scholarly journals Statistical Considerations for Trials in Adjuvant Treatment of Colorectal Cancer

Cancers ◽  
2020 ◽  
Vol 12 (11) ◽  
pp. 3442
Author(s):  
Everardo Delforge Saad ◽  
Marc Buyse
Keyword(s):  
Colorectal Cancer ◽  
Adjuvant Therapy ◽  
Predictive Biomarkers ◽  
Phase 3 ◽  
Design Data ◽  
Study Implementation ◽  
Systemic Adjuvant Therapy ◽  
Therapeutic Development ◽  
Rectal Cancers ◽  
Near Future

The design of the best possible clinical trials of adjuvant interventions in colorectal cancer will entail the use of both time-tested and novel methods that allow efficient, reliable and patient-relevant therapeutic development. The ultimate goal of this endeavor is to safely and expeditiously bring to clinical practice novel interventions that impact patient lives. In this paper, we discuss statistical aspects and provide suggestions to optimize trial design, data collection, study implementation, and the use of predictive biomarkers and endpoints in phase 3 trials of systemic adjuvant therapy. We also discuss the issues of collaboration and patient centricity, expecting that several novel agents with activity in the (neo)adjuvant therapy of colon and rectal cancers will become available in the near future.

Colon cancer: risk factors and screening

2020 ◽  
pp. 13-22
Author(s):  
Mark Natanson
Keyword(s):  
Colorectal Cancer ◽  
Risk Factors ◽  
Cancer Risk ◽  
Clinical Manifestations ◽  
Dysplastic Lesion ◽  
Test Analysis ◽  
Cancer Risk Factors ◽  
Colon Cancer Risk ◽  
Neoplastic Process ◽  
Rectal Cancers

Colon and rectal cancers are usually combined under the same term "colorectal cancer". It should be noted that the lesion of the colon is much more common. Colorectal cancer ranks fourth in the overall structure of oncological pathology in terms of prevalence, and in some countries even comes third after lung and stomach cancer. Risk factors that contribute to the development of colorectal cancer include bowel polyps, ulcerative colitis and Crohn's disease, and a genetic predisposition. Most often, neoplastic transformation occurs at the site of an adenoma or dysplastic lesion of the intestinal mucosa. Due to the high risk of neoplastic process in a sufficiently large number of elderly people, it is recommended that every person over the age of 50 should undergo compulsory screening to detect latent cancer. The simplest, but at the same time insufficiently informative method is a blood culture test - analysis for the presence of blood in the feces. Method of total colonoscopy and double-contrast radiography is distinguished by a higher information content, but at the same time a higher cost. It is recommended to have these examinations every three to five years after the age of 50 years without clinical manifestations, and after the age of 40 for those at risk for colorectal cancer.

scholarly journals Consumption of Lactose, Other FODMAPs and Diarrhoea during Adjuvant 5-Fluorouracil Chemotherapy for Colorectal Cancer

Nutrients ◽  
2020 ◽  
Vol 12 (2) ◽  
pp. 407
Author(s):  
Reetta Holma ◽  
Reijo Laatikainen ◽  
Helena Orell ◽  
Heikki Joensuu ◽  
Katri Peuhkuri ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Adjuvant Therapy ◽  
Gastrointestinal Symptoms ◽  
Mucosal Injury ◽  
Dietary Carbohydrates ◽  
Food Diary ◽  
High Consumption ◽  
Increased Risk ◽  
Symptom Diary ◽  
Low Consumption

Chemotherapy-induced mucosal injury of the small intestine may interfere with the enzymes and transporters responsible for the hydrolysis and absorption of dietary carbohydrates causing diarrhoea, abdominal discomfort and pain. The aim of this study was to investigate the association between the consumption of foods rich in FODMAPs (fermentable oligo-, di- and monosaccharides and polyols) and gastrointestinal symptoms in patients receiving adjuvant therapy for colorectal cancer. The patients (n = 52) filled in a 4-day food diary at baseline and during therapy and kept a symptom diary. The intakes of FODMAP-rich foods were calculated as portions and the intakes were divided into two consumption categories. Patients with high consumption of FODMAP-rich foods had diarrhoea more frequently than those with low consumption (for lactose-rich foods the odds ratio (OR) was 2.63, P = 0.03; and for other FODMAP-rich foods 1.82, P = 0.20). Patients with high consumption of both lactose-rich and other FODMAP-rich foods had an over 4-fold risk of developing diarrhoea as compared to those with low consumption of both (OR, 4.18; P = 0.02). These results were confirmed in multivariate models. Conclusion: Consumption of lactose-rich foods results in an increased risk of diarrhoea during adjuvant therapy for colorectal cancer, especially when the consumption of other FODMAP-rich foods is also high.

scholarly journals Baseline and Kinetic Circulating Tumor Cell Counts Are Prognostic Factors in a Prospective Study of Metastatic Colorectal Cancer

Diagnostics ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. 502
Author(s):  
Virgílio Souza e Silva ◽  
Emne Ali Abdallah ◽  
Angelo Borsarelli Carvalho de Brito ◽  
Alexcia Camila Braun ◽  
Milena Shizue Tariki ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Drug Resistance ◽  
Prospective Study ◽  
Metastatic Colorectal Cancer ◽  
Clinical Outcomes ◽  
Predictive Biomarkers ◽  
Multi Drug Resistance ◽  
Cell Counts ◽  
Potential Clinical Benefit ◽  
A Prospective Study

The discovery of predictive biomarkers in metastatic colorectal cancer (mCRC) is essential to improve clinical outcomes. Recent data suggest a potential role of circulating tumor cells (CTCs) as prognostic indicators. We conducted a follow-on analysis from a prospective study of consecutive patients with mCRC. CTC analysis was conducted at two timepoints: baseline (CTC1; before starting chemotherapy), and two months after starting treatment (CTC2). CTC isolation/quantification were completed by ISET® (Rarecells, France). CTC expressions of drug resistance-associated proteins were evaluated. Progression-free survival (PFS) and overall survival (OS) were estimated by the Kaplan–Meier method. Seventy-five patients were enrolled from May 2012 to May 2014. A CTC1 cut-off of >1.5 CTCs/mL was associated with an inferior median OS compared to lower values. A difference of CTC2−CTC1 > 5.5 CTCs/mL was associated with a reduced median PFS. By multivariate analysis, CTC1 > 1.5 CTCs/mL was an independent prognostic factor for worse OS. Multi-drug resistance protein-1 (MRP-1) expression was associated with poor median OS. CTC baseline counts, kinetics, and MRP-1 expression were predictive of clinical outcomes. Larger studies are warranted to explore the potential clinical benefit of treating mCRC patients with targeted therapeutic regimens guided by CTC findings.

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