The present study reports cases of advanced cancer patient taking an extract of Nerium oleander now in Phase 1 clinical trials in cancer patients. A phytochemical constituent of the extract, oleandrin, has multiple anticancer activities including inhibition of NF-kappaB and induction of apoptosis. We present case reports of 9 metastatic cancer patients who received the extract on personal use exemptions. Five of the patients also received full integrative programs at an integrative medicine center. Cases included 4 colon cancer patients, 3 pancreatic cancer patients (1 neuroendocrine and 2 adenocarcinoma), 1 renal cell carcinoma and 1 lung cancer patient. For the patients at the integrative center, all of whom took the extract during periods when they were receiving chemotherapy, toxicity grading of chemotherapy side effects was performed. We analyzed the case records for potential effects of the extract on tumor regression/stability in the absence of chemotherapy, survival time, use concurrent with chemotherapy and toxicity. The renal cell patient experienced tumor regression for 12 months with the extract alone; the 3 pancreatic cancer patients and a colon cancer patient experienced disease stabilization. Survival times were extended for all patients with survival times ranging from 32 months to 11 years for these patients with metastatic disease. Chemotherapy was well tolerated by colon cancer patients with only grade 1-2 toxicity during as many as 70 cycles of chemotherapy. Mild toxicities thought to be related to the extract included lightheadedness and mild tingling and burning of the mouth with use of the sublingual preparation. Severe toxicities including one myocardial infarction and one deep-vein thrombosis were observed but not suspected to be related to the extract. Good clinical outcomes and low toxicity were thus observed for the extract in these patients.

Citation Format: Keith I. Block, Charlotte Gyllenhaal, Robert A. Newman. Use of a defined oleander extract by advanced cancer patients: Case reports on toxicity and tumor-related outcomes. [abstract]. In: Proceedings of the 105th Annual Meeting of the American Association for Cancer Research; 2014 Apr 5-9; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2014;74(19 Suppl):Abstract nr 4658. doi:10.1158/1538-7445.AM2014-4658