The following statement concerning Coley's mixed toxins, preparations proposed for the treatment of cancer by William B. Coley, M.D. (deceased) and bythe New York Cancer Research Institute, Mrs. Helen Coley Nauts, ExecutiveDirector, was recently distributed to the 59 Divisions of the American CancerSociety for their information.

Coley's Mixed Toxins

After careful study of the literatureand other information available to it,and in view of the length of time whichthese toxins have been under investigation without any scientifically acceptable favorable reports, the AmericanCancer Society has found no evidencethat treatment with Coley's mixedtoxins results in any objective benefitin the treatment of cancer in humanbeings.

In 1893, William B. Coley, M.D. (deceased), formerly of Memorial Hospital, New York City, published paperson the treatment of malignant tumorsby repeated inoculations of erysipelasor the toxic products of erysipelas.These papers were followed by a seriesof other papers by Dr. Coley and different authors on cancer therapy withtoxins, and on the effects of infectionsand various bacterial filtrates onneoplasms.

Dr. Coley's interest in this form oftreatment continued throughout hislife, and his name has been used in association with the products which areusually referred to as Coley's toxins,Coley's mixed toxins, or occasionally asColey's serum. In the years 1892-1936,there were 13 different products produced in which different strains ofstreptococci, frequently combined withBacillus prodigiosus, were used in theirpreparations. Strains of Streptococcuserysipelatus were most commonly used,but the methods of preparation variedand at least five or six different individuals in separate laboratories aresaid to have prepared the various

toxins. Dr. Coley's daughter, Mrs.Helen Coley Nauts, reporting in 1953on her study of the literature, stated:“¿�Unfortunately, all but four of themore than 15 different formulae ofColey's toxins available in the past 60years were weak and variable.―1

In 1939, Mrs. Nauts began the taskof compiling data on various types oftoxins and their preparation; of collecting records of cases treated by Dr.Coley and others; and of reviewing theliterature pertaining to either the useof similar toxins or bacterial filtrates,or to the influence of infection on cancer. Space for her study was providedat Memorial Hospital, and she has enlisted interest and secured assistancefrom many physicians in this and othercountries. Her brother, Bradley L.Coley, M.D., who died in 1962, had alsogiven some aid, but apparently exhibited only limited interest, in theyears before his death.

A preliminary review of data on thetreatment of malignant tumors withColey's toxin was given in Cancer Research in 1946.2 In 1952, a bibliographyof the literature, and, in 1953, a reporton 30 inoperable cases which had beentreated by Coley's mixed toxins andhad survived thereafter for periods offrom 1 to 47 years (20 cases had a survival of over 20 years) were published.'

The report is said to be based on acomparative analysis of over 1,200cases treated with Coley's toxins, and300 cases in which intercurrent infections played a part. Over 270 caseswere said to have shown complete re

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Unproven Methods of Cancer Treatment

gression of the tumor, but the 30 inoperable cases were selected for the report because the diagnoses had beenconfirmed by microscopic examination,and some information on their subsequent history was available. Of the 30tumors, 7 were classified as carcinoma,19 as various types of sarcoma, 2 asmalignant melanoma, and 2 as giantcell tumors.

About 1953, the present ExecutiveDirector, Mrs. William B. Nauts (necHelen Coley) founded the New YorkCancer Research Institute, Inc. InMarch 1962, the address of the institute was given as 1225 Park Avenue,New York 28, N.Y. Fund raising booklets, the last of which was distributedin 1964, list 10 officers, 19 Trustees, anda Scientific Advisory Council consistingof 22 physicians from all parts of thecountry.

According to the 1964 fund raisingbooklet, “¿�painstaking tests of over 200variations in formulae resulted in theisolation of a mixed bacterial endotoxinwhich seems effective against certainexperimental cancers: when mice (inwhich .. . - Sarcoma 37 is growing) aregiven a single injection of this preparation, 50 to 80% of their tumors disappear and do not recur. Furthermore,these mice could not be implanted withthis type of tumor a second time—theyhad become immune. More extensivetests indicated that these mixed toxinswere unable to destroy several othertypes of cancer in mice, rats and rabbits . . - .“Although most of the workwith bacterial endotoxin which was reported was animal experimentation,they claimed in discussing the stimulation of body resistance “¿�byboth bac

terial and fungal extracts― that:“¿�Somepatients with certain cancers tooextensive to remove by surgery, or of atype resistant to radiation, have responded to such therapy. Some of theseextensive tumors have apparently disappeared, others have become operableand have been successfully removed.There is increasing evidence that preriminary treatment with microbial extracts enables patients to tolerate subsequent surgery, radiation or chemotherapy, with less deleterious effects ontheir general health and with more effective destruction of the tumor.―

From 1954-1957, a research groupat the New York University-BellevueMedical Center, New York City, wasgiven a grant by the National CancerInstitute to investigate the bacterialtoxin therapy. An investigator sponsored by the New York Cancer Research Institute undertook the investigation. The grant was not renewed because the study was not being conducted in a manner which would leadto a definitive conclusion as to the placeof bacterial toxins in the treatment ofcancer. There was little objective basisoffered for believing that bacterialthxin therapy had significantly alteredthe course of disease in any of thetreated cancer patients.

References

1. Nauts, H. E.; Fowler, C. A., and Rogatko, F.H.: A re-iew of the influence of bacterial infectwa and of bacterial products (Coley's Toxins) onnrnlzgnant tumors in nian. Aeta Medh-a Seandin.145, Supp.: 1-103, 1953.

f. Nauts, H. E.; Swift, TV. E., and Coley, B. L.:The treatment of malignant tumors by bacterialtoxins as developed by the ktte William B. Coley,M.D., reviewed in the light of modern research.Cancer Res. 6: @05-216,191,6.

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