Author Correction: Chemoprevention of Colorectal Cancer in High-Risk Patients: from Molecular Targets to Clinical Trials

Personalized treatment vs. standard of care is much debated, especially in clinical practice. Here we investigated whether overall survival differences in metastatic colorectal cancer patients are explained by tumor mutation profiles or by treatment differences in real clinical practice. Our retrospective study of metastatic colorectal cancer patients of confirmed European ancestry comprised 54 Americans and 54 gender-matched Germans. The Americans received standard of care, and on treatment failure, 35 patients received individualized treatments. The German patients received standard of care only. Tumor mutations, tumor mutation burden and microsatellite status were identified by using the FoundationOne assay or the IDT Pan-Cancer assay. High-risk patients were identified according to the mutational classification by Schell and colleagues. Results: Kaplan–Meier estimates show the high-risk patients to survive 16 months longer under individualized treatments than those under only standard of care, in the median (p < 0.001). Tumor mutation profiles stratify patients by risk groups but not by country. Conclusions: High-risk patients appear to survive significantly longer (p < 0.001) if they receive individualized treatments after the exhaustion of standard of care treatments. Secondly, the tumor mutation landscape in Americans and Germans is congruent and thus warrants the transatlantic exchange of successful treatment protocols and the harmonization of guidelines.

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The Use of an Algorithm for Prophylactic Mesh Use in High Risk Patients Reduces the Incidence of Incisional Hernia Following Laparotomy for Colorectal Cancer Resection

Cirugía Española (English Edition) ◽

10.1016/j.cireng.2017.03.016 ◽

2017 ◽

Vol 95 (4) ◽

pp. 222-228 ◽

Cited By ~ 2

Author(s):

Núria Argudo ◽

M. Pilar Iskra ◽

Miguel Pera ◽

Juan J. Sancho ◽

Luis Grande ◽

...

Keyword(s):

Colorectal Cancer ◽

High Risk ◽

Incisional Hernia ◽

Prophylactic Mesh ◽

Cancer Resection ◽

High Risk Patients ◽

Colorectal Cancer Resection ◽

Risk Patients

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G-CSF PROPHYLAXIS IN HIGH RISK PATIENTS WITH COLORECTAL CANCER

Shock ◽

10.1097/00024382-200206001-00107 ◽

2002 ◽

Vol 17 (Supplement) ◽

pp. 36

Author(s):

A. Torossian ◽

A. Bauhofer ◽

M. Middeke ◽

U. Plaul ◽

H. Wulf ◽

...

Keyword(s):

Colorectal Cancer ◽

High Risk ◽

High Risk Patients ◽

Risk Patients

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The impact of high-risk patients on the results of clinical trials

Journal of Clinical Epidemiology ◽

10.1016/s0895-4356(97)00149-2 ◽

1997 ◽

Vol 50 (10) ◽

pp. 1089-1098 ◽

Cited By ~ 65

Author(s):

John P.A. Ioannidis ◽

Joseph Lau

Keyword(s):

Clinical Trials ◽

High Risk ◽

High Risk Patients ◽

Risk Patients ◽

The Impact

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Prognostic value of preoperative circulating tumor cells counts in patients with UICC stage I-IV colorectal cancer

PLoS ONE ◽

10.1371/journal.pone.0252897 ◽

2021 ◽

Vol 16 (6) ◽

pp. e0252897

Author(s):

Thaer S. A. Abdalla ◽

Jan Meiners ◽

Sabine Riethdorf ◽

Alexandra König ◽

Nathaniel Melling ◽

...

Keyword(s):

Colorectal Cancer ◽

Overall Survival ◽

High Risk ◽

Tumor Cells ◽

Circulating Tumor Cells ◽

Stage I ◽

Clinicopathological Parameters ◽

Curative Intent ◽

High Risk Patients ◽

Risk Patients

Colorectal cancer (CRC) is one of the leading causes of cancer death worldwide. There is an urgent need to identify prognostic markers for patients undergoing curative resection of CRC. The detection of circulating tumor cells in peripheral blood is a promising approach to identify high-risk patients with disseminated disease in colorectal cancer. This study aims to evaluate the prognostic relevance of preoperative CTCs using the Cellsearch® system (CS) in patients, who underwent resection with curative intent of different stages (UICC I-IV) of colorectal cancer. Out of 91 Patients who underwent colorectal resection, 68 patients were included in this study. CTC analysis was performed in patients with CRC UICC stages I-IV immediately before surgery. Data were correlated with clinicopathological parameters and patient outcomes. One or more CTCs/7.5 mL were detected in 45.6% (31/68) of patients. CTCs were detected in all stages of the Union of International Cancer Control (UICC), in stage I (1/4, 25%), in stage II (4/12, 33.3%), in stage III (5/19, 26.3%) and in stage IV (21/33, 63.6%). The detection of ≥ 1 CTCs/ 7.5ml correlated to the presence of distant overt metastases (p = 0.014) as well as with shorter progression-free (p = 0.008) and overall survival (p = 0.008). Multivariate analyses showed that the detection of ≥ 1 CTCs/ 7.5ml is an independent prognostic indicator for overall survival (HR, 3.14; 95% CI, 1.18–8.32; p = 0.021). The detection of CTCs is an independent and strong prognostic factor in CRC, which might improve the identification of high-risk patients in future clinical trials.

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HIGH-QUALITY COLON CLEANSING IMPROVES REAL-WORLD IDENTIFICATION OF HIGH-RISK PATIENTS: POST HOC ANALYSIS OF RANDOMISED CLINICAL TRIALS USING TWO VALIDATED CLEANSING SCALES

10.1055/s-0039-1681618 ◽

2019 ◽

Author(s):

J Manning ◽

B Amlani ◽

C Hassan ◽

T Ponchon

Keyword(s):

Clinical Trials ◽

High Risk ◽

Real World ◽

Randomised Clinical Trials ◽

High Quality ◽

Post Hoc Analysis ◽

High Risk Patients ◽

Colon Cleansing ◽

Risk Patients ◽

Post Hoc

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Enrollment of high-risk patients with diffuse large B-cell lymphoma in clinical trials.

Journal of Clinical Oncology ◽

10.1200/jco.2017.35.15_suppl.6536 ◽

2017 ◽

Vol 35 (15_suppl) ◽

pp. 6536-6536

Author(s):

Kah Poh Loh ◽

Andrea Baran ◽

John Hu ◽

Carla Casulo ◽

Paul M. Barr ◽

...

Keyword(s):

Clinical Trials ◽

High Risk ◽

Precision Medicine ◽

B Cell Lymphoma ◽

Patient Choice ◽

Rapid Progression ◽

Eligibility Criteria ◽

Histologic Diagnosis ◽

High Risk Patients ◽

Risk Patients

6536 Background: Contemporary precision medicine trials in DLBCL often require real-time central pathology review for enrollment. Central review may lead to treatment delays and prevent high risk patients (pts) with aggressive presentations from enrolling onto clinical trials. We explored reasons pts with DLBCL were not enrolled on trials and the implication of non-enrollment on trial design and interpretation. Methods: We retrospectively analyzed all pts with histologic diagnosis of DLBCL or HGBL from 4/14 to 6/16 at the University of Rochester. Therapeutic trials open during this time included 3 sponsored and 2 NCTN studies. The Kaplan-Meier method was used to estimate the distribution of progression-free survival (PFS; time from start of treatment until progression/death or until the last date the patient was known to be progression free) and overall survival (OS). Results: 140 pts were identified; 22% enrolled on a trial. Reasons for non-enrollment included: 1) Protocol ineligibility (n=58); (2) Physician choice (n=24) and; 3) Patient choice (n=20). Reasons were unclear in 8 pts. Of the 24 pts who were not enrolled due to physician choice, 21 required urgent treatment secondary to symptoms or rapid progression. Compared to pts treated on trial, pts with rapid progression had higher risk clinical features (table). There was a trend towards a lower 1-year PFS rate in pts who required urgent treatment compared to those on trial (72.1% vs. 56.1%; p=0.08). There was no statistical difference in OS. Conclusions: At our institution, for patients with DLBCL meeting trial eligibility criteria, 42% required urgent chemotherapy and failed to enroll. Exclusion of these high risk patients in precision medicine trials has important implications in the interpretation and generalizability of clinical trials in DLBCL. In this curable malignancy, excluding high risk patients from trials limits the event rate, and associated power to demonstrate impact of novel therapies. [Table: see text]

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