44
VIEWPOINT
Breast
cancer
trials:
a
patient’s viewpoint
H. M. THORNTON
The purpose of this article is to describe my views as a patient with breast ductal carcinoma-in-situ (DCIS) and my reaction to being asked to take part in a UK randomised trial for the management of screen-detected ductal carcinoma. The practice of "informed consent" before inclusion in randomised controlled trials is well known. My invitation to participate in such a trial came during a clinic appointment two weeks after an operation to remove an abnormal piece of breast tissue (August, 1991). I was handed a leaflet that explained the need for the DCIS trial and which listed the treatment options. The booklet "Living with breast surgery", published by the UK Health Education Authority, was given to me and I was advised to telephone the British Association of Cancer United Patients and their Families (BACUP) to obtain information on radiotherapy and tamoxifen. I was asked to come back in two weeks with my decision and was assured that, if I declined, my aftercare would not be affected. A layperson’s dilemma is clear. A woman is given a diagnosis that she has never heard of before and a leaflet indicating four widely differing treatment options: no further treatment, a four-to-five week course of X-ray therapy to the breast, one tamoxifen tablet daily for five years, or both radiotherapy and tamoxifen. She has two weeks to deliberate and seek further information. This scenario begs the question: what is informed consent? I sought every means to inform myself during the next two weeks about DCIS and its treatments, and about randomised controlled trials. I quickly became aware that without the facts of my case-eg, size of DCIS, volume of tissue removed, state of marked excision margins, histological sub-type, and oestrogen receptor status-it would be impossible to speculate on the likely effects of the four treatments on offer. I was fortunate to have excellent sources of information. My instinctive reaction against radiotherapy for this non-invasive condition was reinforced by several wellinformed and experienced doctors and radiotherapists who have discussed these issues:’ "To give healthy women who have volunteered for screening a five-week course of radiotherapy, with its associated short-term morbidity and its potentially more serious effects after treatment, seems hard to justify." Radiotherapy is included in two out of the four treatment options in the trial; my feeling was that, because I was unwilling to undergo radiotherapy, I could not take part in this study. To decide whether I might volunteer for single randomisation in the tamoxifen arm of the trial (an option that was available, although I was not advised of such), I needed facts from my case history which I did not possess. However, the advantages of tamoxifen in post-menopausal women over 50 years of age (my own category) led me to believe that this regimen might be valuable in my case. Without the supplementary information that I was able to
myself, I cannot understand how a woman can properly judge the proposal that has been put to her. Even with such information, it is a haphazard assessment for the layperson. I was astonished that the Breast Cancer Trials Co-ordinating Subcommittee of the UK Co-ordinating Committee on Cancer Research seeks the cooperation of all obtain
who have DCIS when the range of treatments is so wide. To suggest that randomised controlled trials are necessary and to ask your average woman-in-the-street to have to decide whether or not to take part at the moment she has just been told she has a carcinoma would seem to be women
asking just too much. of such a request is to leave the patient time when she is much in need of support. She has gone to her appointment expecting to be given a diagnosis and a treatment plan, but she is sent away with no such plan and is given another two weeks to "decide". The delay in discussing the diagnosis with the patient and in planning further treatment, which is introduced by the trial protocol, places a barrier between the patient and the medical team, since the team must not influence her eventual decision. Inevitably, surgeons’ personal preferences for postoperative management vary enormously and these preferences would be revealed during a discussion of the options. A patient who had hoped to have her case discussed and proceed with confidence to postoperative management chosen by her surgeon is sent away to think about a proposal that means little to her. The patient is deprived of the relationship with the surgeon or physician that she needs. After mammographic screening, the medical team will have already made an initial choice between mastectomy and conservative breast surgery. Mastectomy is 100% successful in the treatment of DCIS, whereas conservative breast surgery has a high degree of success when combined with adjuvant postoperative management. The surgeon may have wished to begin tamoxifen immediately after the operation, but the logistics of the trial protocol loses the patient four critical weeks of treatment. Ethically, the UK DCIS trial seems to be unacceptable for reasons other than the damage to the surgeon-patient relationship. Is it fair to make demands on a patient at the time when she has been informed that she has a ductal carcinoma? How can she be expected, as a layperson, to understand the implications of the treatment options available in the trial? How can she be expected to be happy with being randomly allocated either nothing or, say, radiotherapy plus tamoxifen? How will she feel later, if, having been allocated a treatment, she realises that she has received unacceptable care? How much more would a The
outcome
feeling isolated
at a
ADDRESS. "Saionara", 31 Regent Street, Rowhedge, Colchester, Essex CO5 7EA. Correspondence to Mrs H. M. Thornton.
45
patient’s positive attitude contribute to her treatment and well-being if it had been chosen rather than allocated? Randomised controlled trials, by their impersonal nature, take no account of one of the important factors in healing, confidence. The emphasis on chance rather than choice might contribute substantially to the negative feelings of the patient. Surgeons and radiotherapists have widely differing views about the best postoperative management of DCIS. Patients differ in general health, attitude, age, history, intelligence, and emotional stability. I believe that an analysis of treatments selected for patients would allow a better assessment of postoperative management. The leaflet given to patients does not mention that this trial has been preceded by other studies of early breast To quote from the summary in "Treatment of early breast cancer",2 "radiotherapy did not appear to produce any clear improvement in survival." And yet the current UK trial includes radiotherapy in two out of four treatment options. This treatment is given early in the postoperative phase and takes only five weeks, so if a woman decides to withdraw from the trial she may have already cancer
completed a treatment that has been shown not to improve the survival rate and which has short-term morbidity, potentially serious after effects, and reduces the patient’s quality of life. How can those responsible for UK breast trials justify the inclusion of radiotherapy in half of their treatment options? Do these facts enable genuinely "informed consent"? Or is there only, at best, "partly informed consent" or, at worst, "ill-informed consent"? Should the radiotherapy arm of the trial be dropped? I am not willing to damage the quality of my life to reinforce a conclusion that has already been drawn by many: that "radiotherapy does not appear to produce any
improvements".
treatment.
REFERENCES 1. Hamilton CR, Buchanan RB. Radiotherapy for ductal carcinoma-in-situ detected by screening. Br Med J 1990; 301: 224-25. 2. Early breast cancer trials collaborative group. Treatment of early breast cancer, vol I: worldwide evidence 1985-90. New York: Oxford University Press, 1990.
BOOKSHELF Replacement Cardiac Valves
Adjuncts to
Edited by Endre Bodnar and Robert Frater. New York: Pergamon. 1991. Pp 482.$82.50/52.50. ISBN 0-080357733.
About 5000 artificial heart valves are inserted annually in the UK-a fairly constant figure over the past 5 to 10 years, at a rate of about 130 valve replacement operations per million population, and one which is representative of current practice in developed countries. Valve replacement can bring great benefits in life expectancy and in its quality, but artificial valves can also have disastrous and well publicised consequences. There have been many designs and almost as many have disappeared from use; only a handful are now available in the USA because of stringent
licensing requirements. The study of heart valves involves scientists from many disciplines and a great deal is known about the durability of materials and their interaction with blood, flow characteristics, the energy expended in opening and closing a valve, the behaviour of biological materials with time, and the statistical evaluation of clinical results over many years. These topics are all examined from clinical, scientific, and industrial perspectives; ethical, historical, statistical, and legal issues are also considered. Over 40 authors contribute 18 chapters: each review is authoritative and comprehensive, with an up-to-date bibliography. Replacerraerat Cardiac Valves will be an invaluable source of reference for many years, and I am confident that it will be recognised as a landmark in the development of our knowledge about prosthetic heart valves. For me, Eric Butchart’s clarity in the analysis of the problem of thromboembolism and Eugene Blackstone’s brilliant treatise on statistical methods in follow-up are the high points in a book which has a very good standard throughout.
Department of Cardiothoracic Surgery, St George’s Hospital, London SW17OQT, UK
TOM TREASURE
Cancer
Surgery
by S. G. Economou, T. R. Witt, D. J. Deziel, T. J. Saclarides, E. D. Staren, and S. D. Bines. Philadelphia: Lea and Febiger. 1991. Pp 703. 102/$125. ISBN 0-812113276.
Edited
Oncology is an excessively fertile field for research and publications. Rapid strides in our understanding of basic science and the results of clinical trials have given us many opportunities to translate laboratory findings into practice. But how can all this information, with correct emphasis on efficacy of advances, ease of execution, and economics of implementation, be made readily accessible to clinical oncologists? Adjuncts to Cancer Surgery makes a valiant attempt to achieve these objectives and does remarkably well. Most of the authors, like the editors, come from Illinois but their approach is far from parochial. The layout is quite attractive and chapters are well written, amply illustrated, and adequately referenced. The introductory section on "Diagnostic Adjuncts" offers a concise review of newer techniques in pathology (immunohistochemistry, electronmicroscopy, monoclonal antibodies, and flow cytometry) which add precision to diagnosis and prognosis. The role of imaging techniques is well illustrated, with emphasis on their indications and yield at each stage of cancer. It very aptly discusses the declining role of arteriography now that less invasive imaging techniques are available, but the enthusiastic recommendation of mammography screening below the age of 50, where its place is not yet defined, appears to be based more on
needle
emotion than
aspiration,
facts. The 77 pages devoted to endoscopy for cytology and biopsy, and on
these procedures have made on diagnosis and assessment of the spread of disease-but clinicians are adequately cautioned about sensitivity, specificity, and pitfalls of such investigations. The chapter on "Mega Operation" recounts the evolution of such treatments, although the anecdotal support for "mega
laparoscopy speak of the major impact
VIEWPOINT
Breast
cancer
trials:
a
patient’s viewpoint
H. M. THORNTON
The purpose of this article is to describe my views as a patient with breast ductal carcinoma-in-situ (DCIS) and my reaction to being asked to take part in a UK randomised trial for the management of screen-detected ductal carcinoma. The practice of "informed consent" before inclusion in randomised controlled trials is well known. My invitation to participate in such a trial came during a clinic appointment two weeks after an operation to remove an abnormal piece of breast tissue (August, 1991). I was handed a leaflet that explained the need for the DCIS trial and which listed the treatment options. The booklet "Living with breast surgery", published by the UK Health Education Authority, was given to me and I was advised to telephone the British Association of Cancer United Patients and their Families (BACUP) to obtain information on radiotherapy and tamoxifen. I was asked to come back in two weeks with my decision and was assured that, if I declined, my aftercare would not be affected. A layperson’s dilemma is clear. A woman is given a diagnosis that she has never heard of before and a leaflet indicating four widely differing treatment options: no further treatment, a four-to-five week course of X-ray therapy to the breast, one tamoxifen tablet daily for five years, or both radiotherapy and tamoxifen. She has two weeks to deliberate and seek further information. This scenario begs the question: what is informed consent? I sought every means to inform myself during the next two weeks about DCIS and its treatments, and about randomised controlled trials. I quickly became aware that without the facts of my case-eg, size of DCIS, volume of tissue removed, state of marked excision margins, histological sub-type, and oestrogen receptor status-it would be impossible to speculate on the likely effects of the four treatments on offer. I was fortunate to have excellent sources of information. My instinctive reaction against radiotherapy for this non-invasive condition was reinforced by several wellinformed and experienced doctors and radiotherapists who have discussed these issues:’ "To give healthy women who have volunteered for screening a five-week course of radiotherapy, with its associated short-term morbidity and its potentially more serious effects after treatment, seems hard to justify." Radiotherapy is included in two out of the four treatment options in the trial; my feeling was that, because I was unwilling to undergo radiotherapy, I could not take part in this study. To decide whether I might volunteer for single randomisation in the tamoxifen arm of the trial (an option that was available, although I was not advised of such), I needed facts from my case history which I did not possess. However, the advantages of tamoxifen in post-menopausal women over 50 years of age (my own category) led me to believe that this regimen might be valuable in my case. Without the supplementary information that I was able to
myself, I cannot understand how a woman can properly judge the proposal that has been put to her. Even with such information, it is a haphazard assessment for the layperson. I was astonished that the Breast Cancer Trials Co-ordinating Subcommittee of the UK Co-ordinating Committee on Cancer Research seeks the cooperation of all obtain
who have DCIS when the range of treatments is so wide. To suggest that randomised controlled trials are necessary and to ask your average woman-in-the-street to have to decide whether or not to take part at the moment she has just been told she has a carcinoma would seem to be women
asking just too much. of such a request is to leave the patient time when she is much in need of support. She has gone to her appointment expecting to be given a diagnosis and a treatment plan, but she is sent away with no such plan and is given another two weeks to "decide". The delay in discussing the diagnosis with the patient and in planning further treatment, which is introduced by the trial protocol, places a barrier between the patient and the medical team, since the team must not influence her eventual decision. Inevitably, surgeons’ personal preferences for postoperative management vary enormously and these preferences would be revealed during a discussion of the options. A patient who had hoped to have her case discussed and proceed with confidence to postoperative management chosen by her surgeon is sent away to think about a proposal that means little to her. The patient is deprived of the relationship with the surgeon or physician that she needs. After mammographic screening, the medical team will have already made an initial choice between mastectomy and conservative breast surgery. Mastectomy is 100% successful in the treatment of DCIS, whereas conservative breast surgery has a high degree of success when combined with adjuvant postoperative management. The surgeon may have wished to begin tamoxifen immediately after the operation, but the logistics of the trial protocol loses the patient four critical weeks of treatment. Ethically, the UK DCIS trial seems to be unacceptable for reasons other than the damage to the surgeon-patient relationship. Is it fair to make demands on a patient at the time when she has been informed that she has a ductal carcinoma? How can she be expected, as a layperson, to understand the implications of the treatment options available in the trial? How can she be expected to be happy with being randomly allocated either nothing or, say, radiotherapy plus tamoxifen? How will she feel later, if, having been allocated a treatment, she realises that she has received unacceptable care? How much more would a The
outcome
feeling isolated
at a
ADDRESS. "Saionara", 31 Regent Street, Rowhedge, Colchester, Essex CO5 7EA. Correspondence to Mrs H. M. Thornton.
45
patient’s positive attitude contribute to her treatment and well-being if it had been chosen rather than allocated? Randomised controlled trials, by their impersonal nature, take no account of one of the important factors in healing, confidence. The emphasis on chance rather than choice might contribute substantially to the negative feelings of the patient. Surgeons and radiotherapists have widely differing views about the best postoperative management of DCIS. Patients differ in general health, attitude, age, history, intelligence, and emotional stability. I believe that an analysis of treatments selected for patients would allow a better assessment of postoperative management. The leaflet given to patients does not mention that this trial has been preceded by other studies of early breast To quote from the summary in "Treatment of early breast cancer",2 "radiotherapy did not appear to produce any clear improvement in survival." And yet the current UK trial includes radiotherapy in two out of four treatment options. This treatment is given early in the postoperative phase and takes only five weeks, so if a woman decides to withdraw from the trial she may have already cancer
completed a treatment that has been shown not to improve the survival rate and which has short-term morbidity, potentially serious after effects, and reduces the patient’s quality of life. How can those responsible for UK breast trials justify the inclusion of radiotherapy in half of their treatment options? Do these facts enable genuinely "informed consent"? Or is there only, at best, "partly informed consent" or, at worst, "ill-informed consent"? Should the radiotherapy arm of the trial be dropped? I am not willing to damage the quality of my life to reinforce a conclusion that has already been drawn by many: that "radiotherapy does not appear to produce any
improvements".
treatment.
REFERENCES 1. Hamilton CR, Buchanan RB. Radiotherapy for ductal carcinoma-in-situ detected by screening. Br Med J 1990; 301: 224-25. 2. Early breast cancer trials collaborative group. Treatment of early breast cancer, vol I: worldwide evidence 1985-90. New York: Oxford University Press, 1990.
BOOKSHELF Replacement Cardiac Valves
Adjuncts to
Edited by Endre Bodnar and Robert Frater. New York: Pergamon. 1991. Pp 482.$82.50/52.50. ISBN 0-080357733.
About 5000 artificial heart valves are inserted annually in the UK-a fairly constant figure over the past 5 to 10 years, at a rate of about 130 valve replacement operations per million population, and one which is representative of current practice in developed countries. Valve replacement can bring great benefits in life expectancy and in its quality, but artificial valves can also have disastrous and well publicised consequences. There have been many designs and almost as many have disappeared from use; only a handful are now available in the USA because of stringent
licensing requirements. The study of heart valves involves scientists from many disciplines and a great deal is known about the durability of materials and their interaction with blood, flow characteristics, the energy expended in opening and closing a valve, the behaviour of biological materials with time, and the statistical evaluation of clinical results over many years. These topics are all examined from clinical, scientific, and industrial perspectives; ethical, historical, statistical, and legal issues are also considered. Over 40 authors contribute 18 chapters: each review is authoritative and comprehensive, with an up-to-date bibliography. Replacerraerat Cardiac Valves will be an invaluable source of reference for many years, and I am confident that it will be recognised as a landmark in the development of our knowledge about prosthetic heart valves. For me, Eric Butchart’s clarity in the analysis of the problem of thromboembolism and Eugene Blackstone’s brilliant treatise on statistical methods in follow-up are the high points in a book which has a very good standard throughout.
Department of Cardiothoracic Surgery, St George’s Hospital, London SW17OQT, UK
TOM TREASURE
Cancer
Surgery
by S. G. Economou, T. R. Witt, D. J. Deziel, T. J. Saclarides, E. D. Staren, and S. D. Bines. Philadelphia: Lea and Febiger. 1991. Pp 703. 102/$125. ISBN 0-812113276.
Edited
Oncology is an excessively fertile field for research and publications. Rapid strides in our understanding of basic science and the results of clinical trials have given us many opportunities to translate laboratory findings into practice. But how can all this information, with correct emphasis on efficacy of advances, ease of execution, and economics of implementation, be made readily accessible to clinical oncologists? Adjuncts to Cancer Surgery makes a valiant attempt to achieve these objectives and does remarkably well. Most of the authors, like the editors, come from Illinois but their approach is far from parochial. The layout is quite attractive and chapters are well written, amply illustrated, and adequately referenced. The introductory section on "Diagnostic Adjuncts" offers a concise review of newer techniques in pathology (immunohistochemistry, electronmicroscopy, monoclonal antibodies, and flow cytometry) which add precision to diagnosis and prognosis. The role of imaging techniques is well illustrated, with emphasis on their indications and yield at each stage of cancer. It very aptly discusses the declining role of arteriography now that less invasive imaging techniques are available, but the enthusiastic recommendation of mammography screening below the age of 50, where its place is not yet defined, appears to be based more on
needle
emotion than
aspiration,
facts. The 77 pages devoted to endoscopy for cytology and biopsy, and on
these procedures have made on diagnosis and assessment of the spread of disease-but clinicians are adequately cautioned about sensitivity, specificity, and pitfalls of such investigations. The chapter on "Mega Operation" recounts the evolution of such treatments, although the anecdotal support for "mega
laparoscopy speak of the major impact
