ConquerFear-Group: A randomized controlled trial of an online-delivered group-based psychological intervention for fear of cancer recurrence in breast cancer survivors.

OBJECTIVE: Fear of cancer recurrence (FCR) is a distressing concern among cancer survivors. Interventions to address FCR need to be effective but also accessible and low cost. This randomized controlled trial evaluated the efficacy of an online group-based psychological intervention for FCR (ConquerFear-Group). METHODS: Eligible breast cancer (BC) survivors had completed primary treatment 3 months-5 years previously, were ≥18 years, and scored ≥22 on the Fear of Cancer Recurrence Inventory-Short Form (FCRI-SF). Participants were randomized to online ConquerFear-Group (focusing on metacognitive strategies, values-clarification, and education about follow-up behavior) or online group-based relaxation training (active control). Questionnaires were completed at baseline (T1), 1 week post-intervention (T2), three (T3) and six (T4) months later. The primary outcome was FCR (FCRI total). A number of secondary and process outcomes were also collected. Treatment effects were evaluated with mixed linear models. RESULTS: Of 866 eligible BC survivors, 475 (55%) completed the FCR screening, and 85 (18%) were randomized to ConquerFear-Group or relaxation training (2 × 6 groups). Compared with control participants, ConquerFear-Group participants experienced larger reductions in FCR (Cohen's d = 0.47, p = 0.001) and FCR severity (d = 0.57, p < 0.001), as well as mindfulness and decentering from baseline through follow-up, and improvements in emotion regulation (T2), worry (T2, T3) and rumination (T2) at some time points. CONCLUSIONS: The results demonstrated statistically significant and stable effects of ConquerFear-Group on FCR that were maintained over a 6-month period. It is suggested to investigate the program in a real-life setting, where a pragmatic trial can further demonstrate feasibility and effectiveness.

ConquerFear-group: Feasibility study with pilot results of a psychological intervention for fear of cancer recurrence delivered in groups.

OBJECTIVE: ConquerFear has been found to effectively reduce fear of cancer recurrence (FCR). Group interventions may be particularly effective for the treatment of FCR and could lower overall costs. Our objectives were therefore to adapt ConquerFear into a group format (ConquerFear-Group, CF-G), and to evaluate its feasibility, acceptability, and preliminary efficacy. METHODS: Eligible patients had completed treatment for breast cancer 3 months to 5 years previously, were ≥18 years, and scored ≥22 on the Fear of Cancer Recurrence Inventory-Short Form (FCRI-SF). The manual was first evaluated with seven patients (Pilot 1), adjusted in accordance with feedback from the patients, therapists, and the original ConquerFear developers. After further evaluation with eight patients (Pilot 2), and subsequent adjustments, the preliminary efficacy of the final manual was evaluated with 27 patients, randomized in blocks to CF-G (N = 13) or active control (AC) (relaxation training) (N = 14) (Pilot 3). The primary outcome was the FCRI total score. Secondary outcomes included general distress, quality-of-life, and process outcomes pertaining to metacognitions, decentering, and worry. All measures were completed at baseline, post-treatment, and at 3 and 6 months follow-up. RESULTS: Adjustments of the original ConquerFear manual (Pilot 1 and 2) included changes in the order of treatment components, simplified exercises, and shortened homework. Compared with ACs, CF-G participants reported greater reductions in FCRI total scores from baseline to post-treatment (Hedges's g = 0.59, p = 0.004), 3 months (g = 0.50, p = 0.026), and 6 months later (g = 0.93, p = 0.043). Differences corresponding to medium-to-large effect sizes (Pilot 3). Although non-significant, group differences concerning reductions in general distress and maladaptive metacognitions corresponded to small-to-medium effect sizes (g = 0.40-0.61; ps = 0.40-0.61). CONCLUSIONS: CF-G appears feasible and potentially efficacious in treating FCR in a breast cancer population. These preliminary results are promising but need to be confirmed in a larger randomized trial.

Long-term symptoms of polyneuropathy in breast and colorectal cancer patients treated with and without adjuvant chemotherapy.

BACKGROUND: The aim of this study was to assess chemotherapy-induced polyneuropathy (CIPN) 5 years after adjuvant chemotherapy in patients with breast and colorectal cancer. The association of CIPN with quality of life, anxiety, and depression was analyzed. METHODS: Of a set of 100 patients with breast cancer and of 74 with colorectal cancer who had undergone surgery and adjuvant chemotherapy in 2011-2012, 80 and 52 patients alive, respectively, were included together with two reference groups of 249 breast cancer patients and 83 colorectal cancer patients who had undergone surgery only. All patients were sent a questionnaire on alcohol consumption, smoking habits, comorbidity, medicine consumption, and oxaliplatin-specific questions, as well as the Michigan Neuropathy Screening Instrument questionnaire (MNSIq), the Douleur Neuropathique 4 Questions (DN4q), the EQ-5D, and the Hospital Anxiety and Depression Scale. Possible polyneuropathy was defined as the presence of numbness and/or tingling in the feet, secondly as a score of ≥4 on the MNSIq. Possible painful polyneuropathy was defined as pain in both feet and a score ≥3 on the DN4q. RESULTS: The prevalence of possible polyneuropathy defined by numbness and/or tingling in the feet was 38.8% (28.1-50.3) after adjuvant docetaxel and 57.7% (43.2-71.3) after adjuvant oxaliplatin, with no significant difference from a previous 1-year follow-up (P >.35). Fewer had possible polyneuropathy as defined by the MNSIq. Patients with possible polyneuropathy after adjuvant chemotherapy reported significantly lower quality of life than patients treated with surgery only. CONCLUSION: Symptoms of polyneuropathy following adjuvant docetaxel and oxaliplatin persist 5 years after treatment and affect quality of life negatively.

Diffusion gradient nonlinearity bias correction reduces bias of breast cancer bone metastasis ADC values.

CONTRACT GRANT SPONSOR: Health Research Fund of Central Denmark Region. BACKGROUND: Diffusion gradient nonlinearity (DGNL) bias causes apparent diffusion coefficient (ADC) values to drop with increasing superior-inferior (SI) isocenter offset. This is a concern when performing quantitative diffusion-weighted imaging (DWI). PURPOSE/HYPOTHESIS: To investigate if DGNL ADC bias can be corrected in breast cancer bone metastases using a clinical DWI protocol and an online correction algorithm. STUDY TYPE: Prospective. SUBJECTS/PHANTOM: A diffusion phantom (Model 128, High Precision Devices, Boulder, CO) was used for in vitro validation. Twenty-three women with bone-metastasizing breast cancer were enrolled to assess DGNL correction in vivo. FIELD STRENGTH/SEQUENCE: DWI was performed on a 1.5T MRI system as single-shot, spin-echo, echo-planar imaging with short-tau inversion recovery (STIR) fat-saturation. ADC maps with and without DGNL correction were created from the b50 and b800 images. ASSESSMENT: Uncorrected and DGNL-corrected ADC values were measured in phantom and bone metastases by placing regions of interest on b800 images and copying them to the ADC map. The SI offset was recorded. STATISTICAL TESTS: In all, 79 bone metastases were assessed. ADC values with and without DGNL correction were compared at 14 cm SI offset using a two-tailed t-test. RESULTS: In the diffusion phantom, DGNL correction increased SI offset, where ADC bias was lower than 5%, from 7.3-13.8 cm. Of the 23 patients examined, six had no metastases in the covered regions. In the remaining patients, bias of uncorrected bone metastasis ADC values was 19.1% (95% confidence interval [CI]: 15.4-22.9%) at 14 cm SI offset. After DGNL correction, ADC bias was significantly reduced to 3.5% (95% CI: 0.7-6.3%, P < 0.001), thus reducing bias due to DGNL by 82%. DATA CONCLUSION: Online DGNL correction corrects DGNL ADC value bias and allows increased station lengths in the SI direction. LEVEL OF EVIDENCE: 2 Technical Efficacy: Stage 2 J. Magn. Reson. Imaging 2020;51:904-911.

A Large-Cohort, Longitudinal Study Determines Precancer Disease Routes across Different Cancer Types.

Although many diseases are associated with cancer, the full spectrum of temporal disease correlations across cancer types has not yet been characterized. A population-wide study of longitudinal disease trajectories is needed to interrogate the general medical histories of patients with cancer. Here we performed a retrospective study covering a 20-year period, using 6.9 million patients from the Danish National Patient Registry linked to 0.7 million patients with cancer from the Danish Cancer Registry. Statistical analysis identified all significant disease associations occurring prior to cancer diagnoses. These associations were used to build frequently occurring, longitudinal disease trajectories. Across 17 cancer types, a total of 648 significant diagnoses correlated directly with a cancer, while 168 diagnosis trajectories of time-ordered steps were identified for seven cancer types. The most common diseases across cancer types involved cardiovascular, obesity, and genitourinary diseases. A comprehensive, publicly available web tool of interactive illustrations for all cancer disease associations is provided. By exploring the precancer landscape using this large dataset, we identify disease associations that can be used to derive mechanistic hypotheses for future cancer research. SIGNIFICANCE: This study offers an innovative approach to examine prediagnostic disease and cancer development in a large national population-based setting and provides a publicly available tool to foster additional cancer surveillance research.

Treatment of advanced HR+/HER2- breast cancer with new targeted agents in combination with endocrine therapy: a review of efficacy and tolerability based on available randomized trials on everolimus, ribociclib, palbociclib and abemaciclib.

INTRODUCTION: Recently, new targeted agents have been developed, which can prolong the effect of endocrine treatment (ET) by targeting resistance pathways in HR+/HER2- advanced breast cancer. This review examines available studies of everolimus, an mTOR inhibitor, and the CDK 4/6 inhibitors ribociclib, palbociclib and abemaciclib in terms of efficacy, tolerability and safety. MATERIAL AND METHODS: A systematic literature search was performed in Pubmed. Evaluation of the quality of the identified studies was based on selected elements from the GRADE guidelines. RESULTS: The literature search yielded eight randomized trials that all presented a significant increase in the progression free survival (PFS)/time to progression (TTP) for the targeted agents plus ET vs ET only. The improvement was evident as first-line therapy with an increase in PFS of 10-11 months when adding a CDK4/6 inhibitor to ET, as well as in patients previously treated for metastatic disease, with an increase of 5-6 months. The common adverse events (AEs) of the CDK 4/6 inhibitors were due to myelosuppression. In addition, abemaciclib was associated with liver toxicity and diarrhea, and ribociclib with liver toxicity and QTcF prolongation. The most common grade 3/4 AE of everolimus was stomatitis. The majority (five) of the trials had no serious limitations, and thus the quality of evidence was high. DISCUSSION: The new targeted agents are all associated with an improvement of the PFS with an acceptable tolerability, and they should be offered to women with advanced HR+/HER2- breast cancer both as first-line therapy as well as among patients previously treated in metastatic regimens. However, further data regarding the impact on overall survival are required to evaluate the full benefit for patients. Price and differences in AEs could become substantial arguments for the choice of therapy for the individual patient.

Expressive writing intervention and self-reported physical health out-comes - Results from a nationwide randomized controlled trial with breast cancer patients.

The objective was to examine the effect of Expressive Writing Intervention (EWI) on self-reported physical symptoms and healthcare utilization in a nationwide randomized controlled trial with Danish women treated for primary breast cancer, and to explore participant characteristics related to emotion regulation as possible moderators of the effect. Women who had recently completed treatment for primary breast cancer (n = 507) were randomly assigned to three 20 min. home-based writing exercises, one week apart, focusing on emotional disclosure (EWI) of a distressing experience (their cancer or a non-cancer topic) or a non-disclosing topic (control). Outcomes were self-reported physical symptoms and healthcare utilization (visits and telephone contacts with GP) 3 and 9 months post-intervention. Potential moderators were repressive coping, alexithymia, rumination, social constraints, and writing topic. Results revealed no group by time interaction effects for any outcomes. Moderation analyses showed that 1) low alexithymic women in the EWI group showed larger decreases in GP telephone calls over time than both high alexithymic women and controls and 2) women in the EWI group writing about their own cancer, but not women writing about other topics, showed a larger decrease than controls. The results from this large randomized trial are concordant with previous findings showing that EWI is unlikely to be a generally applicable intervention to improve health-related outcomes in cancer patients and cancer survivors. However, written disclosure might have a beneficial impact for individuals who write about their own cancer, as well as for those low in alexithymia.

Mindfulness-based Cognitive Therapy and Persistent Pain in Women Treated for Primary Breast Cancer: Exploring Possible Statistical Mediators: Results From a Randomized Controlled Trial.

OBJECTIVES: The aim of this study was to investigate possible statistical mediators in a randomized controlled trial of mindfulness-based cognitive therapy (MBCT) on pain intensity in women treated for primary breast cancer. MATERIALS AND METHODS: The sample consisted of 129 women treated for breast cancer, presenting with persistent pain, who were randomly assigned to MBCT or a wait-list control. We previously reported a statistically significant and robust effect of MBCT on pain intensity (11-point numeric rating scale), which was included as the primary outcome. The proposed mediators were mindfulness (the Five Facet Mindfulness Questionnaire), self-compassion (the Short-Form Self-Compassion Scale), and pain catastrophizing (the Pain Catastrophizing Scale). Measurement points included baseline (T1), postintervention (T2), and 3- (T3) and 6-month (T4) follow-ups. All indirect effects of the mediators were tested in separate Multilevel Models, using the product-of-coefficients approach with bias-corrected confidence intervals (95% BSCI). The statistically significant mediators were then included in a multiple mediator model. RESULTS: Statistically significant indirect effects were found for mindfulness nonreactivity (B=-0.17, BSCI [-0.32 to -0.04]) and pain catastrophizing (B=-0.76, BSCI [-1.25 to -0.47]). No statistically significant indirect effect was found for self-compassion (B=-0.09, BSCI [-0.30 to 0.04]). In a multiple mediator model, including mindfulness nonreactivity and pain catastrophizing, only pain catastrophizing remained statistically significant (B=-0.72, BSCI [-1.19 to -0.33]), explaining 78% of the effect. DISCUSSION: The results of the present study may have clinical implications. An increased focus on the proposed mediators may optimize the clinical use of MBCT for persistent pain in women treated for breast cancer.

Preferred Place of Care and Death in Terminally Ill Patients with Lung and Heart Disease Compared to Cancer Patients.

OBJECTIVES: The dual aim of this study is, first, to describe preferred place of care (PPOC) and preferred place of death (PPOD) in terminally ill patients with lung and heart diseases compared with cancer patients and second, to describe differences in level of anxiety among patients with these diagnoses. BACKGROUND: Previous research on end-of-life preferences focuses on cancer patients, most of whom identify home as their PPOC and PPOD. These preferences may, however, not mirror those of patients suffering from nonmalignant fatal diseases. DESIGN: The study was designed as a cross-sectional study. SETTING: Eligible patients from the recruiting departments filled in questionnaires regarding sociodemographics, PPOC and PPOD, and level of anxiety. RESULTS: Of the 354 eligible patients, 167 patients agreed to participate in the study. Regardless of their diagnosis, most patients wished to be cared for and to die at home. Patients with cancer and heart diseases chose hospice as their second most common preference for both PPOC and PPOD, whereas patients with lung diseases chose nursing home and hospice equally frequent as their second most common preference. Regardless of their diagnosis, all patients had a higher level of anxiety than the average Danish population; patients with heart diseases had a much higher level of anxiety than patients with lung diseases and cancer. CONCLUSION: Patient preferences for PPOC and PPOD vary according to their diagnoses; tailoring palliative needs to patients' preferences is important regardless of their diagnosis.

Remaining Lifetime After Recognition of Terminal Illness Depends on Diagnosis: A Nationwide Population-Based Cohort Study.

CONTEXT: Timely recognition of the terminal phase of life will benefit patients and caregivers as it may facilitate advance care planning and support. OBJECTIVES: The objective of this study was to investigate the remaining lifetime of patients entering a physician-assessed terminal phase and to analyze variation in remaining lifetime according to diagnosis and sociodemographic factors. METHODS: Danish National Health Registers were used to establish a prospective cohort of adult patients formally registered with drug reimbursement due to terminal illness in 2012 and followed until June 2014. RESULTS: Of the 11,062 included patients, the median remaining lifetime was 55 days and 37% of the patients died within the first month. The majority suffered from cancer (89%). Patients with a noncancer disease had the shortest remaining lifetime (17 days), considerably shorter than patients with cancer (59 days). Patients with prostate cancer had the longest remaining lifetime (76 days), whereas those with hematologic cancer had the shortest among cancer patients (41 days). Compared with lung cancer patients, the probability of death within 30 days were higher for patients with noncancer disease and lower for those with prostate or colorectal cancer. Male gender and high age were associated with higher risk of dying within 30 days. CONCLUSION: This study found a median remaining lifetime of 55 days after recognition of terminal illness. Remaining lifetime differed between cancer and noncancer patients and according to age and gender. Increased attention should be directed toward timely recognition of the transition into the terminal phase, especially for patients with noncancer disease.

Chemotherapy-induced pain and neuropathy: a prospective study in patients treated with adjuvant oxaliplatin or docetaxel.

Chemotherapy-induced peripheral neuropathy (CIPN) is a common side effect of cancer therapy. This study evaluates symptoms of CIPN and CIPN-related pain and its influence on psychological functioning and potential predictors of chronic CIPN and pain. In this large prospective questionnaire study, 174 patients receiving adjuvant oxaliplatin or docetaxel were consecutively included. Patients were asked to complete a questionnaire with validated questions on peripheral neuropathy, pain, anxiety and depression, and quality of life at baseline, after the first cycle, halfway through therapy, and 1 year after baseline. Chronic CIPN symptoms (tingling and/or numbness) in the feet at 1-year follow-up were present in 63.6% of patients without preexisting neuropathy in the oxaliplatin group and in 44.8% in the docetaxel group, whereas pain in hands and feet was found in 31.3% and 35.1%, respectively. Both groups had significantly different pain profiles, and persistent pain in the docetaxel group was found to have effect on psychological function. Cumulative dose predicted oxaliplatin-induced neuropathy (P = 0.004), whereas endocrine therapy predicted peripheral pain in the docetaxel group (P = 0.04). There are important differences in acute neuropathic symptoms and chronic pain profiles in patients after oxaliplatin and docetaxel treatment. It is, however, important to recognize that chronic peripheral pain may be unrelated to neuropathy and can be caused by concomitant treatments. Future studies should focus on characterizing and distinguishing CIPN-related pain from other types of pain to determine the best outcome measures for trials on prevention or relief.

Socio-demographic, clinical, and health-related factors associated with breast reconstruction - A nationwide cohort study.

We collected registry- and questionnaire-based data on socio-economic and health status, tumor- and treatment-related variables, and explored associations with receipt of reconstruction and information about treatment options in a nationwide cohort of Danish women, treated for primary breast cancer. A total of 594 women were available for analysis, 240 (40%) of these received reconstruction. Multivariate analyses showed that receipt of reconstruction was associated with 1) younger age at time of primary surgery (<36 years: OR = 10.04, [3.80-26.50], p < 0.001 and 36-49 years: OR = 2.48, [1.73-3.56], p < 0.001, compared to 50-60 year olds), 2) having received radiotherapy (OR = 0.57, [0.40-0.81], p = 0.002), 3) high income (Second quartile: OR = 1.74, [1.05-2.90], p = 0.033 and fourth quartile: OR = 2.18, [1.31-3.62], p = 0.003, compared with the lowest income quartile), and 4) ethnicity other than Danish (OR = 6.32, [1.58-25.36], p = 0.009). Health-related factors at the time of primary surgery (physical functioning, body mass index, smoking, use of alcohol, and comorbidity) were not associated with reconstruction. Odds of having received information about the option of reconstruction decreased by 8% per year of age in the multivariate analysis (OR = 0.92, [0.87-0.97], p = 0.003). In conclusion, younger age and not having been treated with radiotherapy was independently associated with reconstruction. In addition, higher income was also found to be associated with reconstruction despite free and equal access to reconstruction and healthcare in Denmark. Healthrelated factors were not associated with the use of reconstruction following mastectomy. Our findings underscore the need for physicians to ensure optimal level of information and accessibility to reconstruction for all women regardless of age, treatment, and socio-economic status.

Congruence between preferred and actual place of care and death among Danish cancer patients.

BACKGROUND: Meeting patient's preferences is an important outcome in palliative care. No Scandinavian study has reported systematically collected preferences from patients regarding place of care (POC) and place of death (POD). The extent of possible incongruence between patients' preferences and reality remains unknown. AIM: The aim of this study was to describe patients' preferred POC and POD and changes in preferences over time and to evaluate congruence between preferences and reality. Furthermore, the aim was to search for predictive factors regarding patients' wishes and fulfilment of these. METHOD: This is a prospective interview and questionnaire study. SETTING/PARTICIPANTS: The study was conducted in the former Aarhus County, Denmark and 96 end-stage cancer patients participated. RESULTS: Of the patients, who stated a preference, 84% preferred home care and 71% preferred home death. A positive association between living with a partner and both wishing for home care and home death was observed (prevalence ratio (PR): 1.66 (95% confidence intervals (CI): 1.07, 2.58), p = 0.02 and PR: 2.33 (95% CI: 1.14, 4.77), p = 0.02, respectively). Marked changes in preferences were observed. Overall, preferences were met for approximately half of the patients, although kappa values were low (κ=0.132 for POC and κ=0.034 for POD).We found a significant association between being cared for in the preferred place and having contact with a palliative care team (PR: 2.01 (95% CI: 1.02, 3.98), p = 0.045). CONCLUSION: Regular discussions with patients on this subject are needed. Social and professional support is of importance in meeting patients' preferences. Larger scaled studies and research focusing on meeting patients' preferences are needed.

Prevalence and predictors of sleep difficulty in a national cohort of women with primary breast cancer three to four months postsurgery.

CONTEXT: Mounting evidence suggests that many cancer patients suffer from sleep difficulty, but there is conflicting evidence regarding the prevalence and predictors of this adverse symptom. OBJECTIVES: The present study investigated the prevalence and predictors of clinically significant sleep difficulty in women with primary breast cancer. METHODS: Danish women (n=3343) with primary breast cancer completed the Pittsburgh Sleep Quality Index (PSQI) along with measures of depression, anxiety, physical activity/functioning, and health behaviors three to four months postsurgery. Data on disease status, treatment, and comorbidity were obtained from the Danish Cancer Cooperative Group and surgical departments, and information on sociodemographic factors and psychiatric history was obtained from Danish national longitudinal registries. RESULTS: More than half (57.9%) of the women reported clinically significant sleep difficulty (PSQI >5). Multiple logistic regression identified seven significant predictors of sleep difficulty in the full sample. In order of strength, these were the following: more depressive symptoms, poorer physical functioning, older age, higher levels of trait anxiety, consuming more cigarettes, having undergone lumpectomy, and lower levels of physical activity. Subgroup analysis found that more depressive symptoms and poorer physical functioning were the only two predictors that were significant in both pre- and postmenopausal women. CONCLUSION: These findings indicate that a high proportion of women with breast cancer experience sleep difficulty. Depression and poorer physical functioning appear to be robust predictors of sleep difficulty, whereas other predictors may depend on sample characteristics, including menopausal status.

Factors associated with the prescription of antidepressive medication to breast cancer patients.

UNLABELLED: We evaluated factors associated with use of antidepressant medication subsequent to a diagnosis of breast cancer. We also evaluated the effect of participation in a cancer rehabilitation program on use of antidepressants. MATERIAL AND METHODS: We conducted a register-based cohort study of 1 247 women with breast cancer diagnosed between 1998 and 2006 who attended a week-long rehabilitation program and a comparison group of 2 903 women who did not attend the program matched through the registers of the Danish Breast Cancer Cooperative Group. The associations between breast cancer-related, treatment-related, and sociodemographic factors and use of antidepressants were evaluated in multivariate Cox proportional hazard models separated on use of antidepressants before diagnosis of breast cancer. RESULTS: The mean follow-up for the 4 150 women in the study was 3.3 years (5-95% range, 0.3-7.0 years) and 1 020 (25%) were users of antidepressants after diagnosis of breast cancer. Among women who had not used antidepressants before their breast cancer, the diagnosis of a new primary cancer increased the adjusted hazard ratio (HR) to 3.34 (95% CI, 1.50-7.76), and recurrence of breast cancer increased the HR for first use of antidepressants to 2.56 (95% CI, 1.86-3.52). Unemployment was associated significantly with use of antidepressants, whereas having no children living at home, lower income, and the number of tumor-positive axillary lymph nodes were of borderline significance. No effect of the rehabilitation program was observed on first use of antidepressants after breast cancer. DISCUSSION: Diagnosis of a new cancer or recurrence of breast cancer considerably increased the rate of use of antidepressants. Sociodemographic rather than disease- or treatment-related characteristics at the time of diagnosis were associated with first use of antidepressants after a breast cancer diagnosis.

Phase III randomized study comparing docetaxel plus trastuzumab with vinorelbine plus trastuzumab as first-line therapy of metastatic or locally advanced human epidermal growth factor receptor 2-positive breast cancer: the HERNATA study.

PURPOSE: To evaluate docetaxel or vinorelbine, both with trastuzumab, as first-line therapy of human epidermal growth factor receptor 2-positive advanced breast cancer. PATIENTS AND METHODS: Patients naive to chemotherapy for advanced disease were randomly assigned to docetaxel 100 mg/m(2) day 1 or vinorelbine 30 to 35 mg/m(2) on days 1 and 8, both combined with trastuzumab (8-mg/kg loading dose and 6-mg/kg maintenance dose) on day 1 every 3 weeks. The primary end point was time to progression (TTP). RESULTS: A total of 143 patients were randomly allocated to docetaxel, and 141 patients were assigned to vinorelbine. The median TTP for docetaxel and vinorelbine respectively was 12.4 months versus 15.3 months (hazard ratio [HR] = 0.94; 95% CI, 0.71 to 1.25; P = .67), median overall survival was 35.7 months versus 38.8 months (HR = 1.01; 95% CI, 0.71 to 1.42; P = .98), and the 1-year survival rate was 88% in both arms. Median time to treatment failure for study chemotherapy was 5.6 months versus 7.7 months (HR = 0.50; 95% CI, 0.38 to 0.64; P < .0001). The investigator-assessed overall response rate among 241 patients with measurable disease were 59.3% in both arms. More patients in the docetaxel arm discontinued therapy due to toxicity (P < .001). Significantly more treatment-related grade 3 to 4 febrile neutropenia (36.0% v 10.1%), leucopenia (40.3% v 21.0%), infection 25.1% v 13.0%), fever (4.3% v 0%), neuropathy (30.9% v 3.6%), nail changes (7.9% v 0.7%), and edema (6.5% v 0%) were reported with docetaxel. CONCLUSION: The study failed to demonstrate superiority of any drug in terms of efficacy, but the vinorelbine combination had significantly fewer adverse effects and should be considered as an alternative first-line option.

Associations between home death and GP involvement in palliative cancer care.

BACKGROUND: Most cancer patients die at institutions despite their wish for home death. GP-related factors may be crucial in attaining home death. AIM: To describe cancer patients in palliative care at home and examine associations between home death and GP involvement in the palliative pathway. DESIGN OF STUDY: Population-based, combined register and questionnaire study. SETTING: Aarhus County, Denmark. METHOD: Patient-specific questionnaires were sent to GPs of 599 cancer patients who died during a 9-month period in 2006. The 333 cases that were included comprised information on sociodemography and GP-related issues; for example knowledge of the patient, unplanned home visits, GPs providing their private phone number, and contact with relatives. Register data were collected on patients' age, sex, cancer diagnosis, place of death, and number of GP home visits. Associations with home death were analysed in a multivariable regression model with prevalence ratios (PR) as a measure of association. RESULTS: There was a strong association between facilitating home death and GPs making home visits (PR = 4.3, 95% confidence interval [CI] = 1.2 to 14.9) and involvement of community nurses (PR = 1.4, 95% CI = 1.0 to 1.9). No other GP-related variables were statistically significantly associated with home death. CONCLUSION: Active involvement of GPs providing home visits and the use of home nurses were independently associated with a higher likelihood of facilitating home death for cancer patients. The primary care team may facilitate home death, accommodating patients' wishes. Future research should examine the precise mechanisms of their involvement.

Cancer surviving patients' rehabilitation - understanding failure through application of theoretical perspectives from Habermas.

This study aims to analyze whether the rehabilitation of cancer surviving patients (CSPs) can be better organized. The data for this paper consists of focus group interviews (FGIs) with CSPs, general practitioners (GPs) and hospital physicians. The analysis draws on the theoretical framework of Jürgen Habermas, utilizing his notions of 'the system and the life world' and 'communicative and strategic action'. In Habermas' terminology, the social security system and the healthcare system are subsystems that belong to what he calls the 'system', where actions are based on strategic actions activated by the means of media such as money and power which provide the basis for other actors' actions. The social life, on the other hand, in Habermas' terminology, belongs to what he calls the 'life world', where communicative action is based on consensual coordination among individuals. Our material suggests that, within the hospital world, the strategic actions related to diagnosis, treatment and cure in the biomedical discourse dominate. They function as inclusion/exclusion criteria for further treatment. However, the GPs appear to accept the CSPs' previous cancer diagnosis as a precondition sufficient for providing assistance. Although the GPs use the biomedical discourse and often give biomedical examples to exemplify rehabilitation needs, they find psychosocial aspects, so-called lifeworld aspects, to be an important component of their job when helping CSPs. In this way, they appear more open to communicative action in relation to the CSPs' lifeworld than do the hospital physicians. Our data also suggests that the CSPs' lifeworld can be partly colonized by the system during hospitalization, making it difficult for CSPs when they are discharged at the end of treatment. This situation seems to be crucial to our understanding of why CSPs often feel left in limbo after discharge. We conclude that the distinction between the system and the lifeworld and the implications of a possible colonization during hospitalization offers an important theoretical framework for determining and addressing different types of rehabilitation needs.

Breast cancer patients' narratives about positive and negative communication experiences.

Health staff-patient communication is increasingly considered an important issue in cancer research. However, questionnaires addressing satisfaction with communication limit the issues patients can raise, do not address the context of communication and often show a strong positive skew in responses. Thus, qualitative studies of communication are also needed. Fifteen breast cancer patients were interviewed 3 months after finishing adjuvant treatment. They were asked to tell a 10 minute narrative and recall five experiences from treatment. Themes were extracted using categories derived from previous research while at the same time being sensitive to new elaborations and categories. The participants reported both positive and negative communication-related experiences from a wide range of treatment situations. Two major themes emerged: Information giving as professional care-giving and meeting emotional needs. The analysis suggests that appropriate information giving may have several functions, such as re-establishing the patient's future and reducing worst-case fantasies. Meeting emotional needs was seldom reported as directly talking about negative emotions, but rather through a variety of health staff behaviours. Also, the analysis points to problems in expecting or even pressurizing patients to feel and display negative emotions. The results highlight that meeting medical and emotional needs of patients may be closely intertwined in concrete treatment situations.