EN Official Journal of the European Union CE 33/30

(2004/C 33 E/028)

WRITTEN QUESTION E-0037/03

by Cristiana Muscardini (UEN) to the Commission

(21 January 2003)

Subject: Efficacy of somatostatin in fighting cancer

The International Congress of Oncology in Orlando (USA) and conferences in Naples and Como in Italy have identified vitamin A, retinoids and somatostatin as effective anti-tumour agents. This was in line with the claims made by Prof. Luigi di Bella, whose methods the Italian Ministry of Health deemed to have no scientific basis in 1997.

1. Is the Commission acquainted with the research findings made public at the recent congresses?

2. Does it knows whether the therapy named after Prof. Di Bella has any connection with the latest results emerging from the above-mentioned international congresses on oncology?

3. Does it considers it appropriate to set up a committee to establish the validity of the Di Bella therapy in treating tumours?

4. In view of the scientific basis now recognised for the use of somatostatin in treating certain kinds of tumour, it does not consider it should fund research to ensure that this method is used increasingly in Europe?

Answer given by Mr Busquin on behalf of the Commission

(28 February 2003)

The Commission is aware of state-of-the-art research undertaken regarding the use of somatostatin, retinoids and vitamin A in the treatment of cancer.

Somatostatin analogues have proved to be useful both in experimental tumour models in vitro and in animal models. In human subjects, clinical efficacy in the treatment of acromegaly and, to a lesser extent, in neuroendocrine tumours has also been established.

Derivatives of vitamin A, the retinoids, are being evaluated at present as potential cancer preventing agents. Recent results demonstrate their contribution in treating specific pre-malignant lesions and reducing the incidence of second primary tumours on patients with prior primary head and neck, cancers. It is not yet known, however, whether retinoids will prevent primary tumours at these sites.

The Commission considers the above results on somatostatin and retinoids not adding any relevant information which could help to give further light on the efficacy of Di Bella multitherapy regime or will justify its re-assessment. This method, based on a multidrug regime, included a variety of other components in addition to these two such as melatonin, bromocriptine, adrenocorticotropic hormone (ACTH), cyclophosphamide and hydroxyurea and was administered to cancer specific sites different than those reported above. Extrapolations on the potential efficacy of Di Bella multitherapy based on the above findings are therefore not possible.

The clinical efficacy and antitumour activity of the Di Bella multitherapy was already evaluated, at the request of the Italian Ministry of Health, through a multi-center phase II clinical trial study performed in 26 hospital cancer divisions and enrolling 386 patients with advanced cancer. The conclusion of this trial was that Di Bella multitherapy did not show sufficient efficacy on patients with advanced cancer to warrant further clinical testing. The full report on this trial was published in the international peer review journal British Medical Journal (1).

Cancer research in the 6th Framework Programme is supported within the Thematic Priority ‘Life Sciences, genomics and biotechnology for health’. Amongst other issues, cancer research will concentrate in supporting clinical research, particularly clinical trials, aimed at validating new and improved interventions as well as supporting translational research aimed at bringing basic knowledge through to applications in clinical practice and public health.

In this context, the programme offers opportunities, amongst other subjects, for relevant research applications regarding somatostatin, vitamin A and retinoids in the treatment of cancer.

(1) No 318, pp. 224-228, 1999.