Does neoadjuvant FOLFOX chemotherapy improve the prognosis of high‐risk Stage II and III colon cancers? Three years' follow‐up results of the PRODIGE 22 phase II randomized multicentre trial

Abstract

Aim: Neoadjuvant chemotherapy has proven valuable in locally advanced resectable colon cancer (CC) but its effect on oncological outcomes is uncertain. The aim of the present paper was to report 3-year oncological outcomes, representing the secondary endpoints of the PRODIGE 22 trial. Method: PRODIGE 22 was a randomized multicentre phase II trial in high-risk T3, T4 and/ or N2 CC patients on CT scan. Patients were randomized between 6 months of adjuvant FOLFOX (upfront surgery) or perioperative FOLFOX (four cycles before surgery and eight cycles after; FOLFOX perioperative). In wild-type RAS patients, a third arm testing perioperative FOLFOX-cetuximab was added. The primary endpoint was the tumour regression grade. Secondary endpoints were 3-year overall survival (OS), disease-free survival (DFS), recurrence-free survival (RFS) and time to recurrence (TTR).Results: Overall, 120 patients were enrolled. At interim analysis, the FOLFOX-cetuximab arm was stopped for futility. The remaining 104 patients represented our intention-totreat population. In the perioperative group, 96% received the scheduled four neoadjuvant cycles and all but one had adjuvant FOLFOX for eight cycles. In the control arm, 38 (73%) patients received adjuvant FOLFOX. The median follow-up was 54.3 months. treated with neoadjuvant chemotherapy had a 23% lower risk of death

Different prognostic impact of glucose uptake in visceral adipose tissue according to sex in patients with colorectal cancer

“…A recent randomized trial reported no additional benefit for perioperative chemotherapy in patients who were clinically diagnosed as high-risk, such as T3, T4, and/or N2 colon cancer on preoperative CT scan. Nevertheless, identifying a subgroup of patients who could benefit from this strategy is warranted 22 . In this respect, preoperative imaging biomarkers that can stratify high-risk groups are essential, and the clinical usefulness of visceral fat-derived classification needs to be investigated in the future.…”

Neoadjuvant chemotherapy for colon cancer

“…Однако проведение неоадъювантной химиотерапии не привело к увеличению ни ОВ (3-летний показатель составил 90,4 % в обеих группах, отношение рисков (ОР) 0,85), ни ВБП (76,8 % против 69,2 %, ОР 0,94). Отмечено, что наличие микросателлитной нестабильности (microsatellite instability, MSI) в опухолях было связано с неэффективностью предоперационной химиотерапии (р = 0,05), а поражение 4 и более лимфатических узлов, наоборот, определяло увеличение ОВ при реализации неоадъювантного подхода (р = 0,04) [32].…”

Identification of Candidate Antigens and Immune Subtypes in Colon Cancer for mRNA Vaccine Development

“…[ 1 ] Comprehensive treatment of CC has a better prognosis in its early stage; however, there has been no obvious improvement in advanced CC prognosis for patients who do not respond to adjuvant treatment or radical surgery. [ 1–4 ] After curative‐intent surgery or adjuvant chemotherapy, the recurrence rate is still 27% for stage III CC. [ 5 ] Recurrence occurs in 80% of cases during the first 3 years after resection, and patients after radical resection have a poor prognosis even when radical resection is performed again.…”