FAQ – Frequently Asked Questions
In this FAQ, you will find frequently asked questions and answers about the Cologne Immuno-Oncology Center in Germany and immuno-oncology treatment.
General FAQ
Immunotherapy is all the rage. So why is it that many people—and even some doctors—are still unfamiliar with this form of treatment?
Even for experts, it is difficult to keep track of all the latest developments. On top of that, conventional medicine is deeply rooted in tradition. New therapeutic approaches usually take decades to gain recognition and become widely available.
This is especially true when a fundamentally new idea is put into practice. With conventional treatments, doctors use chemotherapy, surgery, or radiation to try to “defeat the cancer.” With immunotherapy, on the other hand, the goal is to enable patients to fight the disease themselves with the help of their own immune systems.
Immuno-oncology is a very young field of science that is constantly yielding new insights. As a result, doctors must continually update their expertise. While this places high demands on them, it also offers the opportunity to tailor treatment more and more effectively to the individual circumstances of each patient and their tumor.
The successes of immuno-oncology treatments complement and transform existing therapeutic approaches. To achieve broader success in the future, such personalized therapies must be widely implemented in clinical practice. However, this first requires the creation of appropriate structures and conditions. This, in turn, requires a sufficient timeframe.
What are the advantages of immunotherapy over traditional oncological treatments?
It is well known that surgery, chemotherapy, and radiation therapy generally damage healthy cells as well. This can sometimes lead to serious side effects. IOZK immunotherapy, on the other hand, acts in a targeted manner, meaning it targets only malignant cells. As a result, it is virtually free of side effects.
Chemotherapy and radiation therapy damage cells that divide rapidly, but they are ineffective against “dormant” tumor stem cells. A direct therapeutic effect can therefore only be expected for the duration of treatment: just as hair grows back after chemotherapy ends, tumor cells can also regrow. In contrast, IOZK immunotherapy can lead to the development of an “immune memory” that provides longer-lasting protection, similar to what is seen with vaccinations. It is also potentially effective against cancer stem cells.
Does immunotherapy work for all types of cancer? Are there certain types of cancer that respond particularly well to it?
In principle, immunotherapy can be used to treat all malignant tumors because the immune system can reach tumor cells in all tissues and organs. However, its effectiveness has not been studied to the same extent for all types of cancer. To date, immunotherapy has primarily been evaluated in types of cancer for which no highly effective conventional treatment is available. These include, for example, malignant melanoma and glioblastoma.
Is immunotherapy also available at universities or in clinical trials?
Various types of immunotherapy are currently undergoing clinical trials around the world. To assess their effectiveness, these trials typically compare the disease progression in two groups of patients: one group that receives only conventional treatment, and another group that also receives immunotherapy. This means that participants in a (double-blind) study cannot be certain that they are actually receiving immunotherapy.
There aren't suitable studies for every disease, and there are various exclusion criteria for participation.
You can search for suitable studies on the website clinicaltrials.gov
What is an individual treatment attempt?
An individual therapeutic trial is part of a physician’s freedom to choose a course of treatment. It is a procedure performed primarily for the benefit of a patient for whom other treatment options have already been exhausted, or which is initiated early on the patient’s own initiative. Unlike clinical trials, the primary goal is not to gain scientific insights into the effectiveness of a therapy, but rather to provide an individual patient with the best possible treatment.
One specific form of this is the series of therapeutic trials, in which several individual therapeutic trials are conducted concurrently or sequentially. There is no legal limit on the number of individual therapeutic trials. (For further reading, see Huber, Fabian: “Individual Therapeutic Trials and Clinical Experiments,” inaugural dissertation, Faculty of Law, University of Augsburg, 2014.)
FAQ on IOZK Immunotherapy
There are already widely approved immuno-oncology therapies. What makes IOZK immunotherapy different?
Various antibodies are approved in Europe, particularly so-called checkpoint inhibitors. These bind to specific receptors and support an existing immune response against the body’s own tumor cells, although this response is present in only a portion of patients. Accordingly, this form of therapy is effective in up to 20% of patients. In lung cancer, for example, this represents ahigher success rate than that of conventional chemotherapy drugs. For this reason, checkpoint inhibitors are considered the treatment of choice for this indication when the relevant receptors are present.
Unfortunately, checkpoint inhibitors are ineffective in 80% of patients, presumably due to the lack of an immune response against the tumor cells. IOZK immunotherapy aims to trigger such an immune response. There is strong evidence that it can thereby enhance the efficacy of checkpoint inhibitors. This therapeutic approach is being discussed worldwide and tested in clinical trials.
When is the best time to start IOZK immunotherapy?
IOZK immunotherapy can be administered at any stage of a cancer diagnosis. Recent findings indicate that immunotherapy administered in the early stages of the disease yields the best long-term outcomes.
It is best to contact the IOZK before a scheduled surgery, as it is beneficial for DC vaccination if the patient’s own tumor tissue can be used to produce the antigen.
There is evidence that immunotherapy is more effective when the tumor mass is smaller—that is, in the early stages or after surgery. However, an increasing number of successful outcomes are also being reported in patients with advanced disease.
IOZK immunotherapy can generally be combined with any conventional treatment. However, immunosuppressive therapies (e.g., corticosteroids, radiation therapy, or chemotherapy) can temporarily impair the function of the immune system, so it is important to coordinate the various treatments carefully.
If the tumor cells mount a defense against an immune attack, adjuvant PD-1 antibody therapy—which was approved in the summer of 2015—may be helpful.
How much does therapy cost? Is it covered by health insurance?
The cost of treatment depends on the specific resources required to produce the vaccine, the scope of treatment, and the course of the disease. The medical team discusses which treatment options are appropriate for a patient during a tumor board meeting. The treatment options and their associated costs are discussed with the patient.
The high costs are due to the enormous amount of personnel and technical resources required: an individual medication is produced for each individual patient in strict compliance with the legal requirements of the German Medicines Act (AMG).
Since therapy is tailored to each individual patient, costs can vary considerably. Based on our experience, we can provide the following fees as a guide:
- between €3,500 and €5,000 for the laboratory tests required prior to treatment.
- between €23,000 and €28,000 for an IO-VAC® vaccination cycle (At least two vaccination cycles are required for treatment.)
- between €6,000 and €11,000 for a five-day treatment course to induce immunogenic cell death (e.g., as an adjunctive treatment during chemotherapy or as maintenance therapy following completion of the IO-VAC® vaccination cycles).
These amounts do not include any additional costs for individual medications (infusions). The patient agrees to cover the treatment costs, regardless of any reimbursement from insurance companies.
The costs of diagnosis and treatment may be reimbursed by private health insurance companies (depending on the contract taken out), assistance agencies, and professional associations. Immunotherapy is not included in the list of services covered by statutory health insurance. However, under certain circumstances, the costs may be covered on a case-by-case basis upon application.
What does the typical course of treatment look like? How much time does it take?
Cancer and the immune system are subject to dynamic processes that must be taken into account during treatment. For this reason, IOZK immunotherapy is tailored individually to each patient.
Treatment with IOZK immunotherapy must be coordinated with other therapies, such as radiation or chemotherapy, as needed. Unlike chemotherapy or radiation, which follow a fixed schedule, the duration and type of IOZK immunotherapy are tailored to the patient’s individual needs.
The following schedule can serve as a general guide.It includes two vaccination cycles and lasts about five weeks.
Does the treatment have side effects? And if so, what are they?
In our experience and according to scientific studies, the immunological methods used here are well tolerated and can maintain or improve quality of life (often in contrast to conventional therapies). No serious side effects have been observed at our center over the years we have been using these methods, nor have any been described in the scientific literature.
A common side effect is the development of flu-like symptoms the day after the first dose of the Newcastle disease virus. However, this is harmless and easily treatable.
How many patients have been treated so far? What have the results been?
In recent years, the IOZK has treated more than 2,000 patients with a wide variety of tumor types. In each case, treatment was tailored to the patient’s individual needs.
The high degree of personalization makes it difficult to compare treatment outcomes and patient data. Consequently, statistical data on the efficacy of IOZK immunotherapy cannot be derived, as no comparative clinical trials are conducted at the IOZK. However, intensive research on immunotherapy is underway worldwide.
The more sophisticated diagnostic methods become, the clearer it becomes that tumors vary greatly in their biological behavior and their response to specific therapies. Depending on the genetic profile, there are significant individual differences even within the same type of cancer: breast cancer is therefore not simply breast cancer. Traditional efficacy studies rely on comparing large groups of patients who each receive different treatments. Consequently, conducting such studies is becoming increasingly difficult, and the validity of the statistical results is becoming increasingly difficult to apply to individual cases.
IO-VAC® Vaccine: What does "medicinal product for advanced therapy" mean?
IO-VAC® belongs to the class of “advanced therapy medicinal products” (ATMPs). This is an umbrella term for three classes of medicinal products: somatic cell therapies, gene therapies, and biotechnologically processed tissue preparations.
IO-VAC® is a somatic cell therapy consisting of biotechnologically processed tissue (tumor cell components) combined with an oncolytic virus. The drug consists of the patient’s own living dendritic cells and viral oncolysate. The cells used are obtained from the patient’s blood samples, processed in the laboratory (modified in their function), and then re-administered to the patient.
For more information, visit: The IO-VAC® vaccine
IMMUN-ONKOLOGISCHES ZENTRUM KÖLN
Hohenstaufenring 30–32
50674 Köln | Deutschland
T: +49 (0)221 – 420 399 25
E-Mail: info@iozk.de
Hohenstaufenring 30–32
50674 Köln | Deutschland
T: +49 (0)221 – 420 399 25
E-Mail: info@iozk.de