Lesley Fallowfield

Survival and safety of exemestane versus tamoxifen after 2-3 years' tamoxifen treatment (Intergroup Exemestane Study): a randomised controlled trial

BACKGROUND Early improvements in disease-free survival have been noted when an aromatase inhibitor is given either instead of or sequentially after tamoxifen in postmenopausal women with oestrogen-receptor-positive early breast cancer. However, little information exists on the long-term effects of aromatase inhibitors after treatment, and whether these early improvements lead to real gains in survival. METHODS 4724 postmenopausal patients with unilateral invasive, oestrogen-receptor-positive or oestrogen-receptor-unknown breast cancer who were disease-free on 2-3 years of tamoxifen, were randomly assigned to switch to exemestane (n=2352) or to continue tamoxifen (n=2372) for the remainder of a 5-year endocrine treatment period. The primary endpoint was disease-free survival; overall survival was a secondary endpoint. Efficacy analyses were intention-to-treat. This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN11883920. RESULTS After a median follow-up of 55.7 months (range 0-89.7), 809 events contributing to the analysis of disease-free survival had been reported (354 exemestane, 455 tamoxifen); unadjusted hazard ratio 0.76 (95% CI 0.66-0.88, p=0.0001) in favour of exemestane, absolute benefit 3.3% (95% CI 1.6-4.9) by end of treatment (ie, 2.5 years after randomisation). 222 deaths occurred in the exemestane group compared with 261 deaths in the tamoxifen group; unadjusted hazard ratio 0.85 (95% CI 0.71-1.02, p=0.08), 0.83 (0.69-1.00, p=0.05) when 122 patients with oestrogen-receptor-negative disease were excluded. CONCLUSIONS Our results suggest that early improvements in disease-free survival noted in patients who switch to exemestane after 2-3 years on tamoxifen persist after treatment, and translate into a modest improvement in overall survival.

Psychological outcomes of different treatment policies in women with early breast cancer outside a clinical trial.

OBJECTIVES--To assess outside a clinical trial the psychological outcome of different treatment policies in women with early breast cancer who underwent either mastectomy or breast conservation surgery depending on the surgeons opinion or the patients choice. To determine whether the extent of psychiatric morbidity reported in women who underwent breast conservation surgery was associated with their participation in a randomised clinical trial. DESIGN--Prospective, multicentre study capitalising on individual and motivational differences among patients and the different management policies among surgeons for treating patients with early breast cancer. SETTING--12 District general hospitals, three London teaching hospitals, and four private hospitals. PATIENTS--269 Women under 75 with a probable diagnosis of stage I or II breast cancer who were referred to 22 different surgeons. INTERVENTIONS--Surgery and radiotherapy or adjuvant chemotherapy, or both, depending on the individual surgeons stated preferences for managing early breast cancer. MAIN OUTCOME MEASURES--Anxiety and depression as assessed by standard methods two weeks, three months, and 12 months after surgery. RESULTS--Of the 269 women, 31 were treated by surgeons who favoured mastectomy, 120 by surgeons who favoured breast conservation, and 118 by surgeons who offered a choice of treatment. Sixty two of the women treated by surgeons who offered a choice were eligible to choose their surgery, and 43 of these chose breast conserving surgery. The incidences of anxiety, depression, and sexual dysfunction were high in all treatment groups. There were no significant differences in the incidences of anxiety and depression between women who underwent mastectomy and those who underwent lumpectomy. A significant effect of surgeon type on the incidence of depression was observed, with patients treated by surgeons who offered a choice showing less depression than those treated by other surgeons (p = 0.06). There was no significant difference in psychiatric morbidity between women treated by surgeons who offered a choice who were eligible to choose their treatment and those in the same group who were not able to choose. Most of the women (159/244) gave fear of cancer as their primary fear rather than fear of losing a breast. The overall incidences of psychiatric morbidity in women who underwent mastectomy and those who underwent lumpectomy were similar to those found in the Cancer Research Campaign breast conservation study. At 12 months 28% of women who underwent mastectomy in the present study were anxious compared with 26% in the earlier study, and 27% of women in the present study who underwent lumpectomy were anxious compared with 31% in the earlier study. In both the present and earlier study 21% of women who underwent mastectomy were depressed, and 19% of women who underwent lumpectomy in the present study were depressed compared with 27% in the earlier study.) CONCLUSIONS--There is still no evidence that women with early breast cancer who undergo breast conservation surgery have less psychiatric morbidity after treatment than those who undergo mastectomy. Women who surrender autonomy for decision making by agreeing to participate in randomised clinical trials do not experience any different psychological, sexual, or social problems from those women who are treated for breast cancer outside a clinical trial.

Information needs of patients with cancer: results from a large study in UK cancer centres

As part of a multi-centred study evaluating a communication skills training model for clinicians, we collected information preferences using an adaptation of Cassileths Information Needs questionnaire from a heterogeneous sample of 2331 patients. Results showed that 87% (2027) wanted all possible information, both good and bad news and 98% (2203) preferred to know whether or not their illness was cancer. Cross tabulation of responses revealed no significant differences in information preferences for tumour site or treatment aims but did show an effect of age and sex. The few 58/440 (13.2%) patients who stated that in general they preferred to leave disclosure of details up to the doctor, tended to be older patients more than 70 years of age (chi square = 26.01, df = 2, P< 0.0001), although paradoxically they still wanted to know certain specific details. In comparison to men women preferred to know the specific name of the illness (chi square = 4.9, df = 1, P< 0.02) and what were all the possible treatments (chi square = 8.26, df = 1, P< 0.004). The results from this very large sample provide conclusive evidence that the vast majority of patients with cancer want a great deal of specific information concerning their illness and treatment. Failure to disclose such information on the grounds that significant numbers of patients prefer not to know is untenable.

Communicating sad, bad, and difficult news in medicine

In every medical specialty bad, sad, and difficult information must be given to patients and their families. An insensitive approach increases the distress of recipients of bad news, may exert a lasting impact on their ability to adapt and adjust, and can lead to anger and an increased risk of litigation. Many doctors also find these interactions stressful, and in the absence of much effective training they may adopt inappropriate ways of delivering bad news and coping with the emotional fall-out. Recognition of these difficulties has led to many initiatives, ranging from increased communication skills training to the development of guidelines and protocols. We review some of the research on the impact that giving sad, bad, and difficult news has on doctors and patients, and assess whether interventions are helping. We focus mainly on difficulties encountered involving parents in an obstetric or paediatric setting, people in acute trauma situations such as accident and emergency departments, and patients with cancer.

Psychiatric morbidity and its recognition by doctors in patients with cancer

Psychiatric morbidity in patients with cancer is high and without appropriate treatment unremitting. We assessed the ability of 143 doctors to establish the psychological status of 2297 patients during outpatient consultations in 34 cancer centres and hospitals in the UK. Prior to seeing the doctor, consenting patients completed a short self-report questionnaire (GHQ12), designed for the psychological screening of large populations. At the end of the consultation, doctors completed visual analogue scales rating patients’ distress. 837/2297 (36.4%) patients had GHQ scores suggestive of psychiatric morbidity. The doctors’ sensitivity (true positive rate) was 28.87% (SD 25.29), specificity (true negative rate) 84.79% (SD 17.44). The misclassification rate was 34.7% (SD 13.79) meaning that for 797 patients the wrong assessment was probably made. These data show that much of the probable psychiatric morbidity experienced by patients with cancer goes unrecognized and therefore untreated. Doctors need communication skills training to elicit problems during consultations. Appropriate referrals to psychological services are necessary when patients requiring help are identified and ought to be an integral part of cancer care.

ESO-ESMO 2nd international consensus guidelines for advanced breast cancer (ABC2)†

Advanced Breast Cancer (ABC) is a treatable but still generally incurable disease. The goals of care are to optimize both length and quality of life. Due to continuous research, several advances have been made, particularly for the HER-2-positive and for Luminal-like subtypes. Notwithstanding these advances, median overall survival of patients with ABC is still only 2–3 years, although the range is wide [1–5], and survival may be longer for patients treated in specialized institutions [6]. Implementation of current knowledge is highly variable among countries and within each country.

Effective communication skills are the key to good cancer care

Communication within oncology is a core clinical skill but one in which few oncologists or specialist cancer nurses have received much formal training. Inadequate communication may cause much distress for patients and their families, who often want considerably more information than is usually provided. Many patients leave consultations unsure about the diagnosis and prognosis, confused about the meaning of--and need for--further diagnostic tests, unclear about the management plan and uncertain about the true therapeutic intent of treatment. Additionally, communication difficulties may impede the recruitment of patients to clinical trials, delaying the introduction of efficacious new treatments into clinics. Lack of effective communication between specialists and departments can also cause confusion and a loss of confidence amongst the team. Oncologists themselves acknowledge that insufficient training in communication and management skills is a major factor contributing to their own stress, lack of job satisfaction and emotional burnout. Consequently, over the past few years there have been several initiatives aimed at improving basic communication skills training for healthcare professionals in the cancer field. In this paper, some of the issues that influence communication within an oncology setting, and ultimately affect patient care, are discussed.

Comparison of psychological aspects and patient satisfaction following breast conserving surgery, simple mastectomy and breast reconstruction

The aim of this study was to assess and compare the psychological outcome and satisfaction of patients whom underwent wide local excision, mastectomy alone and mastectomy with breast reconstruction. A total of 577 patients had different types of operations for primary breast cancer (254 (44%) had wide local excision, 202 (35%) had simple mastectomy and 121 (21%) had breast reconstruction). Psychosocial morbidity and satisfaction were studied retrospectively using self-evaluation questionnaires. The three different surgical groups were cross-matched into four different age group. Significant statistical differences existed between the three procedures regarding satisfaction and psychosocial morbidity (anxiety, depression, body image, sexuality and self-esteem) in favour of wide local excision followed by breast reconstruction. Greatest morbidity was seen in the mastectomy group. Patient satisfaction of cosmetic outcome and psychosocial aspects was greater with wide local excision than with breast reconstruction or mastectomy. However, since wide local excision is indicated in only a group of patients, breast reconstruction should be an option available to patients requiring mastectomy.

Truth may hurt but deceit hurts more: communication in palliative care

Healthcare professionals often censor their information giving to patients in an attempt to protect them from potentially hurtful, sad or bad news. There is a commonly expressed belief that what people do not know does not harm them. Analysis of doctor and nurse/patient interactions reveals that this well-intentioned but misguided assumption about human behaviour is present at all stages of cancer care. Less than honest disclosure is seen from the moment that a patient reports symptoms, to the confirmation of diagnosis, during discussions about the therapeutic benefits of treatment, at relapse and terminal illness. This desire to shield patients from the reality of their situation usually creates even greater difficulties for patients, their relatives and friends and other members of the healthcare team. Although the motivation behind economy with the truth is often well meant, a conspiracy of silence usually results in a heightened state of fear, anxiety and confusion not one of calm and equanimity. Ambiguous or deliberately misleading information may afford short-term benefits while things continue to go well, but denies individuals and their families opportunities to reorganize and adapt their lives towards the attainment of more achievable goals, realistic hopes and aspirations. In this paper, some examples and consequences of accidental, deliberate, if well-meaning, attempts to disguise the truth from patients, taken verbatim from interviews, are given, together with cases of unintentional deception or misunderstandings created by the use of ambiguous language. We also provide evidence from research studies showing that although truth hurts, deceit may well hurt more. ‘I think the best physician is the one who has the providence to tell to the patients according to his knowledge the present situation, what has happened before, and what is going to happen in the future’ (Hippocrates).

Multidisciplinary teams in cancer care: are they effective in the UK?

Cancer care can be complex, and given the wide range and numbers of health-care professionals involved, an enormous potential for poor coordination and miscommunication exists. Multidisciplinary teams (MDTs) should improve coordination, communication, and decision making between health-care team members and patients, and hopefully produce more positive outcomes. This review describes the many practical barriers to the successful implementation of MDT working, and shows that despite an increase in the delivery of cancer services via this method, research showing the effectiveness of MDT working is scarce.