PANCREA TABS PLUS TRIAL
PANCREA TABS PLUS PLUS

Disease was required to be measurable by RECIST version 1.0 ( 28). PatientsĪ total of 861 adults (≥18 years of age) with a Karnofsky performance status (KPS) score of 70 or higher and histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas were enrolled. All patients provided written informed consent before the initiation of the study. The independent ethics committee at each participating institution approved the study.

The study design and patient characteristics have been described previously ( 17). Additional analyses include the prognostic impacts of baseline CA19-9 levels and NLR on OS and evaluations of treatment effect in patient subgroups defined by these factors. At that time, 90% of patients in the intent-to-treat (ITT) population had died.

PANCREA TABS PLUS TRIAL

This report describes an updated analysis of OS from MPACT with an extended data cutoff (eight months longer) at the time the trial was closed.

The initial publication of the MPACT trial reported an OS analysis in which 80% of patients had died ( 17). Retrospective studies suggest that neutrophil-to-lymphocyte ratio (NLR), a marker of systemic inflammatory response, may provide valuable prognostic information in many malignancies, including pancreatic cancer ( 22–27). Furthermore, an elevated CA19-9 level could lead to a false-positive cancer diagnosis, suggesting that additional markers are needed.

However, not all patients secrete Lewis antigens such as CA19-9, and only 80% to 85% of patients can possibly demonstrate an elevated CA19-9 level ( 19, 21). Carbohydrate antigen 19-9 (CA19-9) is a prognostic marker that has proven useful 18-21).

PANCREA TABS PLUS PLUS

The most common grade 3 or higher adverse events with nab-paclitaxel plus gemcitabine were neutropenia, leukopenia, fatigue, and peripheral neuropathy.Įxamination of prognostic markers at baseline may aid in designing more effective treatment plans for patients with metastatic pancreatic cancer ( 18). 001), and independently reviewed overall response rate (23% vs 7%, response rate ratio = 3.19, 95% CI = 2.18 to 4.66, P <. Treatment with nab-paclitaxel plus gemcitabine demonstrated statistically significant improvements across all endpoints vs gemcitabine alone, including OS (primary endpoint, median = 8.5 vs 6.7 months, HR = 0.72, 95% confidence interval = 0.62 to 0.83, P <. These results led to an international phase III trial (MPACT,, trial number NCT00844649) in which 861 patients with metastatic pancreatic cancer were randomly assigned to receive nab-paclitaxel plus gemcitabine at the recommended doses from the phase I/II study ( nab-paclitaxel 125mg/m 2 plus gemcitabine 1000mg/m 2 on days 1, 8, and 15 of each 28-day cycle) or gemcitabine alone ( 17). A 2011 report revealed encouraging initial findings for patients with metastatic pancreatic adenocarcinoma treated at the maximum tolerated dose of nab-paclitaxel plus gemcitabine in a phase I/II trial: a median OS of 12.2 months, an overall response rate by Response Evaluation Criteria In Solid Tumors (RECIST) of 48%, and a median progression-free survival of 7.9 months ( 16). Nab-Paclitaxel (, Celgene Corporation, Summit, NJ) is an albumin-based formulation of paclitaxel that has demonstrated clinical benefit over solvent-based paclitaxel in patients with metastatic breast cancer ( 14) and non–small cell lung cancer ( 15). 001), although FOLFIRINOX was also associated with a marked potential for toxicity ( 5, 6). 038, 12-month OS rates of 23% vs 17%) and a phase II/III trial that found a statistically significant OS benefit for leucovorin, 5-fluorouracil, irinotecan, and oxaliplatin (FOLFIRINOX, median = 11.1 vs 6.8 months, HR = 0.57, P <. In fact, until recently, only two trials had demonstrated statistically significant improvements in OS over gemcitabine for patients with this disease: a phase III study that showed a modest benefit for patients receiving gemcitabine plus erlotinib (median = 6.24 vs 5.91 months, hazard ratio = 0.82, P =. Experimental treatment arms have failed to statistically significantly improve OS over gemcitabine in numerous phase III trials ( 7–13). Median overall survival (OS) for patients who received gemcitabine monotherapy for advanced pancreatic cancer in key trials has ranged from 5.7 to 6.8 months ( 2, 5, 6). Gemcitabine monotherapy became a standard first-line treatment option for metastatic pancreatic cancer after it demonstrated superior clinical benefit over 5-fluorouracil ( 2–4). Among all cancer types, pancreatic cancer ranks 11th in incidence but fourth in mortality ( 1).

Pancreatic cancer is one of the deadliest tumor types, accounting for approximately 7% of all cancer deaths in the United States ( 1).

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