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Screening tests for specific immunoglobulin E (sIgE) to food allergens, such as the multiple allergen simultaneous test (MAST), are widely used in patients with suspected food allergies in South Korea. We evaluated whether MAST could effectively screen wheat-dependent exercise-induced anaphylaxis (WDEIA) and α-gal syndrome (AGS). We retrospectively reviewed patients with WDEIA and AGS diagnosed with unequivocal history and positive sIgE results for omega-5 gliadin and α-gal using ImmunoCAP, respectively. The clinical manifestations and results of MAST and ImmunoCAP (sIgE to wheat for WDEIA and beef/pork for AGS) were reviewed. In the MAST and ImmunoCAP results, class 0 (<0.35 units in each test) was considered negative. Medical records of 45 patients with WDEIA and 39 patients with AGS were reviewed. For WDEIA, 37 (82.2%) of patients had a history of anaphylaxis. Among those positive for omega-5 gliadin sIgE, 39 (87.7%) and 25 (55.6%) tested positive for gluten- and wheat-sIgE using ImmunoCAP, respectively. MAST performed on 15 patients yielded positive results for wheat-sIgE in 5 (33.3%). For AGS, 23 (59.0%) of patients had a history of anaphylaxis. Among those positive for α-gal sIgE, 32 (85.7%) and 37 (96.4%) tested positive for pork- and beef-sIgE using ImmunoCAP, respectively, whereas MAST could not detect sIgE for pork and beef (0%, 0/17). MAST for sIgE to food allergens cannot screen WDEIA and AGS. The tests for sIgE to a specific component of food allergen, such as omega-5 gliadin for WDEIA and α-gal for AGS, should be used to screen WDEIA and AGS.
GV1001 is a human telomerase peptide vaccine that induces a CD4/CD8 T-cell response against cancer cells, thereby affording an immunological anti-tumor effect. Here, we evaluated the efficacy and safety of GV1001 in combination with chemotherapy in patients with metastatic colorectal cancer who had failed first-line chemotherapy. This multicenter, non-randomized, single-arm phase II study recruited recurrent or metastatic colorectal cancer patients with measurable disease who had failed first-line chemotherapy. Patients received GV1001 and chemotherapy concomitantly based on a pre-established schedule. Cytotoxic chemotherapy and targeted agents (bevacizumab, cetuximab, or aflibercept) were allowed to be used at the discretion of the investigator. The primary endpoint was the disease control rate; secondary endpoints were the objective response rate, progression-free survival, overall survival, and safety outcomes. The baseline serum eotaxin level (a potential predictive biomarker of GV1001) was analyzed. To determine whether an adequate immune response had been induced, a delayed-type hypersensitivity test and a T-cell proliferation test were performed. From May 13, 2015 to October 13, 2020, 56 patients with recurrent or metastatic colorectal cancer treated in seven hospitals of South Korea were enrolled. The median patient age was 64 years (range, 29-82 years); 67.9% were men. Of all patients, 66.1% had left-side colorectal cancer and the RAS mutation was present in 25%. The disease control rate and the objective response rates were 90.9% (95% confidence interval [CI]: 82.4-99.4%) and 34.1% (95% CI, 20.1-48.1%), respectively. The median progression-free survival was 7.1 months (95% CI, 5.2-9.1 months) and the median overall survival was 12.8 months (95% CI, 9.9-15.8 months). The most common all-grade adverse events were neutropenia (48.2%), nausea (26.8%), neuropathy (25.0%), stomatitis (21.4%), and diarrhea (21.4%). Immune response analysis showed that no patient had positive delayed-type hypersensitivity test results; antigen-specific T-cell proliferation was observed in only 28% of patients. The baseline eotaxin level was not associated with any efficacy outcome. Although no clear GV1001-specific immune response was observed, the addition of GV1001 vaccination to chemotherapy was tolerable and associated with modest efficacy outcomes.