Michael Baum

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.

What are the Psychological Factors Influencing Attendance, Non-Attendance and Re-Attendance at a Breast Screening Centre?

trials in homeopathy because each patient is so different and may require a different homeopathic remedy. Fisher et ais study suggests that, with careful patient selection and appropriate clinical trial methodology, it is indeed possible to initiate double-blind controlled trials which satisfy both the conventional doctor and the homeopathic physician. In all these studies homeopathic medications were used that contained no material medicines; the dilutions were below that predicted by the Avagadroo number. The conclusion one draws from these three recent studies is that homeopathy does indeed have an effect greater than that of placebo alone. Furthermore, homeopaths are capable of initiating and completing complex clinical trials to a high scientific standard. However, these studies beg a number of questions. If homeopathy is as effective as these three studies would suggest, what is its mechanism of action? If we believe conventional chemistry is the sole repository of wisdom that underpins modern pharmacology, how can we accept homeopathy? Yet, if these clinical trials are correct, modern pharmacology may yet be rocked to its foundations by researchers working

Counselling breast cancer patients: A specialist nurse service

Abstract The evaluation of a specialist nurse-counselling service is described. Forty newly diagnosed breast cancer patients, treated by mastectomy, were randomised to receive either routine care or routine care plus counselling by a nurse. Psychological morbidity was assessed at one week, 3 months and 12 months postoperatively to determine the efficacy of this service. Comparisons between the groups indicated that counselled patients were significantly less depressed at 3 months postoperatively and reported more beliefs in personal control over health. At 12 months postoperatively there were no significant differences between the groups. Although both groups continued to adjust throughout the year following surgery, this adjustment occurred more rapidly if patients were counselled. The results suggest that a nurse-counselling service can be of value in helping to reduce the amount of distress experienced as a result of the diagnosis and treatment of breast cancer.

Response to toremifene (Fc-1157a) therapy in tamoxifen failed patients with breast cancer. Preliminary communication

Nine patients with measurable lesions of locally advanced or recurrent breast cancer have been treated with toremifene 200 mg daily. A response rate of 33% [complete remission (CR) + partial remission (PR)] or 78% [CR + PR + no change (NC)] has been achieved so far. As all our patients had previously relapsed on anti-oestrogen therapy (tamoxifen), we postulate that our response rate was achieved by a direct oncolytic effect.

The Surgeon’s Role

It is important to be aware of the stress which confronts the patient with breast cancer, but we must not lose sight of the conflicts and uncertainties to which the surgeon also is exposed. These relate to his abilities to treat the disease itself, the way in which he involves the patient in the treatment, and the extent to which he should and can offer support for the patient in adjusting to her illness.

Adjuvant radiotherapy in breast cancer. Consideration of cost-benefits in relation to the CRC (Cancer Research Campaign) (King's/Cambridge) trial.

The Cancer Research Campaign (CRC) Trial demonstrates a decreased incidence of local recurrence for patients randomized to prophylactic radiotherapy following mastectomy. Irradiated patients alive after 5 years, however, have a small increased risk of dying from causes other than breast cancer. How to estimate the cost-benefit of such therapy is discussed.

Assessment, ethics, and the randomized controlled trial

Decision-making in surgical practice is a highly complex interaction between the client (patient) and his or her professional advisor (surgeon). The client approaches the professional advisor full of expectations and fears. The expectations may be realistic or unrealistic, and, in the same way, the fears may be justified or unjustified. Furthermore, the client may have a variety of priorities not immediately apparent to the surgeon and may wish to express different degrees of autonomy. For example, some patients may demand the final say in determining the balance between length and quality of survival, whereas others would be happy to allow complete abrogation of their responsibilities to the surgeon, who is invited to make the difficult decisions concerning the patients utilities. From the viewpoint of the surgeon, the transaction is equally complex, and his or her decisions may be constrained by resource allocation and time available. However, in the final analysis, assuming a beneficent doctor, the most appropriate decision will be determined by the weight of evidence that can be adduced in favor of any intervention.

Simplifying infusion chemotherapy: preliminary communication.

A low-intervention policy for Hickman catheter maintenance has been evaluated and found to be safe and cost effective. A simple, lightweight, disposable device has been used for 24–hour ambulatory home infusion. Implementation of this policy as part of a prospective randomized trial of single-agent chemotherapy in advanced breast cancer has demonstrated that slow intravenous infusion reduces the acute toxicity of epirubicin when compared with bolus injection.

Adjuvant Endocrine Therapy: Its Role in Primary Breast Cancer

Beatson’s experimental confirmation of his hypothesis that advanced carcinoma of the breast is at least partially under ovarian control1 has led to many years of careful experimental work in order that the maximum benefit be obtained by endocrine manipulations. In the clinical setting a logical progression has been to bring forward the time of treatment to earlier stages of the disease and now therapy is widely used as an adjuvant to surgery to delay the recurrence of early breast cancer. It is hoped that this benefit will also translate into an improvement in survival.

THE DESIGN OF ADVANCED BREAST CANCER TRIALS New approaches

The treatment of advanced breast cancer is always palliative. Only a modest prolongation of life is achieved even in the best series, and the traditional criteria of assessment of response take no account of factors other than tumour bulk. Restrictive entry criteria have resulted from the inability to quantify any other measurement of response, and so the power of such chemotherapy trials has been unnecessarily curtailed. We report on the progress being made in this department to develop a self-assessment diary to record quality of life in these patients and to mount a pragmatic trial of two different regimens in advanced breast cancer using this measure.