Survival and prognostic tests in a real-world phase II experience with a safe, moderate-dose, sequential chemotherapy (CT) algorithm (ALGO) for metastatic pancreatic adenocarcinoma (PANC).

Abstract

e16763 Background: Gemcitabine (G), 5-fluorouracil (F), leucovorin (L), irinotecan (I), and oxaliplatin (O), (GFLIO) is safe, employs moderate 1/2-1/3 dosages, offers expanded eligibility (0-2 ECOG PS; no age limit)). Each step reverse resistance (RR) to CT; drug synergism 4-6 simultaneous pairs) improve responses (Rs) and survival (S) (Bruckner ASCO 05, 08, 11, AntiCancer Res 2016; 36 (1), 2018; 38 (1) (ACR), and the immune system (Correale P: J. Immunother 2014; 37). M Caraglia: Front Oncol. 2019). Methods: Eligibility: intent to treat active metastatic PANC, no prior CT: any age: PS 0-2 and expected > 6 weeks S. IRB required safety < 1/10 severe events. ALGO in mg/m2: G 500, F 12-1500 over 24 hrs, L 180, I 80, day2 O (GFLIO) q2 wks, and on progression added in sequence, day 2, docetaxel 20-25 and good counts only mitomycin C 3-6 then bevacizumab 10mg/kg with prior monitoring and modifications (ACR). Median 12, 18, 24 mos Overall Survival (OS), Kaplan Meier estimates with 95% CI were evaluated with age, sex and normal nl and abnl baseline bloods: neutrophils N ANC; Lymphs Ly ALC; platelets; albumin (ALB); Alkaline phosphatase (Alk Ph) abn N alb 3.5 N/L; 2.1 L/monocyte ratios and the A.L.A.N (AS) composite prognostic score (M. Salati E.J.Ca. 2019; 117: 84-90). Results: OS @ 6, 12, 18 & 24 mos, for 53 pts, was 75; 57; 36; 26 % (+/- 8-10%). Median M S was 14.5 mo (CI 9-17mos); S @ all ages ≥ 60, 65 or 70, was not inferior. Women's M S 17 mo. was > men's 10.5: 95/65; 75/46; 48/29; 42/29%. AS for abnl tests was: 0 (18pts): 93: 81: 48; 34% & MS 17 mo vs 1-2 (23)90: 58;42;32% & MS 15.5mo vs 3-4 (12)MS 3 mo. Pts with best 17-14.5 mo MS had nl AS 0 > Alb > AS 1-2 > APh > ANC. Pts with worst 3-6 mo MS had abnl: AS 3-4 < Alb < ANC. No pt had severe infection, neuropathy or gastroenteritis. Pts -/+ 75-100gm ascorbic acid, 25, did not have inferior S in ALAN subsets (H.Bruckner AACR 17). Conclusions: The sequential moderate dose CT ALGO improves eligbility and provides pts with metastatic PANC of any age a well tolerated CT regimen with a high therapeutic index and strong, 12, 18, 24 mo, survival. Prognostic tests can identify subgroups ≥ 75% with favorable vs. unfavorable criteria and improve personalized choices and measures to remedy individual risk factors. Clinical trial information: NCT01905150 .