Activity and outcomes of autologous stem cell transplantation in the private sector in Australia.

BACKGROUND: Few Australasian autologous stem cell transplantation (ASCT) programmes perform ASCT in the private sector. Relatively little is known about ASCT outcomes in the private sector, which varies in care delivery models to the public system. AIMS: To investigate transplantation activity and survival outcomes at Icon Cancer Centre's Brisbane-based private clinical and laboratory ASCT programme over a 23-year period. METHODS: Retrospective, observational study of all adults who underwent ASCT at Icon between 1996 and 2018. Main outcome measures were transplant activity, overall survival (OS) and 100-day and 1-year transplant-related mortality (TRM). Outcomes were benchmarked against the Australasian Bone Marrow Transplant Recipient Registry (ABMTRR). RESULTS: Between 1996 and 2018, 1676 ASCT were performed in 1454 patients. From 2010 to 2018, ASCT performed at Icon contributed 40% of all South East Queensland ASCT. In the past 5 years, 21% of Icon's patients were aged ≥70 years, compared with 5% across Australasia. For the entire cohort, 100-day and 1-year TRM was 1.1% and 1.7%, respectively, while for those aged ≥70 years, it was 2.0% and 3.1%. For ASCT performed between 2014 and 2018, 100-day and 1-year TRM was 0.8% and 1.4%, which was half the TRM rates reported by the ABMTRR. The 10-year post-transplant OS at Icon was higher than the ABMTRR data, across all disease subtypes. CONCLUSION: We report excellent OS and low TRM, demonstrating the critical role of the private sector in the administration of this highly complex therapy. The Icon ASCT programme is the largest ASCT contributor in Queensland. It is inclusive of patients aged ≥70 years, demonstrating low and acceptable TRM.

Physical activity and exercise in adults diagnosed with primary brain cancer: a systematic review.

PURPOSE: The aims of this systematic review were to: (1) describe physical activity (PA) levels following diagnosis of primary brain cancer, (2) determine the relationship between PA levels and health outcomes, and (3) assess the effect of participating in an exercise intervention on health outcomes following a diagnosis of brain cancer. METHODS: PubMed, EMBASE, Scopus and CINAHL were searched for relevant articles published prior to May 1, 2020. Studies reporting levels of PA, the relationship between PA and health outcomes, and exercise interventions conducted in adults with brain cancer were eligible. The search strategy included terms relating to primary brain cancer, physical activity, and exercise. Two independent reviewers assessed articles for eligibility and methodological quality (according to Joanna Briggs Institute Critical Appraisal Tools). Descriptive statistics were used to present relevant data and outcomes. RESULTS: 15 studies were eligible for inclusion. Most adults with brain cancer were insufficiently active from diagnosis through to post-treatment. Higher levels of PA were associated with lower severity of brain cancer specific concerns and higher quality of life. Preliminary evidence suggests that exercise is safe, feasible and potentially beneficial to brain cancer symptom severity and interference, aerobic capacity, body composition and PA levels. However, the level of evidence to support these findings is graded as weak. CONCLUSIONS: Evidence suggests that it is likely appropriate to promote those with brain cancer to be as physically active as possible. The need or ability of those with brain cancer to meet current PA guidelines promoted to all people with cancer remains unclear.

Developing clinical indicators for oncology: the inaugural cancer care indicator set for the Australian Council on Healthcare Standards.

INTRODUCTION: The Australian Council on Healthcare Standards (ACHS) sponsored an expert-led, consensus-driven, four-stage process, based on a modified Delphi methodology, to determine a set of clinical indicators as quality measures of cancer service provision in Australia. This was done in response to requests from institutional health care providers seeking accreditation, which were additional and complementary to the existing radiation oncology set. The steering group members comprised multidisciplinary key opinion leaders and a consumer representative. Five additional participants constituted the stakeholder group, who deliberated on the final indicator set. METHODS AND RECOMMENDATIONS: An initial meeting of the steering group scoped the high level nature of the desired set. In stage 2, 65 candidate indicators were identified by a literature review and a search of international metrics. These were ranked by survey, based on ease of data accessibility and collectability and clinical relevance. The top 27 candidates were debated by the stakeholder group and culled to a final set of 16 indicators. A user manual was created with indicators mapped to clinical codes. The indicator set was ratified by the Clinical Oncology Society of Australia and is now available for use by health care organisations participating in the ACHS Clinical Indicator Program. This inaugural cancer clinical indicator set covers high level assessment of various critical processes in cancer service provision in Australia. Regular reviews and updates will ensure usability. CHANGES IN MANAGEMENT AS A RESULT OF THIS STATEMENT: This is the inaugural indicator set for cancer care for use across Australia and internationally under the ACHS Clinical Indicator Program. Multidisciplinary involvement through a modified Delphi process selected indicators representing both generic and specific aspects of care across the cancer journey pathway and will provide a functional tool to compare health care delivery across multiple settings. It is anticipated that this will drive continual improvement in cancer care provision.

Cost-effectiveness of a pragmatic exercise intervention for women with breast cancer: results from a randomized controlled trial.

OBJECTIVE: To report on the cost-effectiveness of the Exercise for Health trial, comparing an exercise intervention with usual care during and following treatment for women with breast cancer. METHODS: Women with breast cancer were randomized to an 8-month exercise intervention (involving regular contact with an exercise physiologist over the phone, n = 67, or home delivered face to face, n = 67) or usual care (n = 60) group and were assessed pre-intervention (5 weeks post-surgery), mid-intervention (6 months post-surgery), and 10 weeks post-intervention (12 months post-surgery). The benefit measures were "number of improvers" in quality of life (FACT-B+4) and quality-adjusted life years (QALYs). Data on provider, patient, and government costs were used to consider 2 cost scenarios: (1) a service provider model and (2) a private model. RESULTS: There were 69 improvers in the intervention group compared with 21 in the usual care group (odds ratio 2.09, 95% confidence interval 1.08, 4.01; P = .033). The incremental cost per improver was A$2282 to A$2644. Quality-adjusted life years gain for the intervention group versus the usual care group was 0.009, with incremental cost per QALY gain for models 1 and 2 being A$105 231 and A$90 842, respectively. However, sensitivity analyses indicate that incremental cost per QALY gained was volatile to EuroQol-5D-3L weights. CONCLUSIONS: Findings suggest that a pragmatic exercise intervention yields more women with markedly improved quality of life after breast cancer than usual care and may be cost-effective. The results are less certain in terms of incremental cost per quality-adjusted life years; however, this may be an inappropriate measure for reflecting exercise benefit for women with breast cancer.

Weight and weight change following breast cancer: evidence from a prospective, population-based, breast cancer cohort study.

BACKGROUND: While weight gain following breast cancer is considered common, results supporting these findings are dated. This work describes changes in body weight following breast cancer over 72 months, compares weight with normative data and explores whether weight changes over time are associated with personal, diagnostic, treatment or behavioral characteristics. METHODS: A population-based sample of 287 Australian women diagnosed with early-stage invasive breast cancer was assessed prospectively at six, 12, 18 and 72 months post-surgery. Weight was clinically measured and linear mixed models were used to explore associations between weight and participant characteristics (collected via self-administered questionnaire). Those with BMI changes of one or more units were considered to have experienced clinically significant changes in weight. RESULTS: More than half (57%) of participants were overweight or obese at 6 months post-surgery, and by 72 months post-surgery 68% of women were overweight or obese. Among those who gained more weight than age-matched norms, clinically significant weight gain between 6 and 18 months and 6 and 72 months post-surgery was observed in 24% and 39% of participants, respectively (median [range] weight gain: 3.9 kg [2.0-11.3 kg] and 5.2 kg [0.6-28.7], respectively). Clinically-significant weight losses were observed in up to 24% of the sample (median [range] weight loss between 6 and 72 months post-surgery: -6.4 kg [-1.9--24.6 kg]). More extensive lymph node removal, being treated on the non-dominant side, receiving radiation therapy and lower physical activity levels at 6 months was associated with higher body weights post-breast cancer (group differences >3 kg; all p < 0.05). CONCLUSIONS: While average weight gain among breast cancer survivors in the long-term is small, subgroups of women experience greater gains linked with adverse health and above that experienced by age-matched counterparts. Weight change post-breast cancer is a contemporary public health issue and the integration of healthy weight education and support into standard breast cancer care has potential to significantly improve the length and quality of cancer survivorship.

All-trans-retinoic acid, idarubicin, and IV arsenic trioxide as initial therapy in acute promyelocytic leukemia (APML4).

The treatment of acute promyelocytic leukemia has improved considerably after recognition of the effectiveness of all-trans-retinoic acid (ATRA), anthracycline-based chemotherapy, and arsenic trioxide (ATO). Here we report the use of all 3 agents in combination in an APML4 phase 2 protocol. For induction, ATO was superimposed on an ATRA and idarubicin backbone, with scheduling designed to exploit antileukemic synergy while minimizing cardiotoxicity and the severity of differentiation syndrome. Consolidation comprised 2 cycles of ATRA and ATO without chemotherapy, followed by 2 years of maintenance with ATRA, oral methotrexate, and 6-mercaptopurine. Of 124 evaluable patients, there were 4 (3.2%) early deaths, 118 (95%) hematologic complete remissions, and all 112 patients who commenced consolidation attained molecular complete remission. The 2-year rate for freedom from relapse is 97.5%, failure-free survival 88.1%, and overall survival 93.2%. These outcomes were not influenced by FLT3 mutation status, whereas failure-free survival was correlated with Sanz risk stratification (P[trend] = .03). Compared with our previously reported ATRA/idarubicin-based protocol (APML3), APML4 patients had statistically significantly improved freedom from relapse (P = .006) and failure-free survival (P = .01). In conclusion, the use of ATO in both induction and consolidation achieved excellent outcomes despite a substantial reduction in anthracycline exposure. This trial was registered at the Australian New Zealand Clinical Trials Registry (www.anzctr.org.au) as ACTRN12605000070639.

Exercise for health: a randomized, controlled trial evaluating the impact of a pragmatic, translational exercise intervention on the quality of life, function and treatment-related side effects following breast cancer.

Exercise for Health was a randomized, controlled trial designed to evaluate two modes of delivering (face-to-face [FtF] and over-the-telephone [Tel]) an 8-month translational exercise intervention, commencing 6-weeks post-breast cancer surgery (PS). Outcomes included quality of life (QoL), function (fitness and upper body) and treatment-related side effects (fatigue, lymphoedema, body mass index, menopausal symptoms, anxiety, depression and pain). Generalised estimating equation modelling determined time (baseline [5 weeks PS], mid-intervention [6 months PS], post-intervention [12 months PS]), group (FtF, Tel, Usual Care [UC]) and time-by-group effects. 194 women representative of the breast cancer population were randomised to the FtF (n = 67), Tel (n = 67) and UC (n = 60) groups. There were significant (p < 0.05) interaction effects on QoL, fitness and fatigue with differences being observed between the treatment groups and the UC group. Trends observed for the treatment groups were similar. The treatment groups reported improved QoL, fitness and fatigue over time and changes observed between baseline and post-intervention were clinically relevant. In contrast, the UC group experienced no change, or worsening QoL, fitness and fatigue, mid-intervention. Although improvements in the UC group occurred by 12-months post-surgery, the change did not meet the clinically relevant threshold. There were no differences in other treatment-related side effects between groups. This translational intervention trial, delivered either FtF or Tel, supports exercise as a form of adjuvant breast cancer therapy that can prevent declines in fitness and function during treatment and optimise recovery post-treatment.

Changes in nutritional status, body composition, quality of life, and physical activity levels of cancer patients undergoing autologous peripheral blood stem cell transplantation.

PURPOSE: This pilot exploratory study aimed to describe the changes in nutritional status, body composition, quality of life (QoL), and physical activity levels (PAL) of cancer patients undergoing high-dose conditioning and autologous peripheral blood stem cell transplantation (PBSCT) at pre-admission, hospital discharge, and at 100 days post-transplantation, and to examine if changes in these parameters are interrelated. METHODS: Twenty-four patients (56.2 ± 12.9 years; 7 females, 17 males) were recruited from an Australian transplant center. Assessment was prospectively conducted at pre-admission, hospital discharge, and 100 days post-transplantation using the scored patient-generated subjective global assessment, air displacement plethysmography, EORTC QLQ-C30 (version 3), and the international physical activity questionnaire. RESULTS: At discharge, nutritional status deteriorated (patient-generated subjective global assessment (PG-SGA) median, +8.0; interquartile range, 6.0-13.0; p < 0.001) and the number of malnourished patients increased (n = 8/23; p = 0.023). Patients experienced significant loss of lean body mass (LBM; -2.2 kg, CI 95% -3.0, -1.4; p < 0.001), and decrease in QoL (-10.6, CI 95% -24.1, 2.9; p = 0.117); the proportion of patients with high PAL decreased (p = 0.012). By 100 days post-transplantation, all patients were well-nourished; however, LBM remained lower -1.0 kg (CI 95% -1.9, -0.1; p = 0.028). Change in nutritional status (PG-SGA score) was associated with weight (r = -0.46; p = 0.039) and fat mass (r = -0.57; p = 0.013). Change in QoL was associated with nutritional reservoir (i.e., fat; r = 0.54; p = 0.024); QoL was consistently higher for patients with high PAL. CONCLUSIONS: High-dose conditioning and autologous PBSCT is associated with deterioration in nutritional status, QoL and PAL, with LBM remaining below baseline levels at 100 days post-transplantation. A nutrition and exercise intervention program post-hospital discharge may be beneficial for these patients.

The return of the normal heart: resolution of cardiac amyloidosis after chemotherapy and bone marrow transplantation.

BACKGROUND: AL amyloidosis and multiple myeloma result in extracellular deposition of insoluble fibrillar protein in tissues and organs. Untreated median survival has been documented at 12 months. Cardiac infiltration decreases survival to five months. Chemotherapy and bone marrow transplantation (BMT) have been shown to improve survival when haematological remission is documented. This study aimed to assess if remission could result in cardiac structural improvement. METHODS: 269 patients were treated with BMT for amyloidosis from 1997 to 2010. Cardiac amyloidosis was identified in 30 patients by echocardiographic criteria. Echocardiography was performed before and after BMT. RESULTS: Thirteen of 30 patients with cardiac amyloidosis died during follow-up. No change in cardiac structure was seen in 11 patients. Average survival was 49 months from BMT for non-responders. Fifteen patients had cardiac normalisation (responders). The average time to normalisation was 25 months. Only two responders died. Average survival for responders was 71 months (p < 0.0001 compared with non-responders). Normalisation of cardiac structure was highly predictive of survival (Fisher's exact test p = 0.0025, relative risk 0.18). CONCLUSIONS: Cardiac amyloidosis patients with haematological remission after chemotherapy and BMT may subsequently normalise cardiac structure and function. Normalisation is highly predictive of survival.

The safety, feasibility, and efficacy of an 18-week exercise intervention for adults with primary brain cancer - the BRACE study.

PURPOSE: To determine the safety, feasibility, and potential effect of an 18-week exercise intervention for adults with primary brain cancer. MATERIALS AND METHODS: Eligible patients were 12-26-weeks post-radiotherapy for brain cancer. The individually-prescribed weekly exercise was ≥150-minutes of moderate-intensity exercise, including two resistance-training sessions. The intervention was deemed "safe" if exercise-related, serious adverse events (SAE) were experienced by <10% of participants, and feasible if recruitment, retention, and adherence rates were ≥75%, and ≥75% compliance rates were achieved in ≥75% of weeks. Patient-reported and objectively-measured outcomes were assessed at baseline, mid-intervention, end-intervention, and 6-month follow-up, using generalized estimating equations. RESULTS: Twelve participants enrolled (51 ± 19.5 years, 5 females). There were no exercise-related SAEs. The intervention was feasible (recruitment:80%, retention:92%, adherence:83%). Participants completed a median of 172.8 (min:77.5, max:560.8) minutes of physical activity per week. 17% met the compliance outcome threshold for ≥75% of the intervention. Improvements in quality of life (mean change (95% CI): 7.9 units (1.9, 13.8)), functional well-being (4.3 units (1.4, 7.2)), depression (-2.0 units (-3.8, -0.2)), activity (112.8 min (42.1, 183.4)), fitness (56.4 meters (20.4, 92.5)), balance (4.9 s (0.9, 9.0)), and lower-body strength (15.2 kg (9.3, 21.1)) were observed end-intervention. CONCLUSION: Preliminary evidence support that exercise is safe and beneficial to the quality of life and functional outcomes for people with brain cancer.Registration: ACTRN12617001577303.

The BRAin Cancer and Exercise (BRACE) study highlights the need for regular monitoring of disease- and treatment-related side effects which may present as barriers to exercise.Exercise prescription should be modified according to the presence and severity of disease- and treatment-related barriers.Adverse events observed, such as dizziness, highlight the importance of supervised exercise for people with brain cancer.If supervision is not possible, then exercise modes with low risk of harm from falls are recommended (e.g., walking, machine-based resistance training).

Cost-Effectiveness Analysis from a Randomized Controlled Trial of Tailored Exercise Prescription for Women with Breast Cancer with 8-Year Follow-Up.

Studies show conflicting results on whether exercise interventions to improve outcomes for women with breast cancer are cost-effective. We modelled the long-term cost-effectiveness of the Exercise for Health intervention compared with usual care. A lifetime Markov cohort model for women with early breast cancer was constructed taking a societal perspective. Data were obtained from trial, epidemiological, quality of life, and healthcare cost reports. Outcomes were calculated from 5000 Monte Carlo simulations, and one-way and probabilistic sensitivity analyses. Over the cohort's remaining life, the incremental cost for the exercise versus usual care groups were $7409 and quality-adjusted life years (QALYs) gained were 0.35 resulting in an incremental cost per QALY ratio of AU$21,247 (95% Uncertainty Interval (UI): Dominant, AU$31,398). The likelihood that the exercise intervention was cost-effective at acceptable levels was 93.0%. The incremental cost per life year gained was AU$8894 (95% UI Dominant, AU$11,769) with a 99.4% probability of being cost effective. Findings were most sensitive to the probability of recurrence in the exercise and usual care groups, followed by the costs of out-of-pocket expenses and the model starting age. This exercise intervention for women after early-stage breast cancer is cost-effective and would be a sound investment of healthcare resources.

Life-threatening conjunctival presentation of myeloid sarcoma.

Myeloid sarcoma is a life-threatening condition that can present rarely as a conjunctival lesion. This case report describes a 48-year-old woman who was diagnosed after conjunctival biopsy, subsequently systemically investigated and then treated with chemotherapy. Collaboration of the ophthalmologist, pathologist and oncologist was critical in the successful management of this patient.

Regression of cardiac amyloidosis following stem cell transplantation: a comparison between echocardiography and cardiac magnetic resonance imaging in long-term survivors.

BACKGROUND: AL amyloidosis and multiple myeloma result in extracellular deposition of insoluble fibrillary protein in tissue and organs. Untreated median survival is very poor, and even worse with cardiac involvement. Chemotherapy and peripheral blood stem cell transplantation (PBSCT) have been shown to dramatically improve survival, with hematologic remission documented. Regression of cardiac changes has previously been shown, as assessed by echocardiography (TTE) and cardiac magnetic resonance imaging (CMR). This study is a comparison of TTE and CMR in long-term survivors of cardiac amyloidosis with regression. RESULTS: Four long-term survivors with cardiac amyloidosis and regression of cardiac features on TTE were identified. Mean age was 60 years and average survival was 139 months from the time of diagnosis of cardiac involvement. Statistically significant regression of the cardiac features of cardiac amyloidosis were demonstrated on TTE. In these survivors, post-PBSCT structural assessments were similar between TTE and CMR. Classical strain imaging features of cardiac amyloidosis were only present in 50%. All patients had diffuse, patchy gadolinium enhancement on CMR after PBSCT. CONCLUSIONS: Treatment of cardiac amyloidosis with chemotherapy and PBSCT may result in regression of abnormalities on TTE with marked improvement in survival. Post treatment, TTE and CMR structural assessments appear similar. Gadolinium imaging suggests that microscopic residual infiltration persists despite macroscopic regression. Significant cardiac improvements with prolonged survival are seen nonetheless. Multimodality imaging has a vital role in the management of cardiac amyloidosis.

Use of arsenic trioxide in remission induction and consolidation therapy for acute promyelocytic leukaemia in the Australasian Leukaemia and Lymphoma Group (ALLG) APML4 study: a non-randomised phase 2 trial.

BACKGROUND: Initial treatment of acute promyelocytic leukaemia traditionally involves tretinoin (all-trans retinoic acid) combined with anthracycline-based risk-adapted chemotherapy, with arsenic trioxide being the treatment of choice at relapse. To try to reduce the relapse rate, we combined arsenic trioxide with tretinoin and idarubicin in induction therapy, and used arsenic trioxide with tretinoin as consolidation therapy. METHODS: Patients with previously untreated genetically confirmed acute promyelocytic leukaemia were eligible for this study. Eligibilty also required Eastern Cooperative Oncology Group performance status 0-3, age older than 1 year, normal left ventricular ejection fraction, Q-Tc interval less than 500 ms, absence of serious comorbidity, and written informed consent. Patients with genetic variants of acute promyelocytic leukaemia (fusion of genes other than PML with RARA) were ineligible. Induction comprised 45 mg/m(2) oral tretinoin in four divided doses daily on days 1-36, 6-12 mg/m(2) intravenous idarubicin on days 2, 4, 6, and 8, adjusted for age, and 0·15 mg/kg intravenous arsenic trioxide once daily on days 9-36. Supportive therapy included blood products for protocol-specified haemostatic targets, and 1 mg/kg prednisone daily as prophylaxis against differentiation syndrome. Two consolidation cycles with tretinoin and arsenic trioxide were followed by maintenance therapy with oral tretinoin, 6-mercaptopurine, and methotrexate for 2 years. The primary endpoints of the study were freedom from relapse and early death (within 36 days of treatment start) and we assessed improvement compared with the 2 year interim results. To assess durability of remission we compared the primary endpoints and disease-free and overall survival at 5 years in APML4 with the 2 year interim APML4 data and the APML3 treatment protocol that excluded arsenic trioxide. This study is registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12605000070639. FINDINGS: 124 patients were enrolled between Nov 10, 2004, and Sept 23, 2009, with data cutoff of March 15, 2012. Four (3%) patients died early. After a median follow-up of 4·2 years (IQR, 3·2-5·2), the 5 year freedom from relapse was 95% (95% CI 89-98), disease-free survival was 95% (89-98), event-free survival was 90% (83-94), and overall survival was 94% (89-97). The comparison with APML3 data showed that hazard ratios were 0·23 (95% CI 0·08-0·64, p=0·002) for freedom from relapse, 0·21 (0·07-0·59, p=0·001) for disease-free survival, 0·34 (0·16-0·69, p=0·002) for event-free survival, and 0·35 (0·14-0·91, p=0·02) for overall survival. INTERPRETATION: Incorporation of arsenic trioxide in initial therapy induction and consolidation for acute promyelocytic leukaemia reduced the risk of relapse when compared with historical controls. This improvement, together with a non-significant reduction in early deaths and absence of deaths in remission, translated into better event-free and overall survival. FUNDING: Phebra.

Immunological changes after cancer treatment and participation in an exercise program.

PURPOSE: The purpose of this investigation was to evaluate the impact of undertaking peripheral blood stem cell transplantation (PBST) on T-cell number and function, and to determine the role of a mixed type, moderate intensity exercise program in facilitating the recovery of T-cell number and function. METHODS: Immunological measures of white blood cell, lymphocyte, CD3, CD4, and CD8 counts, and CD3 cell function were assessed pretransplant (PI), immediately posttransplant (PII), and 1 month (I1), 2 months (I2) and 3 months (PIII) posttransplant. After PII, 12 patients were divided equally into a control group (CG) or exercise intervention group (EG). RESULTS: Lower total T-cell, helper T-cell, and suppressor T-cell counts (P< 0.01), as well as lower T-cell function (P< 0.01), when compared with normative data, were found at PI. More specifically, 88% of the group had CD3, CD4, and CD8 counts that were more than 40%, 20%, and 50% below normal at PI, respectively. Undertaking a PBST caused further adverse changes to the total leukocyte, lymphocyte, CD3, CD4 and CD8 count, and the helper/suppressor ratio. Although CD8 counts had returned to normal by PIII, CD3, CD4, and the CD4 /CD8 ratio remained significantly lower than normative data (P< 0.01), with 66%, 100%, and 100% of the subject group reporting counts and ratios, respectively, below the normal range. CONCLUSION: The PBST patients were immunocompromised before undertaking the transplant, and the transplant procedure imposed further adverse changes to the leukocyte and lymphocyte counts. The leukocyte and CD8 counts returned to normal within 3 months posttransplant; however, the other immunological parameters assessed demonstrated a delayed recovery. Although participation in the exercise program did not facilitate a faster immune cell recovery, neither did the exercise program hinder or delay recovery.

Body composition following stem cell transplant: comparison of bioimpedance and air-displacement plethysmography.

OBJECTIVE: The aim of this study was to assess the agreement between detected changes in body composition determined by bioimpedance spectroscopy (BIS) and air-displacement plethysmography (ADP) among patients with cancer undergoing peripheral blood stem cell transplantation (PBSCT); and to assess the agreement of absolute values of BIS with ADP and dual energy x-ray (DXA). METHODS: Forty-four adult hematologic cancer patients undergoing PBSCT completed both BIS and ADP assessment at preadmission and at 3 mo after transplantation. A subsample (n = 11) was assessed by DXA at 3 mo after transplantation. Results were examined for the BIS instrument's default setting and three alternative predictive equations from the literature. Agreement was assessed by the Bland-Altman limits of agreement analysis while correlation was examined using the Lin's concordance correlation. RESULTS: Changes in body composition parameters assessed by BIS were comparable with those determined by ADP regardless of the predictive equations used. Bias of change in fat-free mass was clinically acceptable (all <1 kg), although limits of agreement were wide (more than ±6 kg). Overall, the BIS predictive equation accounting for body mass index performed the best. Absolute body composition parameters predicted by the alternative predictive equations agreed with DXA and ADP better than the BIS instrument's default setting. CONCLUSION: Changes predicted by BIS were similar to those determined by ADP on a group level; however, agreement of predicted changes at an individual level should be interpreted with caution due to wide limits of agreement.

Prevalence and prognostic significance of secondary lymphedema following breast cancer.

BACKGROUND: The adverse consequences of lymphedema following breast cancer in relation to physical function and quality of life are clear; however, its potential relationship with survival has not been investigated. Our purpose was to determine the prevalence of lymphedema and associated upper-body symptoms at 6 years following breast cancer and to examine the prognostic significance of lymphedema with respect to overall 6-year survival (OS). METHODS AND RESULTS: A population-based sample of Australian women (n = 287) diagnosed with invasive, unilateral breast cancer was followed for a median of 6.6 years and prospectively assessed for lymphedema (using bioimpedance spectroscopy [BIS], sum of arm circumferences [SOAC], and self-reported arm swelling), a range of upper-body symptoms, and vital status. OS was measured from date of diagnosis to date of death or last follow-up. Kaplan-Meier methods were used to calculate OS and Cox proportional hazards models quantified the risk associated with lymphedema. Approximately 45% of women had reported at least one moderate to extreme symptom at 6.6 years postdiagnosis, while 34% had shown clinical evidence of lymphedema, and 48% reported arm swelling at least once since baseline assessment. A total of 27 (9.4%) women died during the follow-up period, and lymphedema, diagnosed by BIS or SOAC between 6-18 months postdiagnosis, predicted mortality (BIS: HR = 2.5; 95% CI: 0.9, 6.8, p = 0.08; SOAC: 3.0; 95% CI: 1.1, 8.7, p = 0.04). There was no association (HR = 1.2; 95% CI: 0.5, 2.6, p = 0.68) between self-reported arm swelling and OS. CONCLUSIONS: These findings suggest that lymphedema may influence survival following breast cancer treatment and warrant further investigation in other cancer cohorts and explication of a potential underlying biology.

Design and implementation of the Exercise for Health trial -- a pragmatic exercise intervention for women with breast cancer.

BACKGROUND: Exercise for Health was a pragmatic, randomised, controlled trial comparing the effect of an eight-month exercise intervention on function, treatment-related side effects and quality of life following breast cancer, compared with usual care. The intervention commenced six weeks post-surgery, and two modes of delivering the same intervention was compared with usual care. The purpose of this paper is to describe the study design, along with outcomes related to recruitment, retention and representativeness, and intervention participation. METHODS: Women newly diagnosed with breast cancer and residing in a major metropolitan city of Queensland, Australia, were eligible to participate. Consenting women were randomised to a face-to-face-delivered exercise group (FtF, n = 67), telephone-delivered exercise group (Tel, n = 67) or usual care group (UC, n = 60) and were assessed pre-intervention (5-weeks post-surgery), mid-intervention (6 months post-surgery) and 10 weeks post-intervention (12 months post-surgery). Each intervention arm entailed 16 sessions with an Exercise Physiologist. RESULTS: Of 318 potentially eligible women, 63% (n = 200) agreed to participate, with a 12-month retention rate of 93%. Participants were similar to the Queensland breast cancer population with respect to disease characteristics, and the randomisation procedure was mostly successful at attaining group balance, with the few minor imbalances observed unlikely to influence intervention effects given balance in other related characteristics. Median participation was 14 (min and max: 0 and 16) and 13 (min and max: 3 and 16) intervention sessions for the FtF and Tel, respectively, with 68% of those in Tel and 82% in FtF participating in at least 75% of sessions. DISCUSSION: Participation in both intervention arms during and following treatment for breast cancer was feasible and acceptable to women. Future work, designed to inform translation into practice, will evaluate the quality of life, clinical, psychosocial and behavioural outcomes associated with each mode of delivery.