High Protein Oral Nutritional Supplements Enable the Majority of Cancer Patients to Meet Protein Intake Recommendations during Systemic Anti-Cancer Treatment: A Randomised Controlled Parallel-Group Study.

ESPEN guidelines recommend a minimum protein intake of 1.0 g/kg body weight (BW) per day to maintain or restore lean body mass in patients with cancer. During anti-cancer treatment, optimal protein intake is difficult to achieve. We investigated whether a high-protein, low-volume oral nutritional supplement (ONS) supports patients in meeting recommendations. A multi-centre, randomised, controlled, open-label, parallel-group study was carried out in nine hospitals (five countries) between January 2019 and July 2021 in colorectal and lung cancer patients undergoing first-line systemic treatment with chemo(radio-) or immunotherapy. Subjects were randomised (2:1) to receive Fortimel Compact Protein® or standard care. Protein intake was assessed with a 3-day food diary (primary outcome). BW was a secondary outcome. Due to challenges in recruitment, the study was terminated prematurely with 42 patients randomised (intervention group (IG) 28; control group (CG) 14). At T1 and T2, protein intake was statistically significantly higher in the IG compared to the CG (1.40 vs. 1.07 g/kg/day at T1, p = 0.008; 1.32 vs. 0.94 g/kg/day at T2, p = 0.002). At baseline, only 65% (IG) and 45% (CG) of patients met ESPEN minimum protein intake recommendations. However, at T1 and T2 in the IG, a higher proportion of patients met recommendations than in the CG (88% vs. 55% and 40%). No statistically significant difference between study groups was observed for BW. Mean compliance to the ONS was 73.4%. A high-protein, low-volume ONS consumed twice daily enables the majority of patients to reach minimal ESPEN protein recommendations.

Implementing a Standardized Care Pathway Integrating Oncology, Palliative Care and Community Care in a Rural Region of Mid-Norway.

INTRODUCTION: To improve quality across levels of care, we developed a standardized care pathway (SCP) integrating palliative and oncology services for hospitalized and home-dwelling palliative cancer patients in a rural region. METHODS: A multifaceted implementation strategy was directed towards a combination of target groups. The implementation was conducted on a system level, and implementation-related activities were registered prospectively. Adult patients with advanced cancer treated with non-curative intent were included and interviewed. Healthcare leaders (HCLs) and healthcare professionals (HCPs) involved in the development of the SCP or exposed to the implementation strategy were interviewed. In addition, HCLs and HCPs exposed to the implementation strategy answered standardized questionnaires. Hospital admissions were registered prospectively. RESULTS: To assess the use of the SCP, 129 cancer patients were included. Fifteen patients were interviewed about their experiences with the patient-held record (PHR). Sixty interviews were performed among 1320 HCPs exposed to the implementation strategy. Two hundred and eighty-seven HCPs reported on their training in and use of the SCP. Despite organizational cultural differences, developing an SCP integrating palliative and oncology services across levels of care was feasible. Both HCLs and HCPs reported improved quality of care in the wake of the implementation process. Two and a half years after the implementation was launched, 28% of the HCPs used the SCP and 41% had received training in its use. Patients reported limited use and benefit of the PHR. CONCLUSION: An SCP may be a usable tool for integrating palliative and oncology services across care levels in a rural region. An extensive implementation process resulted in improvements of process outcomes, yet still limited use of the SCP in clinical practice. HCLs and HCPs reported improved quality of cancer care following the implementation process. Future research should address mandatory elements for usefulness and successful implementation of SCPs for palliative cancer patients.

When a patient has incurable cancer, it is beneficial to introduce palliative care early in the disease trajectory along with anti-cancer treatment. A standardized care pathway is a method to improve quality and reduce variation in healthcare. It can promote integrated healthcare services in palliative care, e.g. by specifying action points when the patient's situation is changing. In this study, a standardized care pathway for cancer patients with palliative care needs was developed in a rural region of Norway. The pathway focused on patients' needs and symptoms and on smooth transition between levels of care. An educational program and an information strategy were developed to ensure implementation. To evaluate the implementation, all activity regarding the implementation process was registered. Cancer patients and healthcare professionals were interviewed and answered questionnaires. One thousand three hundred and twenty healthcare professionals were exposed to the implementation strategy. One hundred and twenty-nine cancer patients were followed up according to the standardized care pathway. Despite different perspectives of care, it was feasible to develop a standardized care pathway for palliative cancer patients across care settings. A paper-based patient-held record was only found to be useful by a limited number of patients. An extensive implementation process was completed and resulted in improvements regarding healthcare professionals' experience with the quality of cancer care in the region, but limited use of the care pathway in clinical practice. Further research should identify the most important elements for usefulness and successful implementation of the care pathway.

Spiritual quality of life in family carers of patients with advanced cancer-a cross-sectional study.

PURPOSE: Caring affects carers' psychological and physical health, mortality, and quality of life (QoL) negatively. Lower spiritual QoL is associated with anxiety and depression, but the spiritual dimension is rarely investigated in carers. The present study aimed to explore which patient- and carer-related characteristics were associated with spiritual QoL in carers of patients with advanced cancer. METHODS: Secondary analyses were conducted using data from a prospective study investigating integration between oncology and palliative care. Adult patients with advanced cancer and their carers were included, and baseline data considering demographics, clinical characteristics, symptoms, social support, and religious meaning-making were registered. Spiritual QoL was measured using the Functional Assessment of Chronic Illness Therapy - Spiritual well-being (FACIT-Sp-12) questionnaire. Associations to spiritual QoL were explored by bivariate and multivariate regression models. RESULTS: In total, 84 carers were included, median age was 62.5 years, 52 (62%) were female, and the average spiritual QoL score was 23.3. In bivariate analyses, higher education, social support, and lower patients' symptom burden were significantly associated with higher spiritual QoL. The multivariate regression model (n=77) had an explained variance (R2) = 0.34 and showed a significant association for social support, higher education, having children < 18 years living at home, and patient's age. CONCLUSION: The study indicates that spiritual QoL in carers were low and were negatively affected by several factors related to both carers and patients. However, there could be other important factors not yet described. Health care professionals should be aware of the known associated factors, as carers who hold these may need extra support.

PATIENT VOICES, a project for the integration of the systematic assessment of patient reported outcomes and experiences within a comprehensive cancer center: a protocol for a mixed method feasibility study.

BACKGROUND: Listening to "patient voices" in terms of symptoms, emotional status and experiences with care, is crucial for patient empowerment in clinical practice. Despite convincing evidence that routine patient reported outcomes and experience measurements (PRMs) with rapid feed-back to oncologists can improve symptom control, patient well-being and cost effectiveness, PRMs are not commonly used in cancer care, due to barriers at various level. Part of these barriers may be overcome through electronic PRMs collection (ePRMs) integrated with the electronic medical record (EMR). The PATIENT VOICES initiative is aimed at achieving a stepwise integration of ePRMs assessment into routine cancer care. The feasibility project presented here is aimed at assessing the knowledge, use and attitudes toward PRMs in a comprehensive cancer centre; developing and assessing feasibility of a flexible system for ePRM assessment; identifying barriers to and developing strategies for implementation and integration of ePRMs clinical practice. METHODS: The project has been organized into four phases: a) pre-development; b) software development and piloting; c) feasibility assessment; d) post-development. A convergent mixed method design, based on concurrent quantitative and qualitative data collection will be applied. A web-survey on health care providers (HCPs), qualitative studies on patients and HCPs (semi-structured interviews and focus groups) as well as longitudinal and cross-sectional quantitative studies will be carried out. The quantitative studies will enroll 600 patients: 200 attending out-patient clinics (physical symptom assessement), 200 attending inpatient wards (psychological distress assessment) and 200 patients followed by multidisciplinary teams (patient experience with care assessment). The Edmonton symptom assessment scale, the Distress Thermometer, and a tool adapted from existing patient reported experience with cancer care questionnaires, will be used in quantitative studies. A multi-disciplinary stakeholder team including researchers, clinicians, health informatics professionals, health system administrators and patients will be involved in the development of potentially effective implementation strategies in the post development phase. DISCUSSION: The documentation of potential advantages and implementation barriers achieved within this feasibility project, will serve as a starting point for future and more focused interventions aimed at achieving effective ePRMs routine assessment in cancer care. TRIAL REGISTRATION: ClinicalTrials.gov ( NCT03968718 ) May 30th, 2019.

PALLiON - PALLiative care Integrated in ONcology: study protocol for a Norwegian national cluster-randomized control trial with a complex intervention of early integration of palliative care.

BACKGROUND: Several publications have addressed the need for a systematic integration of oncological care focused on the tumor and palliative care (PC) focused on the patient with cancer. The exponential increase in anticancer treatments and the high number of patients living longer with advanced disease have accentuated this. Internationally, there is now a persuasive argument that introducing PC early during anticancer treatment in patients with advanced disease has beneficial effects on symptoms, psychological distress, and survival. METHODS: This is a national cluster-randomized trial (C-RCT) in 12 Norwegian hospitals. The trial investigates effects of early, systematic integration of oncology and specialized PC in patients with advanced cancer in six intervention hospitals compared with conventional care in six. Hospitals are stratified on the size of local catchment areas before randomization. In the intervention hospitals, a three-part complex intervention will be implemented. The backbone of the intervention is the development and implementation of patient-centered care pathways that contain early, compulsory referral to PC and regular and systematic registrations of symptoms. An educational program must be completed before patient inclusion. A total of 680 patients with advanced cancer and one caregiver per patient are included when patients come for start of last line of chemotherapy, defined according to national treatment guidelines. Data registration, clinical variables, and patient- and caregiver-reported outcomes take place every 2 months for 1 year or until death. The primary outcome is use of chemotherapy in the last 3 months of life by comparing the proportion of patients who receive this in the intervention and control groups. Primary outcome is use of chemotherapy in the last 3 months before death, i.e. number of patients. Secondary outcomes are initiation, discontinuation and number of cycles, last 3 months of life, administration of other medical interventions in the last month of life, symptom burden, quality of life (QoL), satisfaction with information and follow-up, and caregiver health, QoL, and satisfaction with care. DISCUSSION: Results from this C-RCT will be used to raise the awareness about the positive outcomes of early provision of specialized palliative care using pathways for patients with advanced cancer receiving medical anticancer treatment. The long-term clinical objective is to integrate these patient-centered pathways in Norwegian cancer care. The specific focus on the patient and family and the organization of a predictable care trajectory is consistent with current Norwegian strategies for cancer care. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03088202. Registered on 23 March 2017.

Power Comparisons and Clinical Meaning of Outcome Measures in Assessing Treatment Effect in Cancer Cachexia: Secondary Analysis From a Randomized Pilot Multimodal Intervention Trial.

Background: New clinical trials in cancer cachexia are essential, and outcome measures with high responsiveness to detect meaningful changes are crucial. This secondary analysis from a multimodal intervention trial estimates sensitivity to change and between treatment effect sizes (ESs) of outcome measures associated with body composition, physical function, metabolism, and trial intervention. Methods: The study was a multicenter, open-label, randomized pilot study investigating the feasibility of a 6-week multimodal intervention [exercise, non-steroidal anti-inflammatory drugs, and oral nutritional supplements containing polyunsaturated fatty acids (n-3 PUFAs)] vs. standard cancer care in non-operable non-small-cell lung cancer and advanced pancreatic cancer. Body composition measures from computerized tomography scans and circulating biomarkers were analyzed. Results: Forty-six patients were randomized, and the analysis included 22 and 18 patients in the treatment and control groups, respectively. The between-group ESs were high for body weight (ES = 1.2, p < 0.001), small for body composition and physical function [handgrip strength (HGS)] measures (ES < 0.25), moderate to high for n-3 PUFAs and 25-hydroxyvitamin D (25-OH vitamin D) (ES range 0.64-1.37, p < 0.05 for all), and moderate for serum C-reactive protein (ES = 0.53, p = 0.12). Analysis within the multimodal treatment group showed high sensitivity to change for adiponectin (ES = 0.86, p = 0.001) and n-3 PUFAs (ES > 0.8, p < 0.05 for all) and moderate for 25-OH vitamin D (ES = 0.49, p = 0.03). In the control group, a moderate sensitivity to change for body weight (ES = -0.84, p = 0.002) and muscle mass (ES = -0.67, p = 0.016) and a high sensitivity to change for plasma levels of 25-OH vitamin D (ES = -0.88, p = 0.002) were found. Conclusion: Demonstrating high sensitivity to change and between treatment ES and body composition measures, body weight still stands out as a clinical and relevant outcome measure in cancer cachexia. Body composition and physical function measures clearly are important to address but demand large sample sizes to detect treatment group differences. Trial registration: ClinicalTrials.gov identifier: NCT01419145.

Integration of oncology and palliative care: a Lancet Oncology Commission.

Full integration of oncology and palliative care relies on the specific knowledge and skills of two modes of care: the tumour-directed approach, the main focus of which is on treating the disease; and the host-directed approach, which focuses on the patient with the disease. This Commission addresses how to combine these two paradigms to achieve the best outcome of patient care. Randomised clinical trials on integration of oncology and palliative care point to health gains: improved survival and symptom control, less anxiety and depression, reduced use of futile chemotherapy at the end of life, improved family satisfaction and quality of life, and improved use of health-care resources. Early delivery of patient-directed care by specialist palliative care teams alongside tumour-directed treatment promotes patient-centred care. Systematic assessment and use of patient-reported outcomes and active patient involvement in the decisions about cancer care result in better symptom control, improved physical and mental health, and better use of health-care resources. The absence of international agreements on the content and standards of the organisation, education, and research of palliative care in oncology are major barriers to successful integration. Other barriers include the common misconception that palliative care is end-of-life care only, stigmatisation of death and dying, and insufficient infrastructure and funding. The absence of established priorities might also hinder integration more widely. This Commission proposes the use of standardised care pathways and multidisciplinary teams to promote integration of oncology and palliative care, and calls for changes at the system level to coordinate the activities of professionals, and for the development and implementation of new and improved education programmes, with the overall goal of improving patient care. Integration raises new research questions, all of which contribute to improved clinical care. When and how should palliative care be delivered? What is the optimal model for integrated care? What is the biological and clinical effect of living with advanced cancer for years after diagnosis? Successful integration must challenge the dualistic perspective of either the tumour or the host, and instead focus on a merged approach that places the patient's perspective at the centre. To succeed, integration must be anchored by management and policy makers at all levels of health care, followed by adequate resource allocation, a willingness to prioritise goals and needs, and sustained enthusiasm to help generate support for better integration. This integrated model must be reflected in international and national cancer plans, and be followed by developments of new care models, education and research programmes, all of which should be adapted to the specific cultural contexts within which they are situated. Patient-centred care should be an integrated part of oncology care independent of patient prognosis and treatment intention. To achieve this goal it must be based on changes in professional cultures and priorities in health care.

Cancer cachexia: rationale for the MENAC (Multimodal-Exercise, Nutrition and Anti-inflammatory medication for Cachexia) trial.

Cancer cachexia is a multifactorial syndrome characterised by an ongoing loss of skeletal muscle mass that cannot be fully reversed by conventional nutritional support alone. Cachexia has a high prevalence in cancer and a major impact on patient physical function, morbidity and mortality. Despite the consequences of cachexia, there is no licensed treatment for cachexia and no accepted standard of care. It has been argued that the multifactorial genesis of cachexia lends itself to therapeutic targeting through a multimodal treatment. Following a successful phase II trial, a phase III randomised controlled trial of a multimodal cachexia intervention is under way. Termed the MENAC trial (Multimodal-Exercise, Nutrition and Anti-inflammatory medication for Cachexia), this intervention is based on evidence to date and consists of non-steroidal anti-inflammatory drugs and eicosapentaenoic acid to reduce inflammation, a physical exercise programme using resistance and aerobic training to increase anabolism, as well as dietary counselling and oral nutritional supplements to promote energy and protein balance. Herein we describe the development of this trial. TRIAL REGISTRATION NUMBER: NCT02330926.

Feasibility and preliminary effects of resistance training and nutritional supplements during versus after radiotherapy in patients with head and neck cancer: A pilot randomized trial.

BACKGROUND: Patients with head and neck cancer (HNC) experience involuntary weight loss that has a negative impact on physical function, morbidity, and survival. The objective of the current study was to evaluate the feasibility of an exercise and nutrition intervention during radiotherapy (RT) compared with after RT, and to examine preliminary effects on skeletal muscle mass. METHODS: Patients with HNC were randomized to an exercise and nutrition intervention during RT (EN-DUR) or after RT (EN-AF). The EN-DUR intervention was conducted at a hospital and the EN-AF intervention took place at a rehabilitation center. The interventions consisted of progressive resistance training (PRT) and oral nutritional supplements (ONS). Feasibility outcomes were tracked weekly and muscle mass was measured by computed tomography scans before and after RT and at 2 months follow-up. RESULTS: Of the 50 eligible patients, 41 (82%) agreed to participate. 90% of patients completed the EN-DUR intervention and the adherence to PRT and ONS was 81% and 57%, respectively. 52% of patients attended the EN-AF intervention and adherence to PRT and ONS was 94% and 76%, respectively. The EN-DUR demonstrated a trend toward mitigating loss of muscle mass during RT and the EN-AF demonstrated a similar trend after RT. No difference in muscle mass was detected between the groups from baseline to week 14. CONCLUSIONS: An exercise and nutrition intervention is feasible for patients with HNC during RT, and the intervention is potentially effective in mitigating loss of muscle mass both during and after RT. Future trials should assess the feasibility and effects of extended interventions during and after treatment. Cancer 2017;123:4440-8. © 2017 American Cancer Society.

A randomized phase II feasibility trial of a multimodal intervention for the management of cachexia in lung and pancreatic cancer.

BACKGROUND: Cancer cachexia is a syndrome of weight loss (including muscle and fat), anorexia, and decreased physical function. It has been suggested that the optimal treatment for cachexia should be a multimodal intervention. The primary aim of this study was to examine the feasibility and safety of a multimodal intervention (n-3 polyunsaturated fatty acid nutritional supplements, exercise, and anti-inflammatory medication: celecoxib) for cancer cachexia in patients with incurable lung or pancreatic cancer, undergoing chemotherapy. METHODS: Patients receiving two cycles of standard chemotherapy were randomized to either the multimodal cachexia intervention or standard care. Primary outcome measures were feasibility assessed by recruitment, attrition, and compliance with intervention (>50% of components in >50% of patients). Key secondary outcomes were change in weight, muscle mass, physical activity, safety, and survival. RESULTS: Three hundred and ninety-nine were screened resulting in 46 patients recruited (11.5%). Twenty five patients were randomized to the treatment and 21 as controls. Forty-one completed the study (attrition rate 11%). Compliance to the individual components of the intervention was 76% for celecoxib, 60% for exercise, and 48% for nutritional supplements. As expected from the sample size, there was no statistically significant effect on physical activity or muscle mass. There were no intervention-related Serious Adverse Events and survival was similar between the groups. CONCLUSIONS: A multimodal cachexia intervention is feasible and safe in patients with incurable lung or pancreatic cancer; however, compliance to nutritional supplements was suboptimal. A phase III study is now underway to assess fully the effect of the intervention.

Integration between oncology and palliative care: a plan for the next decade?

With the groundbreaking work of three Milan professors-Bonadonna, Veronesi, and Ventafridda-in the 1980s as the starting point, this article aims to shed light on the potential benefits of a closer and more formal integration between oncology and palliative care. More specifically, we address why integration is needed, how to do it, and the potential benefits to the patients, families, and society. The costs for cancer care are increasing rapidly. Especially during the last year of life, some treatments are futile and expensive without proven benefit for patients in terms of prolonged survival with adequate quality of life (QoL). The latest WHO definition of palliative care supports an upstream introduction of palliative care. More recent studies indicate that such an early integration has the potential to improve the patients' QoL and reduce their symptom burden. Successful integration presupposes formal structures and explicit obligations on how and when to integrate. The Norwegian model for palliative care is presented. It covers the range of oncologic and palliative services from community health care via the local hospital to the tertiary hospital and rests on standardized care pathway as the key instrument to promote integration. Our present state of knowledge indicates that integration does not shorten life; perhaps even the opposite. Futile oncological treatment can be reduced and the QoL of patients and carers improved. We need more evidence on the potential effect upon costs, but present data indicate that integration does not increase them.

A systematic review on the role of vitamins, minerals, proteins, and other supplements for the treatment of cachexia in cancer: a European Palliative Care Research Centre cachexia project.

We provide a systematic review to support the European Palliative Care Research Collaboration development of clinical guidelines for cancer patients suffering from cachexia. CENTRAL, MEDLINE, PsycINFO, ClinicalTrials.gov, and a selection of cancer journals have been searched up until 15 April 2016. The systematic literature research yielded 4214 publications with 21 of these included in the final evaluation. Regarding minerals, our search identified only one study examining the use of magnesium with no effect on weight loss. As far as vitamins are concerned, vitamin E in combination with omega-3 fatty acids displayed an effect on survival in a single study, vitamin D showed improvement of muscle weakness in prostate cancer patients, and vitamin C supplementation led to an improvement of various quality of life aspects in a sample with a variety of cancer diagnoses. For proteins, a combination therapy of ß-hydroxy-ß-methylbutyrate (HMB), arginine, and glutamine showed an increase in lean body mass after 4 weeks in a study of advanced solid tumour patients, whereas the same combination did not show a benefit on lean body mass in a large sample of advanced lung and other cancer patients after 8 weeks. L-carnitine led to an increase of body mass index and an increase in overall survival in advanced pancreatic cancer patients. Adverse effects of food supplementation were rare and showed mild intensity. There is not enough solid evidence for the use of minerals, vitamins, proteins, or other supplements in cancer. No serious adverse effects have been reported with dietary supplementation.

Multimodal nutrition/anabolic therapy for wasting conditions.

PURPOSE OF REVIEW: Significant progress has been made in the field of defining and describing the pathophysiology of wasting conditions such as cachexia. The number of new promising drugs, nutritional therapy alternatives, and exercise/rehabilitation programs is increasing. The purpose of this review is to give an overview of recent clinical findings from intervention studies investigating multimodal anabolic therapies utilizing drug, nutritional, and/or exercise interventions in order to counteract wasting. RECENT FINDINGS: Anabolic agents such as ghrelin and selective androgen receptor modulators are under late-phase clinical testing and hold promise as new therapies, and their ability to mitigate weight loss and improve muscle mass and physical function is evaluated. In the past 2 years, eight new studies investigating interventions with anabolic potential in wasting have been published, among which three of these studies were multimodal. SUMMARY: Targeted anabolic therapies aiming to prevent or reverse wasting might involve a combination of anabolic pharmacologic drugs, nutrition, and physical exercise working concurrently to enhance muscle protein synthesis and reduce breakdown. Some anabolic pharmacological interventions demonstrate the potential to improve muscle mass, but the multimodal interventions seem in greater extent to also demonstrate improvement in physical function.

A systematic review on the role of fish oil for the treatment of cachexia in advanced cancer: an EPCRC cachexia guidelines project.

BACKGROUND: The European Palliative Care Research Collaboration is developing clinical guidelines on cachexia in patients with advanced cancer. A systematic review on the use of fish oil/omega-3-fatty acids (n-3-FA)/eicosapentaenoic acids (EPA) in advanced cancer patients suffering from cancer cachexia was performed as part of the guideline development. METHODS: The systematic literature search in Medline on the use of fish oil/n-3-FA/EPA identified 244 papers, with 38 publications included in the final evaluation. Some smaller trials, often unrandomized and without a control group, reported a good effect of n-3-FA in patients with advanced cancer and cachexia. However, the results of the larger randomized controlled trials could not support the positive results, as they mostly did not find a significant effect. RESULTS: Adverse effects such as abdominal discomfort, fish belching, fish aftertaste, nausea and diarrhoea were reported with a low incidence. No serious adverse effects were documented, but adverse effects often had an impact on quality of life. This often limited dose escalations or even led to discontinuation of n-3-FA. CONCLUSION: There is not enough evidence to support a net benefit of n-3-FA in cachexia in advanced cancer. On the other hand, adverse effects were infrequent, with no severe adverse effects. The results from the review led to a weak negative GRADE recommendation.

Quality of life in women with breast cancer during the first year after random assignment to adjuvant treatment with marrow-supported high-dose chemotherapy with cyclophosphamide, thiotepa, and carboplatin or tailored therapy with Fluorouracil, epirubicin, and cyclophosphamide: Scandinavian Breast Group Study 9401.

PURPOSE: To compare, in high-risk breast cancer patients, the effects on health-related quality of life (HRQoL) of two adjuvant treatments. Treatments were compared at eight points during the first year after random assignment to treatment with tailored fluorouracil, epirubicin, and cyclophosphamide (FEC) therapy for nine courses versus induction FEC therapy for three courses followed by high-dose chemotherapy with cyclophosphamide, thiotepa, and carboplatin (CTCb) supported by peripheral-blood stem cells. PATIENTS AND METHODS: From March 1994 to March 1998, 525 breast cancer patients (estimated relapse risk > 70% within 5 years with standard therapy) were included in the Scandinavian Breast Group 9401 study. HRQoL evaluation, using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-C30 and EORTC Breast Cancer Module-23, included 408 of 446 eligible patients in Finland, Norway, and Sweden. RESULTS: Eighty-four percent to 95% of the patients completed questionnaires at eight points of assessment. Nostatistically significant overall differences were found between the tailored FEC group and the CTCb group for any of the HRQoL variables. Statistically significant differences over time were found for all HRQoL variables. HRQoL in the CTCb group demonstrated a steeper decrease, but a faster recovery than in the tailored FEC group. Emotional functioning improved with increased time from randomization. Higher levels of problems in body image and arm symptoms were reported in the tailored FEC group compared with the CTCb group. Sexual functioning and satisfaction were impaired during the study period. CONCLUSION: Both treatments had a negative influence on HRQoL during the treatment period. Despite the aggressive therapies, the patient's HRQoL returned to levels found at inclusion on most variables.