Vinorelbine and infusional 5-fluorouracil in anthracycline and taxane pre-treated metastatic breast cancer.

AIMS: To evaluate the efficacy and toxicity of a combination of intravenous vinorelbine and 5-fluorouracil (5-FU) given by continuous infusion in the treatment of metastatic breast cancer previously treated with anthracyclines and taxanes. MATERIALS AND METHODS: Sixty-one patients with metastatic breast cancer were treated with intravenous vinorelbine 30 mg/m2 on days 1 and 8 of each 21-day cycle together with 5-FU 200 mg/m2/day by continuous infusion. All had previously been treated with an anthracycline and 41% had also been previously treated with a taxane. All had normal haematological, renal and hepatic function and all but three had an Eastern Cooperative Oncology Group performance score of 2 or better. RESULTS: The overall response rate by World Health Organization criteria was 46% (28 patients); excluding nine non-evaluable patients gave a response rate of 54%. In patients who had previously been treated with both an anthracycline and a taxane, a response rate of 50% was observed (12 of 24 patients). Severe toxicity was uncommon, as was toxicity attributable to infusional 5-FU. Myelosuppression was rarely severe, but was common and led to delay or dose reduction in 38% of treatments. Eleven patients (18%) were admitted with fever and/or neutropenia and one patient died. The median received dose intensity was vinorelbine 16 mg/m2/week and 5-FU 143 mg/m2/day. CONCLUSIONS: The combination of vinorelbine and infusional 5-FU is active in metastatic breast cancer, including in patients previously treated with an anthracycline and a taxane. Toxicity is generally manageable, but myelosuppression is significant at this dose regimen. Recommended doses for routine clinical use are 5-FU 200 mg/m2/day and intravenous vinorelbine 30 mg/m2 days 1 and 15 on a 28-day cycle.

The universal, situational, and personal needs of cancer patients and their main carers.

The importance of psychosocial factors in the cancer journey for both patients and their carers has been recognised in UK health policy. The aim of this paper is to consider--(1) which needs are regarded as important by patients and their carers; (2) which are the unmet needs of patients and their carers. The study focuses on the responses of 233 paired cancer patients and their carers derived from a cross-sectional questionnaire survey in three health authorities in North West England. The majority of patient-carer pairs expressed the importance of having good relationships with health-care professionals and receiving good-quality information. These can be identified as "universal" needs. A minority of patient-carer pairs expressed the importance of other kinds of needs. These items were mainly to do with managing daily life, emotions, and social identity and can be identified as "situational" or "personal" needs. Where there were discrepancies between patients and carers, patients were likely to identify more needs as important. In contrast, carers have more unmet needs, reflecting their comparative neglect. Broadly, "universal" needs are being met, but "situational" and "personal" needs, particularly among carers, are relatively unmet and require greater attention on the part of nurses and primary care professionals.

Psychosocial needs in cancer patients related to religious belief.

In a study of psychosocial needs amongst cancer patients, the possession of a religious faith has been identified as a significant factor in determining a range of psychosocial needs. Of the 354 respondents to a questionnaire, which included a comprehensive psychosocial needs inventory, 83% said they had a religious faith, and in general these patients were less reliant on health professionals, had less need for information, attached less importance to the maintenance of independence and had less need for help with feelings of guilt, with their sexuality or with some practical matters than those who said they had no religious faith. In addition, they had fewer unmet needs overall (32% compared with 52%). The knowledge of a patient's spirituality should help service providers to predict aspects of psychosocial need and to respond sensitively and appropriately to a patient's experience of cancer.

Cancer and faith. Having faith--does it make a difference among patients and their informal carers?

This research considers the impact of having a religious faith on the cancer experience of patients and informal carers, focusing primarily on the association between faith and psychosocial needs. A questionnaire survey of 1000 patients in the north-west of England returned 402 completed questionnaires; around two-thirds of patients indicated they had an informal carer. Using logistic regression analysis, we examine the relationship between the importance of 48 needs and faith for 189 paired patients and carers, while controlling for the effect of eight socio-demographic and clinical variables. Patients with expressed faith identified fewer psychosocial needs than those without faith. In contrast, carers with expressed faith identified more needs than those without faith in relation to support from family and neighbours. Carers also needed more help with finding a sense of purpose and meaning, and help in dealing with unpredictability. Not surprisingly, both patients and carers with faith identified a greater need for opportunities for personal prayer, support from people of their own faith and support from a spiritual adviser. Various explanations of these differences between patients and carers are proposed. The crucial point is that one should not too readily assume that the cancer experience is shared in the same way by patients and carers. In understanding the faith dimension, one needs to consider both the spiritual and secular aspects of having a religious faith.

The psychosocial needs of cancer patients: findings from an observational study.

The objectives of this study were to identify the prevalence of psychosocial need, and the contributory factors to need, among cancer patients, using a descriptive cross-sectional questionnaire survey of adult cancer patients. The participants were 1,000 patients from four hospitals in the north west of England with the following characteristics: tumour type (breast, colorectal, lymphoma, lung), being 1 month from a 'critical moment' in the cancer journey (i.e. (i) diagnosis, (ii) end of first treatment, (iii) recurrence, (iv) move from active treatment to palliative care), and aged over 18 years. The main outcome measure was a psychosocial needs inventory comprising seven needs categories (48 need items). A sample of 402 was achieved (40% response rate). Psychosocial needs relating to the need categories 'health professionals', 'information' and 'support networks' are commonly expressed and strongly felt by cancer patients. Needs relating to 'identity', 'emotional and spiritual' issues and 'practical' issues are less commonly expressed but are also strongly felt. Particular needs are related to tumour type, illness 'critical moment', age, gender, health status, socioeconomic and other social factors. This information should increase awareness among cancer care professionals about a range of psychosocial needs and may help them target particular patient groups for particular support interventions.

Informal carers of cancer patients: what are their unmet psychosocial needs?

This paper considers the significant unmet psychosocial needs of the informal carers of cancer patients, drawing on data generated in a 3-year UK study (1997-2000) on the psychosocial needs of cancer patients and their main carers. While the needs of the carers of cancer patients are increasingly being recognised in healthcare policy documents, there is relatively little published literature on these needs. A "significant unmet need" is defined here as a need deemed important by the carer, but which has not been met. A descriptive cross-sectional survey of carers was conducted and the responses of 195 carers relating to 48 psychosocial need items were analysed. A subset of these carers (n = 32) were interviewed. Forty-three per cent of carers had significant unmet needs. They were more likely to be those where the relationship to the patient was not that of a partner or spouse, more likely to have other caring responsibilities, and less likely to have friends or relations to call upon for help. Carers with unmet needs were also more likely to be in poor health themselves or to be caring for a patient who had reached the palliation-only phase in their cancer journey. The majority of carers expressed the importance of needs such as having good relationships with healthcare professionals and receiving honest information, but few expressed dissatisfaction with these aspects of need. Items of significant unmet need clustered around aspects of managing daily life, emotions, and also social identity for a sizeable minority of carers. These are the same areas of significant unmet need that concern patients. However, carers have more of these concerns, reflecting their comparative neglect. The paper also considers how these widespread concerns can be addressed.

The significant unmet needs of cancer patients: probing psychosocial concerns.

'Significant unmet needs' are those needs that patients identify as both important and unsatisfied. In this article we ask whether the overall needs of cancer patients are actually being met. We believe that the range of unmet need, and the kinds of patients who are more likely to claim unmet need, should be carefully identified. The needs responses of a series of 295 cancer patients in a cross-sectional survey were analysed. The majority expressed the opinion that information and good relationships with health care professionals were important, and few expressed dissatisfaction with these aspects of need. Similarly, needs items about support from family and friends were largely rated as important and satisfied. For a sizeable minority of patients, items of significant unmet need cluster around aspects of managing daily life, emotions, and social identity. The distribution of significant unmet needs is not random but is more likely to be experienced by patients who are younger, have a long-standing illness or disability, do not own/have use of a car, and/or have no religious faith. Furthermore, significant unmet needs relate to patients' ability to talk freely to a carer about the cancer, the degree to which the cancer interferes with social activities, and whether financial difficulties are experienced. Most of the significant unmet need is beyond the remit of services primarily designed for the treatment of disease. We consider whether multidisciplinary cancer teams can be expected to deal with all aspects of the cancer experience.

Gemcitabine plus best supportive care (BSC) vs BSC in inoperable non-small cell lung cancer--a randomized trial with quality of life as the primary outcome. UK NSCLC Gemcitabine Group. Non-Small Cell Lung Cancer.

Three hundred patients with symptomatic, locally advanced or metastatic NSCLC not requiring immediate radiotherapy were enrolled into this randomized multicentre trial comparing gemcitabine + BSC vs BSC alone. Patients allocated gemcitabine received 1000 mg/m2 on days 1, 8 and 15 of a 28-day cycle, for a maximum of six cycles. The main aim of this trial was to compare patient assessment of a predefined subset of commonly reported symptoms (SS14) from the EORTC QLQ-C30 and LC13 scales. The primary end-points were defined as (1) the percentage change in mean SS14 score between baseline and 2 months and (2) the proportion of patients with a marked (> or = 25%) improvement in SS14 score between baseline and 2 months sustained for > or =4 weeks. The secondary objectives were to compare treatments with respect to overall survival, and multidimensional QL parameters. The treatment groups were balanced with regard to age, gender, Karnofsky performance status (KPS) and disease stage (40% had metastatic disease). The percentage change in mean SS14 score from baseline to 2 months was a 10% decrease (i.e. improvement) for gemcitabine plus BSC and a 1% increase (i.e. deterioration) for BSC alone (P = 0.113, two-sample t-test). A sustained (> or = 4 weeks) improvement (> or =25%) on SS14 was recorded in a significantly higher proportion of gemcitabine + BSC patients (22%) than in BSC alone patients (9%) (P = 0.0014, Pearson's chi-squared test). The QLQ-C30 and L13 subscales showed greater improvement in the gemcitabine plus BSC arm (in 11 domains) than in the BSC arm (one symptom item). There was greater deterioration in the BSC alone arm (six domains/items) than in the gemcitabine + BSC arm (three QL domains). Tumour response occurred in 19% (95% CI 13-27) of gemcitabine patients. There was no difference in overall survival: median 5.7 months (95% CI 4.6-7.6) for gemcitabine + BSC patients and 5.9 months (95% CI 5.0-7.9) (log-rank, P = 0.84) for BSC patients, and 1 -year survival was 25% for gemcitabine + BSC and 22% for BSC. Overall, 74 (49%) gemcitabine + BSC patients and 119 (79%) BSC patients received palliative radiotherapy. The median time to radiotherapy was 29 weeks for gemcitabine + BSC patients and 3.8 weeks for BSC. Patients treated with gemcitabine + BSC reported better QL and reduced disease-related symptoms compared with those receiving BSC alone. These improvements in patient-assessed QL were significant in magnitude and were sustained.

All change: cancer services in transition.

The policy and health service background to this discussion are the radical changes in cancer services currently underway in the wake of the Calman-Hine Report and the wider changes ushered in by the NHS and Community Care Act 1990 (UK). Using the changing face of hospice care as the focus, the authors explore some of the potential issues and dilemmas involved in providing supportive care for cancer patients and their families. Three 'themes', or areas of concern, are highlighted: links between services, changing organizational factors, and increasing 'medical imperialism'. Potential benefits and drawbacks of the changing ethos and organizational structures are discussed. Interview data are used as 'triggers' for the presentation of the authors' own reflections on developments in the hospice and cancer services' arenas. The paper draws on interview data collected in the pilot phase of a 3-year study on the psycho-social needs of cancer patients and their informal carers in north-west England. Twenty-nine interviews were conducted with a range of professionals involved in the provision of cancer services in Lancaster and Kendal. In the spirit of 'gathering thoughts' and facilitating debate, a commentary on developments in the hospice sector is offered rather than any firm conclusion.

Cancer support nurses: a co-ordinating role in cancer care.

Cancer support nurses (CSNs) have a key co-ordinating role in the cancer services in North Lancashire and South Lakeland. The working practices of the three CSNs in North Lancashire are described in detail. There was a total cumulative caseload of 604 patients in September 1996, with 397 referrals in the previous 12-month period. There were 267 deaths during this time. CSNs are an essential element of cancer service provision. A ratio of one CSN to 40,000 population gives a manageable workload, provided there is an infrastructure of supportive care to which patients, carers and bereaved can be referred.

Supportive care and the use of relaxation therapy in a district cancer service.

The development of a cancer support organisation, CancerCare, for North Lancashire and South Lakeland is described. The use of relaxation therapy is described to illustrate the demand for supportive care. Between January 1990 and 1991, 513 patients, 243 relatives and 143 bereaved were referred to five cancer support nurses. One hundred and sixty-two (32%), 29 (12%) and 49 (34%) respectively, used relaxation therapy. The high demand for supportive care suggests that services should be made available in any district health provider unit. Measures of benefit and better definition of services are required before clear recommendations can be made.

Differentiation of enterococci from other group D streptococci by means of a specific monoclonal antibody.

We report on the specificity of a monoclonal antibody which reacts with autoclaved extracts of four species of enterococci but does not react to the same extent with similar extracts from two non-enterococcal group D streptococci. The monoclonal antibody also reacts specifically with purified lipoteichoic acid from Streptococcus faecalis but not significantly with purified lipoteichoic acid from the non-enterococcal species Streptococcus bovis and Streptococcus equinus. The specific antigen detected with this antibody could correlate with the definition of the enterococcus subgroup of the streptococci which would provide further evidence that this sub-group is taxonomically distinct from the other group D streptococci.

Etoposide compared with the combination of vincristine, doxorubicin, and cyclophosphamide in the treatment of small cell lung cancer.

One hundred and three patients with small cell lung carcinoma were stratified according to stage of disease (47 limited disease, 56 extensive disease) and then randomised to receive etoposide 300 mg/m2 alone for two days or a combination (VAC) of vincristine 1 mg/m2, doxorubicin (Adriamycin) 50 mg/m2, and cyclophosphamide 1000 mg/m2. The drugs were given at three week intervals. Patients were assessed after three cycles of treatment and continued with the same regimen if in complete remission and with the alternative regimen if in partial remission; they were withdrawn if the disease had progressed. Twenty four patients (23%) achieved complete remission and this occurred more often when patients were receiving VAC (19 of 82) than etoposide (5 of 75). There was no difference, however, in overall survival between those initially treated with etoposide and those having combination chemotherapy, whether for limited disease (both 8 months) or extensive disease (7 and 5.5 months). Toxicity was less with etoposide. Survival was disappointing, especially with limited disease, even in patients who showed a complete response to treatment.

Direct detection of groups A, C and G streptococci in clinical specimens by a trivalent colour test.

A simple trivalent colour test, developed for the rapid detection and identification of streptococci belonging to Lancefield groups A, C and G, was evaluated for sensitivity and specificity with cultures and when directly used with wound and throat swabs. In tests performed on cultures, all of 94 group A, 78 group C and 94 group G cultures were correctly identified. In direct tests on wound swabs, 49 of 52 group A, 17 of 19 group C and 48 of 51 group G streptococci were detected and correctly identified; no false positives were observed. With throat swabs from pharyngitis patients 34 of 36 group A, 3 of 6 group C and 5 of 8 group G streptococci gave positive results. Almost 10% of these swabs gave false positive reactions with the group C component of the test system. Samples taken from uninfected individuals indicated that the false positives were probably associated with blood group A. The test system gives rapid and reliable results with streptococcal cultures, but when directly applied to clinical samples the results must be interpreted with caution, particularly if the patient's blood group is not known.

Murine monoclonal antibodies for detection of antigens and culture identification of Neisseria meningitidis group B and Escherichia coli K-1.

Four murine monoclonal antibodies which reacted with a (2----8)alpha-linked sialic acid polysaccharide were produced. Three of the antibodies reacted specifically with Neisseria meningitidis serogroup B and Escherichia coli K-1 polysaccharide antigens, whereas one antibody cross-reacted with N. meningitidis group C polysaccharide antigen, a (2----9)alpha-linked homopolymer of sialic acid. By using the most avid antibody (MB 62), a latex particle agglutination test was developed which could detect capsular polysaccharide at 10 ng/ml. It also detected antigen in the cerebrospinal fluid (CSF) of all seven N. meningitidis group B- and two E. coli K-1-infected patients, whereas 57 control CSF samples, including 8 from neonates, were negative. Cultures of 21 N. meningitidis group B strains, 7 E. coli K-1 strains, and 1 Moraxella nonliquefaciens strain gave a positive result, whereas 53 strains from other serogroups were all negative. In a separate clinical evaluation, the overall sensitivity of the latex particle agglutination test was 81% (22 of 27) with fresh CSF samples, 48% (15 of 31) with stored CSF samples, and 94% (32 of 34) with blood cultures. No false-positive reactions were recorded with 165 control CSF samples, and the specificity with blood cultures was 99.4% (519 of 522).

Novel color test for rapid detection of group A streptococci.

A novel color test for the rapid detection of group A streptococci has been developed. The test, designed to be suitable for use in clinical laboratories as well as by less experienced personnel, incorporates the simplicity of latex tests with a color change to indicate the presence of group A streptococcal antigen. The test, which takes 5 min, was evaluated with 646 throat swabs, with a 15.6% incidence of group A streptococci; for swabs which yielded 10 or more group A streptococcal colonies in cultures, the sensitivity was 96.8%, and the specificity was 99.1%. In addition, the color test was 100% sensitive and specific when used to detect group A streptococcal antigen in beta-hemolytic colonies from culture plates.