Do you think that clinical trials for antiangiogenic drugs should follow different rules?

No. The current guidelines for clinical trials are based on determining safety and efficacy and are working well. However, we must not forget the differences between anti-angiogenic therapy and conventional chemotherapy. Some definitions, for example, do not have the same value. One example is the term "stable disease." For conventional chemotherapy it usually means "failure," because it may not last long and may be accompanied by many side effects and a poor quality of life. In contrast, for anti-angiogenic therapy, patients with stable disease have virtually no symptoms and there is less of a risk of drug resistance if they are treated for a long time. Some patients refer to this situation as "having cancer without disease." In this case, the term "stable disease" has a completely different meaning.

Are you involved in the clinical trials of endostatin and angiostatin?

Trials are being carried on at centers in Boston; Houston, Tex.; Madison, Wis.; and Amsterdam and Utrecht in the Netherlands under the supervision of experienced oncologists. I have not participated directly. However, our laboratory has helped to develop some of the blood tests that are being evaluated in these trials and I help oncologists to design the trials.

What are your expectations for the future of these drugs?

My vision is that without any major side effect or resistance these drugs could be used in combination with other drugs or radiation therapy virtually lifelong. For the long term, over the next five to 10 years, we can ask whether the risk of drug resistance and the harsh side effects of treating cancer can be reduced, and whether cancer can ever be converted to a chronic manageable disease like diabetes or heart disease.

Sergio Pistoi is a freelance science reporter based in Arezzo, Italy. He can be found at www.greedybrain.com

Chiara Palmerini is a staff science writer for the Italian weekly magazine Panorama.

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