Interestingly, 6-month OS differed markedly between AHCC02 patients of good status who were on placebo (22%) and similar SAP trial patients who were on placebo (37%).
The SAP trial did not report the proportion that had received loco-regional therapies, but the inclusion of such patients in randomised trials of systemic therapy would be expected to result in a better OS when compared with trials that only recruit patients with advance disease at presentation.
Treatment effects were significantly larger in SDD trials than in SAP trials.
Patients recruited to the SHARP and SAP trials were all ECOG 0-2 and the vast majority were Child-Pugh A (581 out of 602 (96.5%) and 220 out of 226 (97.3%), respectively).
As protein C deficiency has been demonstrated in experimental early SAP, this trial might have been more relevant had it measured protein C as a biomarker.
Before the trial, SAP admitted that its 2005 acquisition TomorrowNow pirated Oracle's intellectual property and used it in order to pilfer customers from Oracle.
One year after the SHARP results, similar benefits for sorafenib were announced from a parallel trial (SAP) (Cheng et al, 2009) in an all-Asian population of 226 patients (HR=0.68, 95% CI=0.50 0.93, P<0.014).
AP: acute pancreatitis; APACHE: Acute Physiology and Chronic Health Evaluation APCC: activated protein C; CT: computed tomography; DIM: difference in means; DST: disialotransferrine; ICU: intensive care unit; LOS: length of stay; MOD: multiple organ dysfunction; RCT: randomized controlled trial; SAP: severe acute pancreatitis; SOFA: Sequential Organ Failure Assessment.
AT1, angiotensin II receptor antagonist subtype 1; CXCL, CXC ligand; ECM, extracellular matrix; FVC, forced vital capacity; IL, interleukin; IPF, idiopathic pulmonary fibrosis; RCT, randomized controlled trial; SAP, serum amyloid P component; TGF-β, transforming growth factor beta; TNF, tumor necrosis factor.
IN THE UNITED STATES On Tuesday, Lawrence J. Ellison, the chief of Oracle, is to testify in a software theft trial against SAP.
