• Introduction
 • Important Warning  
 • About Vitamin B17
 • Vitamin B17 as Preventative
 • Metabolic Therapy in Cancer
 • B17 In Metabolic Therapy
 • Laetrile and Cyanide
 • Graphic on Action of B17
 • Frequently Asked Questions
 • B17 Therapy Components
 • Accessory Supplements
 • B17 Therapy Overview
 • Therapies and Protocols
 • What is in B17 Therapy?
 • Maintenance Dosages
 • Accessory Therapies
 • Positive Thinking
 • Implementing Changes
 • Behaviour of Tumours
 • Criteria For Evaluation
 • B17 - Sickle Cell Anaemia
 • Fluoridation-linked cancer
 • Contacts 
 • In God We Trust
 • References

•  More Studies, Research

Summary
A total of 257 patients with a diagnosis of inoperable lung cancer in all its histologic types, clinical stages and grades of functional capacity (KP.S.—Karnofsky Performance Status) were treated intravenously with AMYGDALIN for three weeks and orally, with or without the intravenous application for the remainder of the study or until voluntary suspension. There were 15 complete remissions, 17 partials and 110 stabilizations for six or more months; 55.25% of the patients survived 12 or more months from the date of diagnosis and 34.63% from the initial dose of AMYGDALIN. It is concluded that although this study is considered to be a Phase II study, it proves the antitumoral effect of AMYGDALIN and justifies more Phase II and Ill studies. We conclude that the use of AMYGDALIN is an acceptable palliative for pa tients with inoperable lung cancer. There was no evidence of AMYGDALIN toxicity.

Introduction
Lung cancer is responsible for more than 20% of the deaths caused by malignant neoplasms in the USA and other highly Industrialized countries. It is the most frequent cause of death from cancer in males and the third in women. After malignant neoplasms of the skin, it is the most frequent and its incidence has not ceased to increase in parallel form to the per capita consumption of tobacco. Its mortality rate is currently 25 times greater than that recorded 45 years ago. Only 20% of those contracting lung cancer will be candidates for surgical treatment leading to a cure and only 10% will survive five years. The me dian survival will hardly pass 25 weeks and in the anaplastic variety of small cells, probably will not ex ceed seven weeks after the diagnosis, if the disease is extensive.

We believe that all of this justifies and makes imperative the search for new substances that will im prove the prognosis and/or the quality of life of the patients with inoperable lung cancer.

This Phase Ill study is based upon the findings reported in our previous Phase I and Phase II studies in which AMYGDALIN showed anti-tumoral effect upon patients with inoperable lung cancer.

Patients and Methods
Included in this study were all those patients who entered the Centro Medico y Hospital Del Mar with confirmed diagnosis of inoperable lung cancer between Jan. 1,1975 and Dec. 31, 1977, and who had received a minimum of six weeks treatment with AMYGDALIN. There was no selection made according to histologic type, extension of the disease or functional capacity.

The patients were evaluated before beginning their treatment, at least with a document that confirmed the histopathological diagnosis of their illness, A-P and lateral chest X-rays, complete blood counts, tests for renal and hepatic functions, glycemia and electrolytes. Their complete clinical history was taken and according to each case, the necessary, complementary studies were requested. Each patient was followed for a minimum of two years or until death.

All patients started on AMYGDALIN the day they entered the institution according to the schedule outlined in Chart I. AMYGDALIN was continued until the patient's voluntary suspension or death oc curred.

Included as an integral part of the treatment for all patients was a diet rich in proteins, moderate in carbohydrates and low in fats and salt. They always received vitamin and mineral supplements, proteolytic enzymes and it was insisted that they avoid the use and ingestion of toxic and/or carcinogenic substances.

The patients were grouped according to their histopathological type, extension of the disease and functional capacity, in accordance with classifications which are accepted on a world wide basis and which are presented in Charts 2, 3 and 4.

An evaluation was made of the objective responses (see Chart 5), the survival to twelve months, from diagnosis and from the initiation of AMYGDALIN. The differences that existed in each one of the histopathological types were analyzed in accordance with the extension of the disease and the functional capacity of the patient upon the initial application of AMYGDALIN. Finally, the results were compared with historic controls. It should be mentioned that concerning the patients who were "lost," the date of the last contact was considered to be the date of death.

Results
A total of 257 patients with inoperable lung cancer, adequately documented, were included in the study. 183 patients were men and 74 were women. The average age was 56, the youngest was 24, and the oldest was 85. Persistence or recurrence of the disease because of failure of previous treatments was verified in 192 patients and 65 patients received radiotherapy to the primary lung tumor simultaneously with AMYGDALIN. At least once, conventional chemotherapy was administered to 21 patients simultaneously with AMYGDALIN. The findings in these last patients will be included in another study.

The distribution of the patients according to histological type, extension of the illness and functional capacity are reported in Chart 6.

Objective Responses
Fifteen patients (5.83%) showed complete remission: nine of the squamous cell type, two anaplastic of small cells, two adenocarcinomas and two with carcinoma of large cells. It should be mentioned that three of these patients with squamous cell carcinoma, one anaplastic of small cells and one with car cinoma of large cells had received other conventional treatments prior to AMYGDALIN, which was felt to contribute definitively to the response obtained. The other nine had failed treatment or had not previously received conventional treatment.

Seventeen patients (6.61 %) showed partial remission: four of the squamous cell type, four anaplastic small cell, five adenocarcinoma, one carcinoma of large cells and three unclassified.

A total of 110 patients (42.8%) showed stabilization of their illness for a minimum of six months from the administering of AMYGDALIN: 44 squamous cell type, 23 anaplastic small cell type, 35 adenocar cinomas, three carcinomas of large cells and five were not classified. The total of complete and partial remissions was 32 patients (12.45%) and 142 of the 257 patients (55.25%) demonstrated, at least, stabilization of their disease.

Average Survival
The average survival, from diagnosis, for the 257 patients was 59.45 weeks: 62.93 weeks for those with squamous cell type; 45.5 weeks for the anaplastic type of small cells; 56.42 weeks for adeno carcinomas; 80.29 weeks for large cell carcinoma and 52.08 weeks for those not classified.

The median survival counting from the initiation of AMYGDALIN for the 257 patients was 35.75 weeks: 34.72 weeks for those with squamous cell type; 26.04 weeks for the anaplastic, small cell type; 32.55 weeks for those with adenocarcinoma, 50.73 weeks for the large cell carcinomas and 26 weeks for the unclassified ones.

Survival According to the Extension of the Disease
Fifty-nine of the 106 patients (55.66%) with limited suffering at the onset of AMYGDALIN survived twelve months or more counting from the diagnosis. Eighty-three of the 151 patients (54.96%) with exten sive suffering at the onset of AMYGDALIN survived twelve months or more from diagnosis. Of the 142 sur viving patients at twelve or more months from the diagnosis, 59 (41 .5%) had limited suffering and 83 (58.5%) extensive disease upon initiating AMYGDALIN. Forty-one of the 106 patients (38.67%) with limited disease survived twelve or more months from the initial dose of AMYGDALIN. Forty-eight of the 151 patients (31 .78%) with extensive suffering, survived twelve months or more from the initial dose of AMYGDALIN. Of the 89 patients who survived twelve months or more from the initial application of AMYGDALIN 41 (46.06%) had limited disease and 48 (53.93%) extensive disease upon initiating AMYGDALIN.

Survival According to Functional Capacity
Ninety-three of the 147 ambulatory patients (63.26%) (K.P.S. 0, 1 and 2) upon initiating AMYGDALIN, survived twelve months or more from the time of diagnosis. Forty-nine of the 110 patients (44.54%) con fined to chair or bed more than 50% of the hours under care (K.P.S. 3 and 4) upon initiating AMYGDALIN, survived twelve months or more from diagnosis. Of the 142 patients who survived twelve or more months from diagnosis, 93 (65.49%) had a K.P.S. of 0, 1 or 2 and 49 (34.5%) had a K·P.S. of 3 or 4 upon initial use of AMYGDALIN.

Sixty-five of the 147 ambulatory patients (44.21%) survived twelve months or more from the initial use of AMYGDALIN. Twenty-four of the 110 patients (21.81 %) with K.P.S. of 3 or 4, survived twelve months or more with the usage of AMYGDALIN. Of the 89 patients who survived twelve or more months from the initial use of AMYGDALIN, 65 (73.03 %) were ambulatory and 24 (26.96%) had a K.P.S. of 3 and 4 upon its initiation.

Survival According to Objective Response
Survival of twelve months, from the time of diagnosis for those patients with complete remission was 86.66% (13 of 15 patients), for those with partial remission was 70.58% (12 of 17 patients), for those showing stabilization 60% (66 of 110 patients) and for those that showed progress 45.21% (52 of 115 patient 5).

Survival to 24 months from the diagnosis for those patients with complete remission was 73.33% (11 of 15 patients), for those with partial remission was 23.52% (4 of 17 patients), for those exhibiting stabilization was 28.18% (31 of 110 patients) and for those who showed progress 9.13% (22 of 115 patients).

The survival of twelve months, from the commencement of AMYGDALIN for the patients with com plete remission was 80% (12 of 15 patients), for those patients with partial remission was 52.94% (9 of 17 patients), for those who exhibited stabilization was 52.72% (58 of 110 patients) and for those that showed progress 19.13% (22 of 115 patients).

Survival to 24 months starting with the initiation of AMYGDALIN for those patients with complete remission was 73.33% (11 of 15 patients, for those with partial remission was 23.52% (4 of 17 patients), for those patients exhibiting stabilization was 19.09% (21 of 110 patients), and for those showing pro gress 5.21% (6 of 115 patients).

The survival of the 257 patients in function of the histological type, extension of the disease, functional capacity and objective response, is summarized in Chart 7.

The comparative analysis of the survival of these 257 patients with historic control is included in Chart 8.

Toxicity
There was no evidence of chronic or acute toxicity attributable to the use of AMYGDALIN in any of the patients exposed to the dosages employed in this study. No patient suspended AMYGDALIN because of undesirable effects.

Other Findings
A total of 191 patients (74.31%) were smokers and 113 (43.96%) had immediate relatives with diagnosed cancer. The frequency of lung cancer was greater in males (2.47:1) and also predominant in the fifth and sixth decades of life. The distribution of metastases was similar to that reported in other studies of metastasis from lung to lung, bone, brain and liver.

Subjective Response
There was clear improvement in the quality of life and capacity, above all in the patients with K.P.S. 3 and 4. Tolerance to radiotherapy was increased significantly in the patients

Discussion
So far as we know, this is the first strictly prospective and non-selective study performed on patients with malignant neoplasms, using AMYGDALIN as the only systemic antitumoral agent. This should be considered a Phase II study because of the use of historic controls for comparative analysis. Even so, the following valid conclusions can be drawn:

All these results are better than those reported in other studies, even with programs of polychemo therapy with illness above 30% and mortality between 34%

We believe, then, that even accepting that this study has faults and deficiencies, it Is sufficient to justify the continuation of Phase Ill studies with stricter criteria than in medical institutions of renowned prestige and experience and that we continue to follow the patients in this study to the end of reporting long-term survivals in subsequent papers.

A Phase Ill study is currently being carefully prepared with a minimum of 100 patients with anaplastic carcinoma of small cells, treated with AMYGDALIN, with or without radiotherapy at the primary tumor site, and other Phase II studies about patients with large cell carcinoma.

We conclude that AMYGDALIN is a successful, anti-tumoral agent for the paliative treatment of pa tients with inoperable lung cancer, in therapeutic dosages which are practically atoxic when prescribed under strict medical supervision and the possibility should be considered of using it: