Broad safety impact of high-dose ascorbic acid and induction chemotherapy for high-risk pancreatic cancer.

Abstract

e15711 Background: High dose ascorbic acid inhibits many tumors in vitro. It may reduce chemotherapy's adverse hematologic events and improve quality of life. Moderate dose gemcitabine, fluorouracil, leucovorin, irinotecan, oxaliplatin (GFLIP) is an effective regimen for patients with many cancers (Anticancer Research 17). High dose ascorbic acid may reverse half the preexisting and largely eliminate the predicted cumulative toxicity of GFLIP (ASCO 15). Methods: High dose ascorbic acid AA 75-100 grams IV was given 1-2 times per week with GFLIP every 2 weeks until progression with serial wkly and Q2wk blood tests and 3 month imaging. Eligibility: Unresectable, III, recurrent and metastatic, mod and high grade typical pancreatic ca; ECOG 0-2; +/- prior chemo; adults of any age with consent. Results: A prescheduled 2 yr analysis found 26 patients; 16 ≥ 65, (9 ≥ 70 years of age). 25 stage IV; Nine had failed at least one prior standard chemo (35%), 3 were PS 2, 9 had severe weight loss. Safety: Five had uncomplicated 3 (19%) and none had 4 neutropenia or neutropenic infection, one (4%) had a 3 anemia and thrombocytopenia without bleeding. Prophylactic growth factors were not used and limited to 1-2 as needed low doses used infrequently. There was no limiting diarrhea, enteritis, stomatitis, weight loss or coagulopathy due to GFLIP. GFLIP is on track to reproduce/retain prior response and survival benefit (ASCO 08). Conclusions: Ascorbic Acid-GFLIP can be exceptionally safe and well tolerated. It may avoid standard 20-40% rates of severe toxicities. It can be, otherwise unavailable, safe reduced cost, treatment for many elderly and prior resistant tumor patients. Given the broad multi-disease role of the GFLIP drugs, and available personalized medicine tests (Cancer Letters), further development is very attractive and feasible. Potential outcome can spare all, and especially high risk pancreatic ca patients, 20k severe toxicities every year toxicities as much as $100 million cost and make some ineligibility criteria unnecessary. Development of safe AA regimens may benefit quality of life and improve survival for many with a broad spectrum of cancers that otherwise go untreated. Clinical trial information: NCT01905150.