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Japanese phase I study of GC33, a humanized antibody against glypican-3 for advanced hepatocellular carcinoma.

Ikeda M, Ohkawa S, Okusaka T, Mitsunaga S, Kobayashi S, Morizane C, Suzuki I, Yamamoto S, Furuse J - Cancer Sci. (2014)

Bottom Line: The most common adverse events were decreased lymphocyte count, decreased natural killer cell count, increased C-reactive protein, and pyrexia.Grade 3 adverse events (increased blood pressure, decreased lymphocyte count, and decreased platelet count) were observed in two or more patients.Furthermore, three patients showed long-term stable disease of more than 5 months.

View Article: PubMed Central - PubMed

Affiliation: Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, Chiba, Japan.

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Immunohistochemistry (IHC) of glypican-3 (GPC3) in hepatocellular carcinoma. (a) Representative GPC3 staining features observed in matched specimens evaluated using two IHC methods. Method 1 was used in a previous first-in-human study; method 2 was a fully automated IHC assay. Scores are indicated under each photograph. Bar = 50 μm (b) Comparison of total GPC3 staining score by method 1 (0–14) and clinical score by method 2 (0–3). Spearman's correlation was 0.76 (P = 0.00255). (c) Comparison of clinical score and membrane H score. (d) Comparison of clinical score and cytoplasm H score. There was a positive association between the H scores and the GPC3 clinical scores, with R2 values of 0.75 and 0.33, respectively.
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fig01: Immunohistochemistry (IHC) of glypican-3 (GPC3) in hepatocellular carcinoma. (a) Representative GPC3 staining features observed in matched specimens evaluated using two IHC methods. Method 1 was used in a previous first-in-human study; method 2 was a fully automated IHC assay. Scores are indicated under each photograph. Bar = 50 μm (b) Comparison of total GPC3 staining score by method 1 (0–14) and clinical score by method 2 (0–3). Spearman's correlation was 0.76 (P = 0.00255). (c) Comparison of clinical score and membrane H score. (d) Comparison of clinical score and cytoplasm H score. There was a positive association between the H scores and the GPC3 clinical scores, with R2 values of 0.75 and 0.33, respectively.

Mentions: All 13 unique core-needle biopsied specimens taken from tumor lesions in the liver were stained by both methods and were evaluated by using their respective scoring criteria. The representative GPC3-IHC features for both staining methods are shown in Figure 1(a) and all cases are shown in Figure S1. Twelve patients had a total GPC3 staining score of 7 or more by method 1, and 12 patients had positive clinical scores by method 2 (Fig. 1b). Both staining methods produced a similar staining pattern in the majority of specimens. The GPC3 staining score of method 1 was highly correlated with the clinical score of method 2 (Spearman's correlation coefficient, 0.76; P = 0.00255). Higher clinical scores appeared to be associated with increased H scores for both the membrane and cytoplasm in this limited number of samples (Fig. 1c,d).


Japanese phase I study of GC33, a humanized antibody against glypican-3 for advanced hepatocellular carcinoma.

Ikeda M, Ohkawa S, Okusaka T, Mitsunaga S, Kobayashi S, Morizane C, Suzuki I, Yamamoto S, Furuse J - Cancer Sci. (2014)

Immunohistochemistry (IHC) of glypican-3 (GPC3) in hepatocellular carcinoma. (a) Representative GPC3 staining features observed in matched specimens evaluated using two IHC methods. Method 1 was used in a previous first-in-human study; method 2 was a fully automated IHC assay. Scores are indicated under each photograph. Bar = 50 μm (b) Comparison of total GPC3 staining score by method 1 (0–14) and clinical score by method 2 (0–3). Spearman's correlation was 0.76 (P = 0.00255). (c) Comparison of clinical score and membrane H score. (d) Comparison of clinical score and cytoplasm H score. There was a positive association between the H scores and the GPC3 clinical scores, with R2 values of 0.75 and 0.33, respectively.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4317809&req=5

fig01: Immunohistochemistry (IHC) of glypican-3 (GPC3) in hepatocellular carcinoma. (a) Representative GPC3 staining features observed in matched specimens evaluated using two IHC methods. Method 1 was used in a previous first-in-human study; method 2 was a fully automated IHC assay. Scores are indicated under each photograph. Bar = 50 μm (b) Comparison of total GPC3 staining score by method 1 (0–14) and clinical score by method 2 (0–3). Spearman's correlation was 0.76 (P = 0.00255). (c) Comparison of clinical score and membrane H score. (d) Comparison of clinical score and cytoplasm H score. There was a positive association between the H scores and the GPC3 clinical scores, with R2 values of 0.75 and 0.33, respectively.
Mentions: All 13 unique core-needle biopsied specimens taken from tumor lesions in the liver were stained by both methods and were evaluated by using their respective scoring criteria. The representative GPC3-IHC features for both staining methods are shown in Figure 1(a) and all cases are shown in Figure S1. Twelve patients had a total GPC3 staining score of 7 or more by method 1, and 12 patients had positive clinical scores by method 2 (Fig. 1b). Both staining methods produced a similar staining pattern in the majority of specimens. The GPC3 staining score of method 1 was highly correlated with the clinical score of method 2 (Spearman's correlation coefficient, 0.76; P = 0.00255). Higher clinical scores appeared to be associated with increased H scores for both the membrane and cytoplasm in this limited number of samples (Fig. 1c,d).

Bottom Line: The most common adverse events were decreased lymphocyte count, decreased natural killer cell count, increased C-reactive protein, and pyrexia.Grade 3 adverse events (increased blood pressure, decreased lymphocyte count, and decreased platelet count) were observed in two or more patients.Furthermore, three patients showed long-term stable disease of more than 5 months.

View Article: PubMed Central - PubMed

Affiliation: Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, Chiba, Japan.

Show MeSH
Related in: MedlinePlus