Similar deleterious effects were seen with acid lipid preparations obtained from organs when their administration apparently was at variance with the pattern present.

W. S., 56 years old, had a carcinoma of the cheek mucous membrane which led to wide perforation. Biopsy of the edges of the ulceration showed squamous cancerous tissue. Based upon the urine analysis, which indicated low specific gravity and high pH, treatment consisted of two daily injections of 1 cc. of the acid lipid fraction of placenta in a 5% solution in oil. As the patient was treated on an ambulatory basis, he was advised to see us in a few days. He continued the treatment without any control for two weeks. When next seen, a marked gelatinous edema of the tissues surrounding the ulceration was found and the patient complained of severe pain. Biopsy at this time revealed, in addition to interstitial edema, a high vacuolization of the cancerous cells which had not been seen in the biopsy done the day prior to beginning treatment. The pain became unbearable a few minutes after each injection. These local changes were accompanied by a marked deterioration of the general condition, the patient complaining of a sensation of weakness. The unfavorable changes which occurred in only two weeks were very impressive.

Favorable results were obtained even in terminal cases with these fraction preparations. In some cases, arrest or disappearance of tumors was noted. In most cases, however, these effects were only temporary. After being arrested for months or even years by these lipid preparations, some tumors began to grow and to become painful and could not be as readily controlled again by the same preparation. In a small number of patients, about 3% of the group of 200 treated with these preparations, the favorable results could be maintained over a number of years.

Even with the relatively strict guidance of therapy by the analyses available at the time, results were not always favorable. We attributed this both to the agents used for therapy and the criteria employed for recognition of offbalances. For a long time, research was devoted to developing means to permit better recognition of offbalances and to ascertain the value of the various analyses used as criteria for the conduct of treatment. Each new urine or blood test was investigated as a criterion for the group of lipids to be administered. This led to better results in controlling pain, improving the general condition and even in objective changes in tumors.

However, the temporary character of the effects obtained with lipids derived from normal organs appeared more and more evident in long term appraisal of results. We changed from human placenta to other sources for both acid and insaponifiable fractions. We prepared and used lipids from different organs of cow, pig, fish, and chicken. We also used mol lusks, chicken embryos, molds and even microbes, as well as milk and eggs as source for these lipids. In one group of investigations, we even tried to use lipids of the organ from which the tumor derived. Most of these preparations satisfactorily controlled pain, and in some cases, good results were seen in the growth of tumors.

The following observation concerns a case treated with the lipoacids of human blood.

A. M., a 56-year old man, was referred to us by his physician with a diagnosis of cancer of the rectum. Difficulty in defecation, mucosanguinol ent discharges, and pain in the rectal region had been increasing in the three months prior to the diagnosis. Examination had revealed a tumor of a cauliflower type, starting at about 4 cm. from the anal orifice and almost entirely filling the rectal ampulla. A biopsy had shown it to be an adenocarcinoma, Grade III. The patient had refused surgical intervention because, years before, a minor operation on his right hand had led to local infection followed by amputation of the hand.

At the time he was referred to us, his main complaints were pain in the rectum, radiating to the left leg, and tenesmus with frequent mucosan guinolent discharges. We employed daily injections of 1 cc. of a 5% oily solution of the acid lipidic fraction obtained from human blood. The treatment was continued for six weeks, the injection being given daily during the first two weeks and twice a week thereafter. After one week, the pain and tenesmus disappeared and there was a decrease in the mucosanguinolent discharge. There was also an obvious decrease in the size of the tumor. In less than a month the tumor regressed to one fourth its original size; in six weeks, digital and proctoscopic examination showed no clinical tumor. A whitish scar could be observed in the posterior wall of the rectum. Thereafter, the condition of the patient was followed indirectly through reports from his physician. There was no tumor recurrence in spite of the fact that he received no further treatment. He died six years later from an acute paratyphoid infection.

Our clinical experience provided ample evidence that the preparations rich in polyunsaturated fatty acids would influence pain as well as the growth and evolution of human cancers. Using the same amounts of poly ethenic fatty acids prepared from various sources, no differences in effects could be noted. The effect upon tumors in all instances was relatively limited.

Our next effort was to try fatty acids unlike those found in the organism. They included norbixine—the monomethyl ester of the bicarboxylic acid, bixine—which we used in a group of patients between 1938 and 1940. With urinary specific gravity and pH as criteria, daily doses of from 1 mgr. to 100 mgr. were administered to 30 preterminal and terminal patients with patterns corresponding to predominance of sterols. Even with small doses, the changes toward a predominance of fatty acids were impressive. Superficial, massive tumors were often seen to melt away within a few days, usually leaving ulceration in their place. This rapid change of a massive tumor into an ulcerated one, however, usually was followed by a manifest deterioration of the general condition. With this preparation, once the offbalance was changed from the original to the opposite type, attempts to control the new offbalance were usually unsuccessful. This led us to discontinue its use at this time in spite of the rapid and intensive changes it induced in tumors.