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Background: It currently remains unclear whether the anatomical pattern of lymph node (LN) spread differs between young (≤ 45 years, Y) and elderly (≥ 80 years, E) patients with stage III colon cancer (CC).Materials and Methods: Two groups of patients (Y and E) with stage III CC who underwent extensive (D3) lymphadenectomy at Japanese centers were retrospectively analyzed. The primary endpoint was the proportion of positive central LN. The planned sample size was at least 210 (Y) based on an expected value of 9.1% and threshold of 5%, and 230 (E) based on an expected value of 2% and threshold of 5%.Results: Two-hundred and ten Y patients and 348 E patients were identified and compared. The total number of LN harvested and the total number of invaded LN were significantly higher in group Y (median of 31.5 (3-151) vs. 21 (3-116), P < 0.001 and median of 3 (1–21) vs. 2 (1–25), P < 0.001, respectively). The proportion of positive central LN was higher in group Y than the prespecified threshold of 5% (9.52% (95% CI: 6.24–14.2%), p = 0.007); however it was similar to the threshold in group E (4.59% (95% CI:2.84–7.31%), p = 0.351). In multivariate models, central LN invasion was identified as a poor prognostic factor in group Y (HR3.66 (95% CI (1.29–8.87)), but not in group E (HR2.02 (0.95–4.27)).Conclusions: Young stage III colon cancer patients have a higher risk of central LN invasion, suggesting a more aggressive disease biology. The presence of central LN invasion is associated with a worse outcome.

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501 Background: Oxaliplatin (l-OHP) is a key drug commonly used in primary and metastatic colorectal cancer treatment. However, l-OHP is associated with non-hematological adverse effects, including peripheral neuropathy (PN). About 90% of patients who received l-OHP experience PN after single dose of l-OHP and PN is likely to be negatively associated with quality of life. There is no established effective prophylactic management for chemotherapy induced PN according to the 2014 American Society of Clinical Oncology (ASCO) guideline. Recently, compression of hands during injection of drugs has been reported to be effective for chemotherapy induced PN. We developed new gloves for compression therapy which are reusable and low cost. We prospectively analyzed the safety of the gloves. Methods: Patients who received l-OHP were eligible for this phase Ⅰ study. Wrist and hand size were measured and appropriate size of gloves were selected. The pressure of hands is estimated as 20-33 hPa. Patients start to wear the gloves on both hands, from 30 min before the injection of l-OHP until 30 min after the injection. Peripheral neuropathy was evaluated at each treatment cycle using common terminology criteria for adverse events (CTCAE) version 4.0. Results: Between October 2017 and August 2018, fourteen patients (median age 66 years [range 39– 79years], 7 male and 7 female) were enrolled and were evaluated. No patients withdrew from this study. No safety concerns were identified for any safety variables assessed during the trial. CTCAE grade 2 or higher sensory PN was observed in four (28.6%) patients. The average time until grade 1 or more neuropathy appeared was 27.8 days and average dose of l-OHP was 225mg. Conclusions: Compression therapy by the new gloves had no safety concerns, demonstrating a profile favorable for further development for prevention of oxaliplatin induced PN. Clinical trial information: 000029671.

and elevated high-sensitivity C-reactive protein (hs-CRP) in the CANTOS study (Ridker et al 2017). Gevokizumab is a high-affinity recombinant mAb that inhibits IL-1b which was previously explored mainly in inflammatory disorders. Preclinical (Carmi Y et al 2013) and clinical (Isambert N et al 2018) studies have demonstrated that dual blockade of IL-1b and vascular endothelial growth factor (VEGF) may decrease angiogenesis and modulate the immune response in the tumor microenvironment resulting in decreased tumor size providing a rationale for combining gevokizumab with established anti-angiogenic agents. Methods: This is a multi-cohort, open-label, multi-center, phase Ib study (NCT03798626) to determine the pharmacodynamically-active dose (PAD) of gevokizumab along with tolerable dose and preliminary efficacy of gevokizumab in combination with the standard of care (SOC) anticancer therapies in patients with 1 st and 2 nd line mCRC, 2 nd line mGEC, and 2 nd /3 rd line mRCC. Key inclusion criteria: !1 measurable lesion, ECOG PS 0-1 and adequate bone marrow and organ functions. Key exclusion criteria: previous treatment with gevokizumab or other IL-1b/IL-6 inhibitors or any of the study drugs, symptomatic brain metastases, significant bleeding risk, uncontrolled cardiovascular disease and prohibited medications per protocol or contraindicated to the SOC regimen. The study will be conducted in part 1 [PAD determination part (1a) and safety run-in (1b) to determine the recommended dose for expansion (RDE)] and part 2 (expansion). In part 1a, patients in cohort A (1 st line mCRC, hs-CRP ! 10mg/L, $30 patients) and cohort B (2 nd line mCRC, hs-CRP ! 10mg/L, $30 patients) will be randomized 1:1:1 to receive gevokizumab 30/60/120 mg IV monotherapy for two weeks. In part 1b, patients from cohorts A and B will continue to receive gevokizumab Q4W at doses administered in part 1a in combination with SOC [bevacizumab þ modified FOLFOX6 (cohort A)/FOLFIRI (cohort B)]. Patients in cohort C (2 nd line mGEC, $6 patients) and cohort D (2 nd /3 rd line mRCC, $6 patients) will start with gevokizumab (PAD)þramucirumabþpaclitaxel, and gevokizumab (PAD)þcabozantinib, respectively. The primary objectives of part 1 include determination of PAD of gevokizumab in mCRC patients as measured by hs-CRP change from baseline (part 1a, cohorts A and B) and establishing the RDE of the regimen (part 1b, all cohorts). In part 2, patients of all cohorts will receive gevokizumab (RDE) along with SOC therapy. Cohorts A and B will include $ 40 patients (20 patients each with hs-CRP ! 10mg/L and hs-CRP < 10mg/L). Cohorts C and D will include $20 patients each with hs-CRP ! 10mg/L. The primary objective of Part 2 is to determine the preliminary efficacy of the gevokizumab combination as measured by PFS rate. Major secondary objectives include ORR, duration of response, OS, safety, the pharmacokinetics of gevokizumab and other agents in the combination regimens, and immunogenicity. P À 285 The role of active nutritional intervention in patients receiving c...