Cipolla B.,CH Prive Saint Gregoire |
Cipolla B.,Faculte Of Medecine Center Hospitalier University |
Cipolla B.,S.A. rue de la Terre Victoria |
Bansard J.-Y.,Faculte Of Medecine Center Hospitalier University |
And 3 more authors.
BioMedicine (Netherlands) | Year: 2013
Background: Polyamine (PA) dietary deprivation may be of clinical interest in castration-resistant prostate cancer (CRPC). Purpose: We assessed tolerance and side effects of PA-free oral nutritional supplement (ONS) combined with partial intermittent intestinal decontamination (PIID) in a Phase I trial. Methods: Ten volunteers of mean age 68 ± 12 years and with symptomatic, metastatic CRPC were enrolled. PA-free ONS was given as the only food source three times daily during the first 2 weeks; twice daily with one PA-reduced meal for 3 weeks; and then once daily with two PA-reduced meals for 7 weeks. Oral neomycin was administered at 0.75 g/day as PIID every other week. Toxicity, performance, and pain status were rated on World Health Organization and European Organisation for Research and Treatment of Cancer scales. Prostate-specific antigen, blood counts, ionograms, and hepatic transaminases were regularly assessed. Bone and computed tomography scans were performed at weeks 0, 5 and 12. Results: One patient disliked the taste and stopped on Day 4. Nine patients experienced transient Grade I diarrhea. Performance status and pain score were significantly improved in five patients and maintained in three patients. No significant differences in body weight, hemoglobin, serum proteins, and ionograms were noted. Four patients had 20-40% prostate-specific antigen baseline decline during the first 5 weeks of the trial. Five patients had bone and computed tomography scan stabilization. Conclusion: This PA-free ONS was safe and well tolerated with PIDD. It seemed to benefit quality of life and control pain. The effects were dose dependent, with maximum improvement observed during the first 5 weeks when PA depletion was maximal. © 2013 China Medical University.
Cipolla B.G.,CH Prive Saint Gregoire |
Miglianico L.,CH Prive Saint Gregoire |
Bligny D.,CH Prive Saint Gregoire |
Artignan X.,CH Prive Saint Gregoire |
Moulinoux J.P.,University of Rennes 1
BioMedicine (Netherlands) | Year: 2013
Introduction: Polyamines are essential for cancer cell growth. Both reducing exogenous polyamines and blocking polyamine synthesis reduce tumor growth and potentiate chemotherapy in tumor models. Purpose: We assessed the tolerance of a polyamine-free oral nutritional supplement alone and in combination with docetaxel in symptomatic castration-resistant prostate cancer patients. Methods: A total of 30 patients (mean age: 71±7 years) were enrolled in a prospective trial. For the first 14 days, the patients were given polyamine-free supplement only as the sole diet, the quantity of which was then progressively reduced and supplemented with low polyamine-containing foods. Combined docetaxel chemotherapy began on Day 21, which included six 75-mg/m2 prednisone injections every 3 weeks. Clinical and biological tolerance, quality of life (QOL), performance status (PS), pain, and objective prostate-specific antigen (PSA) response were assessed. Results: Toxicity was minimal in the polyamine-free supplement-alone phase. In addition, QOL (p=0.03) and pain (p=0.03) scores were improved. When the polyamine-free supplement was combined with docetaxel, Grade 1 or 2 nausea, vomiting, or diarrhea was reported in <35% of patients with no onycholysis or neuropathy. In addition, biological parameters were preserved. Nutritional parameters, PS, pain score, and anorexia were significantly improved. Sixty-three percent of patients reduced their analgesic consumption by at least 30%. Seventy percent of patients who completed the trial had an objective PSA response. Conclusion: Observance of the polyamine-free supplement was good and it was well tolerated when given alone with significant improvements in QOL and pain scores. The tolerance of the combination of docetaxel and polyamine-free supplement is also very good with improved PS, pain score, and analgesic consumption. © 2013.