855 surgical procedures, using historical controls ...

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Mar 16, 1985 - Weston Park Hospital,. Sheffield SlO 2SJ ... Derbyshire Royal Infirmary,. Derby DEl 2QY ... Royal South Hants Hospital,. Southampton S09 4PE.
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infrastructure. Is anyone in Whitehall listening ? M D RAWLINS W'olfson Unit of Clinical Pharmacology, Universitv of Newcastle upon Tvne, Newcastle upon Tyne NE1 7RU

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case, be questioned in view of the survival differences reported when these two treatments are compared with each other.' The uncontrolled trials of local excision and radiotherapy are certainly promising,2 but I am sure that many of us will want to see data for 10 years on controlled series comparing not only survival but the incidence rates of local and regional recurrence before abandoning either the controversy surrounding the treatment of early breast cancer or indeed the time honoured procedure of modified radical mastectomy.

SIR,-It makes a good deal of sense, for prospective candidates and colleagues alike, to implement an interview system such as that proposed by Mr Malcolm Gough (23 FebruT K DAY ary, p 635), particularly at consultant level. Altnagelvin Hospital, My business friends gape in amazement when Londonderry BT47 IJB they learn that an appointment may effectively AO, Prescott RJ, Hamilton T. A clinical be made on the basis of a flying visit by the 1 Langlands trial in the management of operable cancer of the candidate, a few phone calls by sponsors, and Br breast. I Surg 1980;67:170-4. L, Mason AY, Ackerman LV. Local excision a half hour interview, and laugh nervously 2 Wise and irradiation: an alternative method for the treatwhen reminded that such appointments are ment of early mammary cancer. Ann Surg 1971; 174:393-401. for life. They then describe the in depth series of interviews they use when appointing staff equivalent in experience and salary, which may even include a staged accident or SIR,-I must submit this appeal following the the offering of excess alcohol at lunch to check paper of Dr Simon Allan and others (2 Februsocial grace and performance under stress. ary, p 358) summarising the results of treating Indeed, such double interviews are already elderly or frail breast cancer patients with in other standard practice parts of the DHSS's tamoxifen as primary therapy. Their results empire. One of our department staff has just will come as no surprise to workers who have been through a pre-interview (expenses not been using some form of hormone manipulapaid) from which a second smaller shortlist tion in this clinical condition for many years. was produced for the proper interview (ex- Credit for the value of this is usually attributed penses paid). I would not wish to suggest that to Beatson,l who described the value of the post she applied for was in any way in- oophorectomy in metastic breast cancer in ferior, but it did strike me that more care was 1896. More recent clinical experience has being taken over the selection of an assistant underlined the value of secondary and even social worker than is taken with the selection tertiary responses on changing the hormone of senior medical staff. preparation once the clinical response to the ANDREW BAMJI initially tried hormone has waned. Taylor et al Brook Hospital, have thrown doubt on the classical view that the Loindon SE18 4LWN; emergence of hormone independent clones is the cause of relapse after an initial response to Breast cancer endocrine therapy.2 My hope is that clinicians and general SIR,-Mr Robin Tagart and his colleagues practitioners will continue to refer patients to (9 February, p 434) conclude that the con- specialists who can monitor responses even in troversy surrounding the management of early this elderly and infirm group and change treatbreast cancer is over. Their conclusion ments as indicated. This way our knowledge appears to be based on their report of a of the value of hormone manipulation in breast selected group of 37 patients with breast cancer will continue to expand as newer drugs cancer at various sites and of different clinical avail themselves to us. and pathological stages, treated by different MICHAEL McLEAN Radiotherapy Department, surgical procedures, using historical controls. Derbyshire Royal Infirmary, The information provided may give some Derby DEl 2QY crude idea of the likely outcome of partial GT. On the treatment of inoperable cases of mastectomy unaccompanied by further 1 Beatson carcinoma of the mamma: suggestions for a new therapy. However, I cannot believe that the method of treatment with illustrative cases (part 2). Lancet 1896;i:162-5. results of treating this very small, heteroRE, Powles TJ, Humphreys J, et al. Effects genous group of patients furnish sufficient 2 Taylor of endocrine therapy on steroid-receptor content of breast cancer. Br 7 Cancer 1982;45:80-5. information to settle the controversy surrounding this very complex and variable disease. J J BOLGER SIR,-You have recently published two short Weston Park Hospital, reports about breast cancer that cannot be Sheffield SlO 2SJ allowed to pass without comment. Dr Simon Allan and colleagues (2 February, SIR,-I will not be alone in disputing with Mr p 358) describe primary treatment with tamoxiRobin Tagart and his colleagues (9 February, fen in 100 women, 89 of whom had disease p 434) that "the controversy surrounding the confined to the breast and axilla. The group management of early breast cancer is now over." included 11 patients aged less than 70 and 39 The results reported do not appear to support with T1 or T.2 tumours. Although a satisfactory the conclusions. The control group does better response rate is described, the median duration in respect of disease free survival than the of 19 months is, surely, a harbinger of problems group treated by partial mastectomy and radio- to come. Recurrent local disease will, presumtherapy. No statistical analysis is given so it is ably, require treatment, at a time when the difficult to judge the data. The validity of a elderly patients will have aged yet further. control group containing a mixed bag of Tamoxifen, unlike surgery or radiotherapy, patients treated by either modified radical cannot be regarded as a curative treatment and, mastectomy or simple mastectomy must, in any in the absence of clinical trials, their conclusion

that "tamoxifen is an excellent and appropriate primary treatment" displays an astonishing degree of complacency. We accept, of course, that subpopulations of elderly patients are unfit for treatment with curative intent but plead for randomised clinical trials before such sweeping treatment recommendations are made for all elderly patients. The second article, by Dr Robin Tagart and others (9 February, p 434), is perhaps more astonishing. Do the authors seriously contend that their group of 37 patients can in any way be compared with unmatched historical controls ? Their assertion that the reference by Veronesi et al "suggests that the least aggressive approach possible should be used" is untrue. The meticulous trial referred to relates only to T1 tumours, and its conclusions are certainly not applicable to a broader population. Local excision plus radiotherapy is possibly more cosmetically acceptable and results in less morbidity, but we must not forget the lessons of the past 50 years. Local disease control and long term survival must remain the principal goals of treatment for breast cancer. The 400( local relapse rate described in this study indicates inadequate local treatment and in no way supports the case for local excision plus radiotherapy. Unfortunately the controversy surrounding early breast cancer management will only stop when adequate, controlled, long term studies are available for analysis. The data from large uncontrolled trials cannot be accepted as adequate for planning changes in the management of breast cancer: uncontrolled trials of this size are meaningless. G M MEAD C J WILLIAMS J M A WHITEHOUSE R B BUCHANAN V L HALL I TAYLOR CRC Medical Oncology Unit and Department of

Surgery,

Southampton General Hospital, and Wessex Regional Radiotherapy Centre, Royal South Hants Hospital, Southampton S09 4PE

***Dr Tagart and his colleagues and Dr Allan and his colleagues reply below to the comments on their respective papers.-ED, BM7. SIR,-We are fully aware of the value of controlled randomised trials in the assessment of breast therapy and currently are participating in a Scottish trial in which tamoxifen and local excision is one form of treatment for women under 70 years with primary breast cancers which are rich in oestrogen receptor protein. It should also be noted that a controlled trial of tamoxifen versus tamoxifen and surgery in older women is under way in south east England (Cancer Research Campaign, 1982). The main purpose of our report was to review our experience of the use of tamoxifen as primary treatment for breast cancer in older and unfit women, which confirms the views of others that it is effective and nontoxic.' 2 These elderly women have a different life expectancy from that of the younger population. Mueller et al reported that half the deaths from all causes in women with breast cancer of 71-100 years of age occur within four years compared with 115 years for those aged 21-50 years.3 Further, surgery and anaesthesia may be hazardous (as was stilboestrol therapy) if many older women have severe vascular degeneration. Nine of the 14 deaths in our, series were due to vascular events;

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in all of these the breast cancer was satisfactorily controlled until death. We note that our Southampton colleagues still regard local therapy as being "curative" in breast cancer. In our view local therapy provides only local control; tamoxifen may have both local and systemic effects, and to date none of the patients, regardless of tumour stage, has uncontrolled local disease. Twelve non-responders received local irradiation and one had a lumpectomy with axillary clearance. Nor were the deaths from disseminated disease (five to date) excessive; the updated actuarial survival in our series of patients at five years was 62 " , which compares favourably with that in other series.23 It is a fact that not all patients show regression of their tumour. As is noted by Mr McLean, it is important to observe patients carefully so that other treatment options can be reconsidered for some of the patients with less severe coincident disease. In our experience this has not proved a major problem, but our patients are being followed up, and observations on survival, cause of death, and requirements for alternative treatments will be reported. However, these considerations do not negate our view that tamoxifen is an appropriate primary treatment for elderly women with breast cancer, who greatly appreciate avoiding the immediate upset of surgery or radiation therapy. S G ALLAN U CHETTY A P M FORREST A RODGER J F SMYTH R C F LEONARD Department of Clinical Oncology, Western General Hospital, Edinburgh EH4 2XU I Bradbeer JW, Kyngdon J. Primary treatment of breast cancer in elderly women with tamoxifen. Clinl

Onzcol 1983;9:31-4.

2 Preece PE, Wood RAB, Mackie CR, Cuschiere A. Tamoxifen as initial sole treatment of localised breast cancer in elderly women: a pilot study. Br Med J 1982;284:869-70. 3 Mueller CB, Ames F, Anderson GD. Breast cancer in 3558 women: age as a significant determinant in the rate of dying and causes of death. Surgery 1978;83: 123.

SIR,-We see that the controversy surrounding the local management of early breast cancer continues in some quarters. Dr Bolger is right; our results do not settle the controversy but they do add to the increasingly conclusive evidence that patients who have had minimal surgical intervention do not suffer in terms of survival. In the early 1970s few surgeons would consider anything less than a mastectomy and many a much more radical procedure for this diseqse. Here is more evidence that a conservative approach is worth while. The letters of Dr Mead and his colleagues and of Mr. Day rather astonishingly miss the point. Of course without radiotherapy the local relapse rate was unacceptable and for this reason the study was discontinued. Now we add radiotherapy to our management, and while this reduces the incidence of local recurrence it does not improve survival. Our study shows that the most conservative approach possible compares favourably in terms of survival benefit with the mutilating and clearly unnecessary radical surgical procedures of the past. The only way finally to settle this issue would be a large randomised clinical trial of local excision with radiotherapy versus mastectomy. Such a trial would probably be unacceptable to the majority of patients and their physicians.

Despite 30 years of controversy, the end results in managing breast cancer have remained unchanged. We think that time and resources would be better spent evaluating the new methods currently emerging from molecular biology to assess the patient and her disease and getting new systemic approaches into clinical trial. We unhesitatingly advocate local excision followed by radiotherapy to all our patients with early breast cancer. ROBIN TAGART Department of Surgery, Newmarket and West Suffolk Hospitals

DAVID BRATHERTON Department of Radiotherapy, Addenbrooke's Hospital, Cambridge

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1 Calle R, Pilleron JP, Schilcnger P, Zileoq JR. Conservative management of operable breast cancer; 10 year experience at the Foundation Curie. Canicer 1978 42:2045-51. 2 Harris JR, Levene MB, Hellman F. The role of radiation therapy in the primary treatment of carcinoma of the breast. Semin'ars in Onicology 1978;5:403-16. 3 Veronesi U, Saccazi R, Vecchio M, Bansi A, Clemente C, et al. Comparing radical mastectomy with

quadrantectomy, axillary dissection and radiotherapy in patients with small carcinomas of the breast. N EniglJ Med 1981 ;305:6-1 1. 4 Atkins H, Haywood JL, Klugman DJ, Wayte AB. Treatment for early breast cancer: a report after 10 years of a clinical trial. Br MedJ3 1972;ii:423-9. 5 Baum M, Houghton J. Current and future management of "early" breast cancer: attitude survey amongst participants in the Cancer Research Campaign. Lancet 1980;i:929.

Containing the use of diagnostic tests

SIR,-Resources can be spent once only; one KAROL SIKORA patient overinvestigated at too great a cost means another patient underinvestigated. Ludwig Institute for Cancer Research, Addenbrooke's Hospital, Dr F G R Fowkes (16 February, p 488) Cambridge suggests four strategies for reducing overinvestigation. In my experience three of these SIR,-We were surprised to read the conclu- do not work, or have only a temporary effect. sions of Mr Robin Tagart and his colleagues, Feedback of information, decision aids, and who "believe that the controversy surrounding control by diagnostic departments all require the management of early breast cancer is now continual monitoring by our scarce pathology over." The case for conservative management registrars-perhaps transfer of "surplus" of early breast cancer-that is, using treatment clinical registrar posts to pathology would methods which avoid mastectomy-has, of thereby be cost effective. A fifth strategy, course, been strengthened by the reports of teaching the students the proper use of the Calle et al,1 Harris et al,2 and Veronesi et laboratory, also is not effective. As soon as al,3 whose work strongly suggests that local they become house officers-"I know you recurrence rates after partial mastectomy explained, Professor, but Dr X always or "lumpectomy" with radical irradiation are insists that all these tests are done daily." as low as those routinely achieved by modified Only if the consultants are constantly inradical mastectomy. However, of the two ran- volved, and rebuke their juniors for undomised studies performed to date, the British necessary investigations, will the work be one from Guy's hospital showed a worse 10 reduced. This applies especially to emeryear survival for patients with stage II disease gency and on call tests, where the costs are treated by "conservative" surgery, though bankrupting us because of the lack of a admittedly the irradiation dosage was very proper NHS system for 24 hour use of laboralow4; in the Milan study the surgery consisted tory facilities. The only way to involve the clinicians of quadrantectomy and full axillary dissection, which is hardly what most of us would regard effectively is Dr Fowkes's fourth strategy, financial incentives. This means clinical as "minimal."3 We do not yet know that long term survival budgets. There are precedents in the USA, with "conservative" procedures will be as good and he quotes a successful trial at Westas with treatment which includes mastectomy. minster Hospital. A group of clinicians will It also seems clear that psychiatric morbidity have authority to manage their own approved following "lumpectomy" with radical irradia- allocation of resources. If they wished to tion is now being identified. Moreover, the exceed their agreed laboratory budget then lengthy and demanding course of radiotherapy this could come, for example, out of savings takes up to six weeks to achieve the best cos- in their medical imaging budget. If, despite metic result and is logistically much more com- interventions by the review committee, they plex than a straightforward mastectomy. For consistently exceeded all these, and their patients with "early" disease, mastectomy drug budget, then the savings could come remains the most widely performed procedure only from their staff budget. D N BARON in this country,5 suggesting that surgeons in the UK are not yet convinced by the results Department of Chemical Pathology and Human Metabolism, of minimal surgery. Royal Free Hospital and School of Medicine, It seems perverse to suggest a major change London NW3 2QG in policy for one of the commonest of cancers, based on experience with 37 cases, particularly since in Mr Tagart's series the disease Rapid transit system for patients with recurred in 540,( of patients. We feel that sur- fractured neck of femur geons will on the whole remain sceptical until a satisfactory randomised trial has shown that SIR,-Professor J M Sikorski and colleagues "lumpectomy" with radical irradiation offers strongly recommend the use of spinal anaeslocal recurrence and survival figures which are thesia for the repair of the fractured hip the equal of mastectomy, and we would urge (9 February, p 439) but make several stateinterested surgeons to consider joining in our ments which we feel are misleading. They state that spinal anaesthesia does not current study of breast conservation versus cause confusion-that is, confusional states. mastectomy. J S TOBIAS The cause of confusional states is multiM BAUM factorial but a recent prospective controlled study comparing spinal and general anaesCancer Research Campaign Breast Conservation thesia for repair of fractured neck of femur Working Party, Clinical Trials Centre, found no evidence that anaesthetic technique King's College School of Medicine and Dentistry influenced the incidence of postoperative London SE5 9NU