic hematopoietic stem cell transplants (HSCT) survivors in New South Wales, in order to reduce long-term post-HSCT morbidity and mortality and enhance long-term care. PATIENTS AND METHODS: Hematopoietic stem cell transplants survivors aged over 18 years and transplanted between 2000-2012 in New South Wales (NSW) were eligible to participate. Survivors self-completed the Sydney Post BMT Study survey, FACT-BMT (V4), Chronic Graft versus Host Disease (cGVHD) Activity Assessment Self Report, Lee Chronic GvHD Symptom Scale, DASS21, Post Traumatic Growth Inventory, and the Fear of Recurrence Scale. RESULTS: Of the 583 HSCT survivors contacted, 441 (78%) completed the survey. Respondents included 250 (57%) males and median age was 54 years (range 19-79 years). The median age at the time of transplant was 49 years (Range: 17-71), the median time since HSCT was 5 years (Range: 1-14) and 69% had cGVHD. Collectively, 41.7% of survivors reported a vaccine preventable disease (VPD) with the most common being influenza-like-illness (38.4%), varicella zoster/shingles (27.9%), pap smear abnormalities (9.8%), pneumococcal disease (5.1%), and varicella zoster (chicken pox) (4.6%). Only 31.8% had received the full post-HSCT vaccination schedule, and the majority (69.8%) of these had received the vaccines via their General Practitioner. cGVHD was not found to be a significant factor on multivariate analysis for those who were vaccinated. There was a trend toward lower vaccination rates in patients in a lower income strata. CONCLUSIONS: Vaccinating post-HSCT survivors to prevent infections and their consequences have an established role in post-HSCT care. Improving rates of post-HSCT vaccination should be a major priority for BMT units.

The Analysis of CD83 Expression on Human Immune Cells Identifies a Unique CD83+-Activated T Cell Population.

CD83 is a member of the Ig gene superfamily, first identified in activated lymphocytes. Since then, CD83 has become an important marker for defining activated human dendritic cells (DC). Several potential CD83 mRNA isoforms have been described, including a soluble form detected in human serum, which may have an immunosuppressive function. To further understand the biology of CD83, we examined its expression in different human immune cell types before and after activation using a panel of mouse and human anti-human CD83 mAb. The mouse anti-human CD83 mAbs, HB15a and HB15e, and the human anti-human CD83 mAb, 3C12C, were selected to examine cytoplasmic and surface CD83 expression, based on their different binding characteristics. Glycosylation of CD83, the CD83 mRNA isoforms, and soluble CD83 released differed among blood DC, monocytes, and monocyte-derived DC, and other immune cell types. A small T cell population expressing surface CD83 was identified upon T cell stimulation and during allogeneic MLR. This subpopulation appeared specifically during viral Ag challenge. We did not observe human CD83 on unstimulated human natural regulatory T cells (Treg), in contrast to reports describing expression of CD83 on mouse Treg. CD83 expression was increased on CD4+, CD8+ T, and Treg cells in association with clinical acute graft-versus-host disease in allogeneic hematopoietic cell transplant recipients. The differential expression and function of CD83 on human immune cells reveal potential new roles for this molecule as a target of therapeutic manipulation in transplantation, inflammation, and autoimmune diseases.

Invasive Fungal Sinusitis Presenting as Acute Posterior Ischemic Optic Neuropathy.

Invasive fungal sinusitis causes painful orbital apex syndrome with ophthalmoplegia and visual loss; the mechanism is unclear. We report an immunocompromised patient with invasive fungal sinusitis in whom the visual loss was due to posterior ischaemic optic neuropathy, shown on diffusion-weighted MRI, presumably from fungal invasion of small meningeal-based arteries at the orbital apex. After intensive antifungal drugs, orbital exenteration and immune reconstitution, the patient survived, but we were uncertain if the exenteration helped. We suggest that evidence of acute posterior ischaemic optic neuropathy should be a contra-indication to the need for orbital exenteration in invasive fungal sinusitis.

Nutritional issues and body weight in long-term survivors of allogeneic blood and marrow transplant (BMT) in NSW Australia.

PURPOSE: The aims of this study were to describe the long-term nutrition, body weight and body image issues facing survivors of Allogeneic Blood and Marrow Transplant (BMT) and their impact on quality of life. It also describes survivors' perception of enteral feeding during BMT. METHODS: Four hundred and forty-one survivors who had undergone a BMT in NSW, Australia between 2000 and 2012 (n = 441/583) completed the Sydney Post BMT Study Survey (SPBS). RESULTS: Forty-five percent of survivors less than 2-year post-transplant reported a dry mouth, 36 % reported mouth ulcers and 19 % had diarrhoea. This was consistent across all survivor groups, regardless of time since transplant. Patients with one or more gastrointestinal (GI) symptoms had significantly lower quality of life scores. There was a significant difference in quality of life scores when comparing those with no GI symptoms to those with one or more symptoms (P = <0.0001). Quality of life was significantly higher in those who once again enjoyed mealtimes (P < 0.0001). Males were more likely to be satisfied with their body weight compared to females (P = 0.009). The median body mass index (BMI) for all patients reporting body weight satisfaction was significantly lower (BMI 23.5) than those reporting dissatisfaction (BMI 27.5) (P = <0.0001). Survivors who had a normal BMI had significantly higher rates of body weight satisfaction compared to underweight, overweight and obese survivors (P = <0.0001). Those survivors who were overweight or obese were significantly more likely to be diabetic (P = 0.008). CONCLUSION: This study revealed an important relationship between gastrointestinal symptoms, body weight and body image and survivor's quality of life. It provides further support for the importance of nutrition therapy post-BMT.

Haematopoietic stem cell transplantation survivorship and quality of life: is it a small world after all?

PURPOSE: The aim of this qualitative study was to gain a rich understanding of the impact that haematopoietic stem cell transplantation (HSCT) has on long-term survivor's quality of life (QoL). METHOD: Participants included 441 survivors who had undergone HSCT for a malignant or non-malignant disease. Data were obtained by a questionnaire positing a single open-ended question asking respondents to list the three issues of greatest importance to their QoL in survivorship. Responses were analysed and organised into QoL themes and subthemes. RESULTS: Major themes identified included the following: the failing body and diminished physical effectiveness, the changed mind, the loss of social connectedness, the loss of the functional self and the patient for life. Each of these themes manifests different ways in which HSCT survivor's world and opportunities had diminished compared to the unhindered and expansive life that they enjoyed prior to the onset of disease and subsequent HSCT. CONCLUSIONS: HSCT has a profound and pervasive impact on the life of survivors-reducing their horizons and shrinking various parts of their worlds. While HSCT survivors can describe the ways in which their life has changed, many of their fears, anxieties, regrets and concerns are existential in nature and are ill-defined-making it exceeding unlikely that they would be adequately captured by standard psychometric measures of QoL post HSCT.

What They Want: Inclusion of Blood and Marrow Transplantation Survivor Preference in the Development of Models of Care for Long-Term Health in Sydney, Australia.

Four hundred forty-one adult allogeneic blood and marrow transplantation (BMT) survivors participated in a cross-sectional survey to assess long-term follow-up (LTFU) model of care preference. Survey instruments included the Sydney Post BMT Survey, Functional Assessment of Cancer Therapy-BMT, Depression Anxiety Stress Scales 21, the Chronic GVHD Activity Assessment-Patient Self Report (Form B), the Lee Chronic GVHD Symptom Scale and the Post-Traumatic Growth Inventory. We found most BMT survivors (74%) would prefer LTFU with their transplantation physicians alone or in combination with transplantation center-linked services (satellite clinics or telemedicine) Over one-quarter indicated a preference for receiving comprehensive post-transplantation care in a "satellite" clinic staffed by their BMT team situated closer to their place of residence, with higher income, higher educational level, and sexual morbidity being significant social factors influencing this preference. Regular exercise was reported less often in those who preferred telemedicine, which may reflect reduced mobility. The factor most strongly associated with a preference for transplantation center follow-up was the severity of chronic graft-versus-host disease. Full- and part-time work were negatively associated with transplantation center follow-up, possibly implying decreased dependency on the center and some return to normalcy. This study is the first to explore the preferences of BMT survivors for long-term post-transplantation care. These data provides the basis for LTFU model of care development and health service reform consistent with the preferences of BMT survivors.

A survey of fertility and sexual health following allogeneic haematopoietic stem cell transplantation in New South Wales, Australia.

Four hundred and twenty-one adult allogeneic haematopoietic stem cell transplant (HSCT) survivors participated in a cross-sectional study to assess sexual dysfunction and infertility post-transplant. Survey instruments included the Sydney Post-Blood and Marrow Transplant (BMT) Survey, Functional Assessment of Cancer Treatment (FACT) - BMT, the Depression, Anxiety, Stress Scales (DASS 21), the Chronic Graft-versus-Host Disease (cGVHD) Activity Assessment- Patient Self Report (Form B), the Lee cGVHD Symptom Scale and The Post-Traumatic Growth Inventory. Most HSCT survivors reported sexual difficulties (51% of males; 66% of females). Men reported erectile dysfunction (79%) and decreased libido (61·6%) and women reported loss of libido (83%), painful intercourse (73%) and less enjoyment of sex (68%). Women also commonly reported vaginal dryness (73%), vaginal narrowing (34%) and vaginal irritation (26%). Woman had much higher rates of genital cGvHD than men (22% vs. 5%). Age and cGVHD were significantly associated with sexual dysfunction. Few survivors had children following transplant (3·3%). However, for those of reproductive age at HSCT, 22% reported trying to conceive, with 10·3% reporting success. This study is the largest to date exploring sexual function in survivors of allo-HSCT. This data provides the basis for health service reform to better meet the needs of HSCT survivors, including evidence to support counselling and education both pre- and post-transplant.

Episodic fevers and vasodilatory shock mimicking urosepsis in a patient with HIV-associated multicentric Castleman's Disease: a case report.

BACKGROUND: Multicentric Castleman's disease (MCD) is a pre-malignancy that presents with lymphadenopathy and features of systemic inflammation. Human immunodeficiency virus (HIV)-associated MCD is associated with human herpesvirus-8 (HHV-8) infection. If untreated MCD has a relapsing and remitting course that is eventually fatal. CASE PRESENTATION: A 67-year-old man had six hospital admissions over 20 months characterised by fever, urinary frequency and CRP >100 mg/L. The final admission was complicated by hypotension requiring intensive care unit admission and ionotropic support. His history included HIV and Hepatitis B virus (HBV) co-infection on suppressive therapy. Each presentation was managed as presumed urosepsis with use of empirical antibiotics, however numerous blood and urine cultures failed to identify a pathogen. A bone-marrow aspirate and trephine found no evidence of haematological malignancy. A positron emission tomography scan found active lymph nodes, one of which was biopsied and found to contain the plasma-cell variant of Castleman's disease. Ultimately the cause for the recurrent presentations was attributed to progressive MCD. The patient received rituximab monotherapy and has had no further related admissions. CONCLUSIONS: MCD should be considered in patients with chronic HIV infection presenting with recurrent sepsis-like episodes and/or vasodilatory shock, particularly if no pathogen is identified or lymphadenopathy is evident.

Surgical correction of persistent Peyronie's disease following collagenase clostridium histolyticum treatment.

INTRODUCTION: Collagenase clostridium histolyticum (CCH) is an Food and Drug Administration-approved intralesional injection for treatment of Peyronie's disease (PD) that has been shown to reduce penile curvature deformity and PD symptom bother in phase 2b and phase 3 placebo-controlled clinical trials. For some patients, nonsurgical treatment with CCH may not sufficiently improve penile curvature, and surgical correction may be pursued following CCH therapy. AIM: This study aims to examine intraoperative and postsurgical outcomes of surgical correction of persistent penile curvature in patients with PD who had previously received CCH. METHODS: Retrospective chart review was used to identify patients with PD who had received CCH intralesional injection within either the phase 2b or phase 3 CCH clinical trials and then underwent surgical correction due to remaining penile curvature. Surgical techniques used were partial plaque excision and grafting (PEG) and/or tunica albuginea plication (TAP). MAIN OUTCOME MEASURES: Primary assessments included pre- and postsurgery penile curvature, erectile rigidity, stretched penile length, intraoperative time, and occurrence of adverse events. RESULTS: Seven men were identified who underwent surgical straightening with TAP or PEG following CCH treatment. Mean number of days from the final CCH injection to surgery was 182 (standard deviation 118; median 127 days). Average penile curvature prior to surgical straightening was 58°. No anatomical difficulties or complications secondary to the effects of prior CCH treatment occurred during surgery. Intraoperative time was representative of standard TAP and PEG surgeries (range 88-146 minutes). All men reported penile curvature <20° postsurgery. One patient experienced a postsurgery subgraft hematoma that required aspiration. There were no postsurgery reports of decreased penile sexual sensation and no occurrence of vascular compromise or decreased penile rigidity. CONCLUSION: This initial case series supports the hypothesis that prior CCH treatment is not a contraindication to PEG or TAP surgery in the treatment of penile curvature in patients with PD.

Single center outcomes after reconstructive surgical correction of adult acquired buried penis: measurements of erectile function, depression, and quality of life.

INTRODUCTION: Management of adult acquired buried penis is a troublesome situation for both patient and surgeon. The buried penis has been associated with significant erectile and voiding dysfunction, depression, and overall poor quality of life (QOL). AIM: To identify outcomes following reconstructive surgery with release of buried penis, escutcheonectomy, and circumcision with or without skin grafting. METHODS: We retrospectively identified 11 patients treated by a single surgeon between 2007 and 2011, patient ages were 44-69; complete data review was available on all 11. OUTCOME MEASURES: Validated European Organisation for Research and Treatment of Cancer 15 QOL, Center for Epidemiologic Studies Depression Scale (CES-D), and International Index of Erectile Function (IIEF) surveys assessed patient QOL, depression, and erectile function pre- and postoperatively. RESULTS: Mean body mass index (BMI) was 48.8 (42.4-64.6). Mean operative time was 191 minutes (139-272). Mean length of stay was 2.1 days. Ten of 11 patients required phallic skin grafting. There was one perioperative complication resulting in respiratory failure and overnight stay in the intensive care unit. Wound complications were seen in 2/11 patients, and 1 needed surgical debridement for superficial wound infection. Skin graft take was seen in 100% of the patients. Ninety-one percent of patients noted significant improvement in voiding postoperatively. Ninety-one percent of patients reported significant erectile dysfunction preoperatively. Subsequently, IIEF scores improved post surgery by an average of 7.7 points. Clinical depression was noted to be present in 7/11 patients preoperatively and 2/11 postoperatively based on CES-D surveys. QOL improved significantly in 10/11 compared with preoperative baseline; however, many patients noted significant difficulties based on their weight and other comorbidities. CONCLUSIONS: Management of adult acquired buried penis is a challenging, yet correctable problem. In our series it appears that by using established surgical techniques we were able to achieve significant improvements in erectile function, QOL, and measures of depression.

Cost-Effectiveness of Extracorporeal Photopheresis in Patients With Chronic Graft-vs-Host Disease.

Background: The mainstay first-line therapy for chronic graft-vs-host disease (cGVHD) is corticosteroids; however, for steroid-refractory patients, there is a distinct lack of cost-effective or efficacious treatment. The aim of this study was to assess the cost-effectiveness of extracorporeal photopheresis (ECP) compared with standard-of-care therapies for the treatment of cGVHD in Australia. The study formed part of an application to the Australian Government to reimburse ECP for these patients. Methods: A cost-utility analysis was conducted comparing ECP to standard of care, which modeled the response to treatment and disease progression of cGVHD patients in Australia. Mycophenolate, tacrolimus, and cyclosporin comprised second-line standard of care based on a survey of Australian clinicians. Health states in the model included treatment response, disease progression, and death. Transition probabilities were obtained from Australian-specific registry data and randomized controlled evidence. Quality-of-life values were applied based on treatment response. The analysis considered costs of second-line treatment and disease management including immunosuppressants, hospitalizations and subsequent therapy. Disease-specific mortality was calculated for treatment response and progression. Results: Over a 10-year time horizon, ECP resulted in an average cost reduction of $23 999 and an incremental improvement of 1.10 quality-adjusted life-years per patient compared with standard of care. The sensitivity analysis demonstrated robustness over a range of plausible scenarios. Conclusion: This analysis demonstrates that ECP improves quality of life, minimizes the harms associated with immunosuppressant therapy, and is a highly cost-effective option for steroid-refractory cGVHD patients in Australia. Based in part on this analysis, ECP was listed on the Medicare Benefits Schedule for public reimbursement.