Here are brief answers to the questions most frequently asked by referring physicians and their patients. Readers may also find helpful the sections For Referring Physicians and on the Immunepheresis Program.
- How does the therapy work?
Immunepheresis works by physically removing from the bloodstream the inhibitors that are produced by cancer cells that block the immune system. Once they are physically removed – using a specialized extracorporeal system similar to a dialysis machine – the immune system can “see” and destroy the cancer cells. Adjunct methods are used to strengthen and support the immune system throughout the therapy.
- Does it work for every cancer?
One of the most remarkable features of Immunepheresis is that it appears to work in a broad spectrum of cancer types. This is probably because all cancers use the same mechanism to protect themselves from the immune system. It has been proven highly effective for patients with intact immune systems. Most but not all patients show a positive response. (See the full discussion under the Immunepheresis Program.)
- What’s the success rate?
On average, the success rate of Immunepheresis is significantly higher than for chemotherapy or, for patients with metastatic disease, radiation. In oncology a conventional measure of therapeutic success is a 50% or greater reduction in tumor mass after treatment. Overall about 60% of Immunepheresis patients show such a response after the treatment. The major predictors of response appear to be cancer stage and health of the patient’s immune system. For patients with significant prior therapy, the success rate is less. For patients with no prior chemotherapy, the success rate is higher. While these results are better than one would expect from chemotherapy or radiation in similar cases, we emphasize to patients that “success” in this definition means significant tumor reduction, not necessarily cure. Clinical remission has been achieved in many cases but only after multiple rounds of treatment and cannot as yet be predicted.
- What are the side effects?
Side effects are minor compared to those from chemotherapy or radiation. Most patients experience tumor ache, fever, and flu-like symptoms such as headache and myalgia; these symptoms are transient. Patients usually feel well enough to talk, read, and walk around during breaks. However, the induced tumor inflammation of the immune reaction is tiring and most patients simply sleep during sessions. More serious side effects include swelling and pain around tumor sites due to cancer inflammation and cell death, and increased hypercoaguable state associated with tumor breakdown that can cause blood clotting problems. Catheter-related infections and thrombosis are a risk but are rare. Patients must be constantly monitored and side effects managed by trained nursing staff and doctors.
- What does it cost?
The cost is comparable to standard chemotherapy (many forms of chemotherapy are more expensive). Some insurance companies have begun to recognize the value of immunologic therapy and reimburse for it. The Foundation is working to have Immunepheresis recognized as an insurance-reimbursable option for every cancer patient. Unfortunately at this time almost all patients must fund their own treatment.
- Follow-up care after Immunepheresis
The attending physicians personalize both a program to support the immune system and overall health post-therapy, and design a program to monitor the status of the cancer, in consultation with the medical team at home. At the end of the initial round of treatment, patients generally return to their treating physician for an assessment of their response. If the expected positive response is found, additional treatment may be planned to achieve maximum improvement, along with adjunct therapies to strengthen the immune system.
- Can Immunepheresis be repeated or used as adjunctive therapy?
One of the most appealing attributes of Immunepheresis is that unlike chemotherapy, it is not dose-limited; patients who show a positive response but suffer recurrent growths later almost always respond positively to additional therapy. The immune therapy can thus be used as maintenance. Patients who do not show a positive initial response have the same options they had before Immunepheresis. Since Immunotherapy does not appear to cause injury to normal tissue, alternative chemotherapy can be considered.
- What are the risks and potential complications?
Immunepheresis is non-toxic and therefore relatively free of complications. There are two possible complications however that require post-therapy treatment.
- Secondary infection of necrotic tumor, i.e. the therapy has killed so many cancer cells they present an opportunity for infection after treatment.
- Thrombosis at the site of the central venous catheter.
These are relatively rare events, readily diagnosed and managed, and respond well to treatment.
- Special considerations for the medical team at home
The referring physician must be aware that the mechanism of action of immune therapy presents novel considerations for post-therapy evaluation and cancer follow up, especially scans. The cytokine-mediated inflammation elicited by Immunepheresis produces transient inflammation and edema of the tumor. This is followed by hemorrhagic and coagulative tumor necrosis and finally a variable amount of fibrosis. In most cases consulting radiologists have simply never seen such positive reactions and may even confuse the images generated by temporary swelling with those of cancer progression. The expected response to any affective pro-inflammatory tumor therapy is: short-term tumor inflammation and swelling followed by variable haemorrhagic and coagulative necrosis, loss of blood supply, tumor shrinkage, and fibrosis. Radiographically, this produces first increased tumor size attended by decreasing density on non-contrasted CAT scan and increased SUV on PET. Later, decreased density in Hounsfield Units and decreased contrast enhancement with increased SUV. This is followed by tumor shrinkage with failure of the mass to contrast enhance, but the lesion remains PET positive. Finally, the lesion assumes the density of scar tissue, reveals no contrast enhancement and becomes PET negative. In bone lesions, lytic lesions will progress to sclerosis by CAT scan and plain X-ray. Such lesions will reveal PET scans that remain positive for many months possibly relating to increased metabolism of healing tissue and bone remodeling. Close coordination and ongoing discussion with the entire health care team is essential.
- What tests are required before and after treatment?
Complete H&P, before-and-after scans (preferably PET/CT with contrast), and tumor markers are required to guide treatment and assess response. The clinic staff is happy to provide a list of blood tests required pre-treatment.
- Why isn't Immunepheresis more widely available?
Dr. Lentz has been focused on the scientific development and clinical application of this therapy for over 25 years, developing over 60 patents but giving little time to its commercialization. Efforts are currently underway to make the therapy more widely available but regulatory hurdles make this a time-consuming process. For the time being the therapy is available only at the Lentz clinic in Germany.
- Is it difficult for patients to come to Germany for treatment?
The staff, all of whom speak fluent English, will be happy to help answer questions. Most visitors from overseas fly in and out of Munich; the clinic is easily reached by car or train in about an hour’s time. The staff will guide them through details regarding lodging, food, transportation and other necessities of daily life in a foreign country (all care is on an out-patient basis). There is a wide range of lodging options, from hotels to pensions with kitchens. The area around the clinic is famous throughout Europe as a resort, in summer and winter, with sailing, hiking, biking, and skiing. There are many tourist sites nearby, and Munich and Salzburg are a short drive away. Most of the local population is bilingual (English being the most common second language).