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Published on IPT by permission of Donato Perez Garcia, M.D. I. CARCINOMA OF THE BREAST: CASE 1
FIGURES ** Case I Ca of Breast
I. - CARCINOMA OF THE BREAST: CASE 1 <Return to top of page> This is the case of a fifty-three year old female who discovered a mass in her right breast in May of 1985. A mammogram ordered by her treating physician reported findings suspicious for malignancy (figure I.1). An excisional biopsy of the breast mass was done on 6/1/85 revealing an infiltrating ductal adenocarcinoma (figure I.2). Following surgery, the patient was prescribed a course of radiation therapy. She received only three of her scheduled radiation treatments and was subsequently lost to follow-up. This patient received no other form of treatment in the management of her disease. She next sought medical attention for her condition in August of 1986 - some fourteen months later. At this time the patient presented to the Drs. Perez Garcia with complaints of pain, swelling, and ulceration in her right breast with foul smelling discharge. She also complained of pain, swelling, and immobility in her right arm, frequent low-grade fevers, and a weight loss of thirty pounds (fourteen kg) over the previous two months. - PHYSICAL EXAMINATION: The patient appears older than her stated age. She
is pale and weak and in moderate distress due to pain in her right breast and arm. - LABORATORY INVESTIGATIONS: Hgb 12.0 gm%. Hct 39%. RBC 3.2 x 106/mm3. WBC 12,300/mm3 with a normal differential count. Glucose 70 mg%. Sodium 134 meq/L. Potassium 4.2 meq/L. Chloride 98 meq/L. BUN 18 mg%. Creatinine 1.1 mg%. Calcium 8.0 mg%. Phosphorous 3.9 mg%. Cholesterol 200 mg%. Total protein 5.8 gm%. Albumen 3.2 gm%. Globulin 2.4 gm%. Bilirubin (total) 0.4 mg%. SGOT 38 mU/L. LDH 140 mU/L. Alkaline phosphatase 50 mU/L. Urinalysis showed a trace of protein and 5 - 10 WBC/HPF. The chest xray was normal. The patient refused all other investigations ordered (bone scan, brain scan, liver-spleen scan,). As best as could be determined from the available clinical and laboratory data, this patient had a Stage IIIB recurrent carcinoma of the breast (T4C N2 M0). On August 19, she began a series of weekly treatments with IPT during which she received the following medications: regular insulin - 15 units IV; Genoxal (Schering - cyclophosphamide 500 mg/25 ml) 1.0 ml IV; Methotrexate (Lederle - methotrexate 50 mg/20 ml) 3.0 ml IV; and Fluorouracil (Roche -5-fluorouracil 200 mg/10 ml) 5.0 ml. Upon completion of twelve weekly treatments with this regimen, the patient was relieved of all her complaints and abnormal physical findings. There was no more pain in her right breast or arm, and the ulcerated area around the areola had healed leaving some residual thickening in the skin. There were no palpable masses in either breast, and no palpable cervical or supraclavicular lymphadenopathy. The pretreatment involvement of the patient’s right axilla with tumor had resolved completely, and there was a concomitant return to normal size, color, and functional capacity of the affected arm. During the entire course of this patient’s treatment, she experienced no adverse reactions from the chemotherapeutic agents used, nor from the insulin administration. A control mammogram done on October 28, 1986, reported "...a slight thickening in the skin in the right retroareolar area. Actually no calcifications or tumor masses are identified. It is considered that there exists a notable improvement and/or cure" (figure I.3). This patient continues with regular follow-up examinations, and to date (4/92) has shown no evidence of recurrence of her disease. BILATERAL MAMMOGRAM: May 23, 1985. (translation) PATHOLOGY REPORT (translation) BILATERAL MAMMOGRAM: OCTOBER 26, 1986. (translation)
II. - CARCINOMA OF THE BREAST: CASE 2 <Return to top of page>
- PHYSICAL EXAMINATION: The patient appears her stated age and is in no
acute distress. A chest xray and bone scan were negative, and there were no abnormalities in the patient's hematology or biochemistry. This patient's disease was classified as stage IIB (T2 N1 M0). Treatments were begun the day following her xeromammogram which was taken on February 3, 1989. She received a total of eight treatments, twice a week for two weeks and then once a week for four weeks. In these treatments the patient was given the following medications: regular insulin 18 units IV; Genoxal (Schering - cyclophosphamide 500 mg/25 ml) 1.0 ml IV; Methotrexate (Lederle - methotrexate 50 mg/20 ml) 3.0 ml IV; and Fluorouracil (Roche - 5-fluorouracil 500 mg/10 ml) 2.0 ml IV.
III. - METASTATIC CANCER OF THE BREAST <Return to top of page> This is the case of a patient with metastatic breast cancer of the liver who was treated with the IPT protocol by Dr. Michael Fink of the Klinikum Furth in Furth, Germany (Postfach 25 45, 8510 Furth, Germany). Dr. Fink had for some years been working on the concept of insulin-recruitment of breast cancer cells to enhance the effects of chemotherapy. He had come across publications on IPT appearing in the scientific medical literature, and a sharing of information ensued between ourselves and this German physician/researcher. A copy of the IPT protocol for breast cancer was sent to Dr. Fink on December 16, 1991. According to this protocol, subjects receive (intravenously) regular insulin 0.3 units/kg body weight, followed by cyclophosphamide 15 mg/m2, methotrexate 5 mg/m2, and 5-fluorouracil 75 mg/m2, followed again by an infusion of glucose solution. These treatments are given twice a week for three weeks, and weekly thereafter for six to nine weeks according to the clinical response. Dr. Fink's treatment of this patient began in mid-January of 1992. The information about this case was communicated to us informally, by letters (figures III.1 & III.2), thus there is no comprehensive clinical information on the case - except for the history of breast cancer with metastases to the liver documented by ultrasonography. Following applications of the IPT protocol, it was observed by liver ultrasound examinations that this patient's liver metastasis was reduced to seventy percent of its original size after one week (two treatments), and to eighty percent of this residual size after the second week of treatment (figures III.3 & III.4). Thus, overall, the liver metastasis was only fifty-six percent of its initial size after two weeks of treatment using sub-therapeutic doses of anticancer agents administered during a period of insulin-induced hypoglycemia. In this particular patient's case, subsequent IPT treatments failed to provide further reductions in the size of the liver lesion, and it was therefore decided to switch the patient to a more conventional chemotherapy protocol using high-dose epirubicin. This case presentation is illustrative in two important regards. First, it indicates the potentiating effect that insulin can have on the effects of low or sub-therapeutic doses of chemotherapeutic agents. Second, the clinical failure evident in this case points out the great difficulty encountered in treating cases of recurrent malignant neoplastic disease. As is evident from the several cases described in this "Best Case Series", optimal clinical results with the practice of IPT are obtained in the treatment of newly diagnosed cases of malignancy. The years of clinical experience with IPT have produced results which mirror those of conventional oncologic practice. Clinical outcomes are always poorer in those cases where patients have already undergone some course of conventional anticancer treatment, such as extensive surgery, high-dose toxic chemotherapy, and/or radiation.
IV. - CARCINOMA OF THE CERVIX: CASE 1 <Return to top of page> This is the case of a forty year old female with a six month history of vaginal bleeding accompanied by vaginal discharge and burning. She also complained of increasingly severe lower abdominal pains. Ten years earlier, the patient had undergone a partial hysterectomy, leaving her cervix intact. On October 15, 1971, she consulted with a gynecologist who performed a Pap test which was reported as Class IV, strongly suspicious of invasive epidermoid carcinoma (figure IV.1). This diagnosis was confirmed by a cervical biopsy done on November 4 (figure IV.2). The patient presented to Dr. Perez Garcia for treatment of her disease on November 16, 1971. This patient received no other form of treatment in the management of her disease. - PHYSICAL EXAMINATION: The patient is a forty year old female appearing her
stated age, and in no acute distress. Abdomen: Soft. No liver, spleen, or kidneys palpable. No masses. There is diffuse mild tenderness, most marked in the suprapubic area. The bowel sounds are normal. Pelvic examination: Vaginal introitus is morphologically normal with evidence of fetid, bloody vaginal discharge. There is blood and discharge in the vaginal vault. The visualized cervix is deformed and ulcerated by a tumor mass two to three cm. in diameter, and is very tender to palpation. There is no uterine fundus palpable, and there are no adnexal masses. The patient began a course of IPT treatments on November 16, 1971. The medications she received during her treatments were: regular insulin - 20 units IV; Endoxan (Asta Werke - cyclophosphamide 100 mg/ml) 1.0 ml IM. After nine weekly treatments the patient’s physical examination revealed no evidence of tumor. A repeat Pap test on January 17, 1972, was reported as negative (figure IV.3), and a repeat biopsy on January 28, 1972, reported chronic cervicitis without mention of any neoplastic changes (figure IV.4). The patient tolerated her IPT treatments without adverse effects from either the anticancer medications or the insulin. She remained in a good state of health, free from any signs or symptoms of her disease, for at least five years - after which she was lost to direct follow-up. News of this patient's continued survival and good health was received via testimony from several patient-referrals over the ensuing years.
V. - V. - CARCINOMA OF THE CERVIX: CASE 2CARCINOMA OF THE CERVIX: CASE 2 V. - CARCINOMA OF THE CERVIX: CASE 2CARCINOMA OF THE CERVIX: CASE 2 V. - CARCINOMA OF THE CERVIX: CASE 2CARCINOMA OF THE CERVIX: CASE 2 V. - CARCINOMA OF THE CERVIX: CASE 2CARCINOMA OF THE CERVIX: CASE 2 V. - CARCINOMA OF THE CERVIX: CASE 2 CARCINOMA OF THE CERVIX: CASE 2 <Return to top of page> This is the case of a twenty-two year old female complaining of a three month history of lower abdominal pain, dysuria, leukorrhea, and occasional intermenstrual bleeding. The patient was G2 P2 A0 and her last pregnancy was completed in September, 1969, with a normal, full-term vaginal delivery. Her treating physician discovered a mass in the patient’s vagina, and performed a biopsy. This reported a carcinoma of the cervix, mixed type adenoacanthoma (figure V. 1). The patient presented to Dr. Perez Garcia for the treatment of her disease on March 18, 1970. This patient received no other form of treatment in the management of her disease. - PHYSICAL EXAMINATION: The patient is a twenty-two year old female in moderate
distress complaining of lower abdominal and perineal pain. She also complains of dysuria,
tenesmus, leukorrhea, intermenstrual bleeding, and a weight loss of eighteen pounds (8 kg)
over the last month. She appears older than her stated age. Abdomen: The abdomen is flat and moderately rigid with some guarding and tenderness in the lower abdomen. There are no masses or organomegaly. The bowel sounds are normal. Pelvic Examination: Normal introitus with blood-stained, fetid vaginal discharge. The visualized cervix is enlarged and irregularly deformed by a six cm mass which is ulcerated and bleeding. Bimanual examination confirms the size of the lesion and reveals it to be tender and hard to the touch. The uterine fundus is retroverted and not palpable. There are no adnexal masses. Beginning on March 18, 1970, the patient began a series of nine treatments with IPT, receiving the following medications: regular insulin - 20 units IV; Endoxan (Asta Werke - cyclophosphamide 100 mg/ml) 1.0 ml IM. This course of treatment was tolerated without adverse effects from either the anticancer drugs or the insulin. After the patient’s last treatment, she was examined and found to be free of all symptoms and signs of her disease. A Pap test was done and reported as negative (figure V.2). A repeat biopsy was subsequently done and reported, "chronic cervicitis with leukoparakeratosis and foci of squamous metaplasia. No signs of anaplasia are observed" (figure V.3). This patient has remained in good health, free from her disease, and has gone through another full-term pregnancy which she delivered vaginally.
VI. - LARGE CELL ADENOCARCINOMA OF THE LUNG <Return to top of page> This is the case of a forty five year old non-smoking female who developed a left Horner’s syndrome in March of 1985. The diagnosis and etiology of this condition eluded a number of physicians who were consulted about it until September of that year. By that time, the patient had developed a persistent cough and a dull aching pain over her left posterior hemithorax, and she had a weight loss of 15 pounds (6.6 kg). An xray (figure VI.1) and a CAT scan (figure VI.2) of the chest demonstrated an infiltrate in the lower lobe of the patient’s left lung. A percutaneous needle biopsy of this lesion done at the Central Military Hospital in Mexico City reported a large cell adenocarcinoma of the lung. In October, the patient went to the Scripps Clinic in La Jolla, California, to consult on the management of her disease. Chest xrays (figures VI.3) and cytologic studies of fine needle aspirates confirmed the diagnosis of large cell adenocarcinoma of the lung (figures VI.4). After a discussion of treatment options available at the Scripps Clinic, the patient elected to return to Mexico City to receive IPT treatments from the Drs. Perez Garcia. Apart from the diagnostic work-up performed there, the patient received no treatment modalities for her disease during her stay in California. - PHYSICAL EXAMINATION: The patient is a forty-five year old female
complaining of a chronic, non-productive cough, weight loss, and a persistent pain over
her left hemithorax. Head & Neck: There was anisocoria with miosis of the left pupil and ptosis of the left upper eyelid, consistent with a left Horner’s syndrome. The rest of the HEENT was unremarkable. Chest: The respiratory excursions were full, and there was no dyspnea, cyanosis, or clubbing of the fingers. There were decreased breath sounds over the left hemithorax posteriorly and laterally with a few crepitations. The patient began treatments with IPT in January of 1986. In these treatments she received the following medications: regular insulin 15 units IV; Genoxal (Schering - cyclophosphamide 500 mg/5 ml) 1.0 ml IM; Methotrexate (Lederle - methotrexate 50 mg/20 ml) 3.0 ml IV. There were no untoward side-effects of these treatments - neither from the chemotherapeutic agents nor from the insulin. Clinically, the patient’s cough and back pain resolved following her first few treatments. She regained the weight she had lost, however the Horner’s syndrome persisted unchanged. After the eighth IPT treatment, a control chest xray was done. This reported a significant reduction in the size of the lesion in the left lower lobe, and a disappearance of the satellite lesions which had previously been seen in the left lung (figure VI.5). This positive change in the patient's xray, as well as the resolution of her symptoms, had been accomplished with just the sub-therapeutic doses of anticancer drugs and the insulin. The patient continued with several more of her IPT treatments and was thereafter lost to follow-up. When last seen she was in good clinical condition, free from all symptoms of her disease.
VII. - ADENOCARCINOMA OF THE PANCREAS <Return to top of page> This is the case of a sixty-four year old female who developed scleral icterus in September of 1986. This was followed by the appearance of jaundice and symptoms of nausea and anorexia. In October the patient sought consultation with her physician about these complaints, and an ultrasound examination of the liver and bile ducts was done on October 22. This reported a normal liver parenchyma without evidence of metastasis, the presence of cholelithiasis, and dilatation of the intra and extrahepatic bile ducts due to extrahepatic obstructive jaundice. The differential diagnosis was cancer of the head of the pancreas versus cancer of the ampulla of Vater (figure VII.1). On October 27 a CAT scan of the abdomen was done, confirming suspicions of a pancreatic cancer (figure VII.2). The patient was apprised of the possible diagnosis and the poor prognosis under her circumstances. In December, the patient went to the M.D. Anderson Cancer Center in Houston,Texas, to be treated for her condition. There she had a choledochoduodenostomy performed. During the intraoperative period a needle biopsy was taken from tissue in the head of the pancreas, and this reported an adenocarcinoma (figure VII.3). Apart from this palliative surgical procedure (choledochoduodenostomy), the patient received no other form of treatment for the management of her disease. In January, 1987, the patient presented to the Drs. Perez Garcia for treatment of her condition with IPT. - PHYSICAL EXAMINATION: The patient is a
sixty-four year old female complaining of a three months history of nausea, anorexia,
scleral icterus and jaundice, and a weight loss of 12 kg (27 lbs). She states that her
jaundice has diminished somewhat since her surgery in December, 1986. On January 15, 1987, the patient began a series of IPT treatments. The medications administered included: regular insulin 12 units IV; Genoxal (Schering - cyclophosphamide 500 mg/25 ml) 0.5 ml IM; Methotrexate (Lederle - methotrexate 50 mg/20 ml) 0.4 ml IV; and Fluorouracil (Roche - 5-fluorouracil 500 mg/10 ml) 0.2 ml IV. The patient underwent a total of eighteen treatments which she tolerated without adverse effects - either from the chemotherapeutic agents or the insulin. Clinically, her condition improved with this therapy. All her gastrointestinal symptoms abated and she was able to regain her lost weight. Her abdominal exam became essentially normal, and the supraclavicular lymphadenopathy and scleral icterus likewise cleared. On April 22, 1987, an ultrasound examination of the liver and bile ducts was done which reported a tumor in the head of the pancreas measuring 32 x 30 mm (figure VII.4). A repeat examination done on June 5 reported the body and tail of the pancreas to be normal in size with areas present in the head of the pancreas compatible with tissue necrosis (figure VII.5). Following the ultrasound examination in June, the patient began to take treatments on a once-a-month basis instead of once weekly. After her last treatment on October 2, 1987, this patient was lost to further follow-up. At that time, she was observed to be in a good state of health without any complaints or signs of her previously diagnosed condition.
VIII. - HODGKIN’S LYMPHOMA <Return to top of page> This is the case of a forty-five year old male who began experiencing fever and night sweats in November of 1984. Over an ensuing period of three and a half months he also developed dyspnea, dizziness, and a sharp pain in the right posterior hemithorax. A weight loss of 12 kg (27 lbs) accompanied the evolution of all these symptoms. The patient had a 23 pack-year history of cigarette smoking. Previous health history included a hemorrhoidectomy in 1974, and a L5-S1 laminectomy in 1980. The patient first presented with this history to the Central Military Hospital in Mexico City in late January of 1985. - PHYSICAL EXAMINATION: The patient was a forty-five year old male appearing
older than his stated age, complaining of fatigue, dyspnea, posterior chest pain, and
weight loss as above. - LABORATORY INVESTIGATIONS: Hgb 12.0 gm%. Hct 36%. RBC 3.4 x 106/mm3. WBC 15,400/mm3 with a normal differential count. Platelets 701,000/mm3. Glucose 110 mg%. BUN 11 mg%. Creatinine 0.9 mg%. Urinalysis was negative. Sputum for cytology was negative for malignant cells. Bone marrow aspiration showed no malignant infiltration. Liver/spleen scan was negative. AP and lateral chest xray revealed a dense 6 cm mass with irregular contours localized to the right hilar region. Chest tomograms confirmed the presence of the mass confined to the posterior mediastinum and producing extrinsic compression of the right inferior bronchus. Bronchoscopic examination revealed an extrabronchial mass compressing the right inferior bronchus. A biopsy specimen was obtained from the cervical mass. Pathological examination of specimens from the bronchoscopy and the cervical node reported a Hodgkin’s lymphoma, stage II-B (figure VIII.1). The patient was started on a conventional-dose chemotherapy regimen consisting of cyclophosphamide, adriamycin, vincristine, bleomycin, metclopramide, and prednisone. Following only one cycle of the prescribed course of treatment, the patient refused to go on because of severe side-effects of nausea, vomiting, weakness, and malaise. In February of 1985, the patient presented to the Drs. Perez Garcia for management of his condition with IPT. Apart from the one cycle of high-dose chemotherapy this patient had received no other form of treatment for his disease. With the exception of evidence of the recent cervical node biopsy, there was little change in physical findings from those described above. The Hgb was 9.0 gm% with a Hct of 32%, RBC 2.8 x 106/mm3, and WBC 17,500/mm3. The patient received a total of twenty-two IPT treatments at weekly intervals. The medications administered in these treatments included: regular insulin - 15 units IV; Genoxal (Schering - cyclophosphamide 500 mg/5 ml) 3.0 ml IM; Methotrexate (Lederle - methotrexate 50 mg/20 ml) 0.5 ml IM; Blanoxane (Bristol Meyers - bleomycin sulfate 15 units/5 ml) 0.2 ml IV; Adriamycin ( Adria Laboratories - doxorubicin 10 mg/5 ml) 0.2 ml IV; Decadron (dexamethasone 4 mg/ml) 0.2 ml IV. The patient tolerated his treatments without adverse effects, either from the chemotherapy agents or the insulin. The residual cervical mass disappeared, his chest pain, dyspnea, and weakness were relieved, and he gained weight up to 90 kg (203 lbs). All hematologic parameters returned to normal values. His pretreatment chest xray demonstrates the right hilar mass (figure VIII.2). Subsequent chest xrays showed a gradual reduction in the size of the right hilar mass. A chest xray taken following this patient's final treatment showed the right hilum to be essentially clear of the neoplasm (figure VIII.3). Follow-up xrays at yearly intervals have shown no recurrence of the chest lesion. Clinically the patient remains in good health up to the present time(4/92).
IX. - EWING’S SARCOMA OF THE BONE <Return to top of page> This is the case of a three year old female who was treated for an apparent fracture of her left wrist in June of 1970. When the cast was removed, it was observed that the swelling and pain were still present. A repeat xray demonstrated a gross deformity of the left distal radius (figure IX.1), and a subsequent biopsy reported a Ewing’s tumor of the bone (figure IX.2). The parents were apprised of the grave prognosis in the case, and that there was little that could be done with any expectation of saving the child’s life. The parents brought their child to Dr. Perez Garcia for a trial of IPT treatments. This patient received no other form of treatment in the management of her disease. - PHYSICAL EXAMINATION: The patient was a three year old female in distress due
to pain and swelling of her left wrist. She had a history of frequent febrile episodes and
a recent weight loss of 9 pounds (4 kg). The child received a total of seventeen treatments for her disease, beginning on August 18, 1970. These were tolerated without incident or drug-related side-effect. The medications administered during these treatments were: regular insulin - 5 units IM; and Endoxan (Asta-Werke - cyclophosphamide 100 mg/ml) 0.3 ml IM. After the eighth treatment, an xray was taken of the left wrist and demonstrated good bone neoformation with reestablishment of a more normal contour to the distal radius (figure IX.3). Upon completion of the series of treatments, the child was clinically well in all respects. An xray of this subject’s left arm eight years post-treatment shows no abnormalities (figure IX. PATHOLOGY REPORT (translation) Clinical Information: Tumor of the left forearm, radius and ulna with areas of rarefaction. Two months in evolution, afebrile, without pain. Consistency is soft. There is invasion of soft tissues. Inguinal and popliteal nodes are palpable. Macroscopic Description: During the surgical procedure, numerous fragments of tissue were received, pinkish in color and friable in consistency, measuring up to 0.5 cm. in largest diameter. From the frozen section a diagnosis was made of "malignant tumor of bone, probably Ewing’s Sarcoma". Specimens are included for parafin fixing and stained section. Microscopic Description: In the fixed and stained sections a neoplastic process is identified, very cellular consisting of polyhedric cells with round or ovoid nuclei. There are scant mitoses and the cytoplasm is eosinophillic. The cells appear in dense clusters within a thin fibrous stroma, which is well vascularized. There is perivascular infiltration by tumor elements within the tumor. The biopsy does not include normal bone. DIAGNOSIS: - Ewing's tumor of the distal third of the left radius. |
