Assessment and Prognostic Value of Inflammatory Biomarkers in Patients With Colon Cancer—Reply

In Reply We thank McGovern et al for their interest in our analysis of inflammatory biomarkers and survival among patients with stage III colon cancer (CALGB/SWOG 80702). In this cohort study, we reported the levels of plasma inflammatory biomarkers, including interleukin 6 (IL-6), soluble tumor necrosis factor α receptor 2 (sTNF-αR2), and high-sensitivity C-reactive protein (CRP). We found that higher inflammation after diagnosis was significantly associated with worse survival among patients with stage III colon cancer.

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Agosto 2023

Assessment and Prognostic Value of Inflammatory Biomarkers in Patients With Colon Cancer

To the Editor We read the cohort study assessing the association of inflammatory biomarkers with survival among patients with stage III colon cancer by Cheng et al with some interest. This post hoc analysis of 1494 patients who underwent potentially curative surgical resection and adjuvant chemotherapy for TNM stage III colon cancer showed an association between inflammatory status, recurrence, and mortality. In the context of a multicenter, double-blind, phase 3, adjuvant chemotherapy trial of anti-inflammatory agents, inflammatory status was measured using interleukin 6 (IL-6), tumor necrosis factor (TNF) α receptor 2 (sTNF-αR2), and high-sensitivity C-reactive protein (CRP) levels. The values of the objective biomarkers reported in this large, well-designed cohort study allow comparison with previous studies.

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Agosto 2023

Evaluating the efficacy and safety of neoadjuvant pembrolizumab in patients with stage I-III MMR-deficient colon cancer: a national, multicentre, prospective, single-arm, phase II study protocol

Introduction
Within the last two decades, major advances have been made in the surgical approach for patients with colorectal cancer. However, to this day we face considerable challenges in reducing surgery-related complications and improving long-term oncological outcomes. Unprecedented response rates have been achieved in studies investigating immunotherapy in patients with mismatch repair deficient (dMMR) colorectal cancer. This has raised the question of whether neoadjuvant immunotherapy may change the standard of care for localised dMMR colon cancer and pave the way for organ-sparing treatment.

Methods and analysis
This is an investigator-initiated, multicentre, prospective, single-arm, phase II study in patients with stage I–III dMMR colon cancer scheduled for intended curative surgery. Eighty-five patients will be treated with one dose of pembrolizumab (4 mg/kg) and within 5 weeks will undergo a re-evaluation with an endoscopy and a CT scan—to assess tumour response—before standard resection of the tumour. The primary endpoint is the number of patients with pathological complete response, and secondary endpoints include safety (number and severity of adverse events) and postoperative surgical complications. In addition, we aspire to identify predictive biomarkers that can point out patients that achieve pathological complete response.

Ethics and dissemination
The Regional Committee for Health Research and Ethics and the Danish Medicines Agency have approved this study. The study will be performed according to the Helsinki II declaration. Written informed consent will be obtained from all participants. The results of the study will be submitted to peer-reviewed journals for publication and presented at international congresses.

Trial registration number
NCT05662527.

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Giugno 2023