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8. Evaluation of circulating VEGF based biomarkers in INTEGRATE: A randomized phase II double-blind placebo-controlled study of regorafenib in refractory advanced oesophagogastric cancer (AOGC) study by the Australasian Gastrointestinal Trials Group (AGITG).

Author

Zalcberg J.R., Strickland A., Lee J., Cho J.Y., Lipton L.R., Simes J., Pavlakis N., Goldstein D., Yip S., Harvie R., Martin A.J., Sjoquist K.M., Tsobanis E., Kang Y.-K., Bang Y.-J., Alcindor T., O'Callaghan C.J., Burnell M.J., Tebbutt N.C., Young Rha S., Zalcberg J.R., Strickland A., Lee J., Cho J.Y., Lipton L.R., Simes J., Pavlakis N., Goldstein D., Yip S., Harvie R., Martin A.J., Sjoquist K.M., Tsobanis E., Kang Y.-K., Bang Y.-J., Alcindor T., O'Callaghan C.J., Burnell M.J., Tebbutt N.C., and Young Rha S.

Abstract

Background: The INTEGRATE study evaluated activity of regorafinib (REG) v placebo (PBO) in 147 eligible patients with refractory AOGC. REG was highly effective in prolonging progression free survival (PFS). Differences between regions (i.e. Australia New Zealand/Canada (ANZ/CAN) vs Korea) were found in the magnitude of effect, but REG was effective across all regions and subgroups. We report on an exploratory analysis of VEGF biomarkers to identify predictive/prognostic markers. Method(s): Protein biomarkers IL8, VEGF-A,-B,-C-D, soluble(s)VEGFR-1,-2-3 were analysed in plasma at baseline (BL) by multiplex immunoassays (Bio-Plex,BioRad) or ELISA (Abnova). Spearman statistics were used to quantify correlations between markers. Wilcoxon Rank-Sum tests were used to compare markers across regions. The prognostic and predictive value of markers was determined using cox proportional hazards analysis of PFS. Result(s): There were moderate-to-strong correlations between BL levels of IL8 and VEGF-C (rho: = 0.68), IL8 and VEGF-D (rho: = 0.66), VEGF-A and VEGF-C (rho = 0.68), VEGF-A and sVEGFR-1 (rho = 0.54); and a modest negative correlation between VEGF-D and sVEGRF-1(rho = -0.33). The regions differed according to BL levels of: VEGF-A (higher in ANZ/CAN; p = 0.0015), VEGF-B (higher in Korea; p = 0.0003), VEGF-D (higher in Korea; p <.0001), and sVEGFR-1 (higher in ANZ/CAN; p <.0001). Adjusting for treatment group, there were statistically significant negative associations between PFS and BL IL8 (p = 0.047), VEGF-A (p = 0.037) and sVEGFR-1 (p = 0.045). There was no convincing statistical evidence that any BL plasma biomarker modified the effect of REG. The effect of region on effectiveness of REG was maintained when evaluated in conjunction with BL biomarkers individually and in combination. Conclusion(s): Highplasma IL8, VEGF-A and sVEGFR-1 may be adverse prognostic factors. A predictive VEGF blood based biomarker remains elusive. A broader biomarker study including markers be

Published
2016

37. Serum galactosyltransferase isoenzyme patterns of cancer patients with liver involvement

Author

Harvie R, Cahill J, Davey R, and John A. Levi

Subjects
Cancer Research, medicine.medical_specialty, Carcinoma, Hepatocellular, Disease, Biology, Localised disease, Isozyme, Metastasis, chemistry.chemical_compound, Internal medicine, Neoplasms, medicine, Carcinoma, Humans, Galactosyltransferase, Liver Neoplasms, Cancer, medicine.disease, Galactosyltransferases, Sialic acid, Isoenzymes, Endocrinology, Oncology, chemistry, Immunology, Isoelectric Focusing, Research Article
Abstract

The level of galactosyltransferase activity was measured in the serum of 220 patients with a variety of solid tumours. There was a significantly greater proportion of patients with elevated galactosyltransferase in the group with metastatic disease (43%) than for the group with localised disease (16%). Galactosyltransferase was elevated in 69% of patients with liver metastasis compared to 32% of patients with metastatic disease at sites other than liver and this difference was also significant. High resolution agarose isoelectric-focusing was used to determine the 'isoenzyme' pattern of serum galactosyltransferase of 6 patients with liver metastasis and 2 patients with primary hepatoma and these were compared to those of 6 patients with similar primary tumours without liver involvement. There were no qualitative differences in the patterns from the two groups. The average peak height for each of the 19 peaks of activity identified was generally higher in the group with liver involvement, except for those peaks known to contain little or no attached sialic acid. Liver involvement appears not to contribute in any specific way to the altered pattern of serum galactosyltransferase often seen in patients with solid tumours. The tumour rather than the liver is therefore the most likely source of these alterations.

Published
1986

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