If local IL-2 therapy is effective, why is it not a regular therapy for cancer?
Before a new standard therapy is approved it needs to be proven in several research stages, known as a preclinical phase and clinical phase I to III. First, its effectivity is shown preclinical studies, most often performed in laboratory animals. The next step is to show clinical safety and applicabity. These steps have been shown for local IL-2 therapy. For some tumours, we have shown effectivity in clinical phase II studies. Currently we are planning a phase III study for definitive prove of local IL-2 therapy in comination with radiotherapy for treatment of nasopharyngeal carcinoma
How long does it take before an experimental therapy, like local IL-2 therapy becomes the new standard therapy for treatment of cancer?
Preclinical data for local IL-2 accumulated since the 1989. In 1992, we planned a phase I/II clinical trial for nasopharyngeal carcinoma stage III-IV. After having received permission, the patients were treated in 1995-1997. The five-year disease-free survival was analyzed in 2002-2003. Censored five-year disease-free survival was 8% in patients treated with radiotherapy alone, but 63% for patients cotreated with local IL-2 (Jacobs et al., paper accepted in 2004). Based on these results we grant for a phase III study in 2003. We received money for IL-2 in 2004 and are currently planning a phase III study. The patients in this phase III study are planned to be treated in the period 2005-2007. Thus the five-year survival can be analyzed starting 2012 and published around 2014. These data make it clear that we would rather not wait for the prove in nasopharyngeal carcinoma prior proceeding with other kinds of tumours. This is why we are seeking money and medical doctors for cooperation.
What are the side effects of local IL-2 therapy?
Because IL-2 is injected locally at the tumour, site effects will also be limited to the treated tumour (which may become red and swollen). No systemic side effects after local IL-2 therapy have been noticed.
Is local IL-2 therapy effective against metastases?
Effective local IL-2 therapy causes both the rejection of the treated tumour and systemic tumour immunity. This immunity causes the rejection of metastases in e.g. the liver and lungs.
Can I have local IL-2 therapy in stead of conventional treatment
No, if a conventional treatment has a curative potential, replacing it with local IL-2 therapy would be unethical. We do not wish to withhold patient from a putative curative therapy.
Should, however, no curative (e.g. only palliative) conventional therapy exist, local IL-2 therapy is an option. Local IL-2 therapy can also be effective after conventional therapy (see also next 2 questions).
Can local IL-2 therapy be effective if conventional theapies (radiotherapy, chemotherapy, surgery( failed?
Yes. Local IL-2 therapy acts through a different mechanism than convetional therapies (see also next question).
Is local IL-2 therapy effective in end-stage tumours?
Conventional treatments often fail in end-stage tumours because tumour infiltrated in other tissues and metastases are not eliminated. Effective local IL-2 therapy causes systemic immunity which eliminates metastases and tumour infiltrates. Clinical studies show that local IL-2 therapy is at least as effective in end-stage tumours as in earlier stages.
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