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WHOLE BODY HYPERTHERMIA the Development of and Experience with a Clinical Method

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WHOLE BODY HYPERTHERMIA the Development of and Experience with a Clinical Method WHOLE BODY HYPERTHERMIA The development of and experience with a clinical method TOTALE LICHAAMSHYPERTHERMIE De ontwikkeling van en ervaring met een klinische methode Proefschrift Ter verkrijging van de graad van doctor aan de Erasmus Universiteit Rotterdam op gezag van de Rector Magnificus Prof. Dr. A.H.G. Rinnooy Kan en volgens besluit van het college van dekanen De openbare verdediging zal plaatsvinden op woensdag 8 april 1987 te 15.45 uur door Jacoba van der Zee geboren te Zwartewaal PROMOTIECOMMISSIE Promotoren: Prof.Dr. H.S. Reinhold Prof.Dr. W. Erdmann Overige leden: Prof.Dr. D.W. van Bekkum Prof.Dr. B.H.P. van der Wed-Messing CDNI'ENI'S SECI'ION I INriDDUCI'IONARY Cllapter I INriDDUCI'ION History 9 Obje::tives 12 Cllapter II THERIDBIOI.OGY Thernobiology 15 Tumour physiology under normothermic conditions 18 Hyperthermia effe::ts on turnour physiology 19 Hyperthermia in caribination with radiotherapy 21 Hyperthermia caribined with chem::>therapy 23 Cllapter III TECBNIQUES IN\ULVED IN THE APPLIClfi'ION OF HYPERI'HERMIA Introduction 27 Thernophysiology in man 28 Thermoregulation 29 J?ody temperature 30 Thennanetry 31 Te::hniques for the induction of hyperthermia 35 -Local hyperthermia 35 -Regional hyperthermia 38 -Whole body hyperthermia 39 Review of WEfl.T investigations 43 SECI' ION II INrriAL RESEARCH Cllapter IV IEVEIDPMENI' OF THE .AilM'.I'ED EOMP-SIEMENS CABIN ME:I'HOD History 49 The Porrp Siemens cabin 49 Animal experiments 52 1) Investigation of operational aspe::ts and heating capacity of the cabin and general toxicity of WEHI' in dogs 52 2) M=!asurement of cerebral temperature and epidural pressure during WEfl.T in dogs 63 Temperature measurements in some patients under hyperthennic conditions 69 1) Temperature measurements during c. parvun fever therapy 69 2) Temperature measurements in a patient treated in a peripheral clinic 71 The lbtterdam patient series 72 SECriON III THE CLINICAL TREATM!NI' Chapter V MM'.ERIAIS AND MEI'HOOO Criteria fOr selection 79 Patients not accepted 85 Patients accepted 87 The WEHr treatment procedure 87 l'bni toring procedures 90 Hepatic clearance of ICG 92 Evaluation of tumour resp::>nse 94 Case rep::>rts 95 Chapter VI RESUUI'S Efficiency of heating teChnique 115 -Heating rate 116 -Heat dose 118 -Temperature distribution 121 Physiology 125 -'I'umour_I:H 125 -cardiovascular changes during WlHl' treatment 128 Resp::>nse 129 -objective tumour resp::>nse 129 -Palliative effect 133 -'I'he occurrence of metastasis following WlHl' 135 -Survival time 135 Toxicity 135 -General toxicity 135 -Severe toxicity 138 -Hepatic clearance of ICG 142 Cost and benefit 145 Chapter VII DISCUSSION Efficiency of heating technique 149 Turrour pi 154 Tumour response 155 Toxicity 158 -General toxicity 158 -Severe toxicity 161 Induction of metastasis by WlHI' 168 Survival time 169 Profit score 170 Are there future indications for WEHr ? 172 Conclusions 173 SU!vMARY 177 SAMENVMT ING 179 GIDSSARY OF ABBREVI.m'IONS 181 REFERENCES 183 Ili\NKWX)RD 199 CURRICULUM VITAE 205 INTRODUCTIONARY Section I INTRODUCTION Chapter I History The concept that hyperthennia may be useful as a modality for the treatment of malignant tumours is not as recent as it may seem. The history of the use of increased temperature for tumour treatment has been described by a mnnber of authors and one of these reviews dates fran 1927! (Westenna.rk, 1927) As long ago as around 2000 years BC, Rarnajana used ferrum candens to extirpate tu­ rrours. Cauterisation of small and non-ulcerating tumours was also recarrnended by Hippocrates (460-377 BC). In the 15th century, Leonides employed heat for the treatment of large ulcerating tumours, particularly for tumours of the breast. Ferrum candens was used both for destruction of the tumour and to con­ trol the bleeding. Fernnn candens was only infrequently used after this period as increasing skill in controlling haemorrhaging by blood vessel ligation resulted in growing use of the scalpel. HOwever, the high temperature used in the above mentioned techniques, is quite different fran the temperature range used nowadays in the treatment of cancer. The concept that tumour tissue can be destroyed by a temperature increase of only a few degrees above the normal physiological level also has a long history. Kluger (1980) describes how, in the 4th century AC, Rufus of Ephesus 9 had observed the beneficial role of fever, and had advocated the use of fever induction for the treatment of, anong other diseases, malignant tumours. In the 19th century, two pUblications appeared reporting tumour regression and even cure of patients follc:Ming infection accompanied with high fever (Busch 1866, Bruns 1888). At the end of the 19th century, Coley was administering bacterial pyrogens to induce pyrexia in cancer patients. In a review, his daughter (Nauts, 19828) states that cauplete regression and five-year survival had occurred in 46% of 523 inoperable cases and in 51% of 374 operable cases. '!he beneficial effects of such fever therapy are attributed, according to sane imrnunotherapists (Mastrangelo et al, 1984), to stimulation of the immu­ nological system. The observation that results improved When higher tempera­ tures were attained (Nauts, 19828), however, can be interpreted by the finding that heat itself is a cytotoxic agent. In the last decade of the 19th century, several observations were made that are relevant to the present-day status of F Fi~t. 2. Fig. I - 1 HYPERTHERMIA A NEW CANCER TREATMENT MODALITY ? The system used by Westermark ( 1898 ! ) to heat malignant tumours of the uterine cervix. Water heated in the cylinder ("fig. 1") flows through the coil ("fig. 2") which is placed against the cervical tumour. WesJermark observed good palliative results when tumour temperatures of 42-44 C were achieved. 10 hyperthermia. In 1898 Westermark (westermark, 1898) described the results following treat­ ment of uterine tumours, using hot water circulating within a metal tube placed around the cervix (figure I-1). He reported that by using temperatures of at least 42°C within the tube, the symptoms of large ulcerating and bleed­ ing tumours could be alleviated. He also found that, When higher temperatures were employed, the time necessary for syrrptan release became shorter. In the period 1900-1966, publications on hyperthermia began to appear sanewhat more frequently. These reports include investigations on the effect of hyperthermia in experimental tumour systems, both in vivo and in vitro, fever therapy, high frequency induction of hyperthermia, comparisons of nonnal and tumour cell sensitivity, the time-temperature relationship with regard to hyperthermia effect, the combination of hyperthermia and radiotherapy, and many more topics that are even now still being investigated. The relatively low level of interest in hyperthermia before 1967 was probably due to the rapid developments in cancer treatment modalities sudh as surgery, radiotherapy and chemotherapy. M:lreover, any existing interest was hindered by the many technical difficulties involved in the application of hyperthermia. The present revival of research into hyperthermia is believed to start with Cavaliere's publication in 1967, in Which he describes how animal tumour cells are damaged by heat to a greater extent than nonnal cells, and how hyper­ thermic regional perfusion in limbs of patients (41.5°C - 43.5°C) resulted in complete disappearance of tumour in 10 of 22 patients (Cavaliere et al, 1967). Since 1967, the increase in interest in hyperthermia, as measured by the num­ ber of publications and the number of participants in (international) meet­ ings, seems to follow an exponential curve. A large number of investigations was perfonned on the effect of hyperthermia in experimental tumour systems, on cellular as well as tissular level. The aims of these studies were, and still are, to learn how hyperthermia acts and, finally, how hyperthermia can be ap­ plied optimally to patients. The outccme of these investigations has been premising fran the start: hyperthermia results in cell death and, thanks to physiological differences between tumour tissue and nonnal tissue, results specifically in tumour cell death up to a certain dose level. Furthennore, hyperthermia effect appeared to be carq:>lementary to radiotherapy effect in tumour tissue, thus providing a desirable addition to local tumour treatment (see Chapter II). These premising results of experimental researCh -were, almost immediately, followed by an increasing number of clinical inves­ tigations. 11 Participation in the hyperthermia research at the Rotterdam R:tdio-Therapeutic Institute originates fran 1976, when we received, by courtesy fran Messrs Siemens, a "hyperthermia cabin", an apparatus with Which hot air, radio­ frequency and microwave energy could be simultaneously used to induce in­ creased temperatures in tumours in patients. Objectives '!he ultimate aim of the Rotterdam investigation was the hyperthermic treatment of human tumours, in order to eliminate those cell populations Which are resistant to other treatment modalities. By the time that this investigation was started, only few publications on the clinical application of local hyper­ thermia had appeared (Holt 1975, LeVeen et al 1976, Hornback et al 1977). In these publications information on tumour temperatures achieved generally was missing. cne of the problems anticipated to occur during local hyperthermia was the influence of blood flow on temperature distribution. The cells around a blood vessel entering the tumour,
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