Marc Azémar¹, Bernd Hildenbrand¹, Brigitte Haering¹, Manfred E. Heim² and Clemens Unger¹

¹Department of Clinical Oncology at the Tumor biology Center at the Albert-Ludwigs-University in Freiburg, Germany. ²Sonnenberg-Klinik, Bad Sooden-Allendorf, Germany.

Abstract

Purpose: We conducted a pilot trial to assess the tolerability, clinical benefit and antitumoral efficacy of modified (hydrolysed) citrus pectin (MCP) in 49 patients with various solid tumors in an advanced state of progression. MCP are hydrolysed from polysaccharide pectin fi bers, derived from citrus fruits and acting as a ligand for Galectin-3. Preclinical investigations revealed an efficient inhibition of tumor development and metastasis in various tumor models.

Patients and Methods: The treatment consisted of the oral intake of 5 g MCP three times a day. One cycle of therapy was defined as 4 weeks of treatment. Objectives were clinical benefi t (pain, functional performance, weight change), safety, tumor response (RESIST criteria) and quality of life (EORTC QLQ30).

Results: 49 patients were enrolled, 29 patients were able to be evaluated for clinical benefit after 2 cycles of treatment. All patients tolerated the therapy well without any severe therapy-related adverse events. After 2 cycles of oral intake of MCP, 6/29 patients (20.7%) had an overall clinical benefit response associated with a stabilization or improvement of life quality.

On an intent to treat basis 11/49 patients (22,5%) showed a stable disease (SD) after 2 cycles and 6/49 patients (12,3%) had a SD for a period longer than 24 weeks. One patient suffering from metastasized prostate carcinoma showed a 50% decrease in serum PSA level after 16 weeks of treatment associated with a significant increase of clinical benefit, quality of life and decrease in pain.

Conclusion: MCP seems to have positive impacts especially regarding clinical benefit and life quality for patients with far advanced solid tumors. The presented preliminary data encourage us to further investigate the role of MCP in cancer prevention and treatment.