D-Limonene is well tolerated in cancer patients at doses which may have clinical activity. The favorable toxicity profile supports further clinical evaluation.
105AD7 is a human monoclonal antibody that mimics the complement regulatory protein, CD55, overexpressed by many solid tumours including osteosarcoma. This study was designed to assess the toxicity and efficacy of this vaccine in a young age group of patients within 1 -6 months of myleosuppressive chemotherapy. Out of 28, 20 (71%, 95% CI 51 -87%) patients showed a significant T-cell proliferation response in vitro to the 105AD7 protein but not to human IgG. Furthermore, 13 out of 22 (59%, 95% CI 36 -79%) patients showed antigen-specific gIFN secretion (range 20 -370 U/ml). Nine out of 28 (32%, 95% CI 16 -52%) patients made weak antibody responses to CD55. This study showed that 105AD7 was well tolerated in younger patients with osteosarcoma. In addition, two patients with possible clinical responses were given compassionate permission to continue immunisation quarterly for 2 years. They both remain alive and disease free 5.8 and 6.5 years from original diagnosis of osteosarcoma and showed no adverse effects of repeated immunisation. In conclusion, the majority of patients showed measurable T helper responses when vaccination was commenced within a 6-month window of intensive chemotherapy with no clinically significant toxicity. Future clinical trials incorporating immune stimulation strategies should include early introduction of vaccines during the highest risk period for relapse.
The study results did not show a significant association during 8 years among CAD endpoints and periodontal status at baseline. The progression of periodontitis was low in both groups, although the higher proportion of individuals with severe periodontitis among patients with CAD compared with controls remained unchanged over the 8-year follow-up. Further long-term prospective studies are needed to show whether periodontitis can be considered a risk or prognostic factor for CAD, in terms of endpoints including myocardial infarction, new revascularization procedure, and CAD-related death.
We conclude that amsalog can be safely given on a 5-day schedule every 3 weeks at doses up to 200 mg/m2. The dose recommended for further studies is 180 mg/m2 per day for 5 days repeated every 3 weeks. However, in view of the phlebitis, which necessitated the use of central venous catheters for administration, other routes of administration, for example oral formulations, should be explored.
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