This is a phase II trial evaluating efficacy and safety of Aprepitant (AP) in combination with 5-HT3 antagonist and adjusted dose dexamethasone in patients receiving high-dose cyclophosphamide (CY) and filgrastim for stem cell mobilization. We used Simon’s optimal two-stage design constrained to fewer than 40 patients with 10% type I error and 85% statistical power. The first stage of the study required accrual of 18 response-evaluable patients. The primary endpoint was the control of vomiting without the use of any rescue anti-emetics at 24 hours after the administration of high dose CY (4gm/m2). If emesis was controlled in ≥ 9 patients, an additional cohort of 17 patients would be enrolled. The null hypothesis would be rejected if there were ≥ 20 responses among 35 patients. Forty patients were enrolled, five of whom were not evaluable for response. Eighteen evaluable patients were enrolled in the first stage. Acute emesis was controlled in 10 patients; therefore, enrollment proceeded to stage 2. An additional 17 patients were enrolled; 20/35 response-evaluable patients (57%) did not develop acute vomiting or require rescue anti-emetics, thus achieving the goal of the study. A total of 22/35 response-evaluable patients (63%) met the secondary endpoint of delayed emesis control (days 2–5). Thirty three out of 35 patients underwent successful stem cell mobilization. No ≥ grade 3 AP-related adverse events were noted. The AP regimen can effectively control acute and delayed emesis in the majority patients receiving high-dose CY.
Aprepitant; nausea; vomiting; high-dose cyclophosphamide
Few studies have investigated long-term effects of physical activity (PA) interventions. The goal of this study was to evaluate whether or not increased levels of moderate to vigorous physical activity (MVPA) were maintained by cancer survivors one-year after receipt of two home-based interventions.
The FRESH START trial randomized 543 breast and prostate cancer survivors to 1-of-2 mailed print diet and exercise interventions: sequentially-tailored vs. standardized (attention control). Each arm received eight mailings over a 1-year period, with follow-up at 1- and 2-years. This analysis focuses solely on the 400 participants who had suboptimal levels of MVPA at baseline (measured by the 7-Day Physical Activity Recall) and who completed the 2-year study.
Median minutes of MVPA at baseline, 1-year and 2-year follow-up in the tailored intervention arm were as follows: 0, 90, and 60 mins/wk, respectively. The corresponding values in the attention-control group were 0, 30, and 30 mins/wk. Significant improvements in MVPA from baseline to 2-year follow-up were observed in both study arms (p < 0.01). While significant between-arm differences were observed at 1-year follow-up (p < 0.01), by 2-year follow-up there was only the suggestion of a trend (p = 0.08).
This study provides evidence that mailed-print exercise interventions result in significant and sustainable improvements in MVPA among newly-diagnosed cancer survivors that are observed well after the intervention is complete. While tailored interventions, as compared to standardized materials, appear to produce superior improvements in MVPA initially, these differences diminish over time.
breast neoplasms; prostatic neoplasms; maintenance; physical activity; intervention; durability; exercise
This study examined attachment styles in patients with lung cancer and their spouses and associations between attachment styles and patient and spouse adjustment.
One hundred twenty-seven patients with early stage lung cancer completed measures of attachment style, marital quality, self-efficacy, pain, depression, anxiety, and quality of life. Their spouses completed measures of attachment style, marital quality, self-efficacy, caregiver strain, and mood.
Analyses indicated that, among patients, those high in either attachment anxiety or avoidance had significantly higher levels of anxiety and poorer social well-being. Attachment avoidance was also significantly associated with higher levels of depression and poorer marital quality and functional well-being. Spouse avoidant attachment was significantly associated with patient reports of increased pain and poorer functional well-being, and spouse anxious attachment was associated with poorer patient marital quality. Among spouses, those high in attachment avoidance reported significantly higher levels of caregiver strain, anger, depressed mood, and poorer marital quality; those high in attachment anxiety reported higher anxious mood. Dyads in which both partners were insecurely attached had significantly poorer adjustment compared to dyads in which both partners reported secure attachment.
These preliminary findings raise the possibility that attachment styles of cancer patients and their spouses as individuals and as a dyad may be important factors affecting adjustment in multiple domains.
Attachment; Lung cancer; Adjustment; Quality of life; Couples; Caregiving
Nausea and vomiting are among the most feared complications of chemotherapy reported by patients. The objective of this study was to establish the overall complete response (CR; no emesis or use of rescue medication 0–120 h after chemotherapy) with either ondansetron- or palonosetron-containing antiemetic regimens in patients receiving highly emetogenic chemotherapy (HEC).
This was a prospective, open-label, randomized, single-center, pilot study that enrolled patients receiving their first cycle of HEC. Patients were randomized to receive either palonosetron 0.25 mg IV (PAD) or ondansetron 24 mg orally (OAD) on day 1 prior to HEC. All patients received oral aprepitant 125 mg on day 1, then 80 mg on days 2 and 3, and oral dexamethasone 12 mg on day 1, then 8 mg on days 2, 3, and 4. Descriptive statistics were used to summarize the data.
A total of 40 patients were enrolled, 20 in each arm. All patients were female, and 39 received doxorubicin/cyclophosphamide chemotherapy for breast cancer. For the primary endpoint, 65 % (95 % CI, 40.8–84.6 %) of patients in the PAD arm and 40 % (95 % CI, 19.1–63.9 %) of patients in the OAD arm achieved an overall CR.
While CR rates for aprepitant and dexamethasone plus palonosetron or ondansetron-containing regimens have been published previously, this is the first documentation of CR rates with these regimens in the same patient population. These results may be used to design a larger, adequately powered, prospective study comparing these regimens.
Ondansetron; Palonosetron; Aprepitant; Dexamethasone; Highly emetogenic chemotherapy
As the result of a recent national shortage in paclitaxel, some patients who were receiving or scheduled to receive weekly paclitaxel were converted to every 3-week (q3w) docetaxel with granulocyte colony-stimulating factor support. Our institution noted higher than expected incidence of severe skin toxicity events attributable to docetaxel during the shortage period among our breast cancer patients. In this report, we summarize the clinical course of the first five cases, review the literature surrounding docetaxel-induced skin toxicity, and offer possible prevention and treatment strategies to improve docetaxel tolerability.
The observation period for this case series was August 1 through October 21, 2011. All patients treated with docetaxel were identified from our electronic medical record. Operable stage I–III breast cancer patients who received ≥1 dose of docetaxel monotherapy at 75–100 mg/m2 q3w were included in this study. The cases of grade 3–4 docetaxel-induced skin toxicities identified by the treating oncologists were then contacted and signed an informed consent through an Institutional Review Board-approved protocol.
Thirty-four patients met the inclusion criteria. Five patients (14.7 %) experienced grade 3 skin toxicity events attributable to docetaxel, a significantly higher rate than previously reported for docetaxel dosed at 75–100 mg/m2.
Docetaxel-induced dermatologic toxicity is well characterized; nonetheless, its etiology is largely unknown and evidence-based prevention and management strategies are lacking. This report shows that the use of docetaxel 75–100 mg/m2 q3w subsequent to dose-dense doxorubicin and cyclophosphamide regimen can lead to unacceptable rate of severe skin toxicity.
Taxane; Hand–foot syndrome; Breast cancer; Chemotherapy toxicity
This study examined quality of life, transplant-related concerns, and depressive symptoms and their demographic and medical correlates at 1 to 3 years following hematopoietic stem cell transplantation (HSCT).
HSCT survivors (N = 406) completed telephone-administered questionnaires that assessed demographic variables, functional status, quality of life, transplant-related concerns, and depressive symptoms.
The most prevalent concerns among HSCT survivors included physical symptoms (e.g., fatigue, pain), maintaining current health status and employment, changes in appearance, and lack of sexual interest and satisfaction. In addition, almost one-third (32%) of survivors age 40 years and younger reported concern about their ability to have children. Unemployed survivors and those with lower incomes and worse functional status were more likely to experience poorer quality of life in multiple domains. Fifteen percent of the sample reported moderate to severe depressive symptoms, and these symptoms were higher among allogeneic transplant recipients and those with lower functional status.
Results suggest that interventions are needed to address physical symptoms, coping with an uncertain future, infertility, and sexual issues during the early phase of HSCT survivorship.
hematopoietic stem cell transplantation; quality of life; cancer survivorship; psychological; depression; sexual health
Patient satisfaction (PS), a key measure of quality of cancer care, is a core study outcome of the multi-site National Cancer Institute (NCI) Patient Navigation Research Program (PNRP). Despite large numbers of underserved monolingual Spanish speakers (MSS) residing in the United States, there is no validated Spanish measure of PS that spans the whole spectrum of cancer-related care. The present study reports on the cross-validation of the Patient Satisfaction with Cancer Care (PSCC) measure for Spanish (PSCC-Sp) speakers receiving diagnostic and therapeutic cancer-related care.
Original PSCC items were professionally translated and back translated to ensure cultural appropriateness, meaningfulness and equivalence. Then, the resulting 18-item PSCC-Sp measure was administered to 285 MSS. We evaluated latent structure and internal consistency of the PSCC-Sp using principal components analysis (PCA) and Cronbach coefficient alpha (α). We used correlation analyses to demonstrate divergence and convergence of the PSCC-Sp with a Spanish version of the Patient Satisfaction with Interpersonal Relationship with Navigator (PSN-I-Sp) measure and patients’ demographics.
The PCA revealed a coherent set of items that explicates 47% of the variance in PS. Reliability assessment demonstrated that the PSCC-Sp had high internal consistency (α = .92). The PSCC-Sp demonstrated good face validity, and convergent and divergent validities as indicated by moderate correlations with the PSN-I-Sp (p = 0.003) and non-significant correlations with marital status and household income (all ps > 0.05).
The PSCC-Sp is a valid and reliable measure of PS and should be tested in other MSS populations.
This study examined the psychosocial adjustment and needs of family caregivers of head and neck cancer survivors at 6–24 months post-treatment.
Family caregivers of head and neck cancer survivors (N = 89) completed mailed questionnaires that assessed demographic variables, mental health, quality of life, and practical and informational needs.
Thirty-eight percent of caregivers reported moderate to high distress. However, quality of life scores for the entire sample (N = 89) were better than the scores reported in initial validation studies on caregivers of patients undergoing active cancer treatment. Greater time spent caregiving was associated with worse psychological well-being, but also more positive adaptation to caregiving. In addition, 39% of caregivers reported that all of their practical and informational needs were being met.
Findings suggest that research and clinical efforts are needed to address the psychosocial concerns of this population.
head and neck cancer survivors; quality of life; distress; family caregivers
With our population aging, an increasing proportion of cancer deaths will occur in nursing homes, yet little is known about their end-of-life care. This paper identifies associations between residing in a nursing home and end-of-life palliative cancer care, controlling for demographic factors.
For this population-based study, a data file was created by linking individual-level data from the Nova Scotia Cancer Centre Oncology Patient Information System, Vital Statistics, and the Halifax and Cape Breton Palliative Care Programs for all persons 65 years and over dying of cancer from 2000 to 2003. Multivariate logistic regression was used to compare nursing home residents to nonresidents.
Among the 7,587 subjects, 1,008 (13.3%) were nursing home residents. Nursing home residents were more likely to be female [adjusted odds ratio (OR) 1.4, 95% confidence interval (CI) 1.2–1.7], older (for ≥90 vs 65–69 years OR 5.4, CI 4.1–7.0), rural (OR 1.5, CI 1.2–1.8), have only a death certificate cancer diagnosis (OR 4.2, CI 2.8–6.3), and die out of hospital (OR 8.5, CI 7.2–10.0). Nursing home residents were less likely to receive palliative radiation (OR 0.6, CI 0.4–0.7), medical oncology consultation (OR 0.2, CI 0.1–0.4), and palliative care program enrollment (Halifax OR 0.2, CI 0.2–0.3; Cape Breton OR 0.4, CI 0.3–0.7).
Demographic characteristics and end-of-life services differ between those residing and those not residing in nursing homes. These inequalities may or may not reflect inequities in access to quality end-of-life care.
PMID: 17277924 CAMSID: cams3259
Nursing home; Cancer; Place of death; End-of-life; Palliative care
Biosimilars are similar, but non-identical, versions of existing biological drugs for which patents have expired. Despite the rigorous approval process for biosimilars, concerns have been expressed about the efficacy and safety of these products in clinical practice. Biosimilars of filgrastim, based on the originator product Neupogen®, have been available since 2008 and are now in widespread clinical use in Europe and elsewhere. Three biosimilar G-CSFs have been approved based on a combination of physicochemical and biological protein characterisation, pharmacokinetic and pharmacodynamic assessment in healthy volunteers and efficacy and safety data in patients with cancer. To assess whether biosimilars are effective in the real-world clinical practice setting, a pooled analysis of five post-approval studies of biosimilar G-CSF (Zarzio®) that included 1,302 adult patients who received at least one cycle of chemotherapy with G-CSF support for the prevention of neutropenia was conducted. A total of 36 % of patients had a febrile neutropenia risk of >20 %, while 39.6 % had a risk of 10–20 % based on chemotherapy regimen. The occurrence of severe or febrile neutropenia was within the range of that observed in previous studies of originator G-CSF. In addition, the safety profile of Zarzio® was consistent with that reported for originator G-CSF and the known safety profile of G-CSF. Initial concerns about the use of biosimilars, at least with regard to biosimilar G-CSFs, appear to be unfounded. Adoption of cost-effective biosimilars should help reduce healthcare costs and improve patient access to biological treatments.
Biosimilar; Chemotherapy-induced neutropenia; Cost-effectiveness; Filgrastim; G-CSF
Although sexual concerns have been examined in breast cancer (BC), these concerns remain understudied and undertreated for patients with gastrointestinal (GI) cancer. Objectives were to: (1) assess sexual concerns in GI cancer patients compared with breast cancer patients; (2) examine whether sexual concerns are stable over time in GI and breast cancer patients; and (3) evaluate whether sexual concerns in GI and breast cancer are significantly associated with quality of life, symptom severity, and disease interference, and whether these associations change over time.
Data were collected from GI and breast cancer patients during four outpatient clinic visits over 6 months. Measures included sexual concerns (reduced sexual enjoyment, interest, or performance), quality of life (FACT-G), symptom severity, disease interference (MD Anderson Symptom Inventory), and disease-related distress (NCCN Distress Scale). Linear mixed model analyses were conducted.
Sexual concerns were common in both samples, with 57% of GI cancer patients and 53% of breast cancer patients reporting at least mild sexual concerns. Sexual concerns were stable over time and were significantly associated with lower levels of functioning in multiple domains (e.g., quality of life, symptom severity, disease interference, and disease-related distress), irrespective of length of time since diagnosis. Cancer type (GI/breast cancer) was not a moderator of this relationship.
Self-reported sexual concerns were common, stable, and related significantly to quality of life, symptom severity, disease interference, and disease-related distress for both GI and breast cancer patients. Limitations and implications for future research are discussed.
Gastrointestinal neoplasms; Breast neoplasms; Sexuality; Quality of life; Sexual dysfunction, physiological
The PERFORM Questionnaire is a 12-item scale developed for assessing fatigue in cancer patients in the clinical practice. It has advantages over other tools in that it is short and includes beliefs and attitudes of patients about fatigue. It was psychometrically validated in cancer patients with and without anemia.
We evaluated the usefulness of the PERFORM scale to measure fatigue in a large study focusing exclusively on anemic patients.
This was an observational, multicenter, prospective, 3-month study in cancer patients with hemoglobin (Hb)≤11 g/dl. Fatigue was assessed using the PERFORM questionnaire. The overall score ranges from 12 (no fatigue) to 60 (maximum fatigue).
We included 667 patients: 54.1 % women, mean age 60 (standard deviation, 12) years. A highly significant, but mild correlation was observed between low baseline Hb and high patient perception of fatigue (r with PERFORM score=−0.215, p < 0.0001). Of the patients, 65.8 % improved Hb level during follow-up (increase of ≥1 g/dL and/or achieving >11 g/dL), which translated into a significant improvement in the PERFORM score [mean (95 % confidence interval (CI)] change, −1.2 (−0.04 to −2.4), whereas more fatigue was observed in patients without improvement in Hb [change (95 % CI) in PERFORM, +3.3 (1.5 to 5)]. In a multivariate linear regression analysis, the independent factors associated to fatigue at 3 months were a low Hb level, a low Karnofsky index, active chemotherapy, cancer treatment with palliative intention, and transfusion need in the last 3 months.
Minimal increases or decreases in Hb of ≥1 g/dL were associated with meaningful changes in patient-perceived fatigue as measured with the PERFORM questionnaire. In addition to anemia severity, other factors such as active chemotherapy and advanced disease contribute to perception of fatigue by cancer patients.
Fatigue; Anemia; Cancer; Chemotherapy
Goals of work
Disease-related cancer pain is a multidimensional phenomenon. Psychological factors that may alter pain perception in cancer patients have not been well studied. The study purpose was to explore differences in pain, anxiety and depression by type of primary cancer.
Patients and methods
In a cross-sectional study of consecutive patients (80% male, mean age 60.5 ± 11.5 years) undergoing radiation treatment for head/neck (HNC, n = 93), lung (LC, n = 146), or prostate (PC, n = 63) cancers, patients reported pain quality, pattern and intensity with the McGill Pain Questionnaire. They also completed the State Trait Anxiety Inventory, Center for Epidemiologic Studies Depression Scale and Coping Strategies Questionnaire. Comparative statistics, correlation coefficients, and multivariate regression analysis were performed.
Worst pain intensity was significantly greater in LC subjects compared to HNC (p < .05) and PC (p < .001). Pain quality ratings were significantly greater for individuals with LC compared to PC (p < .05), and the regression analyses indicated that pain quality ratings were partially predicted by having LC. Depression levels approached clinical significance and were greatest for individuals with LC. Catastrophizing was correlated with high levels of depression (p < .01) and anxiety (p < .01).
Individuals with cancer undergoing radiation treatment experienced clinically significant levels of unrelieved cancer pain despite standard pain management. Pain intensity and quality ratings were greatest for LC individuals and may contribute to symptoms of depression. Catastrophizing may contribute to psychological factors which may impact the pain experience. Tailored treatments that meet cancer patients’ psychosocial and medical needs may result in improved pain management and functional ability.
cancer; pain; anxiety; depression; coping
Virtual reality (VR) during chemotherapy has resulted in an elapsed time compression effect, validating the attention diversion capabilities of VR. Using the framework of the pacemaker–accumulator cognitive model of time perception, this study explored the influence of age, gender, state anxiety, fatigue, and cancer diagnosis in predicting the difference between actual time elapsed during receipt of intravenous chemotherapy while immersed in a VR environment versus patient’s retrospective estimates of time elapsed during this treatment.
Materials and methods
This secondary analysis from three studies yielded a pooled sample of N=137 participants with breast, lung, or colon cancer. Each study employed a crossover design requiring two matched intravenous chemotherapy treatments, with participants randomly assigned to receive VR during one treatment. Regressions modeled the effect of demographic variables, diagnosis, and Piper Fatigue Scale and State Anxiety Inventory scores on the difference between actual and estimated time elapsed during chemotherapy with VR.
In a forward regression model, three predictors (diagnosis, gender, and anxiety) explained a significant portion of the variability for altered time perception (F=5.06, p=0.0008). Diagnosis was the strongest predictor; individuals with breast and colon cancer perceived time passed more quickly.
VR is a noninvasive intervention that can make chemotherapy treatments more tolerable. Women with breast cancer are more likely and lung cancer patients less likely to experience altered time perception during VR (a possible indicator of effectiveness for this distraction intervention). Understanding factors that predict responses to interventions can help clinicians tailor coping strategies to meet each patient’s needs.
Virtual reality; Time perception; Distraction; Chemotherapy; Cancer
Fatigue is one of the most disturbing complaints of cancer patients and often is the reason for discontinuing treatment. This randomized controlled study tested the hypothesis that increased morning bright light, compared to dim light, would result in less fatigue in women with breast cancer undergoing chemotherapy.
39 women newly diagnosed with Stage I-III breast cancer were randomized to either bright white light (BWL) or dim red light (DRL) treatment and were instructed to use the light box for 30 minutes every morning throughout the first 4 cycles of chemotherapy. The Multidimensional Fatigue Symptom Inventory was administered prior to the start of chemotherapy (baseline), during the chemotherapy treatment week of cycle 1 (C1TW), the last week (recovery week) of cycle 1 (C1RW), chemotherapy treatment week of cycle 4 (C4TW), the last week (recovery week) of cycle 4 (C4RW).
The DRL group reported increased fatigue at C1TW (p=0.003) and C4TW (p<0.001) compared to baseline while there was no significant change from baseline in the BWL group. A secondary analysis showed that the increases in fatigue levels in the DRL group were not mediated through associated with changes in sleep or in circadian rhythms as measured with wrist actigraphy.
The results of this study suggest that morning bright light treatment may prevent overall fatigue from worsening during chemotherapy. Although our hypothesis that overall fatigue would improve with bright light treatment was not supported, the lack of deterioration in total fatigue scores suggests that bright morning light may be a useful intervention during chemotherapy for breast cancer.
fatigue; breast cancer; chemotherapy; light treatment
This study aimed to review quantitative literature pertaining to studies of music-based interventions in palliative cancer care and to review the neurobiological literature that may bare relevance to the findings from these studies.
A narrative review was performed, with particular emphasis on RCTs, meta-analyses, and systematic reviews. The Cochrane Library, Ovid, PubMed, CINAHL Plus, PsycINFO, and ProQuest were searched for the subject headings music, music therapy, cancer, oncology, palliative care, pain, anxiety, depression, mood, quality of life, prevalence, neuroscience, functional imaging, endogenous opioids, GABA, 5HT, dopamine, and permutations of these same search terms. Data for the review were comprised of articles published between 1970 and 2012. References of all the cited articles were also reviewed.
Available evidence suggests that music-based interventions may have a positive impact on pain, anxiety, mood disturbance, and quality of life in cancer patients. Advances in neurobiology may provide insight into the potential mechanisms by which music impacts these outcomes.
More research is needed to determine what subpopulation of cancer patients is most likely to respond to music-based interventions, what interventions are most effective for individual outcomes, and what measurement parameters best gauge their effectiveness.
Music; Cancer; Oncology; Palliative; Neurobiology
Everolimus is a mammalian target of rapamycin (mTOR) inhibitor approved for the treatment of advanced renal cell carcinoma, pancreatic neuroendocrine tumors, subependymal giant cell astrocytoma associated with tuberous sclerosis complex, renal angiomyolipoma and tuberous sclerosis complex, and, in combination with exemestane, for hormone receptor-positive HER2-negative advanced breast cancer after failure of treatment with letrozole or anastrozole. Results from the phase III BOLERO-2 trial demonstrated that everolimus in combination with exemestane provided significant clinical benefit to patients with advanced hormone receptor-positive breast cancer. Although everolimus is generally well tolerated, as with most therapies administered in an advanced cancer setting, drug-related adverse events (AEs) inevitably occur. Most common AEs observed in the everolimus studies include stomatitis, rash, infection, noninfectious pneumonitis, and hyperglycemia. Clinical awareness and early identification of such AEs by oncology nurses are essential to dosing (interruptions, reduction, and treatment discontinuation); quality of life; and, ultimately, patient outcomes. Because everolimus has already been shown to significantly improve clinical efficacy in patients with advanced breast cancer, a proactive approach to the practical management of AEs associated with this mTOR inhibitor as well as other most common AEs observed in this patient population has been reviewed and outlined here.
mTOR inhibitor; Adverse event; Management; Everolimus; Breast cancer; Hormone receptor
Discussing end-of-life care with patients is often considered taboo, and signing a do-not-resuscitate (DNR) order is difficult for most patients, especially in Chinese culture. This study investigated distributions and details related to the signing of DNR orders, as well as the completeness of various DNR order forms.
Retrospective chart reviews were performed. We screened all charts from a teaching hospital in Taiwan for patients who died of cancer during the period from January 2010 to December 2011. A total of 829 patient records were included in the analysis. The details of the DNR order forms were recorded.
The DNR order signing rate was 99.8 %. The percentage of DNR orders signed by patients themselves (DNR-P) was 22.6 %, while the percentage of orders signed by surrogates (DNR-S) was 77.2 %. The percentage of signed DNR forms that were completely filled out was 78.4 %. The percentage of DNR-S forms that were completed was 81.7 %, while the percentage of DNR-P forms that were completely filled out was only 67.6 %.
Almost all the cancer patients had a signed DNR order, but for the majority of them, the order was signed by a surrogate. Negative attitudes of discussing death from medical professionals and/or the family members of patients may account for the higher number of signed DNR-S orders than DNR-P orders. Moreover, early obtainment of signed DNR orders should be sought, as getting the orders earlier could promote the quality of end-of-life care, especially in non-oncology wards.
Chinese culture; Palliative care; Do-not-resuscitate (DNR); End-of-life care discussion; Cancer
Appropriate utilization of treatment is a goal for all patients undergoing cancer treatment. Proper treatment maximizes benefit and limits exposure to unnecessary measures. This report describes findings of the feasibility and acceptability of implementing a short, clinic-based decision aid and presents an in-depth clinical profile of the participants.
This descriptive study used a prospective, quantitative approach to obtain the feasibility and acceptability of a decision aid (DecisionKEYS for Balancing Choices) for use in clinical settings. It combined results of trials of patients with three different common malignancies. All groups used the same decision aid series. Participants included 80 patients with solid tumors (22 with newly diagnosed breast cancer, 19 with advanced prostate cancer, and 39 with advanced lung cancer) and their 80 supporters as well as their physicians and nurses, for a total of 160 participants and 10 health professionals.
The decision aid was highly acceptable to patient and supporter participants in all diagnostic groups. It was feasible for use in clinic settings; the overall value was rated highly. Of six physicians, all found the interactive format with the help of the nurse as feasible and acceptable. Nurses also rated the decision aid favorably.
This intervention provides the opportunity to enhance decision making about cancer treatment and warrants further study including larger and more diverse groups. Strengths of the study included a theoretical grounding, feasibility testing of a practical clinic-based intervention, and summative evaluation of acceptability of the intervention by patient and supporter pairs. Further research also is needed to test the effectiveness of the decision aid in diverse clinical settings and to determine if this intervention can decrease overall costs.
Solid tumors; Decision aid; Janis and Mann conflict theory of decision making; DecisionKEYS
Anamorelin (ONO-7643) is an orally active ghrelin receptor agonist in development for non-small cell lung cancer (NSCLC)-related anorexia/cachexia. It displays both orexigenic and anabolic properties via ghrelin mimetic activity and transient increases in growth hormone (GH). However, increasing GH and insulin-like growth factor-1 in cancer patients raises concerns of potentially stimulating tumor growth. Therefore, we investigated the effect of ghrelin and anamorelin on tumor growth in a murine NSCLC xenograft model.
Female nude mice (15–21/group) with established A549 tumors were administered ghrelin (2 mg/kg i.p.), anamorelin (3, 10, or 30 mg/kg p.o.), or vehicle controls daily for 28 days. Tumor growth, food consumption, and body weight were monitored. Murine growth hormone (mGH) and murine insulin-like growth factor-1 (mIGF-1) were measured in plasma.
Tumor growth progressed throughout the study, with no significant differences between treatment groups. Daily food consumption was also relatively unchanged, while the percentage of mean body weight gain at the end of treatment was significantly increased in animals administered 10 and 30 mg/kg compared with controls (p < 0.01). Peak mGH levels were significantly higher in ghrelin- and anamorelin-treated animals than in controls, while peak mIGF-1 levels were slightly elevated but not statistically significant. All regimens were well tolerated.
These findings demonstrate that neither anamorelin nor ghrelin promoted tumor growth in this model, despite increased levels of mGH and a trend of increased mIGF-1. Together with anamorelin’s ability to increase body weight, these results support the clinical development of ghrelin receptor agonist treatments for managing NSCLC-related anorexia/cachexia.
Anamorelin; Cachexia; Ghrelin; Growth hormone; IGF-1; Non-small cell lung cancer
The purpose of this study was to explore the cancer experience of survivors with pre-existing diagnoses of heart and/or lung disease following active treatment.
The Lance Armstrong Foundation recruited cancer survivors throughout the United States to complete a web-based survey to provide insight into post-treatment supportive care needs. Experts in survey methodology and oncology, as well as cancer survivors, provided input into the survey.
The 137 individuals whose physicians told them they had heart or lung problems were 50 years old on average, and most were more than five years past active treatment. Two-thirds of these respondents reported pain for long periods, and 20% of them agreed that they now need help with everyday tasks that they did not need help with before their cancer. Among those who were tired, had no energy, or had trouble sleeping and/or resting, less than half (47%) agreed that they had received help with this problem. One third of these respondents indicated that they had decreased their physical activity since their cancer diagnosis because of fatigue and 26% decreased their activities because of pain. More respondents indicated that their needs were met during their cancer treatment than afterwards.
Researchers and health care providers are urged to consider the unmet supportive care needs of cancer survivors with co-morbid conditions following active treatment, particularly the need for careful monitoring of their complex health conditions.
comorbidities; long-term cancer survivorship; clinical trials
To obtain estimates of time to recruit the study sample, retention, facility-based class attendance and home practice for a study of yoga in breast cancer survivors, and its efficacy on fatigue, quality of life (QOL), and weight change.
Sixty-three post-treatment stage 0–III borderline overweight and obese (body mass index ≥ 24 kg/m2) breast cancer survivors were randomly assigned to a 6-month, facility- and home-based viniyoga intervention (n = 32) or a waitlist control group (n = 31). The yoga goal was 5 practices per week. Primary outcome measures were changes in self-reported QOL, fatigue, and weight from baseline to 6 months. Secondary outcomes included changes in waist and hip circumference.
It took 12 months to complete recruitment. Participants attended a mean of 19.6 classes and practiced at home a mean of 55.8 times during the 6-month period. At follow-up, 90% of participants completed questionnaires and 87% completed anthropometric measurements. QOL and fatigue improved to a greater extent among women in the yoga group relative to women in the control group, although no differences were statistically significant. Waist circumference decreased 3.1 cm (95% CI: −5.7, −0.4) more among women in the yoga compared with the control group, with no differences in weight change.
This study provides important information regarding recruitment, retention, and practice levels achieved during a 6-month, intensive yoga intervention in overweight and obese breast cancer survivors. Yoga may help decrease waist circumference and improve quality of life; future studies are needed to confirm these results.
yoga; breast cancer; quality of life; weight
Palonosetron (Aloxi®, Onicit®) is a pharmacologically unique 5-HT3 receptor antagonist (RA) approved as a single IV injection for the prevention of nausea and vomiting induced by chemotherapy (CINV) of either moderate or highly emetogenic potential (MEC and HEC, respectively). An oral palonosetron formulation has been developed and compared to the IV formulation.
In this multinational, multicenter, double-blind, double-dummy, dose-ranging trial, 651 patients were randomly assigned to receive one of the following as a single dose prior to moderately emetogenic chemotherapy: oral palonosetron 0.25, 0.50, and 0.75 mg or IV palonosetron 0.25 mg. Patients were also randomized (1:1) to receive dexamethasone 8 mg IV or matched placebo on day 1. The primary endpoint was complete response (CR; no emesis, no rescue therapy) during the acute phase (0–24 h).
Acute CR rates were 73.5, 76.3, 74.1, and 70.4 % for all patients receiving the palonosetron 0.25, 0.50, and 0.75 mg oral doses, and for IV palonosetron 0.25 mg, respectively; delayed CR (24–120 h) rates were 59.4, 62.5, 60.1, and 65.4 %, and overall CR (0–120 h) rates were 53.5, 58.8, 53.2, and 59.3 %, respectively. The addition of dexamethasone improved emetic control (acute CR rate) by at least 15 % for all groups except oral palonosetron 0.25 mg, where the acute CR improvement was approximately 7 %. Adverse events were similar in nature, incidence, and intensity for all oral and IV palonosetron groups, and were the expected adverse events for 5-HT3 RAs (primarily headache and constipation).
Oral palonosetron has a similar efficacy and safety profile as IV palonosetron 0.25 mg and may be the preferred formulation in certain clinical situations. Among the tested oral treatments, a palonosetron 0.50-mg oral dose has been favored for the prevention of CINV in patients receiving moderately emetogenic chemotherapy due to a numerical gain in efficacy without a side effect disadvantage.
Palonosetron; Chemotherapy-induced nausea and vomiting; Moderately emetogenic chemotherapy; 5-Ht3 receptor antagonist
We examined quality of life in spouses of men in the Post-Adjuvant Androgen Deprivation trial after radical prostatectomy.
Men at high risk of prostate cancer recurrence were randomized to receive androgen deprivation therapy or observation. Forty-three couples completed telephone interviews every 6 months for 2 years assessing women’s mood disturbance, mental and physical health, and sexual function and bother as well as men’s symptoms and sociodemographic and marital variables. We used linear mixed modeling to explore relationships between wives’ quality of life and time, treatment group, and men’s symptoms.
Women’s mental health functioning improved over time (p<0.05). Furthermore, women with husbands in the observation group had worse mood disturbance (p=0.01) and poorer mental health (p=0.02) than women with husbands in treatment. Men’s symptoms were associated with worse physical health in wives (p=0.02). Women also reported worse sexual function at 18 and 24 months compared with baseline (p=0.02), but ratings of sexual bother were unrelated to time, treatment, and symptoms.
These exploratory results are consistent with research demonstrating that spousal cancer-related distress decreases over time. Treatment group differences suggest that an examination of caregiving in the context of uncertainty is warranted. Also, the physical burden of caregiving may intensify when men have more symptoms. To inform interventions, future studies should clarify how treatment and symptoms influence wives’ distress by examining expectations and communication.
Prostate cancer; Quality of life; Partners; Symptoms