Adjuvant Hyperthermic Intraperitoneal Chemotherapy in Patients With Locally Advanced Colon Cancer (COLOPEC): 5-Year Results of a Randomized Multicenter Trial.

Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported.Whether adjuvant hyperthermic intraperitoneal chemotherapy (HIPEC) might prevent peritoneal metastases after curative surgery for high-risk colon cancer is an ongoing debate. This study aimed to determine 5-year oncologic outcomes of the randomized multicenter COLOPEC trial, which included patients with clinical or pathologic T4N0-2M0 or perforated colon cancer and randomly assigned (1:1) to either adjuvant systemic chemotherapy and HIPEC (n = 100) or adjuvant systemic chemotherapy alone (n = 102). HIPEC was performed using a one-time administration of oxaliplatin (460 mg/m2, 30 minutes, 42°C, concurrent fluorouracil/leucovorin intravenously), either simultaneously (9%) or within 5-8 weeks (91%) after primary tumor resection. Outcomes were analyzed according to the intention-to-treat principle. Long-term data were available of all 202 patients included in the COLOPEC trial, with a median follow-up of 59 months (IQR, 54.5-64.5). No significant difference was found in 5-year overall survival rate between patients assigned to adjuvant HIPEC followed by systemic chemotherapy or only adjuvant systemic chemotherapy (69.6% v 70.9%, log-rank; P = .692). Five-year peritoneal metastases rates were 63.9% and 63.2% (P = .907) and 5-year disease-free survival was 55.7% and 52.3% (log-rank; P = .875), respectively. No differences in quality-of-life outcomes were found. Our findings implicate that adjuvant HIPEC should still be performed in trial setting only.

Iron therapy for the treatment of preoperative anaemia in patients with colorectal carcinoma: a systematic review.

AIM: Preoperative anaemia is associated with increased morbidity and mortality. The aim of this systematic review is to evaluate the efficacy of preoperative iron supplementation in the treatment of anaemia, and its effect on the postoperative recovery of patients undergoing surgery for colorectal carcinoma. METHOD: This systematic review was performed using MEDLINE, EMBASE and the Cochrane library to assess current evidence on the role of iron supplementation in the treatment of preoperative anaemia. Our main outcomes were absolute increase in haemoglobin, blood transfusion rate and postoperative morbidity. Main inclusion criteria were: preoperative iron supplementation, presence of colorectal carcinoma and elective surgery. The Downs-Black questionnaire was used for quality assessment of the included studies. RESULTS: Of the 605 studies analysed, seven, three randomized controlled trials and four cohort studies, were included. Despite iron supplementation, the three randomized controlled trials showed a decrease in haemoglobin level. This was contrary to the four cohort studies which all showed a significant increase. All studies showed a decreased blood transfusion rate following iron supplementation. None of the included studies assessed postoperative morbidity. Due to heterogeneity in study design, duration of treatment, dosages and variation in iron substrates, we were unable to perform a meta-analysis. CONCLUSION: In anaemic patients who require surgery for colorectal carcinoma, current evidence is of inadequate quality to draw a definitive conclusion on the efficacy of the various measures to treat preoperative anaemia.