Dr. Weeks’ Comment: The risks of chemotherapy clearly outweigh the benefits. If it were not so profitable (each cancer patient is worth approximately $300,000 to the oncologist), chemotherapy would not be offered! IPT is a safer option and more effective but Corrective Cancer Care is the superior option since it addresses the lethal cancer STEM cells while conventional chemotherapy and radiation do NOT effect these cells. Only the cancer STEM cells can metastasize. Everyone but your oncologist will tell you this.
Listen to the experts….
“As a chemist trained to interpret data, it is incomprehensible to me that physicians can ignore the clear evidence that chemotherapy does much, much more harm than good.”
– Alan Nixon, PhD, past President of the American Chemical Society
“Most patients in this country die of chemotherapy. Chemotherapy does not eliminate breast, colon or lung cancer. This fact has been documented for over a decade, yet doctors still use chemotherapy for these tumors”.
– Dr. Allen Levin, UCSF
“A six- or twelve-month course of chemotherapy not only is a very unpleasant experience but also has its own intrinsic mortality…treatments now avert…perhaps 2 or 3 percent…of the 400,000 deaths from cancer that occur each year in the U.S.” ”¨
– Professor John Cairns Scientific American, 1985
“My studies have proven conclusively that untreated cancer victims actually live up to four times longer than treated individuals. For a typical type of cancer, people who refused treatment lived for an average of 12-1/2 years. Those who accepted surgery or other kinds of treatment [chemotherapy, radiation, cobalt] lived an average of only three years. . . . I attribute this to the traumatic effect of surgery on the body’s natural defense mechanism. The body has a natural defense against every type of cancer.”
– Dr. Hardin Jones, Professor at the University of California,
“…if I contracted cancer, I would never go to a standard cancer treatment centre. Only cancer victims who live far from such centres have a chance.”
– Dr. Charles Mathe, French cancer specialist
“…a number of autopsy studies which have shown that cancer patients actually died from conventional treatments before the tumor had a chance to kill them.”
– Dick Richards in his book The Topic of Cancer: When the Killing Has to Stop
CANCER EFFECTING EVER MORE PEOPLE
As of 2011, cancer replaced heart disease as the #1 cause of death in the Western world, and #2 in developing countries.
CHEMOTHERAPY REMAINS POPULAR
When you are diagnosed with cancer, you are suddenly worth $300,000.00 to the cancer industry. Therefore, it should come as no surprise that there has been a 68% increase in the use of chemotherapy drugs since 2003 following the massive increase in the incidence of cancer since then. Given the facts, as we know them today, chemotherapy is still used because the Medical Establishment and Big Pharma make a LOT of money ($100 billion annually) from cancer patients not recovering naturally.
Dr. Glidden explains that, “If you go to a medical doctor with a sinus infection and that doctor prescribes an antibiotic, he gets no financial kickback. Now, if he prescribes 5,000 units of that antibiotic in one month, the drug company that makes it might send him to Cancun for a conference, but he gets no direct remuneration. With chemotherapeutic drugs, it’s different. Chemotherapeutic drugs are the only classification of drugs that the prescribing doctor gets a direct cut of.” The doctor buys it from the pharmaceutical company for $5,000, sells it to the patient for $12,000, insurance pays $9,000, and the doctor pockets the $4,000 difference. Dr. Glenn Warner, who died in 2000, was one of the most highly qualified cancer specialists in the United States. On the treatment of cancer in this country he said: “We have a multi-billion dollar industry that is killing people, right and left, just for financial gain. Their idea of research is to see whether two doses of this poison is better than three doses of that poison.” 9 out of 10 oncologists would refuse chemotherapy if they had cancer.
CHEMO DOES NOT HELP PATIENTS
Appearance of effectiveness ~ We are told that the survival rate has increased. However, what they do not tell you is that:
1. If a person dies during a chemotherapy study, that information is not included in the write up because the patient did not complete the study.
2. They combine data of both local and metastasized cancers; the comparisons are not randomized [Ulrich Abel, Advanced Epithelial Cancer”, 1990 (no longer in print) ]
3. Cancers not factored into the original statistics are now factored in, such as skin cancers, many of which are not fatal and that the statistics are purposely inflated by including people with benign cancers.
4. Technology has helped us to find cancers earlier, so what has lengthened is the survival time from diagnosis to eventual death.
5. They are now including in their stats non deadly skin cancers.
The TNM system classifies tumors on the basis of their gravity: stages I, II, III, IV, and into sub-groups. In the early stages of tumors (prognosis is dubious, a false positive) the recovery rates are extremely high. In the following stages (prognosis is certain) the rates are barely above zero. Adjuvant chemotherapy is often given to patients who might not really need it at all. Therefore, they are likely to get well. This greatly improves the statistical success rate. One study in the Annals of Oncology assessed the different potential long-term adverse events associated with adjuvant chemotherapy in cancer, with a particular focus on long-term cardiac toxicity, secondary leukemia, cognitive function, and neurotoxicity. The authors stated that the adverse events are frequently overshadowed by the highly touted clinical ”˜efficacy’ and/or reassuring short-term safety profiles of the different chemotherapy regimens commonly used today. In clinical studies the manufacturers always compare their new drugs with older cellular poisons. There are no control groups which are given no treatment at all or given effective natural alternatives.
The truth of the matter ~ A German epidemiologist from the Heidelberg/Mannheim Tumor Clinic, Dr. Ulrich Abel, has done a comprehensive review and analysis of every major study and clinical trial of chemotherapy ever done. To make sure he had reviewed everything ever published on chemotherapy, Abel sent letters to over 350 medical centers around the world asking them to send him anything they had published on the subject. Abel researched thousands of articles: it is unlikely that anyone in the world knows more about chemotherapy than he. The analysis took him several years, but the results are astounding: Abel found that the overall worldwide success rate of chemotherapy was “appalling” because there was simply no scientific evidence available anywhere that chemotherapy can “extend in any appreciable way the lives of patients suffering from the most common organic cancers.” Abel emphasizes that chemotherapy rarely can improve the quality of life. He describes chemotherapy as “a scientific wasteland” and states that at least 80 percent of chemotherapy administered throughout the world is worthless, and is akin to the “emperor’s new clothes” – neither doctor nor patient is willing to give up on chemotherapy even though there is no scientific evidence that it works! – Lancet 10 Aug ’91
The reason for failure ~ Chemotherapy does not target cancer cells, cure cancer, or address the underlying causes or the root of the problem. What mainstream medicine considers “successful” chemotherapy treatments only manage symptoms. Therefore, it is neither effective nor does it decrease morbidity, mortality or specific cancer rates. The actual failure rate in treating long-term metastatic cancers is 97%. Peter Glidden, BS, ND reported on the 12-year meta-analysis published in the Journal of Clinical Oncology. The 12-year study looked at adults who had developed cancer as an adult. 97% of the time, chemotherapy did not work in regressing the metastatic cancers. Based on the objective data of cost-effectiveness, impact on the immune system, quality of life, morbidity and mortality, it would be obvious that chemotherapy makes little to no contribution to cancer survival at all.
But don’t let the patient escape ~ One person out of two is claimed to recover from cancer. To the scientists this says: continue the research because it is producing results. Don’t get discouraged by the fact that patients keep on dying every day. To the patients, it provides a warning: you have a 50 percent chance of making it, as long as you obediently follow the Medical Establishment’s therapeutic “Standard of Care” protocols. Don’t try preventive, alternative, theoretical or therapeutic options, nor “useless” alternatives. Frank Wiewel met with some of the top oncologists in the country. He had a lot of questions for them, one of them being: “Knowing the odds of successful outcome using chemotherapy are nil in many cancer cases, why do you continue to prescribe chemotherapy?” The answer he got was: “We give it to patients so they won’t give up hope and fall into the hands of quacks.”
CHEMO HARMS PATIENTS
Causes unpleasant side effects ~ Chemotherapy drugs are “cytotoxic,” meaning that “they kill cells that are extremely active.” Cancer cells are extremely active but so are the cells in your stomach, intestines (70% of your immune system) and hair follicles. Side-effects include dizziness, skin discoloration, sensory loss, audio-visual impairment, extreme nausea and vomiting, diarrhea, loss of hair, loss of appetite (leading to malnutrition), loss of sex drive, loss of white blood cells, permanent organ damage, organ failure, internal bleeding, tissue loss, cardio-vascular leakage (artery deterioration), weight loss, mouth sores, rapid heart-beat, wheezing, difficulty breathing, skin rash, swelling, fever, chills, infection, unusual bleeding, bruising, abdominal and stomach cramps, loss of movement and coordination, muscle spasms, fits, seizures, convulsions, anemia, liver failure, and more aggressive cancer!
Causes DNA damage ~ Researchers tested the effects of a type of chemotherapy on tissue collected from men with prostate cancer, and found “evidence of DNA damage” in healthy cells after treatment (reported in Nature Medicine). This was a big slap in the face to mainstream medical organizations who have been pushing chemotherapy as the only option to cancer patients for years.
Causes cancer to be activated ~ Irwin Bross, a biostatistician for the National Cancer Institute, discovered that many cancers that are benign (although thought to be malignant) will not metastasize until they are hit with chemotherapy. Many people who’ve been diagnosed with metastatic cancer did not have metastatic cancer until they got their chemotherapy. Expensive cancer drugs not only fail to treat tumors, but actually make them far worse. The cancer drugs were found to make tumors metastasize and grow massively in size. As a result, the drugs killed the patients more quickly.
Causes cancer cells to spread faster ~ Chemotherapy is carcinogenic. It causes cancer. As chemotherapy destroys cells, including healthy cells, it disrupts their ability to divide properly. Cells that have lost their ability to regulate their growth are cancer cells. Consequently, secondary cancer usually surfaces months–or even years–after treatment. The most common types of cancers resulting from chemotherapy treatments are lymphomas and leukemias, according to the American Cancer Society. Chemotherapy boosts cancer growth and long-term mortality rates. According to Nature, chemotherapy is a major cause of, rather than a cure for, cancer because it promotes the growth and spread of cancer cells by damaging the healthy tissue that surrounds tumors while destroying the immune system.
Causes cancer to become more deadly ~ Another major side effect of chemotherapy is that cancer cells grow more virulent than they were before the treatment. These “super” cancer cells no longer respond even to the most aggressive forms of chemotherapy, which means the cancer itself is becoming more deadly. “These results delineate a mechanism by which genotoxic therapies given in a cyclical manner can enhance subsequent treatment resistance through cell nonautonomous effects that are contributed by the tumor microenvironment.” Research at the Beth Israel Deaconess Medical Center in Boston examined drugs such as Imatanib® (a leukemia drug that goes by the brand name Gleevec®) and Sunitinib ® (a drug for gastrointestinal tumors ”” brand name Sutent), finding that these drugs may initially reduce tumor size but afterwards cause tumors to metastasize aggressively. This means that the tumors come back much stronger and grow much larger than their original size. Chemo causes cancer cells to develop full-on resistance to the popular treatment, morphing them into “super” cancer cells. When study researchers induced anti-angiogenesis in mice, there was an initial 30% decrease in the volume of the tumor over 25 days. Thereafter, however, the tumors that had metastasized to the lungs tripled! Researchers published the findings in the January 17, 2014 issue of Cancer Cell. Study authors were shocked by the findings. “Whatever manipulations we’re doing to tumors can inadvertently do something to increase the tumor numbers to become more metastatic, which is what kills patients at the end of the day,” said study author Dr. Raghu Kalluri.
Causes cancer to resist subsequent therapy ~ In cancer treatment, tumors often respond well initially. However, rates of tumor cell reproduction have been shown to accelerate between treatments, followed by rapid regrowth and then resistance to further chemotherapy. “Our results indicate that damage responses in benign cells… may directly contribute to enhanced tumor growth kinetics.” The researchers said they confirmed their findings with breast and ovarian cancer tumors. While damaging healthy cells, chemotherapy triggers them to secrete a protein (WNT16B) that sustains tumor growth and resistance to further treatment. “The researchers found that chemotherapy can cause fibroblasts (cell DNA) to increase production of a molecule called WNT16B by 30-fold in tissues surrounding a tumor,” explains the group Cancer Research U.K. “This then helps cancer cells to grow, invade neighboring cells and resist chemotherapy.” Researchers in the United States made the “completely unexpected” finding while seeking to explain why cancer cells are so resilient inside the human body when they are easy to kill in the lab. WNT16B boosts cancer cell survival. Chemotherapy turns healthy cells into WNT16B factories which churn out this “activator” chemical that accelerates cancer tumor growth. “The increase in WNT16B was completely unexpected,” reported study co-author Peter Nelson of the Fred Hutchinson Cancer Research Center in Seattle. “WNT16B, when secreted, would interact with nearby tumor cells and cause them to grow, invade, and importantly, resist subsequent therapy.” Chemotherapy, a recognized poison, damages the DNA of healthy, non-cancerous cells, causing them to produce molecules that in turn produce more cancer cells.
Causes the destruction of good cells ~ You don’t need a degree to figure this one out. Poison kills indiscriminately- always has and always will. Chemotherapy kills far more normal cells than cancer cells, while damaging and intoxicating many of the normal cells that do survive. Healthy brain cells continue to die off long after treatment has ended and may be one of the underlying biological causes of the cognitive side effects (“chemo brain”) that many cancer patients experience. Chemotherapy poisons the body as a whole in an attempt to kill the cancer cells before the “treatment” brings the body to an unrecoverable state. As Gary Null and James Feast write, “(After chemotherapy), the hope is the cancer is going to be totally dead and you are only half dead and recover.”
Causes cardiovascular disease ~ Another study in the American Society of Clinical Oncology determined whether long-term survivors of metastatic testicular cancer have an increased risk of cardiovascular morbidity more than 10 years after chemotherapy. They observed a significantly increased risk for occurrence of cardiac events accompanied by a persisting unfavorable cardiovascular risk profile likely due to chemotherapeutic agents.
Causes additional diseases ~ Chemotherapy can never cure anything because it poisons the body which only causes more disease in the future. More than half of all cancer all patients suffer significant treatment related toxicity. Chemotherapy destroys virtually all cells and systems before getting to the actual cancer. This means your central nervous system, organ systems and your immune system are all compromised even years after the treatment has subsided. Neuro-cognitive abilities decline. Endocrine functions are disrupted causing organ and metabolic toxicities. According to Dr. John Diamond, M.D., “A study of over 10,000 patients shows clearly that chemo’s supposedly strong track record with Hodgkin’s disease (lymphoma) is actually a lie. Patients who underwent chemo were 14 times more likely to develop leukemia and 6 times more likely to develop cancers of the bones, joints, and soft tissues than those patients who did not undergo chemotherapy.” Patients basically will live in a permanent state of disease until their death.
Causes premature death ~ Cyanide, anthrax, arsenic, and zyklon B will kill you; toxic chemotherapy drugs just take a little longer. Most chemotherapy patients either die or are plagued with illness within 10-15 years after treatment. That’s why the 5-year survival rate is used to assess mortality rates. Ask your oncologist why your chances of survival are only 3%. Some 67% of people who die during cancer treatment do so through opportunistic infections arising as a direct result of the immune system failing because of the aggressive and toxic nature of the drugs. Therefore, cancer is not blamed for their death. According to Dr. Charles Mathe, French cancer specialist, “…if I contracted cancer, I would never go to a standard cancer treatment centre. Only cancer victims who live far from such centres have a chance.” Dr. Allen Levin stated: “Most cancer patients in this country die of chemotherapy. Chemotherapy does not eliminate breast, colon, or lung cancers. This fact has been documented for over a decade, yet doctors still use chemotherapy for these tumors.” In his book, The Topic of Cancer: When the Killing Has to Stop, Dick Richards cites a number of autopsy studies which have shown that cancer patients actually died from conventional treatments before the tumor had a chance to kill them. As a result, patients develop life-threatening tumors that oftentimes kill patients more quickly as a result of taking the drug. Dr. Alan C. Nixon, past president of the American Chemical Society writes, “As a chemist trained to interpret data, it is incomprehensible to me that physicians can ignore the clear evidence that chemotherapy does much, much more harm than good.” “Most cancer patients in this country die of chemotherapy,” explains Dr. Allen Levin, M.D., from the University of California, San Francisco, in his book, The Healing of Cancer. “Chemotherapy does not eliminate breast, colon, or lung cancers. This fact has been documented for over a decade, yet doctors still use chemotherapy for these tumors.” Forget about cancer killing you because chemotherapy will do a much better job in the long term. It seems crazy that we suppose our body will get better if we cut off the affected organ, poison the body with chemotherapy and then harm the body even more with radiation. Most cancer patients in this country die of chemotherapy.
Causes dangers for caregivers ~ It is important that anyone who enters the chemotherapy patient’s home, during the Danger Period and until all surfaces in the home are carefully cleaned, understand the dangers to themselves and unborn children. Some cytotoxic chemotherapy drugs remain extremely dangerous AFTER they are infused into the patient. They are excreted as active, dangerous chemicals during the weeks after each infusion. “They can badly injure, even kill, unborn babies and children.” During the Danger Period, the patient’s urine, feces, vomit, sweat and saliva contain huge quantities of these dangerous chemicals! Loved ones will become contaminated by touching bodily waste or touching a contaminated surface. Because the chemicals cross skin, the patient will spread contamination by touch surfaces, kissing family members and eating and drinking from family plates and glasses. Surfaces in bathrooms, sheets and towels will also become contaminated. Keep in mind that this means toilets can be a hazard for children and pets, and it’s important to be careful.
Cleaning every surface and household item that has become contaminated is difficult. Use bleach, a strong window cleaner, 409, alcohol, or liquid carpet cleaner. Caregivers should wear 2 pairs of throw-away gloves if they need to touch any body fluids. They should always wash their hands with warm water and soap afterward – even if they had gloves on. “If chemo has spilled on clothing, remove immediately and take a shower, scrubbing the exposed skin with soap and water. Watch for redness, blistering, or a burning sensation. Contact your nurse to report the spill. She will give you further instructions if necessary.” (from Univ of Iowa’s web site).
Pharmaceutical companies take extensive precautions to protect those involved in the manufacture of chemotherapy agents, sometimes using robots to handle the drugs. Pharmacists must wear gloves and impermeable gowns when handling cytotoxins. Preparation of the drugs is done in special “clean rooms” that are environmentally controlled for heating, ventilation, and air conditioning. Harold DeMonaco, director of innovation and support at Massachusetts General Hospital and the former head of a hazardous drug safety task force, says the hospital has had difficulty completely removing trace amounts of cytotoxins from the environment. He says chemotherapy residue has been found on computer keys and on elevator buttons.
All hospitals struggle – using specially marked laundry bags that are placed in a specially labeled impervious bags. The laundry bags and their contents are then prewashed by laundry personnel wearing latex gloves and gowns. After the first wash, the laundry is then washed for a second time, sending the chemicals into the environment. Because the drugs cannot be effectively removed by septic systems or wastewater treatment plants, they don’t disappear even after they are flushed down the toilet or washed down the drain. The next day, the rest of us may be drinking water thus contaminated. A Rhode Island-based company called Pharma-Cycle says these precautions don’t go far enough, “There is a growing body of scientific evidence showing that toxic chemotherapy drugs are entering public and private water supplies intact, threatening humans and wildlife.” The Environmental Protection Agency says studies indicate pharmaceuticals of all types are present in the nation’s water bodies. “Further research suggests that certain drugs may cause ecological harm.” Cytotoxic drugs in the water supply a “developing time bomb.” Their presence has caused “great alarm” among environmental scientists.
Once inside the caregiver’s body, the cytotoxic drug will attack any fast growing cell, causing cancer or other damage. If the caretaker is pregnant, the baby in the womb can develop birth defects, be still-born or suffer thereafter. At this stage and through childhood, the risk to their health is huge because so many of their cells are rapidly growing. Accidental contamination of health care workers by cyclophosphamide (proven in human studies to cause cancer, birth defects and miscarriages) was extensively studied. In 1985 nurses who worked with the chemotherapy patients were having babies with 4.7-times the number of birth defects as other nurses who did not work with such patients.
The burning and scarring [above] is the result of a spill of chemotherapy. Is it any wonder that people are worried about what might be happening to their insides as chemotherapy is intravenously fed into the body?!
Scientists based at McGill Cancer Centre sent a questionnaire to 118 lung cancer doctors to determine what degree of faith these practicing cancer physicians placed in the therapies they administered to their gullible patients. They were asked which of six current trials they would choose if they themselves had cancer. Of the 79 doctors responding, 64 (81%) would not consent to be in any trial containing Cisplatin ® , one of the common chemotherapy drugs they were testing, (currently achieving worldwide sales of about $110,000,000 a year). 58 of the 79 (73%) found that all the trials in question were unacceptable due to the ineffectiveness of chemotherapy and its unacceptably high degree of toxicity!
Walter Last, writing in The Ecologist, reported recently: ”˜After analyzing cancer survival statistics for several decades, Dr. Hardin Jones, Professor at the University of California, concluded, “…patients are as well, or better off untreated.” Jones’ disturbing assessment has never been refuted’. The vast majority of patients with cancer live longer and better if left without the orthodox treatments. Dr. Hardin Jones, professor of medical physics and physiology at the University of California, Berkeley reported, “My studies have proven conclusively that untreated cancer victims actually live up to four times longer than treated individuals. For a typical type of cancer, people who refused treatment lived for an average of 12-1/2 years. Those who accepted surgery or other kinds of treatment [chemotherapy, radiation, cobalt] lived an average of only three years. . . . I attribute this to the traumatic effect of surgery on the body’s natural defense mechanism. The body has a natural defense against every type of cancer.”
Chemotherapy of advanced epithelial cancer–a critical review.
This article is a short version of a report which presents a comprehensive analysis of clinical trials and publications examining the value of cytotoxic chemotherapy in the treatment of advanced epithelial cancer. As a result of the analysis and the comments received from hundreds of oncologists in reply to a request for information, the following facts can be noted. Apart from lung cancer, in particular small-cell lung cancer, there is no direct evidence that chemotherapy prolongs survival in patients with advanced carcinoma. Except for ovarian cancer, available indirect evidence rather supports the absence of a positive effect. In treatment of lung cancer and ovarian cancer, the therapeutical benefit is at best rather small, and a less aggressive treatment seems to be at least as effective as the usual one. It is possible that certain sub-groups of patients benefit from the treatment, yet so far the available results do not allow a sufficiently precise definition of these groups. Many oncologists take it for granted that response to therapy prolongs survival, an opinion which is based on a fallacy and which is not supported by clinical studies. To date, it is unclear whether the treated patients, as a whole, benefit from chemotherapy as to their quality of life. For most cancer sites, urgently required types of studies such as randomized de-escalations of dose or comparisons of immediate versus deferred chemotherapy are still lacking. With few exceptions, there is no good scientific basis for the application of chemotherapy in symptom-free patients with advanced epithelial malignancy.
Survival in nephroblastoma treated according to the trial and study SIOP-9/GPOH with respect to relapse and morbidity.
Recent Wilms’ tumor (WT) trials and studies have tried to determine the minimal therapy needed for cure. The goal was survival without morbidity.
From January 1989 to March 1994 the German Society of Pediatric Oncology and Hematology registered 440 patients (median age 2.9 years; 231 male, 209 female) with WTs (preoperative chemotherapy 362) for therapy according to the International Society of Pediatric Oncology Trial and Study 9. Therapy for relapse depended on site of relapse and therapy already received. Follow-up included inquiries for morbidity. Prognostic factors for relapse and death were evaluated.
Five-year survival of WTs was 89.5%; 98.2% (385 of 392) of survivors had a follow-up of 5 years (range 0.8-12.6; median 8). In non-anaplastic WTs, young age (<2 years) was of significance (P = 0.026) for a better survival. Non-anaplastic WTs (407 patients) had a 5-year survival of 92.3%, versus 48.5% in anaplastic WTs (33 patients), and a 5-year relapse-free survival of 87.6% versus 42.4%. Survival after relapse was significantly worse for anaplastic than for non-anaplastic WTs (residual 3-year survival 11.8% versus 54.3%; P <0.0001). In preoperatively treated WTs, anaplasia was a strong prognostic factor for death [relative risk (RR) 4.7], followed by poor response to preoperative therapy (RR 3.6), stage IV (RR 3.2) and abdominal stage III (RR 2.2). Low abdominal stages (<III) dominated (280 versus 82). In the 334 unilateral stage I-IV WTs (median age 3.2 years), diffuse anaplasia (21 patients) had a 5-year relapse-free survival of 38.1%, versus 58.4% in blastemal WTs (25 patients); survival was 42.9% in diffuse anaplasia versus 84% in blastemal WTs. None of 46 patients (median age 1.9 years; 91.3% stages I or II) with differentiated WTs (nine epithelial, 37 stromal) relapsed despite their non-response; two died (one therapy related, one due to bilaterization). In the 25 non-anaplastic bilateral WTs, differentiated cases (one epithelial, eight stromal, 33.3% abdominal stage III) were more frequent (P = 0.048) than in unilateral WTs (one stromal, abdominal stage III relapsed). In all, 52.9% of the 5-year survivors had received adriamycin (250-400 mg/m(2)), 25.7% radiation, 6.4% ifosfamide (24-30 g/m(2)) and 6.7% carboplatin plus etoposide. Abnormal parameters according to the National Cancer Institute score were seen in 18.9% during follow-up, but only 6.4% were treated for morbidity at the end of follow-up. Three WTs developed renal failure due to Drash syndrome, but none due to tumor therapy. After adriamycin 1.9% of WTs (9% of those receiving 400 mg/m(2)) required therapy for cardiac toxicity.
Initial therapy should be more individualized, taking the above risk groups (age in non-anaplastic WTs, poor response, anaplasia, etc.) into account, as morbidity even after relapse therapy with ifosfamide, carboplatin and etoposide was not high. Milder therapy in low stages of differentiated and of well responding WTs should be tested.
A randomized multicentre phase II trial comparing adjuvant therapy in patients with interferon alpha-2b and 5-FU alone or in combination with either external radiation treatment and cisplatin (CapRI) or radiation alone regarding event-free survival – CapRI-2.
The 5-year survival of patients with resected pancreatic adenocarcinoma is still unsatisfying. The ESPAC-1 and the CONKO 001 trial proofed that adjuvant chemotherapy improves 5-year survival significantly from approximately 14% to 21%. In parallel, investigators from the Virginia Mason Clinic reported a 5-year survival rate of 55% in a phase II trial evaluating a combination of adjuvant chemotherapy, immunotherapy and external beam radiation (CapRI-scheme). Two other groups confirmed in phase II trials these results to a certain extent. However, these groups reported severe gastrointestinal toxicity (up to 93% grade 3 or 4 toxicity). In a randomized controlled phase III trial, called CapRI, 110 patients were enrolled from 2004 to 2007 in Germany and Italy to check for reproducibility. Interestingly, much less gastrointestinal toxicity was observed. However, dose-reduction due to haematological side effects had to be performed in nearly all patients. First clinical results are expected for the end of 2009.
CapRI-2 is an open, controlled, prospective, randomized, multicentre phase II trial with three parallel arms. A de-escalation of the CapRI-scheme will be tested in two different modifications. Patients in study arm A will be treated as outpatients with the complete CapRI-scheme consisting of cisplatin, Interferon alpha-2b and external beam radiation and three cycles of 5-fluorouracil continuous infusion. In study arm B the first de-escalation will be realised by omitting cisplatin. Next, patients in study arm C will additionally not receive external beam radiation. A total of 135 patients with pathologically confirmed R0 or R1 resected pancreatic adenocarcinoma are planned to be enrolled. Primary endpoint is the comparison of the treatment groups with respect to six-month event-free-survival. An event is defined as grade 3 or grade 4 toxicity, objective tumour recurrence, or death.
The aim of this clinical trial is to evaluate de-escalation of the CapRI-scheme. It is hypothesised that removal of cisplatin and radiotherapy will have no significant effect or only a minor impact on the clinical response but result in substantially lower toxicity.
Current Controlled Trials ISRCTN79802092.